By Kevin E. Noonan –

In addition to the briefs from the parties, seventeen amicus briefs were filed with the Supreme Court in Hikma v. Amarin: six in favor of Petitioner Hikma, seven in favor of Respondent Amarin, and the remaining five on behalf of neither party (although the latter category is in some instances shaded by underlying biases).  Synopses of the briefs in favor of Hikma are provided in this post.  Subsequent posts will provide synopses of the briefs in favor of Amarin and those favoring neither party.

76 Scholars* in Law, Business, Economics, and Medicine

The Scholars’ principal argument is that inducement requires “an act that is specific, unambiguous, and affirmative,” citing Glob.-Tech Appliances, Inc. v. SEB SA, 563 U.S. 754, 766 (2011), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d1464, 1469 (Fed. Cir. 1990).  “Conduct that (1) does not specifically encourage infringement, (2) is ambiguous as to infringing or noninfringing behavior, or (3) is an omission has long been insufficient for patent inducement liability” the brief asserts, accusing the Federal Circuit of “disregard[ing] these principles,” wherein “inducement liability could arise based on speculative inferences from general marketing statements and mandatory drug labeling text—statements that bore no specificity to the patented methods of use at issue,” consistent with the Court’s decision (erroneous in the Scholars’ view) with GlaxoSmithKline LLC v. Teva Pharmaceuticals USA.

These instances are both errors of law and “threaten[] the statutory scheme for generic drug competition, the innovation economy, the patent system’s foundational principles, and patient health and welfare” in the Scholars’ view.

Much of the Scholars’ arguments are consistent with Hikma and other amici, that the Federal Circuit’s decision is contrary to the Congressional scheme under the Hatch Waxman Act to promote generic competition in pharmaceutical products (although there is much less discussion of Congress’s attempt to promote balance between innovator and generic drugmakers).  They also raise a concern (shared in Hikma’s brief and by other amici) that the decision will raise the specter of inducement liability that could chill if not stifle drug competition, made worse by the Federal Circuit’s use of statements required by law (on the label) in support of inducement.

The Scholars posit that the failure of Congress to set forth guidelines and “mechanisms” for determining the standards for inducement in the skinny label context was evidence of “congressional understanding that avoidance of patent inducement is a simple, clear, easily determined matter.”

Doctrinally, the Scholars set forth three requirements for establishing inducement: specific actions, lacking ambiguity, and affirmative acts of commission.  The need for the specific prong of the active inducement standard in the brief is supported in caselaw by A. Stucki Co. v. Worthington Indus., Inc., 849 F.2d 593, 597 (Fed. Cir. 1988); Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003); Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1329 n.2 (Fed. Cir. 2009); DSU Med. Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc); Tegal Corp. v. Tokyo Electron Co., Ltd., 248 F.3d 1376, 1379 (Fed. Cir. 2001).

The Scholars’ support for the “lack of ambiguity” requirement is supported by Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 632 (Fed. Cir. 2015); C.R. Bard, Inc. v. Advanced Cardiovascular Sys., 911 F.2d 670, 675 (Fed. Cir. 1990); HZNP Meds. LLC v. Actavis Lab’ys UT, Inc., 940 F.3d 680, 702 (Fed. Cir. 2019); Eli Lilly & Co. v. Bd. of Regents, 334 F.3d 1264, 1369 (Fed. Cir. 2003).

Finally, the Scholars support for the affirmative “act of commission” requirement finds support in Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d 1558, 1568 (Fed. Cir. 1994); Global-Tech, 563 U.S. at 760; and Tegal, 248 F.3d at 1378.

More generally, the Scholars cite a century and a half of precedent on the standards for inducement of infringement, namely Wallace v. Holmes, 29 F. Cas. 74, 80 (C.C.D. Conn. 1871); Motion Picture Pats. Co. v. Universal Film Mfg. Co., 243 U.S. 502, 516 (1917) (overruling Henry v. A.B. Dick Co., 224 U.S. 1 (1912); Carbice Corp. of Am. v. Am. Pats. Dev. Corp., 283 U.S. 27, 32 (1931); and G.S. Rich in Infringement Under Section 271 of the Patent Act of 1952, 21 Geo. Wash. L. Rev. 521, 542 (1953).

The remainder of the brief sets forth arguments regarding drug policy and the deleterious effects on drug pricing and innovation that will accrue should the Federal Circuit’s decision be permitted to stand.

* Gerard Anderson, Johns Hopkins Bloomberg School of Public Health; Reed Beall, University of Calgary Cumming School of Medicine; Jeremy Bock, Tulane University Law School; Timothy F. Bresnahan (Emeritus), Stanford Department of Economics; Jeremy I. Bulow, Stanford Business School; Darren Bush, University of Houston Law Center; Michael A. Carrier, Rutgers Law School; Michael W. Carroll, American University Washington College of Law; Peter Carstensen, (Emeritus),  University of Wisconsin Law School; Bernard Chao, University of Denver Sturm College of Law; Thomas Cheng, University of Hong Kong, Faculty of Law; Ralph D. Clifford (Emeritus), University of Massachusetts School of Law; Jorge L. Contreras, University of Utah S.J. Quinney College of Law; Rochelle Dreyfuss (Emerita), New York University School of Law;  Charles Duan, American University Washington College of Law; Michael Dube, University of New Hampshire Franklin Pierce School of Law; Stacie B. Dusetzina, Vanderbilt University Medical Center; William Feldman, UCLA David Geffen School of Medicine; H.E. Frech, III, University of California, Santa Barbara, Department of Economics; Erin C. Fuse Brown, Brown University School of Public Health; Michal S. Gal, University of Haifa, Faculty of Law; Jon M. Garon, Nova Southeastern University Shepard Broad College of Law; Shubha Ghosh, Syracuse University College of Law;  Hiba Hafiz, Boston College Law School; Bronwyn H. Hall (Emerita), University of California, Berkeley, Department of Economics; Jeffrey Harrison (Former), University of Florida Levin College of Law; Yaniv Heled, Georgia State University College of Law; Christina S. Ho, Rutgers Law School; Cynthia M. Ho, Loyola University Chicago School of Law; Tim Holbrook, University of Denver Sturm College of Law;  Erik Hovenkamp, Cornell Law School;  Michael J. Hutter, Albany Law School; Aaron S. Kesselheim, Harvard Medical School; Shweta Kumar, University of Kentucky J. David Rosenberg College of Law; Amy Landers, Drexel University Thomas R. Kline School of Law; Stacey M. Lantagne, Suffolk University Law School; Mark A. Lemley, Stanford Law School; Jack I. Lerner, University of California, Irvine School of Law; Christopher R. Leslie, University of California, Irvine School of Law; Yvette Joy Liebesman, Saint Louis University School of Law; Daryl Lim, Penn State Dickinson Law; Orly Lobel, University of San Diego School of Law; Lee Ann Wheelis Lockridge (Emeritus), Louisiana State University Law Center; Brian Love, Santa Clara University School of Law; Duncan Matthews, Queen Mary University of London, School of Law; Mark P. Mckenna, UCLA School of Law; Frances Miller (Emerita), Boston University Law School; Christopher J. Morten, New York University School of Law; Roger Noll (Emeritus), Stanford University, Department of Economics; Tyler T. Ochoa, Santa Clara University School of Law; Luigi Palombi (Former), University of Sydney;  Jordan Paradise, Loyola University Chicago School of Law; Stephanie Plamondon, Brigham Young University J. Reuben Clark Law School; Srividhya Ragavan, Texas A&M University School of Law; Zia Rahman, Sidney Kimmel Medical College at Thomas Jefferson University; Arti K. Rai, Duke Law School; Jason Reinecke, University of Wisconsin Law School; Christopher Robertson, Boston University Law School; Benjamin N. Rome, Harvard Medical School; Joseph Ross, Yale School of Medicine; Ana Santos Rutschman, Villanova University Charles Widger School of Law;  William Sage, Texas A&M University School of Law and College of Medicine; Joshua D. Sarnoff, DePaul College of Law; Ameet Sarpatwari, Harvard Medical School; Kurt Saunders, California State University, Northridge, David Nazarian College of Business and Economics; Fiona M. Scott Morton, Yale School of Management and Yale Law School; Steven Semeraro, Thomas Jefferson School of Law; Michael S. Sinha, Saint Louis University School of Law; Aram Sinnreich, American University School of Communication; Katherine J. Strandburg, New York University School of Law; Hannibal Travis, Florida International University College of Law; S. Sean Tu, University of Alabama School of Law; H.H.B. Vedder, University of Gronigen, Faculty of Law; Liza Vertinsky, University of Maryland Francis King Carey School of Law; Rebecca E. Wolitz, The Ohio State University, Mortiz College of Law; Olivier Wouters, Brown University School of Public Health

Michael A. Carrier, Charles Duan, S. Sean Tu, and Aaron S. Kesselheim are named on the cover of the brief

Shashank Upadhye

The argument set forth by this amicus is that the conduct was lawful and liability depends solely on Hikma’s intent, which amicus does not believe was sufficiently established.  The brief focuses on the proper application of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), and that these decisions “permit heightened specificity” in this instance.  Inducement as defined by this amicus is “not negligence,” “not strict liability,” “not mere foreseeability” but rather “[i]It is a doctrine of purposeful encouragement” for direct infringement based on the same caselaw (Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011); Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 642 (2015); Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005)) cited by others.  Inducement cannot be promised solely on lawful conduct this amicus contends, citing Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003).

The question identified here is “a distinct procedural question: what level of factual specificity is required at the pleading stage when inducement is alleged based on conduct that Congress has affirmatively authorized”?  It cannot be the skinny label itself (nor designation as a generic or a therapeutic equivalent rating) but must be “something more.”  As an indication of what such something more can be, the brief asserts that “when intent is the sole element transforming statutorily authorized conduct into alleged wrongdoing, the pleading burden carries unusual institutional significance.”  Amicus uses Grokster* as illustrative: “inducement liability arose not from neutral instructions or product descriptions, but from an integrated course of conduct designed to foster infringement.”

If the “underlying conduct” is lawful, and liability depends entirely on proving purposeful encouragement beyond that conduct, then plausibility demands concrete factual content, not inference built upon inference, amicus argues, and “when an inducement claim rests primarily on legal conduct Congress has authorized, the complaint must plead with particularity the objective facts that render specific intent plausible by identifying the acts of encouragement, the audience targeted, the connection to the claimed method, and a plausible causal pathway to infringement.”  These arguments are consistent with arguments from other amici that inducement requires “purposeful, culpable encouragement.”

*One difference, of course, is that inducement of infringement is not codified in any statute under Title 17, which might bring some pause to the Court when asked to use copyright principles/jurisprudence in coming to a conclusion here.

