Orange Book Blog

Relaunch of the Orange Book Blog!

We're excited to announce the relaunch of the Orange Book Blog!

First off, a huge thank you to blog founder Aaron Barkoff! While Aaron has moved in-house, he has generously passed the blog along to an expanded team of authors who will provide you with regular updates on what's happening in the ANDA field. We're excited to continue Aaron's work. 

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Federal Circuit grapples with scope of Orange Book listings

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.

Astellas v. Sandoz – Post-Remand Procedural Issues Following At-Risk Launch

    By: Rocco Screnci

Ben recently covered Astellas Pharma, Inc. v. Sandoz Inc., in which the Federal Circuit vacated a district court decision for violating the principle of party presentation. 117 F.4th 1371 (Fed. Cir. 2024). Today’s post focuses on some interesting procedural issues that have since developed on remand.

By way of background, the district court in Astellas found the patent-in-suit invalid under § 101 even though the defendants’ invalidity contentions nowhere raised a § 101 defense and the parties had stipulated to trying only infringement and § 112 invalidity. The Federal Circuit thus vacated and ordered a limited remand to address those issues. But while the appeal was pending, the FDA approved the ANDAs, meaning that the generic manufacturers could launch their competing sustained-release mirabegron tablets. As a result, on remand, Astellas sought to amend its complaint to demand a jury trial and to supplement with infringement claims under 35 §§ 271(a)-(c) based on the generic manufacturers’ post-FDA-approval conduct. The district court, however, denied Astellas’s motion.

As to the infringement claims for the post-approval activities, the district court found that allowing amendment would be “counterproductive to a just, speedy, and inexpensive” disposition. This is because pivoting to a traditional infringement theory would require the parties to conduct additional discovery, address infringement based on the actual products (rather than the ANDA submissions), and assess damages. The district court also reasoned that letting Astellas raise a new infringement theory would contradict the Federal Circuit’s decision, which contemplated a limited remand to decide only the issues “properly raised and adequately supported by the record.” See 117 F.4th at 1379.

As for the jury demand, the court declined to exercise its discretion to empanel a jury to try the ANDA issues for two main reasons. First, the district court explained that Astellas had no Seventh Amendment right to a jury for the ANDA issues because Astellas’s original complaint only sought declaratory and injunctive relief. Second, the district court found that Astellas had waived any jury-trial right on the ANDA issues when it proceeded to a bench trial without objection. According to the court, Astellas made a strategic decision by proceeding with the Hatch-Waxman route—which gave Astellas the chance at an injunction blocking generic entry—rather than letting a claim for damages ripen and thereby suffering real-world economic harm. To this, the court added that the Seventh Amendment does not give litigants “a second bite at the apple” simply because they regret choosing the bench-trial route after an adverse ruling. Slip. op. at 10. That all said, the district court explained that Astellas could still pursue post-launch infringement claims against the generic manufacturers in a separate action. And as the district court emphasized, nothing in its decision would prevent the parties from demanding a jury should Astellas bring those post-launch claims.

Likely unsatisfied with this outcome, Astellas has since urged the court to amend the scheduling order to postpone the trial date and let it present the post-launch evidence to a jury. But unlike the previously denied proposed amended and supplemental complaint, which added infringement claims under §§ 271(a)-(c) that were not ripe at the onset of the case, Astellas’s request to amend the scheduling order premises its request on its prayer for relief in the original complaint under § 271(e)(4)(C). That provision lets a court award “damages or other monetary relief” for infringement under § 271(e)(2) “only if there has been commercial manufacture, use, offer to sell, or sale . . . of an approved drug.” See 35 U.S.C. § 271(e)(4)(C). This framing is seemingly intended to undermine the district court’s stated justification for denying the motion to supplement—that Astellas chose the ANDA route as “a matter of strategy” rather than wait for the more conventional infringement claims to ripen. At the same time, however, the rest of Astellas’s motion echoes the arguments the court rejecting in denying leave to supplement the original complaint and to add a jury demand.

Even so, it seems like Astellas’s recent motion paid off. In response to that motion, the court issued a brief order instructing the parties to submit briefs on how they believe the case should progress, with particular attention to their positions on supplementing the record, bifurcating trial, and conducting a jury trial on damages under § 271(e)(4)(C). It thus appears that the court is somewhat inclined to side with Astellas on supplementation, as the court likely would have denied the motion for the same reasons it denied Astellas leave to amend and supplement its complaint.

But perhaps the most fascinating issue implicated by the court’s order is whether Astellas is entitled to a jury trial because it now seeks monetary relief for infringement. This issue is particularly interesting because caselaw interpreting § 271(e)(4)(C) is scant. And while courts so far have assumed that damages under § 271(e)(4)(C) are no different from those awarded under § 284 for more conventional forms of infringement and thus require a jury trial, others have made compelling arguments that the statutory text mandates that the two damages provisions be treated differently. Robert A. Matthews, 2 Annotated Patent Digest § 10:172.100; Brian D. Coggio & Sandra A. Bresnick, The Right to A Jury Trial in Actions Under the Hatch-Waxman Act, 79 J. Pat. & Trademark Office Soc’y 765, 771-72 (1997). Relevant to Astellas’s recent motion, some have argued that the relief available under § 271(e)(4)(C), though monetary, is equitable because the statute commits the decision to award damages to the court’s discretion. See Coggio & Bresnick, supra, at 777-780.  By contrast, § 284 requires damages be awarded for infringement under §§ 271(a)-(c), and contemplates that a jury—not the court—will usually be responsible for calculating those damages.

