Patent Docs

Time 2020-12-10 18:03:56

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"Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability. By Kevin E. Noonan --Earlier this year, and almost one year to the day (January 17, 2019) that the Opposition Division (OD) of the European Patent Office revoked in its entirety European Patent No. EP 2771468, the Technical Board of Appeal affirmed the revocation (after suggesting it would refer some of the Broad s questions and challenges to the OD s decision to the Enlarged Board of Appeal). A little more than ten months later, the written decision of the Board was published by the European Patent Office, offering cold comfort but at least some detailed explanation for the Proprietors The Broad Institute, MIT, and Harvard College.To recap, this patent was opposed by Novozymes A/S, CRISPR Therapeutics GG, and several strawmen. Representative claims revoked by the OD and affirmed by the Board are as follows:1. A non-naturally occurring or engineered composition comprising: a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system chimeric RNA (chiRNA) polynucleotide sequence, wherein the polynucleotide sequence comprises (a) a guide sequence of between 10 - 30 nucleotides in length, capable of hybridizing to a target sequence in a eukaryotic cell, (b) a tracr mate sequence, and (c) a tracrRNA sequence wherein (a), (b) and (c) are arranged in a 5 to 3 orientation, wherein when transcribed, the tracr mate sequence hybridizes to the tracrRNA sequence and the guide sequence directs sequence-specific binding of a CRISPR complex to the target sequence, wherein the CRISPR complex comprises a Type II Cas9 protein complexed with (1) the guide sequence that is hybridized to the target sequence, and (2) the tracr mate sequence that is hybridized to the tracrRNA sequence, wherein the tracrRNA sequence is 50 or more nucleotides in length.2. A Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector system comprising one or more vectors comprising I. a first regulatory element operably linked to a nucleotide sequence encoding a CRISPR-Cas system chimeric RNA (chiRNA) polynucleotide sequence as defined in claim 1, and II. a second regulatory element operably linked to a nucleotide sequence encoding a Type II Cas9 protein comprising one or more nuclear localization sequences, of sufficient strength to drive accumulation of said Cas9 protein in a detectable amount in the nucleus of a eukaryotic cell;wherein components I and II are located on the same or different vectors of the system.12. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon for genome engineering, provided that said use is not a method for treatment of the human or animal body by surgery or therapy, and provided that said use is not a process for modifying the germline genetic identity of human beings.17. Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon, in the production of a non-human transgenic animal or transgenic plant.The OD had issued its formal opinion on March 26th, which was consistent with a preliminary opinion prior to summoning Proprietor Broad Institute and the opponents to oral hearing. While this opinion found defects in certain substantive matters (such as claims 1, 2, 14, and 15 not satisfying Article 123(2) EPC), the majority of the claims were found to lack novelty (claims 1-6 and 9-17) or inventive step (claims 7 and 8) as a consequence of the OD s decision that EP 2771468 was not entitled to its priority claim.The priority issue was raised based on the earliest two provisional applications (U.S. Provisional Application Nos. 61/736,527 and 61/748,427), as well as U.S. Provisional Application Nos. 61/791,409 and 61/835,931, which named Luciano Marraffini as an inventor, and which were owned by Rockefeller University. The priority documents and their named inventors are as follows:• U.S. 61/736,527 (P1) named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors• U.S. 61/748,427 (P2) named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors• U.S. 61/758,468 named Zhang, Cong, Hsu, and Ran as inventors• U.S. 61/769,046 named Zhang, Cong, Hsu, and Ran as inventors• U.S. 61/791,409 (P5) named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini, Bikard and Jian as inventors• U.S. 61/802,174 named Zhang, Cong, Hsu, Ran, and Platt as inventors• U.S. 61/806,375 named Zhang, Cong, Hsu, Ran, and Platt as inventors• U.S. 61/814,263 named Zhang, Cong, Hsu, Ran, and Platt as inventors• U.S. 61/819,803 named Zhang, Cong, Hsu, Ran, and Platt as inventors• U.S. 61/828,130 named Zhang, Cong, Hsu, Ran, and Platt as inventors• U.S. 61/835,931 (P11) named Zhang, Cong, Hsu, Ran, Cox, Lin, Maraffini, Platt, Santjana, Bikard and Jian as inventors• U.S. 61/836,127 named Zhang, Cong, Hsu, and Ran as inventorsIn Europe, under Article 87 EPC and Paragraph IV of the Paris Convention, priority to an earlier-filed application can be validly claimed by the prior applicant or by her successor in interest. In either case, the applicant must be someone having the right to claim priority. In the U.S., these provisional applications were filed in the name of the inventor and the EPO requires that there be an assignment of the invention on or before a European or PCT application is filed. (Of course, a PCT application can always be filed naming the inventors as applicants.) In this case, proper application of the applicable rules required both the named applicants (The Broad Institute, MIT and Harvard College) and Rockefeller to have been named as applicants when the application was filed.But Rockefeller was not named as an applicant. Accordingly, the OD determined that the named Proprietors could not validly claim priority to provisional applications P1, P2, P5, and P11; the third provisional application thus provided the earliest effective filing date, and by the filing date of that application there had published prior art that invalidated the granted claims. In this regard, the formal opinion followed the earlier preliminary opinion in stating that [i]n both the EPC and the Paris convention systems the decisive fact for a valid claim of priority is the status of applicant, rather than the substantial requirement . . . to the subject matter of the first application (emphasis in opinion). The OD determined that neither the requirement of the applicant s identity nor the proof of a valid success in title [had] been fulfilled for the claimed invention, and stressed that these were requirements to promote legal certainty that would protect third parties interests, and that these requirements were not subject to the national law of the priority document. Nor, according to the preliminary opinion, could the granted European patent properly claim priority to U.S. 61/758,468 because that document failed to disclose the length of the guide sequence as claimed.On appeal, the Board set forth the following as the issue before them: A and B are applicants for the priority application. A alone is the applicant for the subsequent application. Is a priority claim valid even without any assignment of priority right from B to A? The appellants say that the answer is yes and the respondents that the answer is no .The Broad made arguments regarding three questions, none of which were persuasive:1) Should entitlement to priority be assessed by the EPO?2) How is the expression any person in Article 87(1) EPC to be interpreted?3) Does national law (in this case US law) govern the determination of any person who has duly filed in Article 87(1) EPC?And the remedy Appellants requested (and the Board denied) was as follows:1. The decision of the Opposition Division dated 26 March 2018 be set aside.2. …3. Entitlement to priority of the Patent to P1, P2, P5 and P11 is acknowledged as validly claimed.4. Questions are referred to the Enlarged Board of Appeal if the Board is minded not to decide that entitlement to priority of the Patent to P1, P2, P5 and P11 was validly claimed, as set out at pages 70-72 of the grounds of appeal;5. ….6. The case is remitted to the Opposition Division for further prosecution if the Board decides that entitlement to priority of the Patent to P1, P2, P5 and P11 was validly claimed;7. ….8. In case the Board decides not to remit the case to the Opposition Division, to reject the oppositions and maintain the Patent as granted or, alternatively, in the form of any of Auxiliary Requests 1-64.(where grounds 2, 5, and 7 were not pursued in this appeal).With regard to Question 1, the Board characterized the Proprietor s (Broad s) position to be that for a property right devolving from national law the EPO should leave priority challenges to the national courts of each country in which rights are pursued by the Proprietor. This would be consistent with Article 60(3) EPC, wherein the EPO does not adjudicate patent ownership disputes. This argument comes down to matters of jurisdiction and competence according to the Board, which the Proprietor contended were adequately policed by Article 88 EPC and Rules 52 and 53 EPC. The same invention requirement is sufficient to ensure legal certainty for third parties according to the Proprietor s argument. And this principle would be applied to technical deficiencies in a priority claim, something the Proprietor argues is within their area of expertise. Finally, this would not be a challenge that could be raised in opposition proceedings.The Board understood that the Proprietor contended in these arguments that the EPO should not consider the portion of Article 87(1) relating to any person and set forth the Article to illustrate their decision to the contrary:Article 87 Priority right(1) Any person who has duly filed, in or for (a) any State party to the Paris Convention for the Protection of Industrial Property or (b) any Member of the World Trade Organization, an application for a patent, a utility model or a utility certificate, or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application.