The Supreme Court heard oral argument yesterday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. This is a case and an issue that we (and many others) in the pharma-patent world have been watching for a while. But for those who haven’t followed this case, here is a recap of what led us to the Supreme Court:
Amarin obtained a New Drug Application (NDA) for Vascepa, a drug that was originally indicated for lowering triglycerides in patients who have severe hypertriglyceridemia. (the “SH Indication”)
Seven years later, Amarin obtained approval for a new indication: To reduce risk of certain cardiovascular issues when used as an adjunct to maximally tolerated statin therapy in patients with elevated triglycerides. (the “CV Indication”)
In 2016, before Amarin received the CV Indication, Hikma filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification challenging Amarin’s patents that covered the SH Indication.
Hikma prevailed on its Paragraph IV certification. But because Amarin obtained the CV Indication before Hikma prevailed on its Paragraph IV challenge, Hikma needed to address the CV Indication before the FDA could approve the ANDA.
Hikma thus filed a section viii statement, seeking approval only for the uses not covered by Amarin’s patents covering the CV Indication. This led to a so-called “skinny label” for Hikma’s generic product, meaning that the label would omit the CV Indication, and Hikma could only market its generic for the SH-indicated use.
Though the skinny label carved out the CV indication under the “Indications and Usage” section, the label still referenced potential side effects for people with cardiovascular disease. It also referenced the clinical trial that led to the CV Indication.
Upon receiving FDA approval of the ANDA, Hikma began marketing its generic product as a “generic version” of Vascepa, Vascepa’s “generic equivalent,” or “generic Vascepa.” Hikma also described its product as being a generic for “hypertriglyceridemia” and referenced Vascepa’s total sales (i.e., sales for both SH-indicated and CV-indicated uses).
Amarin filed suit, alleging that Hikma’s label and post-approval communications induced infringement of Amarin’s CV Indication patents for several reasons:
Press releases described the “generic version” of Vascepa; A press release in which Hikma referenced Vascepa’s total sales (i.e., sales for both SH-indicated and CV-indicated uses); Hikma’s removal of a statement from the label regarding the unknown effects of the active ingredient on cardiovascular mortality and morbidity; The label’s inclusion of potential side effects for people with cardiovascular disease and mention of the clinical trials related to the CV Indication; and
Website materials that described Hikma’s product as therapeutically equivalent to Vascepa for treatment of hypertriglyceridemia, which Amarin described as being broader than the permitted SH Indication.
The district court dismissed Amarin’s complaint under Federal Rule of Civil Procedure 12(b)(6), noting that the allegations in the complaint did not rise to the level required to allege induced infringement under 35 U.S.C. § 271(b). To that end, the district court ruled that Amarin’s allegations fell short of the necessary “encourage[ing], recommend[ing], or promot[ing]” of the patented use (”taking Hikma’s generic for the reduction of CV risk.”).
The Federal Circuit reversed on appeal. The focus of the analysis turned not on the allegations concerning the label, but on the allegations about the label plus the allegations of Hikma’s other actions. As the Federal Circuit noted, “this is not a section viii case in which the patent owner’s claims rest solely on allegations that the generic manufacturer’s proposed label is ‘not skinny enough,’ such that the label alone induces infringement.” Indeed, the Federal Circuit expressed that it would very likely agreed with Hikma if Amarin’s inducement claims were based solely on the label. Even so, the Federal Circuit held that, at the pleading stage, the additional allegations about Hikma’s press releases and website were enough to plausibly allege that Hikma actively induced infringement of the CV Indication patents.
Hikma petitioned for certiorari, and the Supreme Court of the United States accepted to hear the case on two questions presented:
(1) Whether, when a generic drug label fully carves out a patented use, allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) are enough to plead induced infringement of the patented use; and
(2) whether a complaint states a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use
Argument this morning began, as it does in every Supreme Court case, with arguments from petitioner’s counsel. Hikma’s lawyer started his argument by framing the Federal Circuit’s decision as one that requires generic makers to monitor and actively discourage infringement, which is more than the law requires. Such a requirement, he urged, would disrupt the delicate balance struck by the Hatch-Waxman Act and effectively nullified the section viii pathway by subject generic makers to, at best, paying the hefty legal fees required to defend a lawsuit beyond the pleading stage.
The justices’ questioning of Hikma’s counsel was relatively brief. The most interesting questions were asked by Justice Sotomayor and Justice Jackson. Justice Sotomayor emphasized her concern with announcing bright-line rules in the case because, at bottom, the case was resolved on a motion to dismiss, which presents a case-specific and ultimately fact-specific inquiry. As she noted during her questioning, the Supreme Court usually does not engage in error correction. Justice Jackson, for her part, sought clarification about Hikma’s labeling, asking whether FDA would even permit Hikma to add a disclaimer. This questioning seemed mostly rhetorical, which is a tactic justices may use to signal their position and potentially persuade their colleagues to join them.
Following Hikma’s opening argument, an attorney from the Solicitor General’s office argued. The SG Office’s participation in oral argument is a somewhat common occurrence—albeit slightly rarer in IP cases—when the case involves important issues involving national policy. Deputy Solicitor General Malcolm Stewart, a career attorney in the SG’s office, argued on behalf of the United States in support of Hikma.
A slightly livelier bench asked Deputy SG Stewart questions on topics ranging from the broad policy concerns to purely legal questions. On the former issue, Justices Jackson and Kavanaugh chimed in, both inquiring about the economic consequences for generic manufacturers if the Court set too low a bar for induced infringement in skinny-label cases and how that may disrupt the balance struck by Hatch-Waxman. On the latter, Justice Sotomayor reiterated her concerns about setting bright-line rules. This is a concern the Chief Justice seemingly shared, as he expressed skepticism about the government’s position and the adoption of a bright-line rule that made it too easy for generic companies to avoid induced infringement. Deputy SG Stewart countered this point by noting that the high burden of pleading inducement was “by design” and consistent with the traditional standards for induced infringement. Finally, Justice Alito and Justice Kagan used their razor-sharp styles of questioning to home in on the contours of what legal ruling was at stake in this case. Justice Kagan questioned whether and how the FDA’s determinations about the generic’s label should factor into the analysis. And Justice Alito, in typical fashion, deployed hypotheticals to find the limits of the government’s proposed legal test: What if Hikma not only described its product as “generic Vascepa,” but also mentioned that Vascepa is approved for CV risk? What if Hikma said that ”studies show” that the active ingredient reduces CV risk? Both would, as the government conceded, likely qualify as induced infringement.
After Deputy SG Stewart finished his argument, Amarin’s counsel began to argue his case. He began by noting that the case was not a Hatch-Waxman or skinny-label case, but rather a run-of-the-mill induced infringement case. As he explained, the ultimate issue of inducement is fact intensive and thus not something a court should ordinarily resolve on a Rule 12(b)(6) motion to dismiss, where the Court must accept all well-pleaded allegations as true and draw all reasonable inferences in the non-moving party’s favor.
After counsel for Amarin’s opening remarks, the Justices began asking questions. The bench was notably more interested in asking questions, with each justice (except for the Chief Justice and Justice Sotomayor) interjecting at least once. During this round of argument, two interesting threads emerged.