Association for Accessible Medicines

This amicus argues that offering a drug for sale does not induce infringement of carved-out method patent because Section viii only applies to methods for using an unpatented drug.  Further, the brief asserts that unlike ANDA filings, Section viii does not trigger pre-launch infringement litigation because skinny labels per se do not themselves induce infringement.  The existence of state automatic substitution laws inhibits generic drug companies from prescribing a specific manufacturer’s generic drug according to this amicus.

Amicus sets out the principal differences between ANDA litigation and the Section viii carve-out strategy to be:

[W]ith a skinny label, a generic can get on the market immediately—no litigation, no delays, and under a correct view of the law, no fear that the skinny label will induce infringement.  The results have been spectacular—hundreds of generic drugs on the market sooner, with billions of dollars in savings.

The brief sets forth four errors or “fundamental” misunderstandings of the law by the Federal Circuit that provide a basis for the Court to reverse the judgement:

(1) Section viii applies only to method patents. The sale (or offer for sale) of an unpatented product cannot induce infringement of a patent that claims only one way of using that product.

(2) Skinny labels do not induce infringement of the carved-out patent. That is why the statute requires no notice to the brand and no pre-launch adjudication when the generic carves out the patent, whereas it does require notice and provides for pre-launch adjudication (and delayed FDA approval of the generic) when a generic challenges a patent as invalid.

(3) True statements that a generic product is the “generic version” or “generic equivalent” of a brand product merely echo what the government itself says; they are characterizations of the (unpatented) product, not the labeled uses.

(4) Generics generally do not market their products, because of state automatic-substitution laws, and because doctors do not specify which company’s generic product will be used to fill a prescription. Press releases directed to investors, not doctors, have no bearing on doctors’ prescribing decisions.

Active inducement requires affirmative encouragement and calling a drug “generic” or having a skinny label itself or press releases itself not enough.  This amicus blames high drug costs on lack of competition, using arguments based mostly on a dire consequences scenario:

But if the Federal Circuit’s decision is not reversed, Section viii will plummet in significance.  The Federal Circuit has opened the floodgates for litigation against generic manufacturers, allowing cases to get past the pleading stage merely by alleging conduct that is utterly commonplace in skinny-label launches.

Amicus further argues that that Congress enacted the skinny label regime knowing off-label infringement of the unpatented drug for a patented use would occur (at least under State automatic substitution laws):

Section viii reflects Congress’s judgment that patents on a specific use of an unpatented drug must not delay approval of a generic version of the drug itself, and its insight that removing the patented use from the label suffices to prevent inducement.

This amicus‘ argument came down to (in its view) that Hikma did what it was supposed to do under Section viii, and shared many of the same policy arguments asserted by other amici.

Henry A. Waxman

Not surprisingly, Congressman Waxman’s amicus brief describes in some detail the historical antecedents to Section viii as part of the Hatch-Waxman scheme for facilitating generic drug entry into the marketplace and the success the Act has had in the past forty years in achieving Congress’s aims in that regard.  The brief asserts that the Congressman “believes both that the Federal Circuit’s decision in this case is flatly inconsistent with the language of the Act and congressional intent, and that unless overturned it will devastate the Hatch-Waxman Act’s generic drug program, which has saved patients, the federal government, and other payers trillions of dollars” (“nearly $3.4 trillion” over the past ten years” and later in the brief stating that “In 2024 generic drugs comprised 90% of prescriptions filled nationally, saving $447 billion, including $142 billion in Medicare savings and $62.1 billion in Medicaid savings”).

The principal benefit has been that branded drug makers can be incentivized to find new indications for drugs and at the same time generic drug makers can enter the marketplace for earlier-claimed indications as exclusivities and patents for the drug itself, stating that “section viii provides the mechanism for a generic company to identify those uses, so that a product with a label matching them can quickly come to market,” citing Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415 (2012) (emphasis added); Takeda Pharm. U.S.A., Inc. v. West- Ward Pharm. Corp., 785 F.3d 625, 630 (Fed. Cir. 2015); Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1360 (Fed. Cir. 2003) (emphasis in brief).

The brief cautions that “[c]ourts ‘must respect the role of the Legislature, and take care not to undo what it has done.  A fair reading of legislation demands a fair understanding of the legislative plan,’” citing King v. Burwell, 576 U.S. 473, 498 (2015), and that the Federal Circuit rationale against Hikma in this case “ignores the legislative text and undermines Congress’s careful and considered ‘legislative plan.’”  The brief further asserts that “Congress . . . anticipated this exact situation” in this case, that the Federal Circuit’s decision was “inconsistent [(i.e., cannot be reconciled)] with the statute” and “will have major adverse implications” should the decision be permitted to stand by the Court.  These statements are particularly directed to the evidence considered by the lower court in determining that the question of infringement inducement should have survived Hikma’s motion to dismiss.

Public Citizen

This brief argues that Hikma “played by the [statutory] rules” and the Act does not “permit patent liability to be imposed on generic manufacturers who play by the rules when marketing drugs approved with skinny labels.”  The arguments are particularly focused on “making medicines more affordable [by] the adoption of policies that facilitate regulatory approval and marketing of generic drugs that compete with expensive brand-name drugs.”  The brief further states that “Public Citizen submits this brief to explain that the [Federal Circuit’s] opinion in the case disregards the language and structure of the Hatch-Waxman Amendments, is likely to cause significant harm to consumers, and runs counter to the strong federal policy of promoting the availability of generic medications as a means of lowering costs for patients” (which is exactly that it does in detail, reciting many of the arguments made by Hikma and other amici down to referring to certain of the evidence as comprising “anodyne” statements not supporting a conclusion of inducement to infringe).  The brief concludes with policy arguments that the Federal Circuit’s decision “threaten[s] serious harm to the consumer-protection and public-health goals of the Hatch-Waxman Amendments,” supported by statistics from governmental and non-governmental sources.

Solicitor General

The government’s brief follows the arguments made by the Solicitor General’s brief to the Court giving the Justices its views on whether to grant certiorari.  These include 1) that “Amarin’s allegations do not make out a plausible claim of active inducement to infringe”; 2) The “statements on which the Federal Circuit relied provide no basis for liability”; and 3) “[t]he Federal Circuit’s decision undermines the broader Hatch-Waxman scheme.”  After providing the Court with a thorough but focused synopsis of the Act itself, the course of proceedings below, and the policy goals and questions involved, the brief provides arguments (reciting the characterization of certain of Amarin’s evidence as being “generic manufacturer’s anodyne descriptions of its product”) for the Court to reverse the Federal Circuit’s decision.

By Kevin E. Noonan –

In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not covered in their approved label (known as a “skinny label; see “GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)“).  In the latest instance (see “Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)“), the Solicitor General filed its amicus brief (at the Supreme Court’s behest) regarding the issue, once again (as has been done before; see “Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation“) arguing that the Court should grant certiorari.  Somewhat surprisingly, on January 16, the Court did just that, and will consider one of these two Questions Presented by Hikma in its Petition:

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?

2. Does a complaint state 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?

Perhaps even more surprisingly, the Court set an accelerated schedule for oral argument on April 27.

To recap, the case arose over Amarin’s Vascepa® (icosapent ethyl) drug product, an omega-3 fatty acid from fish oil, for treatment of severe hypertriglyceridemia (blood triglyceride levels at least 500 mg/dL; normal range being less than 150 mg/dL) (termed the “SH indication”).  Amarin also later received approval for a second indication, reducing cardiovascular disease risk (wherein the second approval removed a Limitation of Use in this regard on the original label) (the “CV indication”).  Hikma filed its ANDA against the first approved Vascepa® product indication; upon Amarin receiving its second FDA approval Hikma filed a section viii statement to carve-out the CV indication under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called “skinny label” provision of the statute).  The FDA approved Hikma’s skinny label ANDA in 2020 not containing the CV Limitation of Use on the label.

Thereafter, in a series of press releases, Hikma asserted its product as a “generic version of Amarin’s Vascepa®.”  In a particular press release, Hikma claimed its two-month U.S. sales to be $1.1 billion, a figure for all uses of its product, with up to 75% of these sales being for the putatively carved-out CV (off-label) indication (albeit there being other press releases emphasizing the limitation of FDA approval to the SH indication).  And on Hikma’s website, while asserting an AB rating for its product (generic approval for all indications on the label), the website also said, “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug.”

Amarin sued Hikma for inducement of infringement under 35 U.S.C. § 271(b) of Orange Book listed U.S. Patent Nos. 9,700,537 and 10,568,861 (for claim 1 of the ‘527 patent and claim 1 and 2 of the ‘861 patent):

‘537 patent:

1.  A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:
    identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy3-methylglutaryl coenzyme A reductase inhibitor,
    wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate; and wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and
    wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium.

‘861 patent:

1.  A method of reducing risk of cardiovascular death in a subject with established cardiovascular disease, the method comprising administering to said subject about 4 g of ethyl icosapentate per day for a period effective to reduce risk of cardiovascular death in the subject.

2.  The method of claim 1, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and a fasting baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.

The District Court granted Hikma’s motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim, and the Federal Circuit reversed, relying on Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 632 n.4 (Fed. Cir. 2015), that there is no need to have a generic label contains a “‘clear statement’ discouraging use of the patented indication” to avoid infringement liability.  The Federal Circuit specifically held that:

[I]t [would] at least [be] plausible that a physician could read Hikma’s press releases—touting sales figures attributable largely to an infringing use, and calling Hikma’s product the “generic version” of a drug that is indicated “in part” for the SH indication—as an instruction or encouragement to prescribe that drug for any of the approved uses of icosapent ethyl, particularly where the label suggests that the drug may be effective for an overlapping patient population [and] at least plausible that a physician may recognize that, by marketing its drug in the broad therapeutic category of “Hypertriglyceridemia” on its website, Hikma was encouraging prescribing the drug for an off-label use [emphasis in Hikma’s opening brief].

Amarin’s Respondent’s Opening Brief makes two arguments.  Substantively the brief addresses Hikma’s contentions that Amarin had not provided sufficient support in its complaint to survive its motion to dismiss.  The more cogent argument is procedural, that in response to a motion to dismiss, Amarin was to be given the benefit of all their well-plead facts as being true and having found this to be the case the Federal Circuit did not err in permitting the matter to go to trial (which will be the outcome should the Supreme Court affirm).