(2) Every filing that is equivalent to a regular national filing under the national law of the State where it was made or under bilateral or multilateral agreements, including this Convention, shall be recognised as giving rise to a right of priority.(3) A regular national filing shall mean any filing that is sufficient to establish the date on which the application was filed, whatever the outcome of the application may be.(The Board noted that this Article has the identical wording as Article 4A of the Paris Convention).The Board distilled the requirements of this Article as requiring proper identification by an Applicant of who, where, what, and when an invention was made. Clearly, who is the only question before the Board in this appeal.The Board held Proprietor s position to be directly contrary to the requirements of Article 87(1), saying that Article 87(1) EPC does not require that the any person who has filed the patent application is actually legally entitled to do so, merely that they have done so. The EPO s assessment is thus not of substantive ownership but of the formality of whether the proper who has actually filed the application. And the Board did not find a proper analogy in Enlarged Board of Appeal Decision G 3/92 regarding the adequacy of fulfilling Article 60(3) requirements with regard to the requirements of Article 87(1).The Board agreed with Proprietor that failure to satisfy these formalities requirements as Proprietor has been determined not to can result in loss of rights, but responded by reminding the Proprietor that EPC sets out many formal requirements for obtaining a patent, relating to such things as payment of fees, time limits for carrying out certain actions etc. and [t]he loss of a patent or a patent application due to failure to fulfil such formalities is a feature of the EPC system. That is certainly what happened here, but the opinion states that [i]t is not for the Board to repair such errors, omissions or deliberate choices of a party. Further, the opinion states that [t]he Board can see no basis in Article 88 EPC and Rules 52 and 53 EPC for disregarding the any person requirement of Article 87 EPC, [because] none of these provisions relieve the EPO from the obligation to formally assess who has performed the act of filing the patent application as required by Article 87(1) EPC. The opinion then turned to the relevance of successors in title, which the Proprietor argued is inconsistently applied but the Board stated is merely a supporting argument for the appellants view that a substantive legal assessment of the right to a priority claim should not be carried out. And the Board noted that the issue of successorship in title is not an issue in this case and therefore the appellants arguments on this point are irrelevant for deciding this case. Nor was the Board persuaded by the Proprietor s arguments regarding Article 54(3) EPC because [t]he EPO does not perform a substantial assessment of the legal entitlement to claim priority, but only a formal assessment of who has performed the act of filing the patent application. Regarding Question 1, the Board thus held that the Board concludes that the instances of the EPO are empowered and obliged to assess the validity of a priority right claim as required by Article 87(1) EPC. Turning to Question 2 regarding how the term any person in Article 87(1) should be interpreted, the opinion rejected the Proprietor s view that this term should be interpreted to mean that any of a number of applicants having a valid priority claim can file on behalf all of them and that the EPO s contrary requirement that all applicants be properly named on filing is in contravention of the Paris convention. The Proprietor made semantic/textual arguments (that the use of any person does not mean all, as well as others), and argument that the Paris Convention governs how ambiguous terms must be interpreted in light of their object and purpose which is to assist the applicant in obtaining international protection for his invention (something that interpretation of Article 87(1) does not achieve, inter alia, by imposing additional priority requirements). The Proprietor further argued that national court decisions support their position that how the EPO is applying Article 87(1) was in error, and that there has never been a clear examination of this application on the merits (summarizing this aspect of the Proprietor s argument as contending [i]t was irrelevant whether a practice was well-established. If it was wrong, it was always possible to change such a practice . . . ). Finally, the Proprietor contended that the EPO s interpretation and application of Article 87(1) was intended to prevent multiple proceedings by individual applicants, that could lead to multiple patents.The Board agreed that the interpretation of any person in Article 87(1) EPC was based on Article 4A of the Paris Convention as interpreted using principles set forth in the Vienna Convention, specifically Article 31(1):A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.Under this rubric, the Board agreed with respondents that the term any person is restrictive in meaning and requires strict identity of the applicants. However, the Board also admitted that the ordinary meaning of this term in all the language versions is ambiguous and thus turned to the object and purpose of the Paris Convention upon which this requirement is based (this linguistic genealogy being undisputed between the parties). For this determination the Board turned to Technical Board of Appeal Decision T 0015/01 (cited by the Proprietor) to be to assist the applicant in obtaining international protection for his invention (remembering that the Proprietor cited this language from this decision to illustrate that the EPO s interpretation was contravening this purpose, at least in this case). In the Board s view, on the contrary, the question was rather who is the applicant whose interests are being safeguarded under these objects and purposes. Turning to the introductory hypothetical, the Board noted that:So if A and B file the first patent application together, the appellants interpretation of any person would allow A alone to file and own another patent application in another country claiming the same invention without involving B. This could of course result from an agreement between A and B, it could however equally result from more sinister circumstances, such as A trying to deprive B of its rights to a patent in another country. This second scenario can hardly be thought of as one that the law should seek to protect, and neither safeguards the interests of all of the patent applicants, nor assists the applicants in obtaining international protection.This cannot be the object and purpose of the Paris Convention as understood by the Board.The Board took something of a detour in this section of the opinion in considering the Proprietor s argument that the EPO s application of the priority rule at issue in these proceedings is in violation of the European Convention on Human Rights. But the detour was not extensive or time-consuming; the Board asserted that it found the argument circular: it assumes that the established EPO interpretation of the Paris Convention is wrong, without bringing any supplementary arguments as to why this is the case, and then concludes that, being wrong, the European Convention on Human Rights is violated. With regard to proper interpretation of Article 87(1) the opinion states that its consideration of the language, object, and purpose of the Paris Convention was not dispositive either (although the opinion attests that the Board finds respondents arguments to be more persuasive). And the Board readily admitted that there is no informative case law on the question (the opinion distinguishing the UK and Swiss cases cited by the Proprietor as supporting their position on the proper interpretation of the Article on the basis that these cases involved successorship in title).In such an instance, the Board asserted that [u]sers of the international patent system are thus faced with an established practice, the continued application of which can be seen as an aspect of legal certainty. In general, the bar for overturning long established case law and practice should be a high one because of the disruptive effects a change may have. The opinion also addressed what can be considered an equitable principle at play here that made them disinclined to soften the applicant identity requirements:The Board notes that in the present case it does not appear to have been a mistake of inadvertence that one of the applicants for the Priority Application was excluded from the Subsequent Application, but rather a deliberate choice of the appellants. Moreover, a formal requirement cannot be merely disregarded or ignored if, as the consequence of its non-compliance, it results in the revocation of the patent. It is not appropriate to soften any requirement - be it formal or substantive - for patenting on the sole basis that its non-compliance may result in the revocation of a patent.The Board set forth its conclusion on Question 2 by statingThe ordinary meaning of the term any person in Article 87(1) EPC is ambiguous [due, inter alia, to differences in the languages of the underlying treaties]. The all applicants approach is certainly a plausible interpretation of this term from the ordinary meaning perspective and appears to be the one consistently applied