First, an important legal issue raised in response to questions from Justices Kagan, Gorsuch, and Jackson involved the pleading standard. As Justice Kagan observed, press releases and promotional websites are typically done to influence investors, not prescribers. This creates a problem for Amarin because there would be a disconnect between Hikma’s intent and the unlawful activity. Put differently, Hikma’s intent in releasing the at-issue press releases was to influence investors to buy Hikma’s stock, not to persuade medical professions to prescribe Hikma’s product for off-label, patented uses. Or as Justice Jackson explained: Amarin’s framing of the case improperly focused on how prescribers interpreted the press releases rather than on what Hikma intended in making those press releases. Justice Gorsuch pointed out that this disconnect could pose problems because the pleading standard requires plausibility, not mere possibility. So Amarin would have needed to allege facts indicating that Hikma’s intent in those marketing materials was more likely unlawful (i.e., to promote infringement) than lawful (i.e., to influence investors). In response, Amarin’s counsel noted that Hikma did not challenge the adequacy of the allegations on the “intent” element, so it should not be a basis for reversing the Federal Circuit’s decision.
Second, counsel for Amarin repeatedly emphasized that Amarin had not sued other generic companies. Those companies, unlike Hikma, had not marketed their products in a way that Amarin construed as promoting the patented CV-indicated use. This emphasis seemed to quell some concerns about the impact of the case on generic pharmaceuticals and the viability of the section viii pathway.
So where does this leave things? For now, it is tough to say. My impression is that the Supreme Court is unlikely to write a sweeping opinion that drastically broadens or narrows what qualifies as induced infringement in cases involving skinny labels. I think Amarin can expect a narrow decision that states that, under the generous pleading standard, it has alleged enough facts to support a finding of induced infringement. That said, I would not be surprised if the Court issued a civil-procedure-heavy opinion that rules against Amarin and holds that Amarin’s allegations do not cross the line of plausibility, as Amarin’s allegations make it equally likely that Hikma’s intent was entirely lawful as it was unlawful.
Last week the Federal Circuit decided Teva v. Lilly, restoring the jury’s verdict that Teva’s claims to methods of using CRGP antagonists to treat headache were not proven invalid under 112.
The facts are at a high level, relatively straightforward. Teva’s patent family claimed CGRP antagonists as well as methods of using such antagonists to treat headaches. Lilly challenged those patents through IPRs, with the Board finding the product claims unpatentable based on Lilly’s arguments that the genus of antagonists was well-known and routine to achieve, but upholding the method of use patents finding no reasonable expectation of success in using the genus to treat headaches. The Federal Circuit affirmed both decisions. The parties went to trial, and Lilly argued that the method of use claims were invalid under 112 because they claimed the use of every possible humanized anti-CGRP antibody with no limitation on structure, while disclosing only a single working example within the scope of the claims. The jury found in favor of Teva, but the district court granted Lilly’s JMOL, concluding that the single representative species was not enough under the circumstances of claiming a broad genus. The Federal Circuit reversed, finding substantial evidence could support the jury verdict.
The most controversial aspect of the opinion is that it can be read as drawing a bright-line distinction between claims to a product and claims to method of using the product for the purposes of 112 and applying Amgen. Indeed, the court wrote “Lilly takes issue with the distinction we have drawn between (1) claims to a method of using humanized anti-CGRP antagonist antibodies to treat headache and (2) claims to such antibodies themselves” rejecting Lilly’s argument that this is a “semantic distinction without a difference.” And the court later stated “we note that Lilly’s argument might be more persuasive if the asserted claims were to the genus of humanized anti-CGRP antagonist antibodies themselves. If that were so, this case would resemble Amgen….The asserted claims here are unlike the claims in Amgen[], however, because they do not claim humanized anti-CGRP antagonist antibodies themselves; instead, they claim only the use of such antibodies for the different, limited purpose of treating headache.”
I certainly can’t disagree with anyone who reads this as the holding, and criticizes that holding as nonsensical and emphasizing semantic differences in claiming with unfair results. And I’ll certainly agree the Federal Circuit could have better addressed Lilly’s argument and explained why it was not creating a semantic difference. But I think given the opinion as a whole, that is now how the holding should be read. For example, when distinguishing the cases Lilly cited regarding semantic differences, the court said that neither addressed “a well-known genus used as part of a different invention.” Similarly, when distinguishing Amgen, the court emphasized “In light of the well-known status of anti-CGRP antagonist antibodies and the routine nature of humanization, the more relevant ‘research assignment’ in this case would have been determining which humanized anti-CGRP antagonist antibodies treat headache. [] That assignment was completed; the specification disclosed that all such antibodies work for that purpose.”
In other words, while this point should have been made more clear, I read the holding as turning on the factual determination of the number of representative species and whether there was sufficient support for the genus, not whether it was a method claim. When the court emphasized that the invention was the method of treating headaches, not merely the antibodies themselves, I believe they were inartfully trying to explain why the claims could be novel and non-obvious while relying on the prior art to provide written description and enablement support. But the 112 holding itself was based on finding a sufficient disclosure and enablement of the full genus of antibodies and the belief that the district court too narrowly analyzed the disclosure of the specification in light of the prior art.
Specifically, when analyzing the number of representative species, the district court recognized that “the jury could have found that (1) a POSA would have known methods for making murine (mouse) anti-CGRP antibodies, (2) a POSA could generate anti-CGRP antagonist antibodies, (3) a mouse immunized with CGRP would generate anti-CGRP antibodies, (4) antibodies that antagonize CGRP could be identified using tests that could analyze millions of potentially relevant antibodies in days, and (5) a POSA could confirm an antibody’s ability to antagonize CGRP in animals.” Teva Pharms. Int’l GmbH v. Eli Lilly & Co., No. 18-CV-12029-ADB, 2023 WL 6282898 (D. Mass. Sept. 26, 2023). However, the district court concluded that a “reasonable jury could not have found that the Patents-in-Suit disclosed more than one humanized anti-CGRP antagonist antibody within the scope of the Asserted Claims” and noted that the “jury heard uncontroverted evidence that no humanized anti-CGRP antagonist antibodies were known in the prior art.” Id. at *11.
The Federal Circuit focused on different evidence stating a “reasonable jury could have found that anti-CGRP antagonist antibodies themselves and methods of making them were well known, replete, or extensively described in the prior art—based on Lilly’s own statements that they were ‘well known,’ ‘replete,’ or ‘extensively described’ in the prior art. A reasonable jury could have also found that humanization was a well-established and routine procedure by the priority date—again, based on Lilly’s own statements that it ‘was a well-established and routine procedure’ by the priority date.”
The court elaborated “Although the specification disclosed just one humanized anti-CGRP antagonist antibody, it also disclosed several murine versions and prior-art methods of humanization—against a backdrop of antiCGRP antagonist antibodies (and methods of making them) being well known and humanization being routine.” In other words, the murine antibodies were still relevant and the jury could properly have considered them.
Thus, I do not read the court as holding that the claims pass 112 muster merely because they are method of use claims, but pass muster because based on the evidence (including Lilly’s arguments in the PTAB) a reasonable jury could have found written description support for the full genus. Indeed, the court stated the “jury therefore could have reasonably found that the specification disclosed a representative number of species of humanized anti-CGRP antagonist antibodies for purposes of the claimed invention, thus rendering JMOL of no written description improper.” In other words, in my opinion the court would have reached the same conclusion on 112 if the claims recited the genus of antibodies themselves (those claims simply would have been unpatentable over the prior art).
The court also stated that “critically, a skilled artisan would have understood from the specification that all humanized anti-CGRP antagonist antibodies treat headache.” It also noted elsewhere that Lilly did not dispute that “a reasonable jury could have found that a skilled artisan would have understood from the specification that all humanized anti-CGRP antagonist antibodies treat headache.” In other words, the court found there was support for the genus of antibodies, and support for their use in treating headaches. I think properly read, the holding shows that claiming a method of use requires an additional showing for 112, not an artificially lower burden.