I, for one, am uncertain about the right answer to whether as a matter of first principles relief for at-risk launches ought to go to a jury or the bench. It seems logical and consistent with Hatch-Waxman that Congress intended judges, not juries, to decide all issues relating to an infringement claim brought under § 271(e)(2) and craft the relief accordingly. Indeed, the Supreme Court has emphasized how an action under § 271(e)(2) and the accompanying remedies under § 271(e)(4) are “artificial” and intended to “enable the judicial adjudication” of ANDAs. Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990) (emphasis added).  I also tend to agree that the differences between § 271(e)(4) and § 284—not only in language, but in structure—should make some difference in how the two apply. After all, remedies under the former provision appear aimed at preserving the status quo. And because relief preserving the status quo is traditionally associated with equitable relief, not “legal” relief within the scope of the Seventh Amendment, the defendants could fairly argue that a jury trial is not required there. But I also think that the statutory-interpretation argument can cut the other way. Given that damages are the “quintessential legal remedy,” it seems that specifying that “damages” are available under § 271(e)(4)(C) could be dispositive in the Seventh Amendment analysis.

In any event, it will be interesting to see whether the district court will confront these questions in ruling on Astellas’s motion. A ruling that no jury trial is required under § 271(e)(4)(C) will likely favor defendants generally in future cases, as the consensus is that plaintiffs fare better in patent cases when trying them to a jury. I am also interested in the potential preclusive effects of a judgement in the ANDA case on any post-launch infringement claims that Astellas may bring in a separate action. But I plan to explore those in a separate post depending on how the court rules on the pending motions and the merits of the remaining infringement and § 112 issues.

Collateral Estoppel from IPRs in District Court

Continuing on the subject of defendants challenging multiple related patents, I listened to oral argument recently in a case involving an allegation of collateral estoppel from IPR proceedings on district court litigation of related claims that raised some interesting arguments. (Kroy IP Holdings, LLC v. Groupon, Inc., Case No. 23-1359). 

In that case, the district court granted summary judgment finding claims invalid for not being patentably distinct from related claims invalidated in an IPR. The appellant challenged whether estoppel could apply in district court, given that the evidentiary burden in district court was higher. The panel interrupted the appellant, asking whether they had reviewed the Court's recent decision in ParkerVision, Inc. v. Qualcomm Inc., No. 2022-1755, 2024 WL 4094640 (Fed. Cir. Sept. 6, 2024), which the panel succinctly summarized as saying "you win" and suggesting the appellant take a seat. In ParkerVision, the court held that "Although we have not previously addressed the question of whether a finding underlying an unpatentability decision in an IPR proceeding collaterally estops a patentee from making validity arguments regarding separate, related claims in district court litigation, we now hold that it does not."

The appellee, prepared to address Parkervision, attempted to distinguish it on its facts, noting that there the challenger had unsuccessfully challenged the allegedly patentably indistinct method claims and failed to prove them unpatentable, and that the holding in Parkervision should be limited to scenarios in which the PTAB finds the allegedly estopped claims not proven unpatentable. 

I am skeptical the appellee will prevail on this argument, given that Parkervision's holding was not based at all on the fact that the allegedly estopped claims had been found not unpatentable in an IPR (which was mentioned only in background). In fact, Parkervision did not address an application of collateral estoppel to determine related claims unpatentable, but rather granted a Daubert motion holding the IPR "collaterally estopped ParkerVision from relitigating characteristics of the prior art reference on which Qualcomm's invalidity contentions rested." Thus, the fact that the PTAB had found the method claims not proven unpatentable (which as a matter of logic would necessitate a finding that the method claims were patentably distinct from the invalidated apparatus claims) was not the reason collateral estoppel should not apply, but rather the different burdens of proof on underlying factual findings. The panel rightly seemed skeptical of this effort to distinguish Parkervision. 

However, the appellee further argued (persuasively in my opinion) that the underlying basis for the presumption of validity and subsequent clear and convincing evidence standard is that the patent office has passed upon the validity of the claims, but that this presumption should not apply where the patent office has actually determined that the subject matter claimed is not patentable. The appellee also touched on the Federal Circuit's earlier decision in XY, LLC v. Trans Ova Genetics, 890 F.3d 1282 (Fed. Cir. 2018) (claims cancelled in an IPR have preclusive effect in district court litigation) and briefly touched on the difference between issue preclusion and claim preclusion. In my opinion, this is the key to distinguishing Parkervision. 

The panel appears to have conflated issue preclusion (collateral estoppel applying to factual findings) with claim preclusion (res judicata, precluding relitigation of the same or materially similar claims). The use of these terms interchangeably is commonly done, even by the esteemed judges of the Federal Circuit. See, e.g., Soverain Software LLC v. Victoria's Secret Direct Brand Mgmt., LLC, 778 F.3d 1311, 1319 (Fed. Cir. 2015) ("Soverain argues that issue preclusion should not apply because claim 39 was not previously found obvious and does not present identical issues. Complete identity of claims is not required to satisfy the identity-of-issues requirement for claim preclusion.").