by several member states of the EPC, over the last hundred years. . . . The bar to overturning long established case law and practice should be very high because of the disruptive effects a change may have. The continuation of such long standing and rationally based practices can be considered as an aspect of legal certainty. In the light of these considerations the Board finds that the words any person in Article 87(1) EPC require that all applicants for the priority application, or their successors in title, are applicants for the subsequent application.The final question was whether national law (in this case, U.S. law) should govern the meaning of the term any person in Article 87(1). In particular, this interpretation is apt for answering the question why one inventor was left off the application and their assignee not identified as a co-applicant (which in this case was that the (U.S.) attorneys had determined that the omitted inventor was not an inventor as the application was filed.But this situation raised the issue of how the EPO could determine proper inventorship in EP applications claiming priority, as this one does, to U.S. provisional applications that do not need claims; . . . are never examined; . . . never proceed to grant; [whose] sole purpose is to obtain a filing date; . . . may contain multiple inventions; [and] need not name (an) inventor(s) or applicant(s). The Board responded to this situation by stating that the U.S, as a signatory to the Paris Convention, is bound by its terms, including Article 4A with regard to who falls under the description as any person as discussed by the Board in this case. And the Proprietor s arguments regarding the relevance of the special characteristics of U.S. provisional applications were not relevant to the Board s decision here. The Board rendered its decision, that the OD decision is affirmed and that priority has not been validly claimed for the P1, P2, P5, and P11 references.The Board made one more decision in its opinion, regarding the Proprietor s request that the Board refer a question to the Enlarged Board of Appeal. Specifically, the Board stated that it believed it has been able to answer the questions raised beyond doubt and that no referral was necessary. By Kevin E. Noonan --Trial courts tend to get more than the benefit of the doubt when their decisions are viewed under the abuse of discretion standard, and juries similarly are affirmed unless there isn t substantial evidence supporting their verdicts. Both these rubrics, which extend more generally to cases involving disputes outside patent law, were used by the Federal Circuit to affirm both the finding of infringement and a hefty ($89,712,069) damages calculation in Vectura Ltd. v. GlaxoSmithKline LLC.The case arose involving Vectura s patented components for pulmonary administration for dry-powder inhalers, the components claimed in U.S. Patent No. 8,303,991. Vectura asserted Claim 3, dependent on independent claim 1 as further limited to magnesium stearate as the additive material against GSK in the litigation:1. Composite active particles for use in a pharmaceutical composition for pulmonary administration, each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material, wherein the composite active particles have a mass median aerodynamic diameter of not more than 10 μm, and wherein the additive material promotes the dispersion of the composite active particles upon actuation of a delivery device.(wherein the District Court s construction of the italicized limitations was at issue on appeal).Vectura asserted this claim against three GSK accused infringing articles:• Breo, which comprises two blisters, one containing a mixture of vilanterol, lactose, and magnesium stearate and the second containing a mixture of fluticasone and lactose, but not magnesium stearate.• Anoro, which comprises two blisters, one containing a mixture of vilanterol, lactose, and magnesium stearate and the second containing a mixture of umeclidinium, lactose, and magnesium stearate.• Incruse, which comprises only one blister, containing a mixture of umeclidinium, lactose, and magnesium stearate.GSK s method of preparing its accused infringing articles was relevant to Vectura s infringement accusations:GSK first mixes the lactose excipient with magnesium stearate in the absence of the active ingredient. That step yields lactose particles that are discontinuously coated with magnesium stearate. After a de-lumping step, GSK then mixes the lactose particles with the active ingredient. In that step, small particles of the active ingredient are deposited onto the larger lactose particles, which are already coated with small particles of magnesium stearate.The District Court construed two terms of Claim 3:[T]he court construed the phrase promotes the dispersion of the composite active particles (the dispersion limitation) to mean wherein a composition that contains one or more composite active particles has increased dispersion of the active material upon activating a delivery device for inhalation into the lungs by a patient, as compared to the same composition wherein unmodified active particles are substituted for the composite active particles.The court construed the term composite active particles. GSK s proposed construction of that term included a process limitation requiring that the composite active particles be formed by milling . . . using sufficient energy and duration to ensure sufficient break-up of agglomerates of both constituents, dispersal, and even distribution of additive over the active particles. The district court rejected GSK s proposed construction, holding that the term composite active particles does not include a process limitation. The court construed the term to mean [a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream. The District Court found a distinction without a difference under this claim construction of GSK s process of mixing the active ingredient with magnesium stearate in the presence of lactose instead of in its absence. The jury found that this claim was infringed and not invalid, and GSK appealed the District Court s denial of motions for judgment as a matter of law on infringement and damages. This appeal followed (and did not involve the District Court s judgment that the claims were not invalid).The Federal Circuit affirmed, in an opinion by Judge Bryson, joined by Chief Judge Prost and Judge Wallach. GSK raised four issues on appeal:• First, that the district court should have granted JMOL on infringement because Vectura failed to present substantial evidence that the accused inhalers use additive material that promotes the dispersion of the active material, or in the alternative granted GSK a new trial.• Second, that the district court should have granted JMOL on claim construction, wherein the district court s construction of the term composite active particles was erroneous, requiring a new trial on infringement. • Third, for a new trial on damages because of flaws in Vectura s expert s calculations.• Finally, for a new trial on damages due to prejudicial arguments made to the jury regarding GSK sales made by Vectura s damages expert and counsel.The Federal Circuit opinion set forth for the reader s convenience the standards of its review: substantial evidence for jury verdicts, citing Personalized User Model, LLP v. Google Inc., 797 F.3d 1341, 1345 (Fed. Cir. 2015); and abuse of discretion for its new trial motion, citing Union Carbide Chems. Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167, 1182 (Fed. Cir. 2002).GSK argued that under the District Court s construction it was not disputed between the parties that Vectura had the burden to show the use of magnesium stearate in the accused inhalers improves the dispersion of the active ingredient compared to identical products in which only the lactose excipient is coated with magnesium stearate. GSK argued the District Court erred in denying its motion for JMOL on this issue because in its view the jury based its decision that Vectura had satisfied its burden on an allegedly flawed scientific test. The asserted flaws had to do with whether the lactose alone was covered with magnesium stearate vs. coating the drug-containing particles and the lactose (wherein the latter composition was dispersed better in the lungs). The Federal Circuit found GSK s argument was deficient because this test was not the only basis for the jury s determination. The District Court found in denying JMOL that Vectura relied on aspects other than the flawed study and that there was ample other evidence the jury could have relied upon other than the putatively flawed study. This included evidence that a magnesium stearate coating helps overcome the tendency of the particles to stick together and therefore increases the dispersion of the particles in the lungs and test results wherein GSK s accused infringing products showed the particles were consistently associated with magnesium stearate. The District Court also held that the jury was entitled to rely on GSK documentary evidence regarding satisfaction of the dispersal limitation in Claim 3. Thus, according to the panel, the totality of the evidence developed below was sufficient to satisfy the substantial evidence standard for affirming the jury s verdict of infringement.GSK s second argument on appeal was that proper construction of the claim limitation composite active particles required that these particles be produced by a high-energy milling process (which GSK argued does not describe their process). According to GSK, the 991 specification discloses high-energy milling, and disclosure of this process was used during prosecution of the 991 patent to overcome a