It appears to me that this was likely a very close call on whether the facts truly show full written description support given a single working example within the scope of the claims, but I would view Teva v. Lilly as being limited to its facts and not representing a broad shift in 112 law for method of use claims.
It’s also a good reminder of the interplay between 112 and obviousness and how arguments for one can come back to bite you on the other. For the defense side specifically, keep in mind that obviousness requires only a single embodiment be obvious whereas 112 support must enable the full scope of the claims, so defendants can thread the needle and argue that one embodiment was obvious over the prior art while other embodiments in the scope of the claim are not enabled in light of the same prior art.
I wrote previously about the difficulty challengers to pharmaceutical patents face in proving standing at the Federal Circuit to appeal unfavorable decisions under the Federal Circuit’s view of what constitutes “concrete plans.” Thus, pharma companies may justifiably be hesitant to file petitions for PTAB review too early, lest they have no chance for appeal.
However, the discretionary denial practice under Acting Director Coke Morgan Stewart has focused heavily on “settled expectations” and made it difficult for petitioners to raise challenges more than a few years after issuance, especially if the party waits until litigation has begun. And new Director John Squires has delegated discretionary denial authority to Ms. Stewart, thus I expect this practice to continue. Thus, potential challengers may have an incentive to file early challenges if they want to be able to take advantage of the PTAB.
As others have written, “the PTAB’s role in adjudicating OB patents has been modest, both as an absolute matter and relative to its role for non-OB patents.” Rai, A.K. et al., Post-Grant Adjudication of Drug Patents: Agency and/or Court?, 37:139 BERKELEY TECH. L. J. 139, 166 (2022), available here. As the authors note, this likely is at least in part because the invalidation of a patent in the PTAB does not lift the automatic stay, therefore “the PTAB route is unlikely to be faster than the district court route, and may even be slower.” Id. at 167.
However, this doesn’t account for the benefits ANDA filers could obtain by knocking out patents in advance of filing and the ensuring Hatch-Waxman litigation. The authors noted that biosimilar patents were much more often challenged prior to any litigation (53% v. <10%). Id.
While the potential inability to appeal adverse decisions may dissuade some challengers, the Federal Circuit’s standing doctrine could create an interesting loophole strongly incentivizing early challenges. If a challenger is precluded from appealing the PTAB decision, there is a strong argument collateral estoppel does not apply due to traditional collateral estoppel rules. While Federal Circuit dicta suggests that it would not, the court has not fully answered the question. See AVX Corp. v. Presidio Components, Inc., 923 F.3d 1357, 1363 (Fed. Cir. 2019) (“this court has not decided…whether § 315(e) would have estoppel effect even where the IPR petitioner lacked Article III standing to appeal the Board’s decision to this court. For this court to so hold … we would also have to consider whether § 315(e) should be read to incorporate a traditional preclusion principle—that neither claim nor issue preclusion applies when appellate review of the decision with a potentially preclusive effect is unavailable.”).
Early challengers may be able to have their cake and eat it too – challenge the patents in the PTAB while reserving the ability to raise those challenges again later in district court.
Of course, as I’ve written about previously, challengers likewise cannot benefit from collateral estoppel, thus potentially mitigating the benefits of PTAB challenges in the first place, especially for large patent portfolios.
It will be interesting to see if there are any Congressional efforts to increase the use of PTAB for resolving validity of OB patents, perhaps by giving collateral estoppel effects to related patents, allowing PTAB decision to lift the automatic stay, or creating other incentives for early challenges.
In Incyte Corp. v Sun Pharmaceutical Indus., Inc., the Federal Circuit found a PGR petitioner lacked standing to appeal because its “development plans amount to an expression of intent to create a product that runs a substantial risk of infringement if it is able to clear all development hurdles, secure FDA-approval, and bring its product to market” which was “too speculative to show concrete plans to develop a” product that “will be administered at the claimed dosage.” (emphasis in original).
The majority opinion is hardly surprising to those who have followed this issue. What is far more interesting to me is Judge Hughes’ concurrence. While agreeing the majority decision “is the result compelled by [the Federal Circuit’s] precedent,” Judge Hughes wrote separately because that he believes that “precedent on whether parties have standing to appeal to this court from an adverse administrative post-grant review is too restrictive and creates a special standing rule for patent cases.” Judge Hughes further noted that the “existence of this narrower special rule is even more pronounced in the pharmaceutical space.” I agree with both points.
Judge Hughes then went through several cases, noting the focus on a lack of certainty of when or if a product would get approval and be marketed. But as Judge Hughes rightly points out, “[a]s a practical matter, pharmaceutical drugs generally have long development timelines, which inherently means there is more uncertainty about whether a drug will ever reach the market or infringe a given patent.” As he further noted, precluding appeal is especially harmful because a “party seeking to develop a drug that may infringe an existing patent has a significant interest in trying to invalidate that patent before making the large financial and time investments such development efforts demand.” In other words, challengers are stuck in a Catch 22 – challenge a patent before significant investment and run the risk of no appellate review, or wait until after investment when costs are already sunk (or design around the patent, which may be unnecessary).
I agree with Judge Hughes’ policy concerns, and am interested to see if Incyte takes the invitation to seek en banc or Supreme Court review. What the concurrence is light on, however, is legal analysis of what is required for standing under Supreme Court jurisprudence. Judge Hughes cites a single case on standing, stating “Article III standing requirement is not meant to be a high barrier; the Supreme Court has characterized it as setting ‘the irreducible constitutional minimum.’” citing Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992) (emphasis added by Judge Hughes).
Noticeably absent, for example, is any citation to MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), where the Supreme Court addressed standing in the analogous situation of declaratory judgments, albeit in the context of whether a licensee was required to terminate the license prior to bringing an action. As Justice Scalia noted, the Supreme Court cases on standing “do not draw the brightest of lines between those declaratory-judgment actions that satisfy the case-or-controversy requirement and those that do not.” Justice Scalia quoted an earlier 1941 Supreme Court case, where the Court “summarized as follows: ‘Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.’”
I’m not sure if Incyte is the best vehicle for a challenge. For example, the majority noted that the petitioner’s “declarations show Incyte allocated a small amount of funds one month before filing this appeal for initial development of two topical drugs to treat alopecia areata: one with the active ingredient implicated by the claims at issue, deuterated ruxolitinib, and the other with non-deuterated ruxolitinib, which undisputably would not be covered by the claims at issue” and did not explain why it would likely infringe the dosage limitations other than by providing conclusory testimony. Thus, reasonable minds can certainly differ about whether there was “sufficient immediacy and reality.” However, the majority also made statements such as “The testimony shows that, when it filed this appeal, Incyte faced significant manufacturing, formulation, testing, and regulatory hurdles to bring either product to market” which Judge Hughes noted seems to require facts “that would only happen on the eve of FDA approval or commercial launch.” Requiring a party reach that stage to find “sufficient immediacy” would be a high bar indeed.
As Judge Hughes noted in other cases standing was found lacking where a drug “had already been developed and completed Phase II clinical trials.” citing Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, 85 F.4th 1377, 1380–81 (Fed. Cir. 2023). A case with such indisputably concrete investments might make a better vehicle.
Since it has been a while since my last post, I’m going to do something a little different and do a quick run down of ten Federal Circuit cases that have issued in the past few months and highlight some key takeaways. I’ll give a quick bullet point review of the cases, with slightly more detailed explanation below.