Amarin’s substantive infringement arguments focus on inducement of infringement generally, not limited to the more limited context of the Hatch-Waxman Act or pharmaceuticals.  Amarin argues that the reason for the skinny label pathway is that FDA regulates approval for indications and so a generic drug maker can have approval for a non-patented use but there can be off-label use that is infringing.  Their ultimate argument is that Hikma informed the public that the off-label used was safe and effective for the patent-protected indication, in a context of how the second indication was greeted by doctors (a “game changer,” providing the incentive for off-label use and knowledge of the benefits of that use by doctors).  And regarding the consequence of Hikma’s behavior, Amarin emphasizes the investment (“more than 8,000 hypertriglyceridemia patients taking statins” and costing “hundreds of millions of dollars,” specifically more than $300 million”) needed to establish the safety and efficacy of the second indication, and the relative value of the two indications (“By the time petitioners brought their generic product to market, they knew that Vascepa’s patented CV indication accounted for the vast majority of prescriptions and Vascepa’s commercial identity.”)  These arguments cast Hikma as an infringer taking advantage of Amarin’s investment (matched with a certain amount of hagiography about the second indication and response from physicians, not only for patients but also “the overall healthcare system”).  As a counterargument to the accusations from Hikma (and others) regarding drug prices, the brief asserts that “[o]ne economic study found that the costs of Vascepa are ‘offset by cost savings from reducing the occurrence of high-cost major adverse cardiovascular events.’”

At its roots, Amarin contends that Hikma lied and their marketing that their product was useful for treating “hypertriglyceridemia” was sufficiently broad to encompass both the unpatented SH and the patented CV indications.  According to Amarin, “Petitioners’ statements thus increased the likelihood of infringement in this particular context—even though similar references to other generic medicines in other contexts likely would not raise similar concerns,” distinguishing this fact pattern to constitute a special case (and not to have the Court render a decision directed towards a more general rule).  Amarin argues that the Court should consider the “full course of [Hikma’s] conduct,” not just the label, and that such “full course of conduct” amounted to “deliberate efforts to market their product as ‘generic Vascepa’ to steer sales away from Amarin’s product and toward their own for a patented use.”

Amarin also counters Hikma’s contentions in its Opening Brief that its statements asserted by Amarin in support of their arguments before the District Court and Federal Circuit amounted to merely “anodyne statements about skinny-labeled generics” by asserting that Hikma’s website and advertising statements were not so benign; for example, by using “hypertriglyceridemia” Amarin argues that Hikma intentionally (and “unambiguously”) implicated the infringing use.  The brief provides an apt comparison:

There are seven other manufacturers in the same market selling the same generic drug using materially identical “skinny labels” as petitioners.  But respondents have not sued any other manufacturer that confined its marketing to unpatented indications.  Petitioners alone chose to publish statements that healthcare providers would interpret as encouraging prescriptions that infringe respondents’ patents.

The brief turns to statements from the Solicitor General’s amicus brief (which urged the Court to grant certiorari), that it is “important to the federal scheme that generic manufacturers not urge medical professionals to infringe brand-name manufacturers’ method-of-use patents” because “patents play a critical role in incentivizing drug developers to undertake extraordinarily expensive clinical trials, fund additional research, and discover new cures.”  Approval of the skinny label according to Amarin  is tied to an agreement from generic drug makers not to infringe the patented indications, with the benefit that “[f]iling a section viii statement can avoid the possibility of pre-launch litigation and the automatic 30-month stay of approval under paragraph IV.”  As a consequence, the generic drug manufacturer who obtains skinny label approval “enjoys a lucrative opportunity—the right to sell the same product as the branded drug with only a tiny fraction of the pioneer’s upfront investment” according to Amarin.

With regard to the standards required to establish inducing infringement liability, the brief recognizes the intentional aspect of the tort (Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 642 (2015)), the need for active steps by the inducing party under Metro-Goldwyn-Mayer Studios, Inc. v. Grokster, Ltd., 545 U.S. 913, 935-936 (2005), and that here Hikma’s advertising is enough.  Amarin’s position is that the element at issue was whether Hikma took “active steps . . . taken to encourage direct infringement” under Grokster.  Amarin reminds the Court that the Federal Circuit had found that “[I]t is undisputed that Amarin’s complaint sufficiently alleges (1) that health-care providers directly infringe the asserted patents by prescribing Hikma’s generic icosapent ethyl product for the off-label CV indication, and (2) that Hikma had the requisite intent and knowledge to induce that infringement.”  The brief cites three lines of Supreme Court’s precedent in support of its argument regarding the sufficiency of its complaint: (1) underlying direct infringement by one or more third parties, Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 920-21 (2014); (2) the inducing party’s specific intent to infringe, Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 761 n.2, 766 (2011); and (3) “active steps . . . taken to encourage direct infringement,” Metro-Goldwyn-Mayer Studios, Inc. v. Grokster, Ltd., 545 U.S. 913, 936 (2005).  Amarin cites Grokster as standing for the proposition that advertisement could satisfy this prong, in view of the context of these advertisements (wherein there was established “an inextricable connection in the marketplace between Vascepa and its primary, patented CV indication”).

Amarin also addresses the “inevitable infringement” argument (i.e., that State “automatic substitution” laws would inevitably lead to off-label use to minimize Hikma’s liability for any such infringement) by arguing that absolving infringers from liability on these grounds was not Congress’s intent, and that Hikma had forfeited this argument in the proceedings below.  The brief cites Caraco Pharm. Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415, 419 (2012), in opposition to Hikma’s argument that “doctors and patients will inevitably infringe.”  The brief also contends that the Solicitor General raised the State law automatic generic substitution issue “at the eleventh hour” and the Court should not consider it (albeit that seems unlikely).  Maybe a more compelling argument is that this should not be a question of the quantum of the harm but rather its existence (the brief noting the various extents of such substitutions state-by-state).

Regarding Amarin’s procedural arguments, the brief asserts that because this was a motion to dismiss, Amarin was given the benefit of all their well-plead facts as being true which included that Hikma “‘actively’ induced healthcare providers’ direct infringement.’”  This lower threshold enabled the Federal Circuit to find that the “affirmative” and “active” steps to induce infringement arose from the “label in combination with [their] public statements and marketing materials” (emphasis in brief), and this raised a factual dispute regarding whether Hikma’s behavior amounted to inducement of infringement.  (This is perhaps Amarin’s best legal argument but of course it is also an argument that the Court should not have granted cert in the first place.)  Amarin contends that its complaint stated a plausible claim for induced infringement that the Federal Circuit properly permitted to move to discovery, because “[m]ost elements of induced infringement [were] unchallenged” and active infringement found support in Hikma’s advertising behavior.  Further, Amarin contends that Hikma (and the Solicitor General) were wrong because for the Court to find for Hikma would amount to “adopt[ing] the defendants‘ version (i.e., the movant’s version) of the alleged facts,” which is contrary to the standard for a court to assess a motion to dismiss, and wherein the court’s assessment of those facts “cannot be resolved at the pleadings stage.”  And “Petitioners’ defenses share a fundamental defect: they assume the defendants’ version of facts and draw inferences against the plaintiffs.”  Amarin contends that the proper standard is “whether petitioners’ ‘communications’ could be ‘reasonably understood’ to encourage infringement” and here cardiovascular physicians are “sophisticated actors” in this regard (i.e., not readily fooled).  The brief also rejects Hikma’s “passive” inducement argument, both because it hasn’t been made previously and because there was nothing passive about what Hikma discloses.  Amarin also contends that, “[s]traying even further from bedrock pleading standards, petitioners demand that this Court credit their post-hoc explanations for their statements.”

On factual questions whether the Court should condemn Hikma’s behavior as infringing, Amarin further contends that the language used by Hikma has consequences; it would have been different if Hikma had advertised as “generic icosapent ethyl” instead of “generic Vascepa” in it advertising, for example.  The brief further contends that “Petitioners’ icosapent product is not a full “generic equivalent” or “generic Vascepa” because FDA evaluated and approved it only for the labeled SH indication; FDA did not evaluate its therapeutic equivalence for the CV use” and yet Hikma’s off-label use encourages unvetted outcomes.

The latter portion of the brief raises (as it must before the Supreme Court) the policy implications of finding in Hikma’s favor.  The brief assets that “[a]dopting petitioners’ and the government’s arguments would distort patent law in at least two ways: they would (1) foreclose induced infringement claims unless the defendant used explicit, smoking-gun language; and (2) demand that inducement be the primary or exclusive cause of direct infringement.”  On the other hand, affirming the Federal Circuit’s decision would support the patent and regulatory scheme for pharmaceuticals and not “disturb Congress’s carefully balanced incentive structure and risk stifling revolutionary and life-saving discoveries.”  “Holding generic manufacturers liable for their induced infringement is essential to a properly functioning section viii pathway,” Amarin argues and is based on incentives and costs for secondary indications.  Contrary to Hikma’s arguments, all the other generic icosapent ethyl drugs are on the market with the same label and accordingly, Amarin contends, this it isn’t a defective label problem it is a behavior problem.  The brief further challenges statistics recited by Hikma and amici regarding the effects of GlaxoSmithKline skinny label decision (which the Court deigned not to grant cert); see GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).  Finally, “[t]he economic policy underlying the federal drug and patent laws, moreover, is ‘for Congress, not the courts,’” the brief citing Georgia v. Public.Resource.Org, Inc., 590 U.S. 255, 272 (2020).

The brief calls for the Court to withdraw the writ for inconsistencies between the Petition and Hikma’s argument in its Opening brief.  In recent similar circumstances, Amain contends, where petitioners before the Court have argued one thing to secure review and something else at the merits stage, this Court has dismissed the writs of certiorari as improvidently granted.  See, e.g., Facebook, Inc. v. Amalgamated Bank, 604 U.S. 4 (2024) (per curiam); NVIDIA Corp. v. E. Ohman J:or Fonder AB, 604 U.S. 20 (2024) (per curiam).  The same result may be warranted here.  On these grounds, Amarin suggests that the Court dismiss certiorari and send back to the District Court with instructions to grant Amarin leave to amend according to what the Court determines are the proper standards and not with prejudice as Hikma contends.

By Kevin E. Noonan –

A distinguished groups of retired judges* filed an amicus brief supporting Judge Pauline Newman’s Petition for Certiorari over the unwillingness of the Court of Appeals for the D.C. Circuit to rule on her complaint regarding constitutional violations by the Federal Circuit Judicial Council (see “Judge Newman Seeks Recourse from Supreme Court“). 

The gist of Judge Newman’s Petition is that the Judicial Council has de facto removed the Judge from the bench, contrary to the Constitution and the provisions therein for impeaching a federal judge.  The Question Presented addressed by these amici is whether 28 U.S.C. § 357(c) of the Judicial Conduct and Disability Act’s bar of judicial review of the Council’s previously issued “orders” and “determinations” deprive a court of jurisdiction to consider claims that seek forward-looking relief to enjoin future unlawful actions.