prior art reference. Thus, according to GSK, a correct construction of the composite active particles requires the particles (and drugs made from those particles) to be made using a high-energy milling process.On the merits, the Federal Circuit considered this case [to] fall[] between two prior cases from this court: Continental Circuits LLC v. Intel Corp., 915 F.3d 788 (Fed. Cir. 2019), and Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361 (Fed. Cir. 2007). In the Continental Circuits case, the Federal Circuit had refused to import a process limitation into an apparatus claim, whereas in the Anderson case, the Court had construed an apparatus claim to encompass a process limitation. From these cases the panel enunciated a standard, wherein process steps can be treated as part of the product claim if the patentee has made clear that the process steps are an essential part of the claimed invention. As a practical matter, the opinion states this standard another way, saying the Court looks to language of requirement, not preference. Here, from the Federal Circuit s assessment of the 991 patent specification the Court reached the conclusion that the disclosure in the specification was more similar to the circumstance in the Continental Circuits case, where the specification set forth a preference but not a requirement for the process step (citing several instances in the specification supporting this view). And with regard to the prosecution history, the opinion states the Court rejected GSK s argument because the distinction GSK raised to overcome the asserted prior art reference was directed at another aspect of the method for making the claimed composition.With regard to damages, the Federal Circuit considered the parties prior licensing history, wherein Vectura had previously granted GSK a nonexclusive license that had expired in 2016. This license had had a tiered structure ( a royalty of 3% on its first 300 million British pounds in sales, 2% on sales between 300 million and 500 million pounds, and no additional royalties on sales above 500 million pounds ) that Vectura s expert used as a comparable license in reaching her damages conclusions. Significantly, however, the expert did not include the cap of no additional royalties after 500 million pounds, based on changed circumstances. In contrast. GSK s royalty rate was much lower (only 0.0187%).GSK argued that Vectura s analysis was flawed because it used the entire market value approach rather than distinguishing the non-infringing components of the accused infringing articles. The Court considered the damages theories to relate to a rather unusual circumstance, because the choice is usually between where an entire-market-value royalty base is appropriate only when the patented feature creates the basis for customer demand or substantially creates the value of the component parts, and apportionment is required when an entire-market-value royalty base is inappropriate, citing Virnetx, Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1326 (Fed. Cir. 2014). Here, however, the Court thought that any such apportionment is contained ( built-in ) in the earlier license so re-apportionment was unnecessary. The panel opined that the District Court properly credited Vectura s expert s testimony regarding the comparability of her damages calculations as a reasonable royalty and the terms of the earlier license. And with regard to the lack of a royalty cap, the Court held that [i]t was . . . permissible for the jury to credit Ms. Schenk s testimony and to award damages without applying a royalty cap. GSK s other grounds for a new trial based on damages was that Vectura s damages expert and counsel mentioned the total sales of GSK s products and that this was prejudicial. The District Court had found some of these references to be improper but in total that they were not so prejudicial as to warrant a new trial. Asserting that [o]n the issue of the impact of improper conduct at trial, the views of the judge who supervised the trial proceedings are entitled to considerable weight, Fineman v. Armstrong World Indus., Inc., 980 F.2d 171 (3d Cir. 1992), the Federal Circuit found these disclosures not to be sufficiently prejudicial for it to find the District Court s denial of JMOL to be an abuse of discretion.Vectura Ltd. v. GlaxoSmithKline LLC (Fed. Cir. 2020)Panel: Chief Judge Prost and Circuit Judges Bryson and WallachOpinion by Circuit Judge Bryson By Michael Borella --One would think that inventions relating to computer game software would easily meet the requirements for patent eligibility, as these inventions fundamentally involve technological processes and require computer implementation. But that is not always the case. Under current interpretations of the eligibility standard, not only does the language of the actual claims matter, so does the context of the invention.Gree was issued U.S. Patent No. 9,597,594, and it was timely challenged in a Post Grant Review (PGR) by Supercell. The challenger is a mobile game development company, responsible for the widely-popular Clash of Clans and related apps. The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) ultimately found the majority of the claims under review to be ineligible for patenting under 35 U.S.C. § 101. Gree appealed.Claim 1 of the 594 patent, which is representative, recites:A method for controlling a computer that is provided with a storage unit configured to store game contents arranged within a game space, first positions of the game contents within the game space, and a template defining second positions of one or more of the game contents, and that progresses a game by arranging the game contents within the game space based on a command by a player, the method comprising: when the template is applied to a predetermined area within the game space based on the command by the player, moving, by the computer, the game contents arranged at the first positions within the game space to the second positions of the game contents defined by the template within the predetermined area.The invention described as being applicable to how a user controls city-building games, in which a player builds a city within a virtual space (hereinafter referred to as game space ) provided in the game program in a computer. These virtual cities include arrangements of game contents, i.e., items such as protective walls, buildings, . . . soldiers, weapons, etc. The problem being solved is related to managing game contents in large cities. According to the specification, it is very complicated for a player to change positions, types, levels, etc., of individual items in the cities. As a consequence, users who play the game for some time find it increasingly necessary to micromanage these resources.The claimed invention overcomes these drawbacks by creating a template defining positions of one or more game contents and subsequently applying the template to a predetermined area within the game space. Doing so causes the computer to move[] the game contents arranged within the game space to the positions of the game contents defined by the template. Particularly, when the numbers of game contents of each type defined by the template match the numbers of game contents of each type in the game space to which the template is to be applied[, this causes] all game contents arranged within the game space [to be] moved to positions of game contents as defined by the template. Put another way, a single pre-defined operation can be used to replace a potentially large number of user interface interactions.Other claimed embodiments include handling mismatches between the numbers of game contents of each type defined by the template and the numbers of game contents of each type in the game space to which the template is to be applied. When the number of game contents is larger, those with the smallest moving distance (e.g., Manhattan distance) to positions defined by the template may be moved to the positions of game contents as defined by the template. Conversely, when the number of game contents is smaller, all game contents . . . may be moved to positions of game contents defined by the template, to which the moving distance is the smallest, with positions on which no game contents are arranged among the positions of game contents defined by the template. In Alice Corp. v. CLS Bank Int l, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101. One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion. But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle. While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.Recently, the Federal Circuit provided a major clue as to how to think about patent eligibility in practice. In Dropbox Inc. v. Synchronoss Techs. Inc. the Court wrote that an inventive concept exists when a claim recites a specific, discrete implementation of the abstract idea where the particular arrangement of elements is a technical improvement over the prior art. This suggests that in order for a claim that is otherwise directed to an abstract idea to be successful under § 101, it should have three qualities: specificity, a technical solution that it provides, and some degree of novelty. More particularly, there should be a nexus between these three factors -- specificity, technical character, and novelty should appear in the same claim element or at least be explicitly linked in some fashion in the recitation of the claim.The outcome of the PGR trial was that claims 1, 8, and 10-20 of the 594 patent were found to fail the eligibility test. On review, the Federal Circuit agreed with the PTAB that, under part one of Alice, all claims are directed to the abstract idea of creating and applying a