But these are slightly different concepts. See Phillips/May Corp. v. United States, 524 F.3d 1264, 1267 (Fed. Cir. 2008) ("The doctrine of res judicata involves the related concepts of claim preclusion and issue preclusion.”). Parkervision addressed issue preclusion ("a finding underlying an unpatentability decision"), not claim preclusion (whether the claims are materially distinct). The Kroy case in contrast, addresses whether claim preclusion applies to the bar relitigation of patentably indistinct claims . Thus, a conclusion in Kroy that claim preclusion may still apply would not be in conflict with Parkervision, and would seem to be in harmony with XY. After all, if the PTAB's unpatentability determination effectively cancels the claim, why shouldn't it apply to patentably indistinct claims? Of course, the challenger still must prove the claims to be patentably indistinct.

Further, the panel did seem concerned about the practical effects of requiring defendants to challenge every single asserted claim in an IPR—a concern that would be obviated by drawing a distinction between issue and claim preclusion in this context. Such a ruling would allow a defendant to knock out all patentably indistinct claims in one IPR, but also preserve a patentee's right to assert patentably distinct claims without any estoppel effects for underlying factual findings made on a lower evidentiary standard in IPR. 

I'll be interested to see how the panel handles the case, and if it does not draw this distinction, whether it entertains further briefing in rehearing allowing the appellee to more fully address Parkervision (which issued after briefing had occurred). 

PTO considering OTDP and Terminal Disclaimer Rule Change - Is There a Compromise?

Following up on Rocco's discussion of obviousness-type double patenting (OTDP), I have some thoughts on the PTO's proposed rule changes to OTDP and terminal disclaimer practice.

In May, the patent office proposed a rule in which "to overcome double patenting the patentee would need to agree that the patent with the terminal disclaimer will be enforceable only if the patent is not tied and has never been tied through one or more terminal disclaimers to a patent in which any claim has been finally held unpatentable or invalid over prior art." By now the proposed rule changed to obviousness-type double patenting and the filing of terminal disclaimers has been heavily discussed, and heavily criticized. 

As many have discussed, it seems highly unlikely this rule would pass, and questionable whether the patent office even has the authority to pass such a rule in light of a Congressional statute that unequivocally stated "Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims." 35 U.S.C. § 282. Nor does it seem particularly fair to patentees to make such a rigid rule in which a single overly broad claim could invalidate an entire patent family. 

But the concern of the patent office is quite valid, as practitioners in the ANDA field are quite aware, litigation costs can balloon when patentees seek numerous continuations and create what some call a "patent thicket," or serially bring continuation patents in new litigations. And it does seem materially unfair to Defendants to repeatedly face litigation on claims the patent office deemed materially indistinct from invalidated claims, each time obtaining a fresh presumption of validity, requiring clear and convincing evidence to overcome.

While I admittedly have not exhaustively reviewed the writing on this topic, there seems to me a simple and obvious compromise that I have not seen discussed, that would preserve a patentee's right to continue to assert related claims while protecting Defendants from serially having to prove invalidity by clear and convincing evidence: for any patent which contains a terminal disclaimer over an invalidated patent, shift the burden to the patent owner to prove by a preponderance of the evidence that the claims are patentably distinct and thus valid.

This would seem to be a fair compromise, in that a patentee who essentially acquiesces to a finding that the claims are not patentably distinct in the patent office must bear the burden of proving otherwise in court, while avoiding a rigid rule in which a single invalidated claim knocks out an entire family. 

I tend to agree that this change cannot come from the patent office. But given that OTDP is a judge-made doctrine, it seems like the change could come from the judiciary in addition to Congress. Indeed, a panel of the Federal Circuit appeared to come pretty close to this compromise in SimpleAir, Inc. v. Google LLC, 884 F.3d 1160 (Fed. Cir. 2018), but determined it was bound by earlier precedent.

In an opinion authored by Judge Lourie, the panel stated "Although a terminal disclaimer does not conclusively show that a child patent involves the same cause of action as its parent, the terminal disclaimer is still very relevant to that inquiry" and "a terminal disclaimer is a strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent." "But as our precedent indicates, that strong clue does not give rise to a presumption that a patent subject to a terminal disclaimer is patentably indistinct from its parent patents." Specifically Judge Lourie wrote, "our cases foreclose the inference that filing a terminal disclaimer functions as an admission regarding the patentability of the resulting claims" and, perhaps suggesting to the defendant that it seek en banc hearing, stated "As a panel, we lack the authority to deviate from this precedent."

Interestingly, Google did file a petition for rehearing en banc, but did not argue for any rebuttable presumption. Rather, it appeared to argue for an absolute rule akin to that proposed by the Patent Office. The Federal Circuit did take the somewhat unusual step of inviting a response, but ultimately denied the petition for en banc hearing without comment or dissent. 

I do wonder if at least Judge Lourie might have been interested in taking the case en banc to address a compromise position, such as a rebuttable presumption. Perhaps someone will try this and we'll see what the Federal Circuit's appetite is. That seems more likely to me than Congress intervening, though perhaps the PTO's actions will force Congress to act. But this does seem to be an issue gaining attention, and I expect we'll see some changes sooner rather than later.

I welcome any thoughts or comments anyone has!

 

 

 

Obviousness-Type Double Patenting for Patent-Term-Adjusted Patents post-Allergan and In re Cellect (2/2)

  by: Rocco J. Screnci

This is the second post in a two-part series on obviousness-type double patenting (“ODP”). Part one summarized the two recent precedential Federal Circuit decisions in this area.