Metacel Pharms. LLC v. Rubicon Research Private Ltd., No. 2023-2386, 2025 WL 1178384 (Fed. Cir. Apr. 23, 2025) – ANDA label suggesting storage at room temperature but permitting refrigerated storage did not induce infringement of claims to refrigerated storage
Azurity Pharms., Inc. v. Alkem Lab’ys Ltd., No. 2023-1977, 2025 WL 1036994 (Fed. Cir. Apr. 8, 2025) – Brand’s disclaimer of propylene glycol by addition of “consisting of” preamble in parent patent precluded finding of infringement
Janssen Pharms., Inc. v. Mylan Lab’ys Ltd., No. 23-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) – Label describing reinitiation protocol for schizophrenia drug induced infringement of claims to reinitiation process
Actavis Lab’ys FL, Inc. v. United States, 131 F.4th 1345, 1353 (Fed. Cir. 2025) – Generic Hatch-Waxman litigation expenses deductible as ordinary business expenses
Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 130 F.4th 1372 (Fed. Cir. 2025) – Claims reciting separate elements VEGF antagonist and buffer not likely to be infringed by product with self-buffering VEGF antagonist because of Becton presumption that separate elements are distinct components and intrinsic record supported, rather than rebutted, that presumption
Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 130 F.4th 1363 (Fed. Cir. 2025) – PTE statute applies to reissued patent that retained original claims based on regulatory delays following issue date of original patent
In re Xencor, Inc., 130 F.4th 1350 (Fed. Cir. 2025) – Claims to method of treating a patient with an antibody not patentable for lack of written description support for treating a patient portion of preamble
In re Strongbridge Dublin Ltd., No. 2023-2302, 2025 WL 751116 (Fed. Cir. Mar. 10, 2025) – Claims to a method of administering a drug without concomitant administration of other drugs did not require actively discouraging concomitant usage, but finding mere silence in prior art clinical report not substantial evidence of lack of concomitant use and remanding for further consideration
CQV Co. v. Merck Pat. GmbH, 130 F.4th 1344 (Fed. Cir. 2025) – Remanding where Board did not fully address evidence of prior art’s public availability
ImmunoGen, Inc. v. Stewart, 130 F.4th 1328 (Fed. Cir. 2025) – Affirming obviousness finding for claims to dosing regimen based on Adjusted Ideal Body Weight because ocular toxicity was a known problem for similar drugs, AIBW dosing regimens were known for avoiding ocular toxicity, and prior art taught dosing in similar amounts based on Total Body Weight
In Metacel Pharms. LLC v. Rubicon Research Private Ltd., No. 2023-2386, 2025 WL 1178384 (Fed. Cir. Apr. 23, 2025) the Federal Circuit affirmed a grant of summary judgment of non-infringement where the claims required storage at “at from about 2 to about 8°C” and the accused ANDA label instructed storage at room temperature and stated only that the product can be refrigerated and “can also be stored at 2°C to 8°C.”
The Federal Circuit described this type of label as an “if/then” statement, i.e., “if a downstream user decides to refrigerate the product, despite instructions to store the product at room temperature (which is noninfringing), then it should store the product at temperatures from 2°C to 8°C” and held “[t]hat is not inducement.” The panel then held that “where, as here, a label is unambiguous, circumstantial evidence cannot override its plain language.” It nevertheless considered the circumstantial evidence but found it too did not create a genuine dispute of material fact. First, it held “Rubicon’s FDA submissions are not available to downstream users and therefore cannot cause inducement.” It then considered expert testimony that a doctor would turn to the brand label which would lead to infringement, but rejected that argument “because it relies on downstream users turning to Metacel’s own Ozobax label as evidence of Rubicon’s specific intent to induce” which was “not persuasive.” The case reaffirmed that the induced infringement standard for ANDAs focuses first and foremost on the label and that the mere probability that users might infringe is not sufficient, absent evidence of specific intent from the ANDA holder.
In Azurity Pharms., Inc. v. Alkem Lab’ys Ltd., No. 2023-1977, 2025 WL 1036994 (Fed. Cir. Apr. 8, 2025) the court affirmed a finding following a bench trial that Alkem’s generic product could not infringe the patents because Azurity had disclaimed any use of propylene glycol during the prosecution.
During prosecution of a parent patent, Azurity attempted to distinguish a prior art reference using negative limitations excluding propylene glycol as a carrier and eventually obtained claims using the transitional phrase “consisting of” and distinguishing the claims from that prior art reference arguing “the absence of propylene glycol in the claimed invention, in part, distinguish it from [the prior art]” which the Examiner cited as a basis for allowance. During the later application that became the asserted patent, and following receipt of Alkem’s Paragraph IV letter, the applicants stated “For the record, Applicant did not disclaim propylene glycol when submitting the arguments in U.S. 15/126059, and reserves the right to claim propylene glycol in the instant and future cases in this patent family.” However, the claims still used the “consisting of” preamble and did not list propylene glycol.
Azurity argued that propylene glycol could be the claimed “flavoring agent” and thus was not excluded from the claims due to the closed “consisting of” language. The panel was not convinced, noting that the claims of the asserted patent were nearly identical to the claims of the parent patent, which Azurity had repeatedly argued excluded propylene glycol, and giving little attention to Azurity’s attempt to walk back the disclaimer. The panel noted that while Azurity had tried to narrowly exclude propylene glycol as a carrier, it had relented and used the closed “consisting of” language. Thus, the panel held that even if in the prior art propylene glycol functioned only as a carrier, “what matters most is the broad language that Azurity used to distinguish Palepu” and “[j]ust as the echo matches the shout, Azurity’s repeated, sweeping statements—endorsed by the examiner—return an equally sweeping disclaimer.”
Finally, the panel agreed with the district court that a stipulated finding of fact that “Suitable flavoring agents include for use in the Asserted Claims include flavoring agents with or without propylene glycol.” The panel noted that the section began with a statement that Alkem “contends that it does not infringe the Asserted Claims due to the presence of propylene glycol in Alkem’s ANDA Products” and it would be nonsensical for Alkem to have framed the infringement dispute that way, but then stipulated to infringement. Among other factors, the panel agreed that in context, the “district court correctly concluded that the disputed stipulation did not preclude application of disclaimer in this case.”
The case is a good reminder to prosecutors that broad disclaimers in a parent application can limit later claims and that later attempts to undo a disclaimer are unlikely to be effective. And while Alkem prevailed, the case is also a good reminder to be careful with pretrial statements of undisputed facts.
In Janssen Pharms., Inc. v. Mylan Lab’ys Ltd., No. 23-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025), the court affirmed a DNJ decision finding Janssen had proven induced infringement of claims to treating patients with paliperidone palmitate (PP) who had missed a treatment and that Mylan had not demonstrated invalidity by clear and convincing evidence.
PP, used to treat schizophrenia, comes in two forms, a form that lasts one month (PP1M) and a form that lasts three (PP3M). Janssen markets Invega Trinza, a PP3M. The asserted patent covers methods of reintroducing PP3M to patients who have missed a dose, by first administering PP1M. The label specifically instructs that if a patient has missed a dose, i.e., had his or her last dose between 4 and 9 months ago, “do NOT administer the next dose…[i]nstead, use the re-initiation regimen” recited in the claims.
Mylan presented three non-infringement arguments: (1) Mylan cannot induce infringement because its label discourages missing doses in the first place; (2) Janssen failed to show infringement would inevitably occur; and (3) there was a divided infringement problem. The panel did not find any argument persuasive. On the first issue, the panel agreed with the district court that “the fact that Mylan’s proposed ANDA labels ‘discourage missed doses’ does not mean that the labels ‘discourage or make optional the practice of the asserted claims (or any claimed steps) in the inevitable situation that doses are missed.” On the second issue the panel found sufficient evidence that some users would inevitably miss doses and be reinitiation, including the testimony of Mylan’s own expert. On the third issue, the panel agreed with the district court that “Mylan’s divided infringement theory was not disclosed in its contentions, and appeared improperly for the first time in Mylan’s rebuttal expert report” and that in view of the “deferential review standard” the district court did not abuse its discretion in not considering it.