template of positions of one or more game contents. The Court further agreed with the PTAB that certain claims of the 594 patent are broad enough to cover simply implementing the long-standing and conventional game of correspondence chess using chess templates on a computer. [1]Gree attempted to argue that the claims involved an improved graphical user interface. But the Court rapidly dismissed this effort because only one of the claims specifically recited such features and did so at a high level.Finding the claims directed to an abstract idea, the Court turned to part two of Alice. There, it found that almost all of the claims -- claim 1 included -- lacked an inventive concept. In particular, the computer hardware limitations merely invoke generic computer components performing their standard functions to limit the use of the abstract idea itself to the technological environment of a game space on a computer. Further, the Court indicated that claims 1, 8, and 10–20 are so broad that they encompass automation of . . . well-understood, routine, conventional activity. In contrast, the Court found that claims 5-7, directed to the mismatched template scenarios, did include significantly more than the abstract idea itself. These claims recite:5. The method according to claim 1, wherein when the number of game contents arranged within the game space is smaller than the number of game contents for which the second positions are defined by the template, the computer moves the game contents arranged at the first positions within the game space to the second positions of the game contents defined by the template to which the moving distance is the smallest.6. The method according to claim 5, wherein out of the second positions of the game contents defined by the template, the computer displays positions on which no game contents are arranged and the game contents, in a discernible condition.7. The method according to claim 1, wherein when the number of game contents arranged within the game space is larger than the number of game contents for which the second position[s] are defined by the template, the computer moves the game contents arranged at the first positions within the game space for which the moving distance to the second positions of the game contents defined by the template is the smallest, to the positions.Unlike the other claims, claims 5-7 recite specific steps for applying templates in mismatched template scenarios, these claims require something more than automating correspondence chess. Further, Supercell has not shown that conventional correspondence chess template application included any technique—let alone the specifically claimed technique—for applying a template in the claimed mismatched template scenarios. In summary, the Court concluded that claims 1-4, and 8-20 were ineligible and that claims 5-7 were eligible. Putting this into the Dropbox framework described above, the ineligible claims were non-specific and overlapped with known features from the prior art. In contrast, the eligible claims were drawn toward specific features that were not known to be in the prior art. The Court never explicitly addressed whether the claims had sufficient technical character, but seeing as it found some claims eligible, it appears that was the case.But before finishing its opinion, the Court made an interesting criticism of PTAB s § 101 analysis that may be helpful for practitioners. The Court observed that:The Board also determined that under the Alice framework, Petitioner only needed to account for each claim limitation under either a formulation of the concept a claim is directed to or under Alice step two. To the extent that the Board meant that a proper § 101 analysis may consider some claim limitations only at Alice step one and others only at Alice step two, we do not agree with its reading of Supreme Court precedent. Instead, both steps of the Alice inquiry require that the claims be considered in their entirety.Thus, the propensity for the PTAB and USPTO Examiners -- and frankly other Federal Circuit panels -- to analyze claim elements under the auspices of either Alice part one only or part two only, is incorrect.[1] As described in the opinion, in correspondence chess, a first player fills out a post card with information that represents the current state of the board and makes an indication on the post card of the first player s intended move and mails the post card to a second player who, having already set up a chess board, moves a piece on the board in accordance with the instruction on the post card. The template in correspondence chess would be the move as indicated on the post card.Gree, Inc. v. Supercell Oy (Fed. Cir. 2020)Panel: Circuit Judges Lourie, Hughes, and StollOpinion by Circuit Judge Stoll By Kevin E. Noonan --Interferences were rendered unnecessary with the passage of the Leahy-Smith America Invents Act in 2011, but they linger in disputes between patents and applications claiming priority to applications filed before the change to a first-inventor-to-file system. The Federal Circuit recently upheld the Patent Trial and Appeal Board s priority determination in Chevron U.S.A. Inc. v. University of Wyoming Research Corp. in a decision based on the Board s construction of an undisputedly dispositive term.U.S. Interference No. 106,064 was declared between the University of Wyoming Research Corp. (over involved U.S. Patent No. 8,367,425 and Chevron U.S.A. s Application No. 12/883,814). The Count in the interference (which defines the interfering subject matter) was defined in the alternative as Claim 1 of the 814 application:1. A method for determining asphaltene stability in a hydrocarbon-containing material having solvated asphaltenes therein, the method comprising the steps of: (a) precipitating an amount of the asphaltenes from a liquid sample of the hydrocarbon-containing material with an alkane mobile phase solvent in a column; (b) dissolving a first amount and a second amount of the precipitated asphaltenes by gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent having a solubility parameter at least 1 MPa0.5 higher than the alkane mobile phase solvent; (c) monitoring the concentration of eluted fractions from the column; (d) creating a solubility profile of the dissolved asphaltenes in the hydrocarbon-containing material; and (e) determining one or more asphaltene stability parameters of the hydrocarbon-containing material.orClaim 5 of the 425 patent:5. A method for determining asphaltene stability in a hydrocarbon-containing material having solvated asphaltenes therein comprising the steps of: (a) intentionally precipitating an amount of the asphaltenes from a liquid sample of the hydrocarbon-containing material with an alkane mobile phase solvent in a column that has a substantially chemically inert stationary phase established therein, wherein the substantially chemically inert stationary phase is substantially chemically inert relative to the precipitated asphaltenes; (b) dissolving a first amount and a second amount of the precipitated asphaltenes by changing the alkane mobile phase solvent to a final mobile phase solvent having a solubility parameter that is higher than the alkane mobile phase solvent; (c) monitoring the concentration of eluted fractions from the column; (d) creating a solubility profile of the dissolved asphaltenes in the hydrocarbon-containing material; and (e) determining one or more asphaltene stability parameters of the hydrocarbon-containing material; wherein said step of dissolving comprises the step of dissolving by gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent having a solubility parameter that is at least 1 MPa0.5 higher than the alkane mobile phase solvent.Wyoming copied this claim to provoke the interference. Wyoming was designated as the Junior Party in the interference as declared, the Board recognizing their earliest priority date as September 23, 2011 (the filing date of U.S. Application No. 13/243,782, now U.S. Patent No. 8,273,581) and Chevron as Senior Party, having the benefit priority to U.S. Provisional Application Nos. 61/242,280, filed 14 September 2009 and 61/312,765, filed 11 March 2010). However, in its Decision on Motions, the Board granted Wyoming benefit of priority to U.S. Provisional Application 60/711,599 (filed Aug. 25, 2005), and U.S. Application No. 11/510,491 (filed Aug. 25, 2006), and declared Wyoming the Senior Party. Chevron filed a Priority Statement establishing its earliest conception date (supported by evidence of diligence from conception to its earliest filing date) of March 1, 2009. Accordingly, the Board held that Chevron was unable to establish its date of invention to be earlier than Wyoming s earliest priority date (the 599 application filing date) and entered judgment in favor of Wyoming. This appeal followed.The Federal Circuit affirmed, in an opinion by Judge Schall joined by Judge Lourie; Judge Newman filed a dissenting opinion. The basis of Chevron s appeal was that the Board had erred in determining that Wyoming was entitled to its earliest filing date based on an erroneous claim construction. Specifically, Chevron contended that the Board had misconstrued the limitation gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent to mean the alkane mobile phase solvent is incrementally removed from the column over a period of time by continuously adding a final mobile phase solvent (for the meaning of gradually ) and without interruption for the term continuously. Chevron urged that this limitation should be construed to mean the amount of alkane mobile phase solvent fed into the column is incrementally decreased from 100% to 0% over a period of time without interruption while the amount of final mobile phase solvent fed into the column is incrementally increased from 0% to 100% over the same period of time, as Chevron had argued before the Board. (Neither party disputed the construction given by the Board to the term continuously. ) The panel recognized that the appeal concerned that one, narrow issue of claim construction, because there was no dispute that Wyoming s 425 patent and the priority applications have written description support for the limitation under the Board s construction, but that they lack such support under the construction urged by Chevron. Accordingly if the Board properly construed this term, Chevron was not entitled to priority for the Count.The Federal Circuit majority (as had the Board) based its decision affirming the Board on express disclosure in the 814 specification regarding the term gradually :The term gradually as used herein shall be understood to mean that the alkane mobile phase solvent is incrementally removed from the column over a period of time by continuously adding a final mobile phase solvent having a solubility parameter at least 1 MPa0.5 higher than the alkane mobile phase solvent to the column.