Amici contend that the D.C. Circuit’s interpretation and determination that they are bound by the 25-year-old precedent of McBryde v. Committee to Review Circuit Council Conduct and Disability Orders, 264 F.3d 52 (D.C. Cir. 2001), is erroneous as recognized by the Court in Johnson v. Robison, 415 U.S. 361, 367 (1974).  Under the Robison precedent, it is contrary to the constitutional-avoidance canon of statutory construction wherein a court should “first ascertain whether a construction of the statute is fairly possible by which the constitutional question(s) may be avoided”—and if that is the case to adopt that more limited construction.  Moreover, the Supreme Court has recognized that there is a “strong presumption” against Congress enacting a statute that prohibits all judicial review of “federal Action” they argue, citing Dunlop v. Bachowski, 421 U.S. 560, 567 (1975), and to require “clear and convincing evidence” of such intent, citing Bowen v. Mich. Acad. of Family Physicians, 476 U.S. 667, 681 (1986), and SAS Institute Inc. v. Iancu, 584 U.S. 357, 370 (2018).  In amici’s view, the language of § 357(c) “does not come close” to providing the requisite “clear and convincing” evidence that Congress intended to bar judicial review of Judge Newman’s constitutional claims, inter alia, because the statutory language itself is silent as to limits on judicial review of constitutional claims (which was sufficient in Robison for the Court to conclude that that statute did not bar judicial review of constitutional claims).  And amici argue that the express limitation in the statutory language is to “orders and determinations,” which are past actions, while Judge Newman asked the Court for “prospective relief” regarding the Judicial Council’s renewal of the current suspension (as the Council had done twice before and appears to have every intention of continuing to do until the Judge capitulates or the matter becomes moot).  Amici also note that even though the D.C. Circuit recognized the “clear and convincing evidence” standard, the Court did not apply it.

The brief also considers the patency of the distinction in McBryde regarding facial constitutional challenges and “as-applied” challenges and finds little statutory support for the distinction (other than a purported “compromise” decision in the McBryde decision itself; this is another instance for amici to remind the Court that the D.C. Circuit stated that the distinction in this case at least raised “constitutional concerns”).  The significance of this understanding is that despite having said so, the en banc D.C. Circuit did not address the constitutional issues even though Judge Newman had expressly requested them to do so.  Another reason asserted in the brief for the Court to grant Judge Newman’s petition is that statutes that abrogate a right enshrined in the Constitution itself is likely to be unconstitutional, citing Boumediene v. Bush, 553 U.S. 723 (2008).

The brief considers the expansive scope of 28 U.S.C. § 1331, which grants to federal district courts “original jurisdiction of all civil actions arising under the Constitution.”  Amici judges recognize that Congress can enact legislation that limits this jurisdictional scope, but cite Robison once again, this time for the rubric that Congress is loath to do so on constitutional grounds.  In this context amici argue that the D.C. Circuit’s application of § 357(c) is erroneous and deserving of the Court’s review.  The brief reminds the Court that Judge Newman “challenges Respondents’ actions designed to permanently deprive her of her office, and she seeks prospective relief against future actions by Respondents—which she alleges to be imminent” without there being any clear and convincing evidence that Congress “intended to foreclose jurisdiction to issue injunctive relief to prevent future conduct that violates Petitioner’s constitutional rights” (emphasis in brief).  In addition, amici remind the Court that the Act itself provides that “under no circumstances may the judicial council order removal from office of any judge appointed to hold office during good behavior” under 28 U.S.C. § 354(a)(3)(A) (which is precisely what Judge Newman asserts the Judicial Council has done).

Amici further provide their analysis of the application of the constitutional-avoidance canon and make a comparison of the similarities with the statute in Robison, wherein the Court permitted the District Court to consider constitutional claims to avoid the consequences of not doing so.  Here, amici argue that the distinction under McBryde between facial and as applied constitutional challenges, and the Court’s jurisdiction over each, was “unsupported and unsupportable” because, inter alia, “[n]either the text nor the legislative history of the statute supports such a distinction” (which the brief suggests arose because jurisdiction over facial challenges appeared to have more support than did as-applied challenges did).  Amici draw a direct comparison between Robison and this case, asserting that “McBryde‘s distinction [between facial and as-applied constitutional claims] cannot be squared with Robison,” and that “if (as McBryde conceded) the statutory language of § 357(c) ‘closely parallels’ the language of 38 U.S.C. § 211(a), then Robison requires a finding that § 357(c) permits federal courts to exercise jurisdiction over all constitutional claims against Judicial Council actions, not simply facial claims.”  Further, amici claim that “there [is no] logical reason why Congress would decide to bar all as-applied constitutional claims while simultaneously authorizing facial constitutional challenges,” and in a particularly apt assertion, “[a] plaintiff suffering constitutional injury is no less aggrieved simply because the defendant’s misconduct affected no one other than the plaintiff.”

With a modicum of sympathy to the D.C. Circuit, amici acknowledge that the Court identified the defects in McBryde but were stymied (“felt compelled – solely on stare decisis grounds”) to affirm based on jurisdictional grounds (“[t]his panel has no authority to depart from McBryde“).

These amici characterize the issue before the Court as being one of “exceptional importance” because it provides an avenue for de facto removing judges from the federal bench regardless of the propriety of such removal under the Constitution.  Amici conclude their substantive arguments by reliance on Boumediene v. Bush, 553 U.S. 723 (2008), which involved the constitutionality of Section 7(a) of the Military Commissions Act of 2006 (MCA), preventing federal courts from considering habeus corpus actions by individuals alleged to be foreign terrorists detained at Guantanamo.  The Court in ruling against the government cited “serious separation of powers concerns,” rejected the capacity of the political branches to “switch the Constitution on or off at will” and be contrary to Marbury v. Madison, 1 Cranch 137, 177 (1803), regarding exercise by the judicial branch of saying “what the law is.”  Amici contend that permitting § 357(c) to stand as construed by the D.C. Circuit would raise separation of powers concerns at least as serious as those in Boumediene.

Amici also emphasize the context of the dispute as a threat to judicial independence (“Authorizing Congress to eliminate the authority of federal courts to decide whether a federal judge has been improperly deprived of life tenure would be a devastating blow to [judicial] independence,” in their view).  The mere filing of a complaint, they assert, “is one means by which individuals can seek to undermine the authority of a federal judge,” particularly insofar as such complaints “often result in some curtailment of the judge’s activities (including a bar on the assignment of certain categories of cases) while a Judicial Council is investigating the complaint” (Judge Newman’s experience having gone much beyond such temporary discomfiture).  The risk, of course (similarly tracking Judge Newman’s experience) is that these circumstances provide a method (increasingly common, according to amici) by which “a judge’s antagonists can circumvent the constitutionally prescribed impeachment process.”  The Court’s review, accordingly, “is warranted to call a halt to this unconstitutional practice.

The effect on the Justices’ consideration of Judge Newman’s case is at best uncertain.  It must be recalled that this Court has spent the better part of the last quarter century disagreeing with and overruling decisions of the Federal Circuit (often 9-0), written by or concurred with by two former Chief Judges of the Federal Circuit.  At least this suggests that the judicial thinking on the Court is sufficiently at odds with amici that any solace that can be gotten by this amicus brief may be very little indeed.

*Amici:

Hon. Janice Rogers Brown served as a Judge on the United States Court of Appeals for the District of Columbia Circuit from 2005 to 2017.  From 1996 to 2005, she served as an Associate Justice on the California Supreme Court.

Hon. Kent A. Jordan served as a Judge on the United States Court of Appeals for the Third Circuit from 2006 to 2025.  From 2002 to 2006, he served on the United States District Court for the District of Delaware.

Hon. Paul R. Michel served as a Judge on the United States Court of Appeals for the Federal Circuit from 1988 to 2010.  He served as Chief Judge of that court from 2004 to 2010.

Hon. Randall Ray Rader served as a Judge on the United States Court of Appeals for the Federal

Circuit from 1990 to 2014.  He served as Chief Judge of that court from 2010 to 2014.

Hon. Thomas I. Vanaskie served as a Judge on the United States Court of Appeals for the Third

Circuit from 2010 to 2019.  He served as a Judge on the United States District Court for the Middle District of Pennsylvania from 1994 to 2010; he served as Chief Judge of that court from 1999 to 2006.

Hon. Paul G. Cassell served as a Judge on the United States District Court for the District of Utah

from 2002 to 2007.  He is currently a Presidential Professor of Criminal Law and a University Distinguished Professor at the University of Utah.

Hon. Susan G. Braden served as a Judge on the United States Court of Federal Claims from 2003 to 2019.  She was designated by the President as Chief Judge in 2017, assumed senior status in 2018, and retired from the bench in 2019.

By Kevin E. Noonan –

In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not covered in their approved label (known as a “skinny label; see “GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)“).  In the latest instance (see “Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)“), the Solicitor General filed its amicus brief (at the Supreme Court’s behest) regarding the issue, once again (as has been done before; see “Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation“) arguing that the Court should grant certiorari.  Somewhat surprisingly, on January 16, the Court did just that, and will consider one of these two Questions Presented by Hikma in its Petition:

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?

2. Does a complaint state 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?

Perhaps even more surprisingly the Court set an accelerated schedule for oral argument on April 27.

To recap, the case arose over Amarin’s Vascepa® (icosapent ethyl) drug product, an omega-3 fatty acid from fish oil, for treatment of severe hypertriglyceridemia (blood triglyceride levels at least 500 mg/dL; normal range being less than 150 mg/dL) (termed the “SH indication”).  Amarin also later received approval for a second indication, reducing cardiovascular disease risk (wherein the second approval removed a Limitation of Use in this regard on the original label) (the “CV indication”).  Hikma filed its ANDA against the first approved Vascepa® product indication; upon Amarin receiving its second FDA approval Hikma filed a section viii statement to carve-out the CV indication under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called “skinny label” provision of the statute).  FDA approved Hikma’s skinny label ANDA in 2020 not containing the CV Limitation of Use on the label.

Thereafter, in a series of press releases, Hikma asserted its product as a “generic version of Amarin’s Vascepa®.”  In a particular press release, Hikma claimed its two-month U.S. sales to be $1.1 billion, a figure for all uses of its product, with up to 75% of these sales being for the putatively carved-out CV (off-label) indication (albeit there being other press releases emphasizing the limitation of FDA approval to the SH indication).  And on Hikma’s website, while asserting an AB rating for its product (generic approval for all indications on the label), the website also said “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug.”

Amarin sued Hikma for inducement of infringement under 35 U.S.C. § 271(b) of Orange Book listed U.S. Patent Nos. 9,700,537 and 10,568,861 (for claim 1 of the ‘527 patent and claims 1 and 2 of the ‘861 patent):

‘537 patent:

1.  A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:
    identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy3-methylglutaryl coenzyme A reductase inhibitor,
    wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate; and wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and
    wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium.