To sum up where last post left off: The Federal Circuit’s decision in Cellect initially seemed to drastically expand the application of ODP, and the Allergan decision limited the broadest readings of Cellect by explaining that later-filed, later-issued patents cannot be used as ODP references against the “first” patent in the family even if patent-term adjustment (“PTA”) awarded for Patent Office delays during prosecution means that the “first” patent expires later. At the same time, Allergan seemingly reaffirmed its earlier ODP cases, including Cellect, in which expiration date controlled the outcome. This leaves a few important takeaways.

First, Allergan did not disturb past cases applying ODP to invalidate later-filed and later-expiring patents. Indeed, Allergan contrasted its facts with those in past cases, like Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366 (Fed. Cir. 2014), in which the patentee secured a second, later-expiring patent by filing a continuation that received 750 days more PTA than the first patent in the family, and Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), in which the patentee secured a second, later-expiring patent by beginning a new application chain with a later priority date. With that in mind, it is important for defendants to always keep an eye on a plaintiff’s earlier-filed, earlier-expiring patents as potential grounds for invalidity against later-filed, later-expiring patents. And plaintiffs will need to keep its earlier-filed, earlier-patents in mind when developing their prosecution and Orange Book-listing strategies.

Second, Allergan left intact Cellect’s central holding: that the PTA-added expiration date is the expiration date that matters for ODP purposes. It will thus be important for ANDA filers to keep track of not just when Orange Book-listed patents expire, but also when the NDA holder’s other patents expire. What’s more, given that PTE and PTA are treated differently for ODP purposes, ANDA filers will want to account for both PTE- and PTA-added expiration dates when planning their filing strategies. On the flipside, NDA holders will want to consider revisiting their Orange Book-listed patents to see if any terminal disclaimers are necessary for later-filed patents with PTA.

Third, Allergan clarified that issuance date matters in the ODP analysis. This limits the available references that can be asserted to support an ODP defense. Defendants now know that they cannot simply invoke PTA-added expiration dates when arguing invalidity on ODP grounds. That said, the precise contours of Allergan’s holding on that point are a bit unclear.

On one hand, Allergan seems to shut the door on the idea that a later-filed, later-issued “child” patent without PTA can invalidate a “first” or “parent” patent. But that only invites the question of what it means to be a “first” or “parent” patent. Recall that the ODP reference patents in Allergan were not the immediate descendants of the challenged “first” patent in the family. The ODP reference 011 and 709 patents in Allergan were the metaphoric grandchild and great-grandchild, respectively, of the 356 patent. The 011 patent issued on a divisional of an application that itself was a continuation of the 356 patent’s application, and the 709 patent was a continuation of the 011 patent’s application. Indeed, the 356 patent issued before the applications leading to the 011 and 709 patent were filed. And the Federal Circuit emphasized those facts when explaining why the facts in Allergan exemplified why ODP did not apply. As a result, some may construe Allergan as narrowly applying to the precise fact pattern there: The patent issuing from the first nonprovisional application in the family cannot be invalidated by later-issued patents that were applied for only after the first patent issued. This could mean that patents issuing from continuations are still susceptible to attack, or that a different rule applies if the reference patent’s application was copending.

On the other hand, some may read Allergan as foreclosing ODP whenever the later-expiring patent was earlier filed and earlier issued than the would-be reference patents, even if the patents were copending and have different priority chains. This broad reading stems from Allergan’s favorably citing past cases in which the Federal Circuit declined to extend ODP to similar situations. See 111 F.4th at 1370. But those cases were limited to distinct scenarios or expressed their narrow views on ODP only in dicta. See Cellect, 81 F.4th at 1230 (“We do, however, note that the non-asserted claims in the challenged patents are entitled to their full term, including the duly granted PTA, unless they are found to be later-filed obvious variations of earlier-filed, commonly owned claims.”); Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1374 (Fed. Cir. 2018) (“[T]he traditional concern with obviousness-type double patenting” is not raised where “it is the earlier-filed, earlier issued ... patent, not the later-filed, later-issued ... patent, that has the later expiration date”); Novartis Pharms. Corp. v. Breckenridge Pharm. Inc., 909 F.3d 1355, 1366 (Fed. Cir. 2018), (declining to invalidate patent on ODP grounds “[i]n th[e] particular situation where we have an earlier-filed, earlier-issued. . . patent that expires after the later-filed, later-issued . . . patent due to a change in statutory patent term law”).

Of course, the real impact of Allergan is yet to be seen and likely lies somewhere between the narrowest and broadest possible readings. One can imagine a middle-ground approach that forecloses ODP as a form of patent patricide. In other words, the rule from Allergan would bar defendants from pitting later-filed, later-issued patents against the earlier-filed, earlier-issued patents in the same priority chain. This rule would potentially balance the Federal Circuit’s policy concerns about depriving patentees of their original patent terms while leaving room for the courts to curb any gamesmanship that may arise when patentees try to stagger priority chains to secure longer patent terms.