(And because the Board thus relied on intrinsic evidence, it did not consider the testimony of either of the parties expert witnesses and the Court s review was de novo.) On this basis, the Board (giving the limitation its broadest reasonable interpretation) held that the term gradually and continuously changing referred to the change of solvents in the column rather than at the inlet of the column (neglecting the physical reality that the introduction of the continuously changing solvent occurs, as it must, at the inlet, then proceeding through the column as chromatography continues). Chevron for its part argued (before the Board and here) that the 814 specification contained several instances wherein the solvent change was described as occurring at the column inlet. And Wyoming countered that these citations were directed to disclosure reciting where the solvent was gradually and continuously added not where the solvent was gradually and continuously changed.The panel majority agreed that the Board had properly construed the dispositive limitation under the broadest reasonable construction standard, particularly in view of the express definition of the term gradually in the 814 application specification. The Court also found reliance to be supported by other disclosure in the specification in adjacent paragraphs. The majority rejected Chevron s legal argument that the Board decision was contrary to the Federal Circuit s precedent from In re Suitco Surface, Inc., 603 F.3d 1255 (Fed. Cir. 2010), stating that unlike in that case here, the Board s construction was not unreasonably broad and was supported by express disclosure. Because the majority found that the Board s construction was consistent with express disclosure and its own precedent regarding proper use of disclosure from the specification in construction under the broadest reasonable construction standard, the Federal Circuit affirmed the Board s priority determination in Wyoming s favor.Judge Newman dissented. In the Judge s view, [t]he Wyoming specification does not describe and does not support the claims copied from Chevron. In its chain of applications Wyoming describes and claims a different method. Thus the proper outcome would have been a determination that there was no interference in fact, particularly because the priority benefit accorded to Wyoming precludes Chevron s disclosure from being prior art to Wyoming s claims. The Judge expressly disagrees with the majority s lack of consideration of the standard of the Court s uniform precedent that requires that the interference count is construed in light of the application from which it arose; that is, Haemonetics Corp. v. Baxter Healthcare Corp., 607 F.3d 776, 781 (Fed. Cir. 2010) and Bicon, Inc. v. Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006). As a consequence, in Judge Newman s view, the majority was able to ignore dispositive differences between the inventions claimed in the parties applications, namely that Wyoming s method differed [from the claimed Chevron method] in that Wyoming required an abrupt and discontinuous solvent change yet nevertheless granted priority to Wyoming. These differences (or the consequences thereof) were for Judge Newman illustrated in each of the parties disclosures:Wyoming:Chevron:And the Board understood these differences:The underlying facts in this situation are, for the most part, not in dispute. [Wyoming s] example utilizes abrupt solvent input changes . . . , while [Chevron s] examples use solvent changes that are less so.Because [w]hen claims are copied to provoke an interference, the copied claims are [to be] construed in light of the application from which the claims are copies the Judge opines, citing Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1375 (Fed. Cir. 2009).In addition, in light of these differences, Judge Newman believes that Wyoming proved neither conception nor reduction to practice of the Count (which is a function of the parties priority status regarding Wyoming being declared the Senior Party and thus not having this burden). But both the law and PTAB rules (specifically 37 C.F.R. § 41.202) contain that requirement which was not complied with here. Seeing this as threshold issue, Judge Newman would have dissolved the interference and permitted both parties to have patents claiming their distinct inventions.Chevron U.S.A. Inc. v. University of Wyoming Research Corp. (Fed. Cir. 2020)Panel: Circuit Judges Newman, Lourie, and SchallOpinion by Circuit Judge Schall; dissenting opinion by Circuit Judge Newman By Kevin E. Noonan --It has long been understood that claim construction can, and frequently is, dispositive in patent litigation. This truism was the basis for the Federal Circuit affirming the District Court s decision against a generic drug producer in its recent decision in Par Pharmaceutical, Inc. v. Hospira, Inc. And the case being decided on whether Hospira s formulation described in its ANDA would constructively infringe Par s patented formulation, the clear error standard of view also had a part to play in the outcome.These issues arose in ANDA litigation, wherein Plaintiffs asserted U.S. Patent Nos. 9,119,876 and 9,925,657 against Hospira over Par s Adrenalin® product (epinephrine) and methods for administering the drug (by injection). Hospira asserted non-infringement and invalidity as defenses (the District Court ruled against Hospira on the latter and they were not on appeal). The Par patents were directed to formulations that overcame deficiencies in prior art epinephrine formulations, principally short shelf life due to three different routes of degradation (oxidation, racemization, and sulfonation). Claim 1 of the 876 patent is representative:A composition comprising: in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or salts thereof, in the range of about 6 to 8 mg/mL of a tonicity regulating agent, in the range of about 2.8 to 3.8 mg/mL of a pH raising agent, in the range of about 0.1 to 1.1 mg/mL of an antioxidant, in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent, wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite.(where boldface type is used in the opinion to designate limitations relevant to Hospira s appeal). After defining these limitations, the opinion set forth the District Court s construction of the word about as it was used for each limitation. Specifically, the parties agreed that this term be given its plain and ordinary meaning, i.e., approximately significantly for the Federal Circuit in this appeal, Hospira did not assert a contrary construction.The parties proffered expert testimony regarding the three limitations emphasized above. Par s expert testified that the tonicity range -- 6-8 mg/mL -- could be satisfied for the court s infringement determination by 9 mg/mL sodium chloride (Hospira s concentration, although concentrations as low a 8.55 mg/mL were also used) because it would suffice for the intended purpose, i.e., maintain[ing] the integrity of living cells following the injection of epinephrine into the bloodstream. Hospira s expert only disputed his counterpart with regard to whether the skilled artisan would consider 9 mg/mL to fall within the range of about 6-8 mg/mL.For the transition metal complexing limitation, the District Court relied on evidence that citric acid was a known chelating agent, and that the amount of elemental impurities (metals) was represented by Hospira in its ANDA as being within international standards (specifically, the ICH Q3D guidelines). The correspondence between this standard and the concentration of metal chelating agent recited in the claim was attested by Par s expert to fall within the claimed range. Hospira s expert again did not contest Par s expert in general but did testify that the upper limit of the ICH Q3D guidelines were an inappropriate standard for the District Court to apply. Rather, in his view the proper amount should be derived from Hospira s test batches, which he opined would require a much lower amount of citric acid as a chelator.The parties contested the concentration of the pH lowering agent, Hospira s ANDA specifying citric acid as a buffer (with its sodium citrate salt), which together are considered in the art to be pH raising (whereas it was undisputed that citric acid by itself is a pH lowering agent). According to Par s expert, subtracting the amount of citric acid in Hospira s formulation left sufficient citric acid to fall within the range of Par s claimed pH lowering agent, even while those same citric-acid