‘861 patent:

1.  A method of reducing risk of cardiovascular death in a subject with established cardiovascular disease, the method comprising administering to said subject about 4 g of ethyl icosapentate per day for a period effective to reduce risk of cardiovascular death in the subject.

2.  The method of claim 1, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and a fasting baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.

The District Court granted Hikma’s motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim, and the Federal Circuit reversed, relying on Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 632 n.4 (Fed. Cir. 2015), that there is no need to have a generic label contains a “clear statement’ discouraging use of the patented indication” to avoid infringement liability.  The Federal Circuit specifically held that “it [would] at least [be] plausible that a physician could read Hikma’s press releases—touting sales figures attributable largely to an infringing use, and calling Hikma’s product the ‘generic version’ of a drug that is indicated ‘in part’ for the SH indication—as an instruction or encouragement to prescribe that drug for any of the approved uses of icosapent ethyl, particularly where the label suggests that the drug may be effective for an overlapping patient population” and “at least plausible that a physician may recognize that, by marketing its drug in the broad therapeutic category of ‘Hypertriglyceridemia’ on its website, Hikma was encouraging prescribing the drug for an off-label use” (emphasis in Hikma’s opening brief).

Hikma’s opening brief characterizes the issues before the Supreme Court as involving “the affirmative conduct a complaint must allege to state a plausible claim of ‘actively induce[d] infringement of a patent’” under 35 U.S.C. § 271(b) and emphasizes Congressional intent to “facilitate the approval of generic drugs as soon as patents allow” under the Hatch-Waxman Act, citing Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012).  Also, Hikma argues that Congress enacted the Section viii carveout in the Hatch-Waxman Act fully aware of the existence of state laws regarding “automatic substitution” of generic for branded drugs (Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 847 & n.4 (1982)), as introducing a certain inevitability for “off-label” use under the Section viii carve-out regime, and relying on the need for affirmative conduct to raise inducement to infringe liability for generic drugmakers.

The brief cites earlier Federal Circuit precedent that seemed to accommodate these circumstances, citing AstraZeneca Pharms. LP v. Apotex Corp., 669 F.3d 1370, 1380 (Fed. Cir. 2012), but argues that if these situations were no longer accommodated (“If merely alleging that a generic drug with a skinny label will inevitably be substituted for patented uses were enough to plead active inducement”) then the skinny label regime would be at risk and Congressional intent thwarted (“At the time of section viii’s adoption, it was thus widely understood that doctors and patients necessarily would infringe method-of-treatment patents despite the use of skinny labels”).  With regard to that intent, Hikma tells the Court that Congress enacted the statute to provide the advantages to generic drugmakers that it does not provoke litigation like a Paragraph IV notice does and does not involve the 30-month stay for approval (with resulting delay in getting generic drugs to patients directed to indications no longer having regulatory or patent exclusivity).

Regarding the evidence that proved persuasive before the Federal Circuit, the brief adopts the Solicitor General’s language that it constitute “the most routine and anodyne statements about skinny-labeled generics” as well as not being limited to statements addressed to doctors and patients.  Hikma argues that:

Where, as here, a skinny label fully carves out all patented uses under section viii, allegations that the generic drugmaker simply calls its product a “generic version” of the branded drug and cites public information about the drug (for example, sales figures) are insufficient to state a claim under § 271(b).

The quanta of evidence accepted by the Federal Circuit in coming to its conclusions were three according to the brief:  Hikma communications contained in its FDA-approved skinny label; pre-launch press releases to investors announcing litigation victories; and information appearing on its website.  Hikma argues that the evidence attributed to the label included the absence of a “CV Limitation of Use” on Hikma’s “skinny” label (because that limitation was not on the Amarin label and those labels were required under FDA regulations to be identical); warnings on patient information leaflets stating possible side effects including cardiovascular disease; statements on patient information leaflets regarding alternative prescriptions (“other purposes”); and “other elements” of the label, such as administration accompanying statin use.  This evidence, Amarin had successfully argued before the Federal Circuit, supported its inducement of infringement assertions considered in combinations of the skinny label in view of Hikma’s public statements, including prelaunch press releases related to Hikma’s litigation victories, baldly stating “Hikma’s generic version of Amarin Corporation’s Vascepa®” does not infringe six US patents.  Hikma accuses Amarin of asserting inducement because the materials do not include affirmative prohibitions against using Hikma’s Vascepa® generic for “the CV indication” and included its sales information that included all uses not just the approved (and non-infringing) SH uses.

Hikma argued that there was no evidence of active inducement and thus the Federal Circuit was not justified in requiring discovery, and that “mere inferences or assumptions about how third parties might react to vague communications that lack any instruction or encouragement to infringe cannot trigger liability.”  Further, according to Hikma’s brief “[the Court] did not identify any alleged statement by Hikma that mentions, much less encourages, administering icosapent ethyl for ‘reducing risk of cardiovascular death’ or ‘reducing occurrence of a cardiovascular event’ when taken with a statin, as Amarin’s patents require.”  Also, “[n]or did the Federal Circuit point to any alleged statement by Hikma instructing doctors and patients that they should use its generic product as they use Vascepa for its CV indication (no such statement exists).”  Hikma contends that establishing inducement required “active inducement” (unambiguously) and liability would only properly arise by the accused infringer taking affirmative steps, citing Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936–937 (2005) (“The inducement rule, instead, premises liability on purposeful, culpable expression and conduct, and thus does nothing to compromise legitimate commerce or discourage innovation having a lawful promise”) and Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 760 (2011) (“the inducer must persuade another to engage in conduct that the inducer knows is infringement”), analogized to aiding-and-abetting liability under Smith & Wesson Brands v. Estados Unidos Mexicanos, 605 U.S. 280, 291 (2025).  Further, Hikma argues that the induced acts must be infringing, citing Commil USA, LLC v. Cisco Sys., Inc., 575 U.S. 632, 637 (2015), and the behavior Amarin asserts was not infringement because it was limited to the unpatented invention (the SH embodiments).  Under these circumstances, Hikma argues Amarin’s complaint failed to make a claim, relying on the difference between enabling the court to draw a reasonable inference of liability from the facts asserted in the claim and facts merely consistent with liability (“it stops short of the line between possibility and plausibility of entitlement to relief”).

The brief makes a variety of procedural arguments based on the status of the case (on a motion to dismiss under Fed. R. Civ. Pro. 12(b)(6)) and sufficiency of pleadings standards citing Ashcroft v. Iqbal and Bell Atl. Corp. v. Twombly (“there is no plausible allegation that Hikma’s statements actively induce specific conduct that satisfies all claim steps for any asserted claim”).  These include that “Amarin and the Federal Circuit purport to ‘read’ instructions that Hikma never made into anodyne statements of generic equivalence—effectively misattributing a physician’s intervening reliance on their own knowledge and independent judgment to Hikma.”  The consequence of the Court not remedying this situation will be, as Hikma argues, that “[a]llowing cases like this one to survive the pleadings stage would eviscerate section viii, which was designed to expedite generic-drug competition without litigation” (emphasis in brief).

Applying these pleading standards to Amarin’s complaint, Hikma argues that Hikma’s label encourages non-infringing use (i.e., only the non-infringing SH indication) and that Hikma did not actively induce infringement for other uses (and even when cardiovascular uses are mentioned there is a warning against doing so).

On the merits Hikma argues that the accused statements were insufficient to encourage infringement, in part because they were accurate, i.e., that Hikma’s product was a generic version of Amarin’s drug.  Further, Hikma contends that the information regarding Vascepa’s sales not relevant to how the drug is prescribed or taken, and the website was not directed to doctors or patients but rather to investors (although that information was available to both doctors and patients,

Finally, the brief contains policy arguments regarding the consequences should the Court permit the Federal Circuit’s decision to stand.  These include that it would act to nullify Section viii by creating disincentives for using the skinny label approach; these consequences are based on the fact that, unlike ANDA litigation, cases brought under §271(b) would be brought after the generic version of a branded drug was sold on the market and thus subject to monetary damages (which, as here, would be exposed to willful infringement enhancement).  Nor would the § 271(b) regime provide the 30-month stay in generic drug approval which has provided an incentive for generic drug development.  Hikma urges the Court that “[a]bsurdly, the decision below makes skinny labels riskier than paragraph IV certifications” on these grounds.

Amarin’s brief will be the subject of a future post.

By Kevin E. Noonan –

The Federal Circuit reversed a District Court grant of judgment as a matter of law (JMOL) that overturned a jury verdict that defendant Eli Lilly had not satisfied the clear-and-convincing-evidence standard in challenging on Section 112(a) grounds claims asserted by Teva Pharmaceuticals in Teva Pharmaceuticals International v. Eli Lilly & Co.  In addition to providing a “man bites dog” aspect to the case, the opinion also sets forth circumstances where an insufficient disclosure in a patent specification relating to components of the claimed invention can be supplemented by the knowledge of one having ordinary skill in the art.

The case arose in patent infringement (not ANDA) litigation between the parties over claims in U.S. Patent Nos. 8,586,045; 9,884,907; and 9,884,908, relating to the use as a headache treatment (Teva’s Anjovy, Eli Lilly’s Emgality) comprising antibodies immunologically specific for calcitonin gene-related peptide (CGRP), wherein this protein can cause or exacerbate headache when binding to certain cell surface receptors and increasing blood flow thereby.  The antibodies prevent such binding and thus reduce or eliminate headache.  Claim 30 of the ‘045 patent is set forth as representative:

A method for reducing incidence of or treating headache in a human, comprising administering to the human an effective amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a . . . humanized monoclonal antibody.

The parties had been involved in several inter partes review (IPR) proceedings that had resulted in invalidation of Teva’s claims directed to the antibodies themselves (U.S. Patent Nos. 9,340,614; 9,266,951; 9,890,210; 9,346,881; 9,890,211; and 8,597,649).  The evidence from those IPRs according to the opinion was that murine anti-GCRP antibodies “were well known in the art” and that the art was “replete with exemplary disclosures of anti-CGRP antagonist antibodies,” as were methods for producing these antibodies (which were “extensively described”).  The antibodies recited in both the antibody and headache patents being humanized, Lilly had asserted evidence in the IPRs that humanization (modifying murine antibodies to be sufficiently human-like antibodies and thereby avoid immunological rejection) was “was a well-established and routine procedure” at the time these patents were filed.  On the other hand, Eli Lilly was unsuccessful in establishing for the Board that claims for methods of treating headache using these antibodies were invalid in view of the prior art.

In the face of a jury verdict that Eli Lilly had not satisfied the clear and convincing evidence standard to invalidate the asserted claims on § 112(a) grounds, the District Court granted JMOL on Eli Lilly’s § 112(a) defenses because, even though the jury could have reasonably found that murine anti-CGRP antibodies were known in the art and that the skilled artisan would have known how to make such antibodies, humanize such antibodies, and use such humanized antibodies to treat headache, as a matter of law the claims were invalid for failure to satisfy both the written description and enablement requirements of 35 U.S.C. § 112(a).