Regarding invalidity, the panel found no clear error in the district court’s findings that “nothing in the prior art motivated a skilled artisan to use PP1M after a patient has been advanced to PP3M” and that even considering the prior art teaching of starting on PPM1M, there would have been no apparent reason to transition within the claimed 23rd-27th day where the art taught to stabilize a patient on PP1M for 17 weeks.
What’s interesting to note with this decision is that it effectively allows Janssen to block an undisputed non-infringing use (regular treatment with PP3M) based on the reinitiation language of the label. Of course substantial non-infringing uses is relevant to contributory infringement, not induced infringement. It is unclear from the record whether Mylan could have carved out the reinitiation language, but it should be a warning to generics that induced infringement can be found even for instructions that do not go to the primary use.
In Actavis Lab’ys FL, Inc. v. United States, 131 F.4th 1345, 1353 (Fed. Cir. 2025) the Federal Circuit agreed “with the trial court’s conclusion that Actavis may deduct its Hatch-Waxman litigation expenses as ordinary and necessary business expenses.” This was hardly a surprise, given the Third Circuit’s similar holding in Mylan Inc. v. Comm’r of Internal Revenue, 76 F.4th 230, 233-38 (3d Cir. 2023), but it’s an interesting read with a concise background of the Hatch-Waxman process. While the nuances of tax law are probably not our reader’s primary interests, the decision was interesting in that it rejected an argument that ANDA litigation was an expense occurred in obtaining capital, holding “the origin of the claim in Hatch-Waxman litigation is a patent claim brought by the NDA holder, and not the pursuit of effective FDA approval of an ANDA sought by the ANDA filer” because “the issues in the litigation and the issues in the regulatory approval process are different, and they are resolved by different decision-makers.” It similarly noted the “intangible asset sought by the ANDA filer is final, effective approval of the ANDA itself – and acquisition of that asset is not facilitated by Hatch-Waxman litigation.”
In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 130 F.4th 1372 (Fed. Cir. 2025) the court affirmed a WDVA court’s denial of Regeneron’s motion for preliminary injunction, finding the trial court correctly held that the separate listing of “VEGF antagonist” and “buffer” required two separate components and could not read on a self-buffering antagonist.
I wrote about the district court’s decision back in October and was unsurprised to see an affirmance based on the Becton line of cases holding that “where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.”
The panel first rejected Regeneron’s argument that Becton did not apply because the district court had previously construed “buffer” to cover proteins like aflibercept (the alleged VEGF antagonist), stating that Regeneron “conflates two independent claim construction inquiries” because “claim construction inquiry relevant here, under Becton, is directed to whether a formulation is claimed in a way that clearly implies it requires distinct components” not simply whether the scope of “buffer” and “VEGF antagonist” can overlap.
Applying the Becton presumption, the panel agreed with the district court that not only did the intrinsic evidence overcome the implication, but that the claims and specification “only reinforce that the claimed components are distinct.” It agreed that all of the claims treat VEGF antagonist as separate from the buffer component, for example reciting their concentrations in different units, and the “the specification describes a formulation containing a VEGF antagonist plus a distinct buffer component” including a separate buffer in all eight examples. The panel noted that “Regeneron’s avoidance of the specification’s disclosures, or lack thereof, is telling and is an apparent concession” the specification did not help. Instead, Regeneron primarily argued that the plain meaning of buffer was broad enough to cover a aflibercept and Regeneron had not disavowed the full scope. But the panel found this unconvincing in light of Becton and the fact that the patent nowhere suggested a VEGF antagonist buffer was a part of the invention.
The panel also agreed with the district court that it need not even address the extrinsic evidence, but that it in any case it did not err in considering and discounting that evidence finding that it was reasonable for the district court to conclude that a contemporaneous reference’s teaching of buffer-free formulations “actually supports Amgen’s contention that self-buffering proteins were not well known” and that the contemporaneous art “advanced the art over the ’865 patent precisely by disclosing certain buffer-free formulations in which the therapeutic protein is itself capable of maintaining pH stability.”
While the panel (and district court) seemed unequivocal that infringement could not be found, it didn’t need to go that far, concluding “there is at least a substantial question of noninfringement” and thus Regeneron was not entitled to a preliminary injunction. I expect Amgen to prevail on motion for summary judgment on remand shortly.
In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 130 F.4th 1363 (Fed. Cir. 2025) the court affirmed a DNJ district court’s conclusion that a reissued patent was entitled to a five-year patent term extension and had not expired.
Merck’s 340 patent issued on December 30, 2003, directed to cyclodextrin derivatives. Four months later, Merck applied for approval of sugammadex, the active ingredient in BRIDION®. During the pendency of FDA review, Merck filed for a reissue, retaining the original claims but also adding narrower claims to cover sugammadex specifically. BRIDION® was approved in 2015, and Merck successfully filed for PTE seeking the five year maximum, extending expiration of the patent from 2021 to 2026.
The generic defendants argued that the plain language of the PTE statute (35 U.S.C. § 156) only allows for an extension of “the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued” and that “the patent is issued” should mean the reissue date of the patent, dramatically cutting the length of the extension.
The panel first found that the statute was ambiguous as to which issue date the statute refers to. It then turned to the context of the PTE statute which it stated was clear: “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.” It sided with Merck, holding that such a construction “compensates Merck for the period of exclusivity lost due to regulatory delay” while the defendants’ reading “denies Merck compensation for all but a small period of the delay” and “[t]here is no reason why the Hatch-Waxman Act’s purpose would be served by disabling extensions of the unexpired term solely based on a patent holder’s decision to seek reissue.” It will be interesting to see if future cases apply Merck as a per se rule, or confine it to the facts of this case where the reissue patent contained the same original claims. For example, would the same result hold if Merck had cancelled its broader original claims and replaced them with all new narrower claims? Perhaps we’ll find out soon.
In In re Xencor, Inc., 130 F.4th 1350 (Fed. Cir. 2025), the court affirmed a PTAB Appeals Review Panel decision refusing to grant a claim to a method of “treating a patient by administering an anti-C5 antibody” and a similar Jepson claim as lacking written description support.
The panel first construed the claims and agreed with the PTAB that the “treating a patient” language in the preamble was limiting, because (1) the second part of the preamble, “administering an anti-C5 antibody” was limiting and it would not “splice” the clause into limiting and non-limiting portions; (2) “the more reasonable reading is that both sections of the preamble… give color and meaning to the other”; and (3) “the language in the preamble provides a raison d’être for the claim” and the claim would otherwise be a mere “academic exercise.”
Then panel then found substantial evidence supported the PTAB’s determination that the specification lacked written description support for treating a patient because it “does not define the term ‘treating,’ and it does not describe or provide any data associated with treating any patient with any disease or condition with any anti-C5 antibody, including an anti-C5 antibody with the claimed Fc modifications.”
The panel also agreed that the preamble of a Jepson claim requires written description support, otherwise a patent could evade the written description requirement, using the hypothetical that a “patentee cannot obtain a Jepson claim with a preamble that says that a time machine is well-known in the art without describing a time machine, in sufficient detail to make clear to a person of ordinary skill in the art that the inventor is in possession of such a time machine.” It then found that substantial evidence supported the Board’s conclusion that anti-C5 antibodies were not well known in the art.