molecules would be part of the buffer system (citric acid combined with sodium citrate) that would serve as a pH raising agent. (Despite the apparent paradox it is helpful to remember that infringement is a question of fact and the Federal Circuit reviews factual determinations by the District Court in a bench trial for clear error.) Hospira s expert disagreed with Par s expert, testifying (reasonably, on its face) that the citric acid molecules in the formulation should not be considered as both pH-lowering and pH raising components of the formulation. Nevertheless, the District Court ruled in Par s favor, that Hospira s formulation would infringe Par s patent claims. This appeal followed.The Federal Circuit affirmed, in an opinion by Judge Taranto, joined by Judges Dyk and Stoll. Hospira addressed on appeal the District Court s determinations for each of the three limitations at issue. The Federal Circuit in its opinion first affirmed the District Court s finding that Hospira s 9 mg/mL sodium chloride concentration in its formulation fell literally within Par s claim limitation of about 6-8 mg/mL. The panel noted that when the term about is used, it avoids a strict numerical boundary to the specified parameter, citing Cohesive Techs. v. Water Corp., 543 F.3d 1351 (Fed. Cir. 2008), relying on Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995). The extent to which a claimed numerical range can extend outside that range when modified by about in a claim is limited to what the skilled worker would reasonably consider the claim would encompass according to the opinion, citing Monsanto Tech. LLC v. E.I. DuPont de Nemours Co., 878 F.3d 1336, 1342 (Fed. Cir. 2018). In cases like these, where no party argues for a narrower claim construction, the determination is governed by the Cohesive standard. The elements of this standard include whether the accused infringing formulation differs from the claimed range by a modest amount (Conopco, Inc. v. May Dep t Stores Co., 46 F.3d 1556, 1562 (Fed. Cir. 1994)), and how critical the claimed range is to the purpose of the limitation (not the invention) itself. Although recognizing the contribution of claim construction to a Court s decisions on this question, the Federal Circuit stated that it is a question of technologic fact whether the accused device meets a reasonable meaning of about in the particular circumstances, citing Modine Manufacturing Co. v. U.S. Int l Trade Comm n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). Here, the panel opined that the District Court had properly applied its precedent as set forth herein, and that its basis for the decision was dependent on expert testimony. The District Court found Par s expert to be more persuasive than Hospira s, particularly to the extent that it was dependent on the technological facts, the importance of the purpose of the limitation, and the limitation s noncriticality. In contrast, the District Court found that Hospira s expert did not provide a meaningful analysis of the technologic context or the function of the claimed amount of tonicity regulating agent. On these facts the panel found no clear error.With regard to the transition metal complexing agent limitation, the Federal Circuit rejected Hospira s argument that the District Court should have focused on its proposed generic formulation rather than on what was set forth in its ANDA. The panel found that the District Court correctly considered citric acid to be a transition metal complexing agent as recited in the claim, which was consistent with the expert testimony from both parties. The opinion rejected Hospira s argument that it did not intend citric acid to function as a chelating agent, in light of testimony that citric acid actually does act as a chelating agent. The standard for finding infringement in ANDA litigation under 35 U.S.C. § 271(e)(2) is what is described in the ANDA (the filing of which is, as the Court noted, the constructive act of infringement), citing Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Fed. Cir. 2013). And Hospira s reliance on the ICH Q3D standard for its ANDA supported the District Court s finding, not at least because this citation was added to the ANDA after the FDA requested alternative information in this regard. The ANDA not being silent on this question the Federal Circuit held that the District Court had sufficient evidence for finding that Hospira s formulation literally corresponded to this limitation.Finally, with respect to pH-affecting properties of citric acid and buffers made therefrom, the Federal Circuit affirmed based on Hospira not having preserved a claim-construction argument on this issue. Moreover, the Federal Circuit understood that the (identical) specifications of the 876 and 657 patents, in the panel s view at least strongly suggest[ed] the opposite. Because it had not challenged claim construction on this (or any other) point, the Federal Circuit held that the District Court had not clearly erred in concluding that Hospira s formulation infringed the claims as construed (which, inter alia, depended on the disclosures in the specification), and affirmed.Par Pharmaceutical, Inc. v. Hospira, Inc. (Fed. Cir. 2020)Panel: Circuit Judges Dyk, Taranto, and StollOpinion by Circuit Judge Taranto The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving. It is also our hope that all of our readers, along with their families and friends, stay safe during the holiday. Publication of Patent Docs will resume on November 28th. By Kevin E. Noonan --The Federal Circuit has taken the occasion, in appeals from the Patent Trial and Appeal Board as well as district courts, to remand judgments whenever the Court believes that the record below is devoid of sufficient detail to properly assess the correctness of the decisions made below (see Merck Sharp Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019) and NeuroGrafix v. Brainlab, Inc. (Fed. Cir. 2019) ). Recently, the Court took advantage of another opportunity to remind a district court of the need to provide ample factual bases for its decisions and avoid a rush to judgment, in Ferring B.V. v. Allergan, Inc.The case involved the claims to patent ownership of a former consultant, Seymour Fein, for Ferring Pharmaceuticals. Mr. Fein was a consultant for Ferring Pharmaceuticals for a little less than four years, until Ferring terminated his consulting agreement in November 2002. During his contract, employment Mr. Fein was involved in a project involving desmopressin, a synthetic analog of naturally occurring arginine vasopressin that is a hormone related to water retention in humans. In particular, desmopressin was used to treat sleep disruption caused by nocturia. The compound had low bioavailability and a large range of absorption, and it was thought that increasing desmopressin doses (to reduce these aspects of use of the drug) could pose a safety issue. A study performed by Ferring scientists starting in October 2000 supported the use of low doses and plasma concentrations of desmopressin as a clinically effective nocturia treatment. However, the drug was also accompanied by hyponatremia (low blood sodium ion concentration), which can be life-threatening, and Mr. Fein was asked to consult on this problem as part of his consulting duties. According to the opinion Mr. Fein suggested using low doses of desmopressin formulated in a waterless orodispersible form (a melt ) [and administered] sublingually through the mucosal membranes of the mouth as a solution to the problem. When tested, such a formulation showed double the bioavailability of previously marketed forms of the drug. Clinical trials and a patent application filing by Ferring followed (but this application named no inventors). Thereafter, Mr. Fein was not further involved with development of these formulations of the drug. Instead, he was tasked with overseeing (until Ferring cancelled his consulting agreement) an intravenous desmopressin administration study, where he suggested improvements that permitted a greater weight range of participants. When Ferring filed a PCT application claiming priority to the initial application, Mr. Fein was named as an inventor but his contract with Ferring was terminated shortly thereafter.Mr. Fein communicated with Ferring through his attorney for the next two years regarding his inventive contribution to embodiments of the invention encompassing sublingual desmopressin administration. In his extensive correspondence, Mr. Fein informed Ferring that his consulting agreement contained no obligation that he assigned any inventions to Ferring and his inventive contribution to the invention claimed in Ferring s PCT application (as acknowledged by Ferring naming him as an inventor). In response, Ferring informed Mr. Fein that it had dropped the sublingual administration feature of the claimed invention and hence Mr. Fein was no longer properly an inventor. Mr. Fein acquiesced to Ferring s decision but informed the company that he was also an inventor of the associated low dosage possibilities enabled by the sublingual administration route which had not been specifically claimed in the pending application. Somewhat aggressively, Mr. Fein notified Ferring that he intended to pursue patent protection on the sublingual administration route invention as well as the associated low dosage possibilities which he assumed Ferring would relinquish any claims thereto. Ferring s response included its reasoning that it was not pursuing these aspects of the invention because they were in the public domain. However, Ferring refused to provide a blanket disclaimer of ownership or inventorship by Ferring employees without reviewing any patent application