In any event, perhaps the most important takeaway from Allergan is that the Federal Circuit continues to develop its view on ODP case-by-case. In its latest cases addressing ODP, the Federal Circuit has carefully parsed its ODP jurisprudence to determine how ODP ought to apply to the issues on appeal. Allergan continues this trend by limiting earlier ODP cases to their particular facts and by narrowing Cellect to the issue framed by the appellant about how PTA interacts with ODP. This trend is important for two key reasons. First, it shows how critical it is for defendants to continue to identify and raise potential ODP defenses as the law in this area continues to develop, and for plaintiffs to anticipate these arguments when preparing for litigation. Second, it reminds all litigants to consider how they frame arguments. Given some of the Federal Circuit’s concerns in Allergan, perhaps the fact pattern in Cellect could have played out differently had the appellant taken a more moderate approach in urging to reverse the ODP determinations by the Patent Trial and Appeals Board.

Obviousness-Type Double Patenting for Patent-Term-Adjusted Patents post-Allergan and In re Cellect (1/2)

    by: Rocco J. Screnci

This post is the first in a two-part series about recent developments in the law of double patenting. This post provides relevant background and summarizes the Federal Circuit’s recent decisions in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023) and Allergan USA, Inc. v. MSN Laboratories Priv. Ltd., 111 F.4th 1358 (Fed. Cir. 2024). For those already familiar with the decisions, please feel free to move on to the next post in this series, which discusses the potential implications of these cases for Orange Book patents.

The doctrine of obviousness-type double patenting (“ODP”) is judge made and bars a patentee from securing multiple patents with different expirations for patentably indistinct (i.e., obvious) variants of the same invention. The doctrine developed to address gamesmanship that arose under earlier versions of the patent act when patent applications were not published and when expiration dates were determined by the issuance dates. ODP was thus needed to combat “submarine” patents, a practice by which patentees maintained a chain of secret applications before drafting patentably indistinct claims on a competing product long after the original patent had expired. But submarine patents are now a relic of the past. This is because applications are published and because filing date—not issuance date—determines patent term. Even so, ODP still persists as an invalidity defense when two patents claiming patentably indistinct subject matter expire at different times.

In fact, the law on ODP is dynamic as ever. Last year, in In re Cellect, the Federal Circuit explained for the first time how ODP interacts with patents that have received a patent-term adjustment (“PTA”) for delays during prosecution. The patentee in Cellect had secured a web of patents with a shared priority date, but having different PTAs and thus different expiration dates as depicted in the following timeline. Several patents were challenged on ODP grounds in petitions for ex parte reexamination. Because each of the challenged patents were patentably indistinct from the reference patents (as shown in the table below), the sole issue was what expiration date mattered when analyzing ODP.

Challenged Patent	ODP Reference Patent
742	369
369	036
626	369
621	626

The patentee relied on earlier decisions that had held that ODP challenges to patents with patent-term extensions (“PTE”)—additional patent term awarded to certain drug or medical device patents due to time spent awaiting FDA approval—must use the expiration date before accounting for any PTE. In other words, if there are no ODP concerns for a patent’s original patent term, it can enjoy its full original patent term plus PTE. The patentee in Cellect argued that the same rule should apply for PTA, but the Federal Circuit disagreed. As a result, each patents was held invalid on ODP grounds.

Many saw Cellect as a drastic expansion of ODP. While some took issue with the disparate treatment of PTE and PTA when evaluating ODP, the bigger concern was the Cellect seemingly stood for the premise that PTA-added expiration date—and that expiration date alone—is all that matters for ODP purposes. This would mean that later-filed, later-issued patents could invalidate earlier-filed, earlier-issued patents simply because the earlier patent received PTA and the later patents did not. That rule would be surprising because it would create an invalidity defense that escapes prosecution. Usually, the Patent Office catches ODP concerns during examination of later-filed patent that claim obvious variants of previously issued patents. To overcome an ODP rejection, the applicant must file a terminal disclaimer, which ties expiration date of the later-filed claims to those of the earlier-filed claims. But a broad reading of Cellect would flip that scenario on its head, meaning that issued patents could have their patent terms truncated if later continuations received less PTA. And because earlier Federal Circuit decisions prevent patentees from terminally disclaiming to already-expired patents, that broad reading would mean that it was too late to save some otherwise valid patents. This reading would be even more impactful given that Cellect arose from ex parte reexaminations.

Ex parte reexamination is a post-grant proceeding in which the Patent Office reopens patent prosecution if a petition for reexamination identifies a "substantial new question of patentability." While the petitioner in an ex parte reexamination has less involvement in proceedings than its counterpart in inter partes review ("IPR"), ex parte reexamination has some noteworthy advantages over IPR. For one, IPR has tighter filing deadlines and limits challenges to novelty and obviousness based on printed prior art (i.e., patents and publications). A petition for ex parte reexamination, by contrast may be filed any time before the patent expires and also may raise ODP as an invalidity ground. The generous filing deadline makes ex parte reexamination a particularly powerful tool in the ODP context because it means that a party can wait until after the reference patents expire to challenge a patent on ODP grounds, leaving the patentee no time to file a terminal disclaimer to overcome ODP. With that in mind, a broad interpretation of Cellect would empower defendants to invalidate an entire patent simply by waiting until it is too late to cure ODP with a terminal disclaimer.