The decision highlights the importance of language in the preamble and the need to not allow patentees to overreach in claiming. Interestingly, the decision focuses heavily on the “treating a patient” language, begging the question of whether the claim would have been allowed if it simply recited “administering anti-C5 antibodies” without any identified purpose of administration, let alone test results. Perhaps it would have led to a utility/enablement problem. See In re ‘318 Pat. Infringement Litig., 583 F.3d 1317, 1327 (Fed. Cir. 2009) (claims to treating Alzheimer’s lacked enablement where no test results of any kind because “at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient”). It’s interesting to me the panel did even mention whether such claims might have been patentable.
In In re Strongbridge Dublin Ltd., No. 2023-2302, 2025 WL 751116 (Fed. Cir. Mar. 10, 2025) the court confirmed that a method of administering a drug without “concomitant” drugs did not require actively discouraging use of the concomitant drugs, but only that a single patient not be given the concomitant drugs, but remanded for the Board to determine whether a POSA would have understood a clinical study not mentioning the concomitant drugs to have meant one or more patients was not taking such drugs.
The panel first construed the term “avoiding concomitant administration” and held that it did not require actively encouraging patients to avoid such drugs, because the “plain and ordinary meaning of ‘avoid’ is [] consistent with claim coverage in situations in which patients are simply not taking famotidine or methotrexate while they are taking dichlorphenamide” noting that by “way of example, a person who drives one route home from work avoids or keeps away from a traffic jam that takes place on an alternative route home even if that person does not take the active step of deciding to avoid that traffic jam.” The panel further noted that the applicants had originally sought claims with more active language and thus was not attempting “to rewrite the claims to confine them to the very claims it cancelled.”
Interestingly, the panel then turned to the Board’s finding of anticipation by a reference (Sansone) that disclosed the treatment method claimed, but did not mention the concomitant drugs, but held that there was not substantial evidence that the reference taught the method without the use of those drugs. It held that the “correct anticipation inquiry in this case is whether the examiner established on a preponderance of evidence that only one patient in Sansone was not taking” the concomitant drugs.
It then held that the Board’s findings that (1) Sansone does not mention the concomitant drugs and (2) the patient classes in Sansone are unrelated to the patient classes who take the concomitant drugs “are relevant but not substantial evidence in and of themselves” because “[t]here must be something more to suggest that the silence is significant, or other reasons that establish by a preponderance of the evidence that it is likely that one or more of the patients in Sansone were not taking famotidine or methotrexate at some time during the nine week and/or fifty-two-week length of the study.” “This could include, for example, proof from the structure of the study, the results of the study, or statistical analysis as to the likelihood that at least one patient was not taking famotidine or methotrexate.” I’m a bit surprised by this holding, as it seems to require the Examiner/Board to obtain expert testimony analyzing the Sansone reference or performing statistical analysis. It seems clear to me at least, that there is sufficient evidence for one to infer that a study would have mentioned concomitant administration of other drugs and their absence is at least prima facie evidence, sufficient to shift the burden to patentee. Otherwise, this seems to make it extremely difficult for examiners to ever reject claims with such negative limitations. Perhaps the Examiner/Board could have evaded such a problem by issuing an obviousness rejection in the alternative. It will be interesting to see how it handles the case on remand.
In CQV Co. v. Merck Pat. GmbH, 130 F.4th 1344 (Fed. Cir. 2025) the court remanded a final written decision finding claims not unpatentable because the Board failed to address all of the evidence showing a sample batch was prior art.
The court first addressed Merck’s argument that CQV lacked standing to appeal, but held that “[g]iven at least one customer’s purchase and use of Adamas® products in the United States, Merck’s communications with that customer [asserting infringement], and CQV’s indemnity agreement with that customer, CQV has established that it has standing to pursue this appeal.”
The court then addressed CQV’s arguments on the merits and found them persuasive. The Board considered three pieces of evidence that demonstrated that “Sample C” was publicly available: (1) “general statements about the availability of the Xirallic® product line that were not linked to Sample C”; (2) fact testimony that “CVQ purchased Sample C in about October 2011”; and (3) evidence that “Merck manufactured Sample C in 2007 and is incentivized to sell a batch as soon as possible so as not to waste shelf-life.” However, the Board did not address other evidence, such as testimony that after being released from quality control, a customer can purchase product. The panel stated that “CQV raised highly material and unrebutted evidence that Sample C would have been made available to the public within a few weeks of being placed into quality control, which the Board discarded without explanation.”
While noting that “failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it,” (quoting Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017)) the panel held that the Board’s decision “goes beyond a failure to discuss a ‘cursory argument’” and the panel “cannot reasonably discern whether the Board followed a proper path.” Thus, it remanded the case for further fact finding. Interestingly, the panel did not address whether substantial evidence would have supported the Board’s determination.
I expect this decision to be cited often in appeals from IPR decisions whenever a party perceives that the Board did not fully address all arguments. It will be interesting to see how future panels strike a balance between the holding here and the holding in Novartis.
In ImmunoGen, Inc. v. Stewart, 130 F.4th 1328 (Fed. Cir. 2025), the court affirmed the district court’s agreement with the PTAB/examiner’s rejection of claims to dosing regimens of a drug for treating ovarian and peritoneal cancer.
The panel first addressed ImmunoGen’s arguments that because the claimed drug was not known to cause ocular toxicity, such concerns could not have motivated a POSA to modify the prior art, but rejecting it noting that while “[w]here a problem was not known in the art, the solution to that problem may not be obvious,” (quoting Forest Lab’ys, LLC v. Sigmapharm Lab’ys, LLC, 918 F.3d 928, 935 (Fed. Cir. 2019), “it does not follow that a claimed solution to an unknown problem is necessarily non-obvious.” The panel then found no clear error in the district court’s “findings that a person of ordinary skill in the art, despite not knowing of IMGN853’s ocular toxicity, would have nonetheless been motivated to monitor for those side effects when administering the drug to humans” because ocular toxicity was a “well-known adverse event in the administration” of related compounds.
It then addressed ImmunoGen’s arguments that a POSA would not have been motivated to try a “AIBW” dosing regimen, but again found no clear error in the court’s findings that such a regimen “would have been within the range of knowledge of a person of ordinary skill in the art when confronted with dosing-induced toxicities, and particularly when confronted with dosing-induced ocular toxicity” because “AIBW dosing was a well-known methodology that had been implemented on drugs both smaller and larger than IMGN853 and had been used to specifically reduce ocular toxicity.”
Then panel then addressed whether a POSA would have been motivated to select the claimed dose of 6 mg/kg AIBW (AIBW “refers to a size descriptor that accounts for sex, total body weight, and height” and is a modification of total body weight or TBW). The panel then noted that two prior art references taught dosing of the drug at 6 mg/kg of TBW and 5 mg/kg TBW, and agreed with the district court that a POSA “would start with doses of around 5 mg/kg or 6 mg/kg AIBW and then determine the precise dose based on routine optimization.” Indeed, the panel noted that evidence showed that “for patients who weigh exactly their ideal body weight, a dose of 6 mg/kg AIBW is identical to a dose of 6 mg/kg TBW,” and thus for some patients the prior art explicitly taught the claimed dosing amount.
Finally, the panel rejected ImmunoGen’s argument that the district court failed to find a reasonable expectation of success “that a 6 mg /kg AIBW dose would solve ocular toxicity” because the “claims are silent as to any ocular toxicity problem.”
The case is a good reminder of the flexibility of the obviousness inquiry and the difficulty on appeal of attacking motivation to combine factual findings.