Mr. Fein might thereafter file.Mr. Fein did file his application, PCT/US2003/014463, naming himself as sole inventor and claiming priority to the earlier-filed Ferring application. The claims were directed to low dose desmopressin formulations not limited to a sublingual route of administration. In response (the next day, according to the opinion), Ferring filed its own new PCT application, claiming priority to its earlier applications, that did not contain claims directed to desmopressin formulations for sublingual administration nor name Mr. Fein as an inventor. According to the opinion, these various Ferring PCT applications resulted in eventual grant of U.S. Patent Nos. 7,569,429 and 7,947,654. For his part, Mr. Fein conducted clinical trials and filed U.S. patent applications, which resulted in grant of U.S. Patent No. 7,799,761 containing claims reciting pharmaceutical compositions comprising varying low doses of desmopressin administered by various routes of delivery (not limited to sublingual delivery routes). This prompted Ferring to write to inform Mr. Fein that it believed his patent applications contained proprietary and confidential information and that Mr. Fein was not entitled to the invention claimed in the 761 patent. Continued correspondence between the parties failed to resolve these issues. In the meantime, Mr. Fein took steps to commercialize the invention encompassed by the 761 patent claims and pursued further patent protection, including U.S. Patent Nos. 7,405,203 and 7,579,321. In response, Ferring attempted without success to have the Patent Trial and Appeal Board re-examine the 203 patent.Ferring filed suit in the Southern District of New York to correct inventorship under 35 U.S.C. § 256 and for state law claims. In that suit, co-defendant Allergan (joined by all co-defendants) moved for summary judgment that Ferring s claims under § 256 were barred by equitable estoppel and District Court Judge Sweet granted that motion. The basis for summary judgment grant by the District Court was that Ferring s inaction for over seven years after Mr. Fein s correspondence (through his attorney) satisfied the misleading conduct prong of the equitable estoppel standard. The Court understood the evidence to show that Ferring s response to Mr. Fein s assertion that he had invented low-dose desmopressin formulations was not that the low dosage invention was Ferring s intellectual property, but that it was not patentable at all, and that Ferring would no longer be pursuing claims directed toward it. Under the facts before it, the Court held that the reliance and prejudice prongs of the equitable estoppel standard were also satisfied and granted summary judgment accordingly. Thereafter, the Court granted Ferring a stay and certified the judgment to permit Ferring to appeal.After Judge Sweet s unfortunate demise, the judge assigned to the case addressed co-defendant s counterclaims that Mr. Fein should be named as an inventor of Ferring s 429 and 654 patents, refusing to amend inventorship. This appeal followed.The Federal Circuit vacated and remanded the decisions of the District Court, in an opinion by Judge O Malley joined by Judges Reyna and Chen. The panel rejected Ferring s challenges on the grounds that the District Court had misapplied the law, specifically with regard to consideration of pre-issuance conduct in MCV, Inc. v. King-Seeley Thermos Co., 870 F.2d 1568, 1572 (Fed. Cir. 1989), and the effect of differences in claim scope under Radio Sys. Corp. v. Lalor, 709 F.3d 1124 (Fed. Cir. 2013), and John Bean Techs. Corp. v. Morris Assocs., Inc., 887 F.3d 1322 (Fed. Cir. 2018). With regard to the latter argument, the panel declined to adopt a bright-line rule that equitable estoppel cannot apply whenever the scope of the issued patent is different than what the parties discussed in communications leading to the allegedly misleading conduct while recognizing that differences in claim scope are relevant to the equitable estoppel inquiry. Nevertheless, the Court stated that such differences can give rise to material issues of fact that the remainder of its opinion addressed. Specifically, Ferring argued that the District Court drew inferences in support of defendants regarding its misleading conduct that were not the only inferences that could be drawn. The panel noted that most commonly a patentee objects to activities as infringing and then fails to file suit for years. Under these circumstances the Court recited these elements of the equitable estoppel defense:(1) the patentee engages in misleading conduct that leads the accused infringer to reasonably infer that the patentee does not intend to assert its patent against the accused infringer; (2) the accused infringer relies on that conduct; and (3) as a result of that reliance, the accused infringer would be materially prejudiced if the patentee is allowed to proceed with its infringement action.And relevant to the issue before the Court, the opinion asserts that [t]o justify summary judgment of equitable estoppel, any inference that a patentee made a misleading communication by omission or acquiescence must be the only possible inference from the evidence, citing SCA Hygiene Prods. Aktiebolag v. First Quality Baby Prods., LLC, 767 F.3d 1339, 1350 (Fed. Cir. 2014). The panel did not believe the inference drawn by the District Court in defendants favor, that Ferring purportedly acquiesced to sole inventorship by Mr. Fein, was not the only inference. Thus, the Court opined that the District Court erred in concluding as a matter of law that Ferring s attempt to correct inventorship contradicted its earlier position as reflected in correspondence with Mr. Fein s attorney. The error was the District Court s view that the scope of the claims discussed in that correspondence was commensurate with the scope of Mr. Fein s granted claims. And by fail[ing] to address material differences in the scope of Fein s issued patent claims as compared to the invention described in the [attorney] correspondence and Fein s application claims the District Court abused its discretion. Specifically, the panel understood (and believed the parties understood) that Ferring had disavowed any ownership claim to the sublingual, transmucosal route of delivery of desmopressin and its associated low-dosage possibilities that Fein identified as his invention. But those are not the claims Mr. Fein pursued. Instead, Fein pursued claims untethered to sublingual administration of desmopressin, according to the opinion (in fact the panel understood the claims to be untethered to any particular administration route). And none of those claims are limited to sublingual administration. Moreover, these claims were pursued despite Ferring s caution that they were not disavowing any claim to other material that could be in those applications. Under these circumstances, the Court believed that a reasonable factfinder could conclude that it would have been unreasonable for Fein to infer from Ferring s pre-2004 communications that Ferring intended to relinquish inventorship rights in the issued claims of the Fein patents. In addition, the opinion disagrees with the District Court s conclusion that Ferring was put on notice when Mr. Fein communicated his patent applications to them, because that conclusion rested on an inadequate claim scope analysis. In particular, the panel focused on duration of action limitations contained in most of Fein s issued claims that were completely absent from Fein s application claims. This was relevant because Ferring based its § 256 claims in part on the very duration of action limitations the district court overlooked. The Court also disagreed with the District Court s conclusions because in the panel s view its interpretation of the significance of the correspondence was not the only reasonable one, and [t]o justify summary judgment of equitable estoppel, any inference that a patentee made a misleading communication by omission or acquiescence must be the only possible inference from the evidence, citing A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020, 1042 (Fed. Cir. 1992) (en banc). Much of the Federal Circuit s concern in this regard involved the usual back-and-forth between Fein and Ferring counsel in this correspondence which is open in retrospect to differing interpretations and is not sufficiently straightforward to justify the District Court s inferences or conclusions. Accordingly, the Court stated [i]n view of the varying reasonable interpretations of the [attorney] correspondence, we must vacate the district court s summary judgment of equitable estoppel and remand for further proceedings. Finally, the Federal Circuit addressed the issue of unclean hands. Being an equitable remedy, defendants assertion of equitable estoppel requires their own conduct to be without reproach. In this case, Ferring contended that the district court erred by ignoring evidence that Fein intentionally and deliberately copied Ferring s . . . clinical study protocol for use in his own clinical studies. Ferring asserted several bases for its unclean hands allegations that the panel did not specifically address. However, the opinion notes that for some of these arguments and evidence supporting them there was no discussion in the record and thus [we have] no basis to infer that the district court considered Ferring s evidence in this regard, which the Court found was another abuse of discretion. The Court accordingly left correction of these errors to the District Court on remand.Ferring B.V. v. Allergan, Inc. (Fed. Cir. 2020)Panel: Circuit Judges O Malley, Reyna, and ChenOpinion by Circuit Judge O Malley

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