The Federal Circuit reversed and remanded, in an opinion by Judge Prost joined by Judge Cunningham and the Honorable Richard G. Andrews, District Judge, U.S. District Court for the District of Delaware, sitting by designation.  On de novo review under First Circuit law, the panel found that the District Court’s JMOL grant was not supported by evidence that “so strongly and overwhelmingly” was in Eli Lilly’s favor that “a reasonable jury could not have returned the verdict” that the claims were not invalid, under Acevedo-Diaz v. Aponte, 1 F.3d 62, 66 (1st Cir. 1993).  The opinion first addressed written description issues.  The opinion recites the now-established standard that for a genus claim the specification must disclose a representative number of species or structural features in common between the members of the genus; in this case, it was the “reasonable number of species” prong of the test that was at issue.  But the opinion also cautions that “there are no ‘bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention,’” citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), which many will recognize as the culmination of the development of written description jurisprudence beginning with Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997).  For their analysis of the issues supporting the jury’s decision (and that the District Court erred in granting JMOL), the panel turned to Ajinomoto Co. v. International Trade Commission (Fed. Cir. 2019), which stands for the proposition that when assessing the disclosure a specification is “read in light of the background knowledge in the art” that can establish that the representative number of species requirement was satisfied.  The Court then cited In re Herschler, 591 F.2d 693, 695 (C.C.P.A. 1979), for similar rubrics, where the invention was the use of dimethylsulfoxide (DMSO) to facilitate transfer of steroid drugs through the skin.  The written description requirement was satisfied in that case because, although only one species of steroid drug was disclosed, the skilled worker would have recognized that “while steroids ‘as drugs’ might vary broadly in their physiological activity, steroids ‘as a class of compounds carried through a layer of skin by DMSO’ appeared on the record to be ‘quite similar’” in the capacity to be more effectively transferred through the skin by DMSO.

Applying this precedent, the panel understood the invention to be a method using “anti-CGRP antagonist antibodies, or humanized versions thereof, to treat headache—not such antibodies themselves,” and that distinction is the basis for their opinion.  This shifts the focus away from the issues arising in Ariad and, more recently, Amgen v. Sanofi because the invention is this use, not the antibodies per se.  In a footnote, the opinion mentions Judge Bryson’s conclusion, sitting by designation in Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276 F. Supp. 3d 629, 648 (E.D. Tex. 2017), that “when a genus is well understood in the art and not itself the invention but is instead a component of the claim, background knowledge may provide the necessary support for the claim” (emphasis in opinion).

The opinion states that the basis for reversing the District Court’s grant of JMOL is whether a reasonable jury could have come to its original conclusion (i.e., that Lilly had not established invalidity under the written description requirement by clear and convincing evidence), illustrating the changing criteria used by the Court.  What might have required express disclosure 20 years ago no longer does so, because of the development of additional knowledge in the art in the interim, wherein the inventor is entitled to include what the person of ordinary skill in the art would understand to supplement what is expressly disclosed.  This brings to mind the admonition that “a patent need not teach, and preferably omits, what is well known in the art,” in Hybritech Incorporated v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986), citing Lindemann Maschinenfabrik GmbH v. American Hoist and Derrick Co., 730 F.2d 1452, 1463 (Fed. Cir. 1984).

According to the panel, the prior art had disclosed several murine versions and prior-art methods of humanization against a backdrop of anti-CGRP antagonist antibodies (and methods of making them) being well known and humanization being routine.  This supplies what was not explicitly disclosed but does not have to be in view of what was known in the art.  “And, critically, a skilled artisan would have understood from the specification that all humanized anti-CGRP antagonist antibodies treat headache,” according to the opinion.  Treating headache was what was claimed (“[a] method for reducing incidence of or treating headache in a human”) and it is this claim against which the written description requirement was properly applied by the jury according to the Court.

The panel reviewed and dismissed as lacking Eli Lilly’s arguments to the contrary.  These include that humanized versions of the therapeutic antibodies (anti-CGRP antagonist antibodies) were not known in the art.  The panel rebutted this argument with the facts that murine versions of humanized versions of the therapeutic antibodies were known and the skilled artisan would understand methods for humanizing that were also known in the art.  This conclusion was supported by the Ariad decision, wherein a specification need not show an actual reduction to practice in order to satisfy the written-description requirement and that, at the time the application was filed amino acid sequencing of antibodies was routine.  Eli Lilly also cited Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004), for the principle that claims to methods of use require written description disclosure of what is used in the methods.  The Federal Circuit distinguished that opinion because in Rochester “the specification did not disclose any compounds usable in the claimed methods, nor was there any evidence that such compounds were known.”  The Court apparently recognized (without expressly stating so) that the Rochester claims were so-called “single means claims,” i.e., “methods of doing X using something that does X,” while in Ariad the claims were to “methods of doing X, and the claims ‘encompass[ed] the use of all substances’ that did X.”

The opinion then turns to Eli Lilly’s argument regarding the “structural or functional differences among the genus of humanized anti-CGRP antagonist antibodies” (there are three of them, although the anti-CGRP antagonist antibody disclosed in the specification bound only one of them).  In rejecting this argument, the opinion states that “a reasonable jury could have found that a skilled artisan reading the specification would have understood that ‘anti-CGRP antagonist antibodies could bind to different regions of CGRP and still accomplish the claimed function of treating headache,’” once again applying the written description standard to what was claimed, treating headache.  Lilly (also unsuccessfully) argued that, because its product differs structurally and functionally from the sole humanized anti-CGRP antagonist antibody disclosed in the specification, written description must be inadequate for a lack or “representativeness,” citing AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014).  The Court rejects this argument because written description provides no “bright-line rules governing . . . the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention” and that:

[A] skilled artisan reading the specification would have understood that anti-CGRP antagonist antibodies were well known (and disclosed), that humanizing [antibodies] was routine (and disclosed), and that, insofar as treating headache is concerned, all humanized versions of such antibodies work [in the claimed method].

With regard to enablement, the panel asserted the standard that a disclosure must be “at least commensurate with the scope of the claims” under Amgen Inc. v. Sanofi, 987 F.3d 1080, 1084 (Fed. Cir. 2021), aff’d 598 U.S. 594 (2023).  Lilly makes the conventional breadth argument (unsuccessfully) regarding purportedly undue experimentation required to enable all anti-CGRP antagonist antibodies.  The Court concedes that if enablement required “screening and testing” the expected “very large number of candidate antibodies” to identify anti-CGRP antagonist antibodies, even if routine at the time the application was filed, it would constitute undue experimentation under Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1163 (Fed. Cir. 2019).  But the opinion distinguishes this required scope of enablement based on differences between composition claims and methods of using compositions not otherwise claimed, stating that “[t]he asserted claims here are unlike the claims in Amgen and Baxalta [Inc. v. Genentech, Inc., 81 F.4th 1362, 1366 (Fed. Cir. 2023)], 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.”  Here, “[i]n 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” according to the opinion.

Finally the Court distinguishes the situation in this case over that in Idenix because in that case there was no evidence that all the undisclosed species had the claimed structure, whereas in this case “it is undisputed that a reasonable jury could have found that all humanized anti-CGRP antagonist antibodies treat headache, thereby obviating any extensive screening to determine which ones do.”                                                                                      

As with all cases regarding sufficiency of disclosure, the outcome relied heavily on the facts.  To the extent that this decision provides any strategic recommendations it was the focus in the claims regarding methods for treating a specific ailment (headache) using known antibodies (anti-CGRP antagonist antibodies) to a known antigen (CGRP) or antibodies that could be produced using known methods (humanization), all in view of the understanding of the skilled artisan.  Also important was the capacity of all anti-CGRP antagonist antibodies to achieve the headache-relieving effect.  This case brings to mind opportunities for using (however counterintuitively) acknowledgment of what is known in the art (which Eli Lilly did not do in pursuit of claims to anti-CGRP antagonist antibodies lost in IPR) to provide sufficient support for what is not (using the anti-CGRP antagonist antibodies for treating headache).

* Eli Lilly was likely precluded by the provisions of 35 U.S.C. § 315(e)(2) from asserting these defenses at trial due to the PTAB and Federal Circuit’s determinations to the contrary in the IPRs.

Teva Pharmaceuticals International v. Eli Lilly & Co. (Fed. Cir. 2026)
Panel: Circuit Judges Prost and Cunningham and District Judge Andrews
Opinion by Circuit Judge Prost

By Michael Borella –

The U.S. Patent and Trademark Office has extended its Artificial Intelligence Search Automated Pilot Program (ASAP!) until June 1, 2026.  Originally slated to close to new petitions on April 20, 2026 (see “USPTO Announces That It Has Turned the Corner on Unexamined Application Backlog“), the Office has expanded both the duration and the scope of the program “in order to obtain more information to evaluate the effectiveness of the program.”  At the same time, the USPTO has waived the program’s fee. 

By way of background, ASAP! is a pilot program under which an original, noncontinuing, nonprovisional utility application filed under 35 U.S.C. § 111(a), and including Track One applications, is subjected to an automated, AI-driven prior art search prior to examination.  The results are delivered to the applicant as an Automated Search Results Notice (ASRN), which lists up to ten documents ranked by relevance, along with a search string that can be entered into the Patent Public Search tool to retrieve the cited U.S. patents and publications.  The ASRN does not require a reply.  Nonetheless, an applicant who receives an ASRN may elect to file a preliminary amendment, request deferral of examination, or expressly abandon the application to recover the applicant’s search fee and any excess claims fees.  The examiner eventually assigned to the application is free to use or disregard the ASRN when conducting their own search.

Three aspects of the extension are worth highlighting.  First, the USPTO has increased the program’s target from approximately 1,600 applications (200 per Technology Center) to at least 3,200 applications (400 per Technology Center).  Second, the USPTO will continue to accept petitions until the earlier of June 1, 2026 or the date on which each Technology Center has been docketed with at least 400 applications accepted into the program.  Third, and perhaps most consequentially for cost-sensitive applicants, the $450 petition fee has been waived for any petition filed on or after March 23, 2026.  As before, the petition must be filed electronically in Patent Center on the filing date of the application, and the application must be filed in DOCX format.

The fact that the USPTO is extending the program and eliminating the petition fee is telling.  It suggests that uptake until now was uneven across Technology Centers or otherwise insufficient to support any evaluation the USPTO would presumably like to perform on the program’s efficacy.  Indeed, as of the time of this writing, only 169 petitions have been filed across all the Technology Centers, and just 76 of these have been granted.

