Insights

In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.

Before leaving for an extended recess period ahead of the November general election, Congress left unfinished several proposals with ramifications for generic and biosimilar drug competition. This client alert summarizes some of that legislation and possible next steps in the “lame duck” period before the end of the year.

Following federal lawmakers’ initiative to lower prescription drug prices under the Inflation Reduction Act of 2022, several states have taken similar steps to limit certain drugs’ prices. Drug affordability for consumers is a top priority for federal and state lawmakers and regulators because it is a bipartisan issue that directly impacts consumers’ wallets. With negotiations between the federal government and drug manufacturers over 10 drugs’ prices for Medicare beneficiaries well underway under the Inflation Reduction Act, 11 states, including Maryland and Colorado, have created drug affordability review boards to more directly tackle rising prices for both brand and generic drugs.[1] And another 12 states have pending legislation to create these boards.[2] 

On March 1, 2024, Judge Colm F. Connolly of the District of Delaware granted the government’s motion for summary judgment in the first substantive ruling on the constitutionality of the Inflation Reduction Act (“IRA”).  The court first held that AstraZeneca Pharmaceuticals LP and AstraZeneca AB’s (collectively, “AstraZeneca”) lacked Article III standing to challenge the Center for Medicare and Medicaid Services’ (“CMS”) guidance under the Administrative Procedure Act (“APA”).  The court then rejected AstraZeneca’s challenge to the IRA as an unconstitutional taking on the merits because, in its view, AstraZeneca “ha[d] not identified a property interest protected by the Constitution that is put in jeopardy by the Program.”[1] The court’s opinion comes on the eve of oral argument in a closely-followed related case in the District of New Jersey and marks a significant development in IRA jurisprudence.

On February 12, 2024, Judge David Alan Ezra of the Western District of Texas dismissed a lawsuit challenging the constitutionality of the Drug Price Negotiation Program of the Inflation Reduction Act of 2022, P.L. 177-169 (IRA).[1]

In Vanda Pharmaceuticals, Inc. v. United States, No. 23-629C (Fed. Cl. 2024), 2024 WL 201890, the Court of Federal Claims (COFC) addressed whether government disclosure of a company’s trade secrets and commercial information could create a viable claim for a taking under the Fifth Amendment or for breach of an implied-in-fact contract.  The company, Vanda Pharmaceuticals (Vanda), claimed that the government’s disclosure of its confidential trade secrets—including its trademarked drugs’ dissolution rates—to competitors seeking U.S. Food and Drug Administration (FDA) approval of generic drug alternatives was an unlawful regulatory taking that diminished the value of Vanda’s brand name drugs and infringed upon Vanda’s right to exclude generics from the market.  The government moved to dismiss Vanda’s claims for lack of subject matter jurisdiction and for failure to state a claim.  The COFC denied the government’s motion in part, holding as a matter of first impression that Vanda adequately stated a takings claim based on the government’s disclosures but failed to state a claim for breach of an implied-in-fact contract.  The COFC also held that Vanda’s claims involving one generic drug manufacturer were outside the Tucker Act’s six-year statute of limitations and were time barred. 

The Patent Prosecution Highway (PPH) is a work-share arrangement between the patent offices of different countries. It allows for participating patent offices to share—and thus benefit from—work already performed by other participating patent offices.

Since the Supreme Court’s 2017 sea change venue decision in TC Heartland v. Kraft Food Group Brands, the Northern District of West Virginia has seen an uptick in substantive Hatch-Waxman litigation involving local pharmaceutical company, Viatris Inc. (formerly known as Mylan Pharmaceuticals). Viatris is frequently named as a defendant in Hatch-Waxman litigations, each of which is triggered by Viatris’s service of a statutorily-required notice letter stating why the patents that allegedly cover the brand name drug are invalid and/or not infringed by a proposed generic drug. Hatch-Waxman litigants have battled over the requirements for these notice letters in other courts. In Bausch Health Ireland Ltd. et al. v. Mylan Pharms. Inc., the Northern District of West Virginia has now added to that body of law, adopting a holding consistent with other courts that a generic drug company is not foreclosed from asserting additional defenses in litigation even if those defenses were not raised in the generic drug company’s notice letter. See No. 1:22CV20, 2023 WL 2726432, at *3 (N.D.W. Va. Mar. 30, 2023).

Just over a week after the Supreme Court’s decision in Arthrex, the USPTO has issued preliminary guidance on how the Office plans to implement the Director-review process required by the Court’s decision. The Office intends to treat the Director reviews much like the current request for rehearing process. Namely, a request for the Director’s review must satisfy the timing requirements of a request for rehearing (37 C.F.R. 42.71(d)), and a timely request for Director review will reset the time for appeal or civil action pursuant to 37 C.F.R. 90.3(b). But unlike requests for rehearing by the panel of administrative patent judges, which must point out an argument or issue that the Board “misapprehended or overlooked,” the Director can review any issue, whether one of fact or law. The Director also has de novo review authority, so need not give deference to the panel’s decisions under review. Further, the Director can initiate a review sua sponte. When sua sponte review is initiated, the parties to the proceeding will be given notice and may be given an opportunity for briefing.