At least one district court endorsed that broad reading of Cellect. In Allergan v. MSN Laboratories, the district court applied ODP to invalidate Allergan’s Orange Book-listed 356 patent covering eluxadoline, a drug used to treat IBS-D sold under the brand name Viberzi®. The district court found that the 356 patent was patentably indistinct from Allergan’s two earlier-expiring patents in the same patent family that also claimed eluxadoline. Relying on Cellect, the district court said it was irrelevant that the 011 and 709 patents were later-filed, later-issued descendants of the 356 patent. The district court read Cellect for the broad proposition that “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates…[N]o exception[s].” Allergan USA, Inc. v. MSN Laboratories Priv. Ltd., 694 F. Supp. 3d 511, 540 (D. Del. 2023).

But in late-August, the Federal Circuit explained that Cellect is not so broad. In a precedential decision, the Federal Circuit reversed the district court in Allergan v. MSN Laboratories, 111 F.4th 1358 (Fed. Cir. 2024). The court explained that Cellect addressed only the narrow issue about how ODP interacts with PTA. “Cellect does not address,” the court continued, the threshold issue about when a patent “can properly serve as an ODP reference.” Allergan, 111 F.4th at 1368. The court then concluded that the 011 and 709 patents could not be asserted as ODP references against the 356 patent because the 356 patent was the “first” patent to cover eluxadoline. There was thus no concern that Allergan tried to prolong its monopoly on eluxadoline beyond the original patent term because the first-issued, first-filed 356 patent—not the later-filed, later-issued 011 and 709 patents—dictated that patent term. Put another way, the Federal Circuit declined to let a “second” patent truncate the effective patent term of the “first” patent.

The Federal Circuit also took time to address pre-Cellect cases that seemingly stood for the proposition that patent filing dates are irrelevant when analyzing ODP. The court distinguished those cases by explaining that they confronted different scenarios. Those cases, the court explained, each involved later-expiring patents that, at a minimum, were filed after the ODP reference patents. According to the court, those cases presented the opportunities for gamesmanship that ODP seeks to prevent. By contrast, the facts in Allergan presented, as the court put it, “‘a prime example’ of when ODP does not apply.” 111 F.4th at 1371. Because the 011 and 709 patents did not exist when the 356 patent issued, the 356 patent in no way “result[ed] in an extension of patent term of the invention[s] claimed in the [011 and 709] patent[s].” Id. In other words, the court recognized that letting the later-filed, later-issued patents invalidate the "first" patent would defy the rationale underlying ODP, which is to prevent a patentee from using serial continuations to prolong a patent monopoly. If later-filed, later-issued patents could serve as ODP reference patents, patentees would effectively be forced to forgo PTA or cease filing continuations altogether.

While Allergan seems to have reined in Cellect’s impact, the Federal Circuit still left intact most pre-Cellect caselaw. Part two of this post explores what this means for Orange Book patents. It also identifies a few ambiguities in Allergan and their potential implications.

WV court denies Regeneron's motion for PI in Eylea litigation

In a recently unsealed opinion, a N.D.W.V. court denied Regeneron's motion for a preliminary injunction against Amgen seeking to enjoin Amgen's ABP 938, a biosimilar version of Eylea. Regeneron had previously been successful in obtaining preliminary injunctions in the same court against a number of other defendants. But Amgen's formulation differed from those defendants, resulting in a different outcome.

In short, the claims of the Regeneron's 865 patent separately listed "a vascular endothelial growth factor (VEGF) antagonist" and a "buffer." Amgen's formulation utilized the antagonist as a buffer, and did not contain any separate buffer, i.e., it is self-buffering. The district court, relying primarily on the Federal Circuit decision in Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249 (Fed. Cir. 2010) and cases citing it, construed the claims to require the VEGF antagonist and buffer to be separate components in the formulation. Because it was undisputed that Amgen's formulation lacked a separate buffer, the court found Regeneron was unlikely to be able to prove infringement. 

Becton and its progeny hold that the separate listing of elements creates a presumption that the components are distinct. Thus, the focus of the arguments was on whether the specification provided any suggestion that one component could satisfy multiple limitations. The court found none.

It noted, for example, that the claims not only separately listed the antagonist and the buffer, but dependent claims contained separate units of measurement for each component, with dependent claim 2 reciting an antagonist concentration of 40 mg/ml and dependent claim 7 reciting a concentration range of the buffer of 5-25nM. The court then addressed Regeneron's arguments that a POSA could easily convert between the two units of measurement, but rejected that argument because 40 mg/ml of the antagonist would be "substantially outside of the claimed concentration range of 5-25 nM recited for the 'buffer' in claim 7." The court concluded that such claim language "is rendered nonsensical unless the 'VEGF antagonist' and 'buffer' are interpreted as separate and distinct components." While I agree with the district court that the listing of separate measurements for the two components generally supports an understanding that they are separate components, the district court's logic seems to be conflating infringement of dependent claim 7 with the scope of claim 1. More specifically, the district court's logic seemed to be that because it would be impossible for this formulation to simultaneously meet both dependent claim 2 and dependent claim 7, the formulation could not be covered by independent claim 1. That logic escapes me. That in a particular example, a formulation might not meet the limitation of a dependent claim (let alone two dependent claims) does not render the claim  language in the independent claim nonsensical. Indeed, it is hardly surprising that some formulations would fall within the broader scope of the independent claim, but not within the narrower scope of dependent claims.