The fee, while modest in absolute terms, is a real deterrent for applicants who see only a questionable benefit in return.  Removing that fee is an acknowledgment that the initial cost-benefit balance was tilted in the wrong direction.  Further, the applicant would presumably want to review any references cited by ASAP! for relevance, which would incur its own administrative costs in terms of time and/or attorney’s fees.  Thus, even without the fee, the program is not truly “free.”

 On the balance, the fee waiver and the expanded intake should make ASAP! a more attractive proposition for applicants who were on the fence.  The upside is a free automated search that may (or may not) surface relevant prior art of which the applicant’s was unaware.  For applicants filing in technology areas where the USPTO’s AI search tool has access to a deep and well-classified corpus (e.g., software and electrical arts), the ASRN may prove genuinely useful. 

One further development is worth flagging.  At last week’s University of San Diego Patent Law Conference, it was reported that Director Squires announced a version 2 of the AI search tool that will be released in the near future.  The principal improvement, as described by Squires, is that the updated tool will actually search the claims of the submitted application.  Apparently, the version currently in use under the pilot has been searching based on the specification alone.  That is a surprising admission, and a meaningful one.

Any prior art search should include and focus on the claims, because the claims define what is actually being examined for novelty and non-obviousness.  A search drawn only to the specification will tend to surface prior art relevant to the disclosed embodiments as a whole, rather than art that maps to the specific limitations an applicant has chosen to claim.  Thus, the usefulness of the current program is questionable on its face.  But if version 2 delivers, the quality of the ASRN should improve materially.

By Donald Zuhn –

In a press release issued last week, the U.S. Patent and Trademark Office announced that for the first time in nearly a decade, the number of first Office actions that the USPTO has issued during the fiscal year is exceeding the number of new applications that are being filed.  The Office noted that as of April 6, the number of unexamined U.S. patent applications had dropped to 776,995 – the lowest level in two years – which is down from a high of 837,928 unexamined applications in January of 2025.  The Office also noted that in view of historical trends, the inventory of unexamined applications is expected to further decline through the third and fourth fiscal year quarters.  The Office stated that the reduction in unexamined patent applications has been achieved while also exceeding all fiscal year patent quality compliance targets.

Significantly, the Office noted that it is close to achieving its “aggressive fiscal year goal of virtually eliminating its inventory of unexamined applications that would otherwise exceed 36 months.”  USPTO Director John A. Squires pointed out that “[h]itting this subtle but important increment early bodes well because we are intent on slashing application examination wait time,” adding that “reduced wait time means money – our studies show even a one-week reduction in pendency increases a U.S. company’s value by approximately $35,000 on average.”  As for the reasons for the reduction, Director Squires stated that the Office has been “steadily releasing robust AI tools to assist our examiners, and we’re about halfway to our aggressive goal for new examiner hires.”

With respect to the “robust AI tools” mentioned by the Director, the USPTO announced last month that it was waiving the petition fee for the Artificial Intelligence Search Automated Pilot (ASAP!) program.  The Office noted that the petition fee set forth in 37 C.F.R. § 1.17(f) for petitions filed under 37 C.F.R. § 1.182 was being waived in order to alleviate any financial barriers to participation in the ASAP! program.  The Office also announced that it was increasing the number of applications to be accepted into the program to at least 3,200 applications (and at least 400 applications per Technology Center).  ASAP! program petitions will be accepted until the earlier of Monday, April 20, 2026, or the date that a Technology Center has docketed at least 400 applications accepted into the program.

The ASAP! program, which was announced last fall, is intended to test the efficiency of the USPTO’s internal AI tool for conducting pre-examination prior art searches.  In October, when the program was first announced, Director Squires noted that the ASAP! program “is the first of many planned AI pilots designed to help examiners and applicants alike ensure their patents are born strong.”  The program provides Applicants with an initial communication – an AI-Assisted Search Results Notice (ASRN) – identifying a list of potential prior art issues in need of attention, affording Applicants with an early opportunity to assess their claims against the prior art before substantive examination begins.  Automated searches are conducted using an internal AI system that derives contextual information from the classification of the application under the Cooperative Patent Classification (CPC) system, as well as from the specification, claims, and abstract of the application.  The ASAP! program will help the Office assess outcomes for pre-examination searches, evaluate the scalability of generating the ASRN, and collect data to inform next steps and companion pilots.  Additional information regarding the ASAP! program was provided in a Federal Register notice (90 Fed. Reg. 48161) issued last fall.

One AI “tool” that the USPTO will not be relying on to help reduce the unexamined application backlog, however, is the “first-of-its-kind” agentic AI tool, MATTHEW (McConaughey Agentic Tasking Technology Helping Examiner Workload), that the Office highlighted in a press release issued on April 1 (hint, hint).  The Office’s “explanation” can be found here.

By Kevin E. Noonan –

The alacrity with which the Patent Trial and Appeal Board (PTAB) came to the same conclusion in its latest priority determination in favor of the Senior Party in interference No. 106,115 that it had almost eleven months ago precluded an assessment of Broad’s Brief in Opposition to CVC’s Opening brief or both Parties’ Reply briefs,* but relevant portions of those submissions can be referenced for both Parties consistent with the arguments made throughout this interference and related Interference No. 106,048.

Broadly, the Broad’s position is consistent with its argument, expressed more directly in Interference No. 106,048, that the complexity of performing CRISPR in eukaryotic cells renders any conception incomplete unless and until there is a successful reduction to practice.  That argument faded in the ‘048 interference (when application of the “two-way obviousness test” sufficed for Broad to prevail; see “PTAB Decides CRISPR Interference in Favor of Broad Institute – Their Reasoning“), and Broad did not explicitly rely on that concept (which gained traction during the heyday of obtaining patents in isolated gene-encoding nucleic acids) in the current interference (at least not by name).  But it remains at the heart of Broad’s arguments, now couched in assertions that CVC’s conception was incomplete due to failure to reduce to practice prior to Broad’s success (the success of this misconception was at least part of the basis for the Federal Circuit to vacate and remand the PTAB’s earlier judgment in Broad’s favor).  This argument runs through their submissions in both interferences, which is not surprising in view of the timeline of actual reduction to practice for the parties.

The Board’s decisions show that another Broad argument resonated as well, wherein in addition to having reduced eukaryotic CRISPR to practice a few months earlier Broad argued that the several labs that used the sgRNA component of CRISPR undisputedly conceived by CVC:

were of greater than ordinary skill in the art, and thus these labs achieving actual reduction to practice did not show that the person ordinary skill in the art would have been able to do so by being informed of this species in conjunction with the capacity to express RNA (e.g., using the U6 promoter) and Cas9 protein (using recombinant expression known in the art for over a generation) in eukaryotic cells.  Broad was able to use the efforts by CVC and the time taken to achieve actual reduction to practice, as well as the litany of purported uncertainty by those CVC inventors gleaned by their improvident statements on the record, to convince the PTAB (once again) that Broad’s actual reduction to practice provided priority.  This argument, negating CVC’s conception, also was once again used to overcome CVC’s derivation arguments, because if several components other than sgRNA were required then Dr. Marraffini’s disclosure to the Broad inventors could not be sufficient to support their derivation argument.

CVC for its part argued that the critical conception was the sgRNA, using the historical fact that until that species was known (from its disclosure) the art did not evince the capacity to achieve CRISPR in eukaryotic cells.  The timing between Dr. Marraffini’s disclosure to Broad’s actual reduction to practice supported the conclusion that this species played some role in the achievement; this conclusion was also supported by labs other than Broad’s that used sgRNA acknowledging CVC’s contribution to their achievement.  The PTAB did not, on the other hand, seem to give the same type of credence to evidence that Broad’s inventors were themselves having difficulties achieving eukaryotic CRISPR until the sgRNA species was disclosed to them (including multiple instances of Zhang himself and his students evincing sentiments of failure prior to obtaining their invention from Dr. Marraffini (“the results were ‘nonspecific’” (Zhang); “wondering whether “‘other factors need to be identified’ for a working CRISPR system” (Lin); “Zhang’s experiments ‘all failed’; ‘d[id] not work in human cells; and had ‘fail[ed] to induce genome modification’”; “‘it was really a pity’ that Zhang’s lab ‘did not work it out before seeing [CVC’s] paper.’” (Lin)).  Also unavailing was the history (and Broad’s reliance on it, for example in its Supplemental Priority Statement filed under PTAB Order) that showed their construct for eukaryotic CRISPR:

(very different from CVC’s sgRNA) was not the species used to support actual reduction to practice more than six months after being submitted as part of an NIH grant proposal, where such actual reduction to practice using sgRNA took only a few weeks.

Unmentioned in all the briefing is the simple argument that, taking heed of Broad’s assertions in both the ‘048 and ‘115 interferences the complexities of eukaryotic cells made it just sufficiently less likely for a three component complex (Cas9, crRNA, and tracrRNA) to form in such cells than for a two component complex to do so (sgRNA and Cas9).  The oligonucleotide linker joining the crRNA and tracrRNA species in CVC’s sgRNA would have this advantage over the more complicated construct disclosed in their January 2012 NIH grant proposal by Broad, wherein when expressed the tracrRNA and crRNA would need to coalesce independently with Cas9 to form an active CRISPRR complex.

The question before the Federal Circuit will be whether the PTAB heeded the earlier panel’s appreciation that the Board had not properly considered the role of earliest conception followed by diligence towards reduction to practice, or be convinced that the complexities of achieving eukaryotic CRISPR were sufficient that only actual reduction to practice will suffice.  It might be fruitful for the Court to consider whether there is a “losing the forest for the trees” aspect of the PTAB’s analysis, unsurprising in view of the vigor with which Broad made its arguments asserting eukaryotic cell complexities, and whether the evidence is more consistent with sgRNA being the critical component of the CRISPR complex that permitted successful CRISPR cleavage in eukaryotic cells.

*Such analyses are forthcoming in perhaps more abbreviated form for completeness.

By Donald Zuhn –

Last week, Mexican law firm OLIVARES reported that Mexico had published amendments to the Federal Law for the Protection of Industrial Property (FLPIP) on April 3, 2026, that introduce changes that will impact patent filing and prosecution strategies in that country.  The report notes that the amendments incorporate mechanisms that are commonly used in other jurisdictions and introduce new procedural tools aimed at increasing flexibility, legal certainty, and efficiency in the Mexican patent system.

Among the changes that will affect patent practice in Mexico are:

• Restoration of priority rights – allows applicants to restore priority rights within a two-month period following the expiration of the original deadline (i.e., 12 months for patents and utility models, and 6 months for industrial designs).  The report notes that this change aligns Mexico with international practices that provide corrective measures for priority claims.  Significantly, OLIVARES noted in a separate alert that the amendments to the FLPIP did not address the time limits applicable to national phase entries of PCT applications – but suggested that the recent amendments may open the door for Mexico to review and potentially lift the restrictions currently in place with respect to national phase applications.