I wrote previously about oral argument in the Kroy v. Groupon case, where the Federal Circuit grappled with how to apply collateral estoppel from PTAB decisions in IPRs and PGRs where related unchallenged claims from the same patent are at issue in district court. As I wrote then, the appellant presented an interesting argument that the clear and convincing evidence standard should not apply since the patent office has revisited the patentability determination of related claims.
The Federal Circuit finally issued its opinion, and confirmed its view that collateral estoppel simply does not apply due to the different evidentiary standards. Unfortunately, the Federal Circuit dodged the appellant's strongest argument. This argument may not have been fully developed in the briefing (which took place before the Federal Circuit's previous opinion reaching a similar conclusion in Parkervision), but I am a bit surprised that the panel did not address it, especially given the length of time it took for the opinion to issue.
But the takeaways are clear—an accused infringer must challenge all patents in the patent office to take advantage of any collateral estoppel effects of a final written decision. Thus, defendants in district court litigation should be prepared to challenge every claim of any asserted patent within the one year time bar.
Not only will the defendant not be able to argue for collateral estoppel, the defendant likely will not be able to raise the IPR to a jury at all. See, e.g., Prolitec Inc. v. ScentAir Techs., LLC, No. CV 20-984-WCB, 2024 WL 341342, at *1 (D. Del. Jan. 30, 2024) (Bryson, J., sitting by designation) ("The invalidity of the unasserted claims is irrelevant to the issues in this case. And any effort to mitigate the risk of prejudice to Prolitec from disclosing that those claims have been held invalid would require excessive digression into the nature of inter partes review proceedings and the different standard of proof applied to invalidity inquires in inter partes review proceedings, as compared to district court proceedings. Accordingly, the jury will not be told that those claims have been held invalid."); Medtronic, Inc. v. Axonics Modulation Techs., Inc., No. 8:19-CV-02115-DOC-JDE, 2024 WL 3550482, at *5 (C.D. Cal. July 18, 2024) ("any probative value of discussion of the PTAB's invalidation of other claims of the patents-in-suit would be substantially outweighed by the dangers of unfair prejudice, jury confusion, and waste of time").
In today’s blog, we are straying from our Orange Book roots to discuss the Federal Circuit's recent decision in Regeneron Pharmaceuticals v. MylanPharmaceuticals, a case arising under the BPCIA. Regeneron owns several patents covering its EYLEA® product. EYLEA® contains the protein aflibercept, a VEGF antagonist, and is used to treat various conditions that affect the eyes. Several companies filed abbreviated Biologics License Applications (aBLAs) seeking approval for EYLEA® biosimilars. Regeneron then sued four of these aBLA filers in West Virginia and secured a preliminary injunction against them.
On appeal, one of the defendants—Samsung Bioepis—argued that the preliminary injunction should be reversed on the merits and because the district court in West Virginia could not exercise personal jurisdiction over Samsung because Samsung was “at home” in Korea and lacked adequate suit-related conduct in West Virginia to establish the requisite “minimum contacts” there. The court, however, disagreed with Samsung and affirmed. And while the decision includes some interesting obviousness-typedouble-patenting analysis, perhaps the most interesting part of the Federal Circuit’s opinion is the part that addresses personal jurisdiction. To this end, the court held that, under its decision in Acorda Therapeutics v. Mylan Pharmaceuticals, 817 F.3d 755 (Fed. Cir. 2016), personal jurisdiction in West Virginia was appropriate because Samsung’s proposed bioequivalent product will be sold throughout the U.S., including West Virginia, albeit through a distributor. Regeneron, slip op. at 13.
By way of background, Acorda addressed whether an ANDA filer could be sued under the Hatch-Waxman Act in Delaware even though it was “at home” for personal jurisdiction purpose in another state, prepared the ANDA in that other state, and filed the ANDA at the FDA’s Maryland office. The court said, “Yes.” While the Due Process Clause requires a defendant to have adequate “minimum contacts” with a forum before it can be sued there, the Acorda court held that those contacts could be established through reliable, non-speculative evidence about conduct that will take place should the defendant’s ANDA be approved. Acorda, 817 F.3d at 762. Or as the court put it: “[I]t suffices for Delaware to meet the minimum-contacts requirement in the present cases that Mylan’s [ANDA] filings and its distribution channels establish that Mylan plans to market its proposed drugs in Delaware and the lawsuit is about patent constraints on such in-State marketing.” Id. at 762-63. Through that lens, Regeneron seems like a natural application of Acorda in the BPCIA context. But that lens glosses over some key factual differences between the two cases.
For starters, the Acorda defendant and Samsung have very different relationships with their respective forum states. In Acorda, the defendant was “registered to do business and appointed an agent to accept service in Delaware,” and registered with the Delaware Board of Pharmacy as a licensed “Pharmacy-Wholesale” and a “Distributor/Manufacturer CSR.” Acorda, 817 F.3d at 758, 763. Indeed, it even sent the Paragraph IV notice letter to the plaintiff’s U.S. subsidiary’s headquarters in Delaware. Samsung, by contrast, has no facilities in West Virginia, no employees there, has not registered to do business with the West Virginia Secretary of state, does not have a registered agent for accepting service in West Virginia, and has no current or planned business with companies in West Virginia.
Second, and perhaps more importantly, evidence showed that the Acorda defendant had, unlike Samsung with West Virginia, taken concrete, affirmative steps to exploit the Delaware market. More specifically, the Acorda defendant had established “a network of independent wholesalers and distributors with which it contracts to market the drugs in Delaware.” Acorda, 817 F.3d at 763. But Samsung has no such network. Indeed, the sole basis for finding personal jurisdiction in West Virginia over Samsung was that Samsung had contracted with Biogen for nationwide distribution rights for the biosimilar and that Samsung “has not sought to limit the States where SB15 will be marketed, distributed, or sold.” Regeneron, slip op. at 14 (emphasis added). And while it was unclear exactly how much control Samsung would have over Biogen’s distribution and sales of the prospective biosimilar product, see generally id. at 13-14, the court outright rejected the argument that it made a difference whether Samsung used a third-party distributor or did its own distribution based on the language in Acorda about the defendant’s Delaware distribution network. See slip op. at 15.
But the factual differences between Acorda and Regeneron are quite significant ones for personal jurisdiction. The typical rule is that the defendant must purposefully direct conduct to the forum state for that conduct to count in the “minimum contacts” analysis. Acorda, as I understood the decision until recently, adhered to that rule by focusing on concrete steps that the defendant had taken to exploit the Delaware market with its proposed ANDA product. Regeneron, on the other hand, focuses not on any purposeful conduct directed at West Virginia, but on the absence of any disclaimer of future conduct directed there. This seemingly turns decades of jurisprudence on its head. In effect, Regeneron holds that prospective biosimilar (or generic) manufacturers have purposefully availed themselves to states that they may never actually do business in for a drug that may never launch simply because they have chosen not to narrow their distribution plans a priori. The upshot is that, absent a carve out, a nationwide distribution agreement may subject the companies to personal jurisdiction in every judicial district in every state.
In sum, Regeneron seems to drastically expand the scope of personal jurisdiction, particularly for foreign-based prospective defendants who have few ties to the United States. This may have huge consequences for generic and biosimilar manufacturers who hope to avoid litigating in certain forums, so it will be interesting to see how Regeneron influences companies’ pre-approval, pre-commercialization conduct.
The Federal Circuit today affirmed the D.N.J. decision that Teva's inhaler patents cannot be listed in the Orange Book, because they do not claim the drug for which the application was listed.