Regardless, there was other claim language supporting the district court's interpretation. It further noted that because claim 1 recited "wherein said VEGF antagonist fusion protein is glycosylated and comprises amino acids 27-457 of SEQ ID NO:4," the claims effectively required the VEGF antagonist to be the protein aflibercept, which would mean under Regeneron's theory the antagonist is always a buffer, rendering the buffer limitation superfluous. While Regeneron argued that the aflibercept may only act a buffer under certain conditions, the court noted that Regeneron had previously argued against other defendants (in the context of 112) that the buffer limitation was structural, not functional. 

The court then turned to the specification and found no support for any embodiment in which the antagonist and buffer were the same component. To the contrary, it found in all twenty two described embodiments, the buffer was a distinct component. The court found Regeneron's counterarguments unconvincing. Regeneron first argued that the 865 patent incorporated by reference a second patent, which disclosed that other components (not the antagonist or buffer) could have different functions than those specified in the 865 patent. Regeneron also argued the specification states that "all technical and scientific terms and phrases used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs." Unsurprisingly, the district court was not persuaded that either passage suggested that the antagonist and buffer could be the same component. 

Though it noted that it didn't believe it was necessary to consider extrinsic evidence, the court did so "for completeness" and found it did not provide any evidence rebutting the Becton presumption. Interestingly, Regeneron attempted to rely on an Amgen patent application, filed slightly before the 865 patent (but not yet published) as prior art demonstrating a POSA's understanding that proteins could act as buffers. While questioning whether it was even proper to rely on "secret prior art" to show the ordinary meaning in the art, the court further found that Amgen's patent application further demonstrated that POSAs would not have understood the claims to cover self-buffering proteins. In sum, there was no evidence that a POSA would commonly assume that the protein antagonist could also serve as a buffer in Regeneron's claims. 

Finally, the court noted again that Regeneron's arguments conflicted with arguments Regeneron made in previous injunction motions against other defendants, where when defending against 112 invalidity arguments it argued that a buffer is a well known class of excipient.

Based on its construction, the court held that Regeneron was unlikely to show literal infringement, and that an injunction based on DOE was rare. It further noted that Regeneron's arguments appeared to entirely vitiate the buffer limitation. Again while noting such an analysis was unnecessary, the court stated its agreement with Amgen that the insubstantial differences test for DOE was more appropriate, and that it was likely a self-buffering composition was substantially different, as Amgen's biosimilar, if approved, would be the first buffer-free fusion protein formulation approved by FDA. It also found Regeneron was unlikely to succeed under a function-way-result analysis as well.

Harkening back to my last post, this again illustrates the importance of 112 arguments for defendants to box in a plaintiff's arguments—even if the 112 defense is not successful. The district court repeatedly cited the plaintiff's own 112 arguments against it. And had Regeneron succeeded in its claim construction argument, it seems like it would have had a clear 112 problem in demonstrating it was in possession of self-buffering formulations.  

Federal Circuit rejects sua sponte 101 invalidation

In Astellas Pharma v. Sandoz et al the Federal Circuit vacated the judgment of the Delaware district court finding claims of U.S. Patent No. 10,842,780 invalid under 35 U.S.C. §101 as directed to an ineligible natural law. 

This was an interesting case. Not only had the defendants not made a 101 challenge, they had stipulated at trial to only challenge the claims' validity under section 112. But the district court found that by arguing for enablement based on a routine methods obeying a natural law, Astellas had conceded that the claims were not patent eligible. Unsurprisingly, the Federal Circuit vacated, holding the district court to the party presentation rule - that district courts are to decide the issues presented to them.

The panel rejected the idea that patent eligibility was a threshold issue and stated that "the presumption of validity afforded to patents under § 282 applies equally to all grounds of validity, including the eligibility of the claimed subject-matter." While this was not a new holding, as the Court cited the 2019 decision in Cellspin v. Fitbit reaching the same conclusion, it is interesting to note that many courts had previously ruled the presumption did not apply to eligibility (e.g., Kindred Studio Illustration & Design, LLC v. Elec. Commc'n Tech., LLC, No. 2:18-CV-07661 (GJS), 2019 WL 3064112, at *9 (C.D. Cal. May 23, 2019) ("The presumption of validity, however, does not equate to a presumption of patent eligibility.")- and Judge Mayer in a concurrence argued that it should not. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 720 (Fed. Cir. 2014) ("Because the PTO has for many years applied an insufficiently rigorous subject matter eligibility standard, no presumption of eligibility should attach when assessing whether claims meet the demands of section 101....Although the Supreme Court has taken up several section 101 cases in recent years, it has never mentioned—much less applied—any presumption of eligibility."). It will be interesting to see if anyone tries to get the Federal Circuit to weigh in en banc on this issue.

The panel also rejected Sandoz's argument that the "stunning admissions at trial regarding the invention" justified the district court sua sponte eligibility analysis, finding Sandoz's cited cases pre-dated the codification of the presumption of validity in the 1952 patent act and its corresponding requirement that a patent challenger affirmatively plead its defenses. Interestingly, the court refused to consider Sandoz' position at oral argument that a section 101 defense had been plead, finding it was forefeited for not being briefed. While in my opinion this would have been unlikely to change the outcome given the pre-trial stipulation, it is interesting the court did not reject the argument on its merits as well. Nor did the panel leave open the opportunity of defendants adding a 101 defense on remand, stating unequivocally the issues on remand "are limited to infringement and validity under 35 U.S.C. § 112."