• Provisional patent applications – allows applicants to secure an early filing date with reduced formal requirements, with the applicant then filing a complete application within a non-extendable 12-month period.  Mexican provisional applications may not claim priority from any prior application, will not be published, and will not be subject to examination.

• Priority documentation – allows the Mexican Institute of Industrial Property (IMPI) to require the submission of a certified priority document and its Spanish translation within five (5) business days following the expiration of the current term (i.e., three months from the filing date).

• Restoration of procedural rights – allows applicants to request reinstatement of rights lost due to missed deadlines, including the failure to respond to office actions or pay grant fees.  Requests for reinstatement must be filed within fifteen (15) business days from the expiration of the missed deadline (counted from the business day following the expiration of the missed deadline), together with the previously omitted requirement and payment of the corresponding official fee.  If the request is accepted, the IMPI will allow the application to continue prosecution.  The report notes that this change represents a shift from the prior system, where abandonment was final and irreversible.

• Reduced prosecution timelines and number of office actions – in an attempt to accelerate prosecution at the IMPI, this change establishes a maximum period of one year for the issuance of a final decision in patent, utility model, and industrial design applications, once substantive examination begins.  If after the one year period there has been no resolution, the applicant may request the issuance of a mandatory resolution through a newly created specialized technical committee that is appointed by IMPI’s board of directors.  The one-year maximum prosecution period will apply for patent applications filed after the amendments were published.  However, applicants having applications that were filed and pending prior to publication of the amendments can still apply for a mandatory resolution once the specialized technical committee has been assembled.

Regarding the above change, OLIVARES suggested that:

While the effort to reduce prosecution timeframes is recognized, there is general uncertainty on the feasibility for the Mexican PTO to handle this significant increase in their workload and if this shortening of timeframes could provoke a massive filing of requests for mandatory resolutions by applicants.  There is also concern that there will be a decrease in the quality of the substantive office actions in view of the reduced timeframes.

In addition to the one-year maximum prosecution period, OLIVARES noted in a separate alert last month that an amendment to the administrative regulations that was published in the Mexican Official Gazette in March reduces the number of substantive office actions from four to two for patent and utility model applications.  A third office action that either allows or denies the application will follow the previous two.  The administrative amendment reducing the number of office actions took effect on March 12, 2026, but does not apply to applications that were filed prior to the effective date, which will continue to be examined under the rules in force at the time the application was filed.

• Third-party observations – allows for the submission of third-party observations for utility model and industrial design applications within a two-month period from publication.  Under the prior system, third-party submissions were limited to patent applications.

The report notes that the changes took effect on the day after their publication and that pending applications would continue to be prosecuted under the legal framework that was in force at the time those applications were filed.  One of the alerts also notes that further developments are anticipated, as the implementing regulations of the new IP law are still pending issuance and are expected to be published in the near term.

OLIVARES has provided additional information regarding the amendments to the FLPIP on its website:

• “Amendments to Mexico’s Intellectual Property Law: Principal aspects for patent practice.“
• “Mexico introduces new corrective mechanism for priority documentation.“
• “Reinstatement of rights following missed prosecution deadlines.“
• “Mexico introduces provisional patent applications.“
• “Mexico introduces restoration of priority rights for patent, utility model and industrial design applications.“
• “Mexico reduces prosecution timelines.“
• “New Technical Committee Mechanism.“

The Decision on Priority

By Kevin E. Noonan –

On March 26, the Patent Trial and Appeal Board, without holding an oral hearing and despite a rather sharply worded opinion by the Federal Circuit vacating and remanding its earlier priority decision (see “Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2025)“), granted priority in Interference No. 106, 115 to Senior Party The Broad Institute, Harvard University, and MIT (collectively, “Broad”) over Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”).  To the extent that the Federal Circuit held that the Board erred in the manner in which the evidence was considered and settled interference law applied, this Decision on Priority shows little evidence of any inclination by the Board to reconsider either aspect of its prior analysis, once more seemingly being content to focus on the trees at the expense of the forest.

Procedurally, the Decision properly imposes the burden on CVC to show earlier conception by a preponderance of the evidence.  The Decision delves deeply into the details of the methods for achieving eukaryotic CRISPR, assessing that evidence and finding the same indications in favor of Broad directed to their earlier reduction to practice swaddled in the language of conception (albeit avoiding the “incomplete conception” terminology found in their first priority decision).  The Board rejects as unsupported by the evidence that achieving eukaryotic CRISPR would be “straightforward,” as some evidence and testimony asserted, once the sgRNA species was disclosed, the Decision stating that:

[W]e find that one of ordinary skill in the art would have been a practicing Ph.D. research scientist who would have known about the routine techniques and methods available but would have been less capable than the Zhang, Church,  Kim, and Joung labs to reduce an embodiment of Count 1 to practice,

the Board apparently being convinced by Broad’s argument that the laboratories that quickly reduced eukaryotic CRISPR to practice (asserted by CVC as evidence that the methods used were “routine and well-known to the worker of ordinary skill) were not persons of ordinary skill but rather persons having sufficiently extraordinary skill to disqualify their efforts for the role attributed to them by CVC, despite the contemporaneous attribution to CVC of the methods for successfully performing CRISPR cleavage in eukaryotic cells.  Paradoxically the Board’s appreciation that the Broad inventors may have been of greater than ordinary skill did not provide an explanation for why they were able to achieve actual reduction to practice of eukaryotic CRISPR slightly more rapidly (only a matter of a few months) than the CVC inventors were able to achieve.

Somewhat ironically, the Board once again focuses on statements by the CVC inventors regarding their difficulties in achieving CRISPR cleavage in eukaryotic cells, supported in this approach by their understanding that:

The court stated that “[t]he Board erred in its analysis by failing to consider routine methods or skill, and, instead, focusing almost entirely on Regents’ scientists’ statements about perceived experimental difficulties and doubts about success,” but the court did not say that the Board erred in considering the CVC inventors’ statements and the extent of their research or experimentation at all in the determination of the preponderance of the evidence of conception.

But the Board seemingly ignored similar references to the frustrations of failure emanating from the Broad lab prior to the disclosure of sgRNA species by Dr. Marraffini (see CVC Opposition to Broad Opening Brief, which recites multiple examples of similar frustrations that seemed to disappear after Dr. Marraffini’s disclosure, including multiple instances of Zhang himself and his students evincing sentiments of failure prior to obtaining their invention from Marraffini (“the results were ‘nonspecific’” (Zhang); “wondering whether “‘other factors need to be identified’ for a working CRISPR system” (Lin); “Zhang’s experiments ‘all failed’; ‘d[id] not work in human cells; and had ‘fail[ed] to induce genome modification’”; “‘it was really a pity’ that Zhang’s lab ‘did not work it out before seeing [CVC’s] paper.’” (Lin)).  The Board justifies its focus on any changes in the CRISPR methods during development by CVC as being evidence of incomplete conception (albeit avoiding that particular sobriquet) because:

Count 1 includes the ability of the CRISPR-Cas9 system to cleave or edit DNA in the eukaryotic cell to alter gene expression, we consider any additional requirements that affected the ability of the CRISPR-Cas9 system to cleave or edit DNA in the eukaryotic cell to alter gene expression to be a substantive aspect of the inventors’ conception of an embodiment within the scope of Count 1.

And there are other assertions in the Decision indicating a particular perspective when considering  the relationship between conception and reduction to practice that seem inconsistent with the Federal Circuit’s concerns with the Board’s prior assessment of priority, for example “[t]he need for seven months of diligent work is not consistent with the CVC inventors having  conceived of and described a complete system that would have required only ordinary skill, without extensive research or experimentation, to reduce to practice.”

In addition, CVC’s arguments suffered from the Federal Circuit’s decision not to overturn the Board’s determination that CVC’s earliest provisional applications (U.S. Provisional Application Nos. 61/652,086, P1, and 61/716,256, P2) did not provide a constructive reduction to practice of eukaryotic CRISPR (ironically because they did not disclose an actual reduction to practice of eukaryotic cell CRISPR), as illustrated in this graphical representation:

The Board’s decision is based on Broad’s earlier evidence of actual reduction to practice and the later filing date of CVC’s U.S. Provisional Application No. 61/757,640 (which was credited with constructive reduction to practice for containing experimental evidence of actual reduction to practice).  Underlying this analysis is a sub silentio acceptance of Broad’s long-standing argument that the complexity of performing CRISPR in eukaryotic cells raised a “simultaneous conception and reduction to practice” standard as applied but not enunciated in the Decision.

The Decision relies as well on certain structural differences in the sgRNA species developed by Broad, which could be relevant to their success in achieving actual reduction to practice according to Broad, as shown in these illustrations wherein the top illustration was used in vitro (CVC) and the bottom in vivo (Broad):

The Board apparently disregarded the history of the efforts to practice CRISPR cleavage in eukaryotic cells, which showed various variations and timelines of success, but that the one thing that all the labs had in common was using sgRNA to do so, a species unrecognized by any of these groups (including the Broad) prior to CVC’s disclosure of it.  As pointed out in CVC’s Opposition to Broad’s Opening Brief on Remand, prior to Dr. Marraffini’s disclosure on June 26, 2012, the RNA components of CRISPR used by Broad (as disclosed in the January 12, 2012 NIH grant relied upon for Broad’s additional priority claim; see Parties Supplemental Priority Statements on Remand) had the structure:

as compared with the sgRNA invented by CVC and disclosed by Dr. Marraffini and used substantially identically by Broad and the four other labs identified and relief upon by CVC:

Regarding derivation, as in its earlier Decision, the Board adopts the position that its determination regarding conception suffices to reject CVC’s arguments about derivation.  By determining that CVC did not have sufficiently complete conception to be entitled to priority it follows (for the Board) that CVC’s inventors could not have disclosed the invention sufficiently for the Broad inventors to have derived it.

This Decision, like the one before it, will no doubt be appealed and that will give the Federal Circuit the opportunity to inform the PTAB, and the rest of us, whether its earlier decision and the instructions contained therein were followed or disregarded by the Board in arriving at substantially the same decision arrived at four years ago (see “PTAB Grants Priority for Eukaryotic CRISPR to Broad in Interference No. 106,115“).  Ultimately, the question will be whether in the Board’s reconsideration of its determination of priority, the Federal Circuit believes that reconsideration of  the issue of conception was performed “under the proper application of the legal framework.”

There is likely to be some comfort the CVC inventors can take from this outcome:  whether the party who ultimately gets priority to the patents for this invention is remembered in the future, Jennifer Doudna and Emmanuelle Charpentier will be always remembered for winning the 2020 Nobel Prize for Chemistry for CRISPR.