As I wrote in my last post below, I thought Teva would have a hard time prevailing given that the patents at issue did not even claim an active ingredient, let alone any specific active ingredient. The Federal Circuit panel agreed, focusing on this absence.
For example, in its discussion of the patents, it noted "None of the claims in the five asserted patents explicitly require the presence of an active drug, let alone any specific active drug." Interestingly, the panel ruled entirely based on the first clause, requiring that the patent to "claims the drug" and not the more specific requirement that the patent “is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent.” 21 U.S.C. § 355(b)(1)(A)(viii). Specifically, the panel held that "claims a drug" means "when it particularly points out and distinctly claims the drug—not simply when the claim could somehow be interpreted to read on the drug." It then rejected Teva's argument that the definition of drug controlled, focusing instead on the entirety of the FDA regulatory scheme. The panel noted that while Teva's product may be a drug, the inhaler alone (without an active ingredient) would be a device, not a drug, and it is only the active ingredient that makes the product a drug. Thus, "to claim that drug, the patent must claim at least the active ingredient."
The Court then addressed a question I raised in my previous post—how specific must one claim the active ingredient to "claim a drug." Teva argued that the claims, though not explicitly reciting an active ingredient, should be construed to require one. The panel found this argument "dubious" but held even a "claim requiring the presence of 'an active drug' is far too broad to particularly point out and distinctly claim the drug approved in Teva’s NDA." The panel left open the question of what would be sufficient (e.g. claiming albuterol generally? A class that includes albuterol?).
The clear message to patent drafters is that to be listable, a claim must be as specific as possible in claiming the active ingredient approved.
As readers of this blog surely known, parties seeking to launch a generic drug must address the patents listed in the Orange Book for the reference listed drug. Listing of a patent in the Orange Book is a powerful tool for pharmaceutical patent owners, as it gives the right to an automatic 30 month stay against generic competition without meeting the stringent requirements for a preliminary injunction (an "extraordinary remedy"). Moreover, unlike a typical preliminary injunction which requires the patentee to post a bond allowing the enjoined party to seek compensation for its losses during the enjoined period if the patent is determined to be invalid or not infringed, there is no effective recourse for lost sales of a generic during during the automatic 30-month stay (at least that I am aware of).
Understandably then, much attention has been given to what patents may be listed in the Orange Book. The senate passed the Orange Book Transparency Act of 2020 (unanimously!), which in part sought to clarify the scope of patents that could be listed in the Orange Book, limiting them to “claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent” or "claims a method of using such drug for which approval is sought or has been granted in the application." 21 U.S.C. § 355(b)(1)(A)(viii)(I). The OBTA replaced language that allowed listing of "any patent which claims the drug for which the applicant submitted the application" which was introduced in response to a concern that companies may be “submitting patents potentially for the purpose of blocking generic competition.” H.R. Rep. No. 116-47 at 4 (2019).
In Teva et al. v. Amneal et al., Teva sued Amneal for filing an ANDA to a generic version of ProAir HFA, which Teva describes as being regulated “single-entity combination products,” meaning a drug and a device “combined or mixed and produced as a single entity, asserting claims reciting the inhaler portion (but as best I can tell, not claiming even a genus of the active ingredient). Amneal counterclaimed for an injunction requiring Teva to delist the patents. The district court granted Amneal's motion for judgment on the pleadings and ordered delisting. Teva appealed, and the Federal Circuit recently heard oral argument. See https://oralarguments.cafc.uscourts.gov/default.aspx?fl=24-1936_11082024.mp3.
On appeal, Teva focused on the definition of "drug" in the FDCA, which it argued broadly covers "not just the active ingredient, but the entirety—specifically including any 'component'—of any article' used for the 'treatment' or prevention of disease' or to 'affect … any function of the body,' for example." Citing 21 U.S.C. § 321(g)(1). Thus, Teva argued a patent need not "recite the active ingredient by name in order to claim the drug" because "a patent claiming a genus of compounds reads on a drug whose active ingredient is one species within the genus." Teva thus argued that "the scope of what a patent 'claims' must be determined through an infringement-type analysis," i.e., that if the claims would cover the drug product, they claim the drug product.
Amneal defended the district court's judgment, arguing that to qualify for listing, a "drug product" patent "must satisfy three criteria": (1) a claim of infringement can be reasonably asserted (citing 21 U.S.C. § 355(b)(1)(A)(viii)); (2) the patent is a “drug product” patent, i.e., claims a drug product (citing 21 U.S.C. § 355(b)(1)(A)(viii)(I)) and (3) “claims the drug for which the applicant submitted the application.” (again citing 21 U.S.C. § 355(b)(1)(A)(viii)(I)). Amneal argued that the "second and third requirements work in tandem to require a drug product patent to claim not just any 'drug product,' but the specific NDA 'drug product,' as that term is defined by the FDA" which requires the drug product to "contain a drug substance" or "active ingredient." Citing 21 C.F.R. § 314.3. Amneal argued that Teva's argument would render the "claims the drug" requirement superfluous, and that the statute cannot be read to treat a device as if it is a drug.
The briefing of both parties is heavy on statutory and regulatory citations which I have not exhaustively reviewed, but the Federal Circuit panel seemed to struggle with a more simple issue – what does it mean to claim a "drug product." The panel used the hypothetical of a steering wheel and a car. Does a claim to a steering wheel cover a car? the panel asked. According to Teva, the answer was yes, a claim to a steering wheel claims a Ford Bronco. Judge Taranto seemed skeptical, saying "nobody, nobody, would think that if I have a patent, which I claim as my invention the steering wheel, that I'm claiming the car that it is in." But Teva responded that if the claim recited a "car comprising a steering wheel" it would claim a car. Judges Taranto and Prost seemed skeptical. Teva argued that Amneal's construction would require a claim to cover every component of a drug product to claim the drug product and would threaten listings for inactive ingredient and genus claims.
The panel seemed more interested in this concern, and asked Amneal to address it. Amneal argued that Teva can still assert the inhaler patents, they simply don't get the "superpower" effect of Orange Book listing given under the statute. Amneal argued that if the statute allowed Orange Book listing for any patent that "claims a drug" then Teva would win, but the statute does not.
Like the panel, I am skeptical of Teva's position broadly that any claim to any component of a drug product is sufficient, regardless of whether it claims the specific drug substance. Surely a claim to an excipient used in the NDA product does not "claim" the drug product, even though it would read on the product. But Teva's argument about genus claims is a bit more interesting. For example, the active ingredient in the drug product is albuterol sulfate, a class of bronchodilators. It seems clear a claim to an "inhaler comprising albuterol sulfate" would claim the "drug product" (even though it doesn't claim every single component or excipient). Presumably too, a claim to an "inhaler comprising albuterol" would suffice. But would a claim to "an inhaler comprising a bronchodilator"? How broad can the genus be and still claim the "drug product"? Would "an inhaler comprising a drug substance" be sufficient?
While Teva argued that Amneal's construction would exclude claims to genuses, it didn't appear to make any argument that any of its claims included a limitation to a genus (and the claim it identified on the front cover of its brief does not claim any genus of active ingredients). I am thus skeptical the Court will need to grapple with this line drawing or that Teva will prevail on a genus argument.
An interesting issue is what tools to generics have to combat improper Orange Book listings? While Amneal was apparently able to get a relatively rapid ruling from the district court, Teva still obtained roughly a quarter of the 30 month automatic stay. It will be interesting to see if Congress attempts to make any sort of recourse available for generics who are found to be improperly stayed. Or will courts consider this a ground for awarding attorneys fees? Time will tell.
Orange Book Blog 