The case provides a key lesson, especially to those representing defendants, preserve your defenses and embrace in-the-alternative arguments. See Nuvo Pharms. (Ireland) Designated Activity Co. v. Dr. Reddy’s Lab’ys Inc., 923 F.3d 1368 (Fed. Cir. 2019) (finding claims invalid under 112 in part based on patentee's non-obviousness arguments).

A final interesting note was the district court's readily apparent frustration with ANDA litigants - stating that industry has "perverted the intent of the Hatch-Waxman amendments" and parties "have colluded to protect weak or invalid patents and share in the startling profits." While the panel agreed such statements had no relevance, and it understood Astellas' concerns, the panel declined to send the case to a different judge on remand, though it did caution the district curt that "these proceedings are not an appropriate venue for those frustrations to be aired, let alone acted upon."

Minerva v. Hologic: A Review in Poetry

    by Alejandro Menchaca

I've previously written about the Minerva assignee estoppel case, currently pending at the Supreme Court: here.

In case you don't have time to read my article, I've summarized the parties' arguments in the following short poem.

Patent Assignor:

In daytime, I write up the patents.

By nighttime, the patents are sold.

The buyer asserts them against me.

Can't challenge validity, I'm told.

But now the Supreme Court will help me.

Sellers can take patents down.

Your patent is really worth nothing.

The buyer has only a frown.

Patent Assignee:

Now that we bought up the patent,

The seller infringes, that's cold.

We'll sue, infringement, to stop them.

Can't challenge validity, we're told.

Supreme Court has taken the question.

Can seller undo what it sold?

Prior courts have settled the matter.

Can't change law that is already old.

U.S. Government:

Both sides to the question have merit.

The cases on this are quite old.

But what if the buyer has changed it,

Beyond what the seller has sold?

In cases of change, there's an answer.

This, we think you should hold

The seller can challenge the patent.

And delete the patent from all scrolls.

Federal Circuit Dramatically Narrows Scope of Proper Venue in Paragraph IV Litigation

Valeant v. Mylan, No. 19-2402 (Fed. Cir.)

    by Alex Menchaca

In a precedential decision last week, the Federal Circuit settled how the Supreme Court's TC Heartland decision bears on venue issues in Hatch-Waxman litigation. Valeant details the court's pre-TC Heartland patent venue jurisprudence when venue for patent infringement cases could be established by showing personal jurisdiction—i.e., for large corporations, virtually anywhere in the United States. Valeant further explains how the court's Acorda decision, addressing specific personal jurisdiction in ANDA cases, led to a wide-open venue analysis. In Acorda, the Federal Circuit had held that "planned future acts were sufficient to justify the exercise of specific personal jurisdiction over a defendant in ANDA cases." As noted, pre-TC Heartland wherever there was personal jurisdiction, there was venue.

Valeant settles that venue in Hatch-Waxman litigation must follow the example of TC Heartland and its narrow reading of 35 U.S.C. § 1400(b). The patent venue statute provides for establishing venue in two ways: (i) where a defendant resides or (ii) where the defendant has committed acts of infringement and has an established place of business. TC Heartland established that for purposes of this statute a defendant resides only in its place of incorporation, thus eliminating the pre-TC Heartland wide-open venue analysis based on a mere showing of personal jurisdiction. With the first prong of the venue statute narrowed by TC Heartland, patent owners relied on the second prong to litigate in their favored districts—in ANDA cases often New Jersey and Delaware. Valeant addresses the second prong of the patent venue statute and greatly narrows its reach, likely limiting access to those favored districts.

Before Valeant, district courts struggled to define what was the "act of infringement" in an ANDA case for purposes of the venue statute. In Valeant, the Federal Circuit examines two district court decisions—one from Delaware and the other from New Jersey—that conclude potential future nationwide sales of the generic product may be considered the act of infringement for purposes of establishing venue. Such an analysis subjects the ANDA applicant to nationwide venue. The Federal Circuit, however, rejects that analysis and instead defines a much more narrow conduct that may constitute the act of infringement for venue purposes: "it is the submission of the ANDA, and only the submission, that constitutes an act of infringement." Therefore, when a patent owner seeks to establish venue by alleging a local act of infringement (35 U.S.C. § 1400(b)), only the submission qualifies as such an act and not some potential future plans to sell the ANDA product throughout the United States. In Valeant, the ANDA was sent from West Virginia for filing with the FDA in Maryland. West Virginia (and perhaps Maryland (question not considered)) is the proper venue in this case. This decision dramatically restricts the scope of proper venue for U.S.-based ANDA filers, and will likely lead to a dispersal of ANDA cases outside of Delaware and New Jersey in the future.

Interestingly, the Federal Circuit criticizes the characterization of 35 U.S.C. § 271(e)(2) infringement as an "artificial act of infringement." The statute defines what constitutes infringement and the ANDA filing is simply another form of infringement, according to the court. Perhaps this criticism will remove the phrase "artificial act of infringement" from patent bar parlance.

Also interesting is the Federal Circuit's discussion of Acorda. As noted above, Acorda established specific personal jurisdiction based on "planned future acts." In limiting "acts of infringement" to the sending and filing of the ANDA, Valeant criticized consideration of "planned future acts" in venue considerations. Acorda appears inconsistent with Valeant, but the Federal Circuit may not need to address that inconsistency because Valeant’s clear-cut venue rule may short-circuit any consideration of specific personal jurisdiction issues.