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The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality, many in the pharmaceutical and biotechnology industries received the opinion under a cloud of uncertainty and concern for exclusivity rights broad enough to both protect clinical candidates and deter competitors. While the patent bar may remain apprehensive, the Supreme Court kept the door open to genus claims.  The impact of the decision may not be as far-reaching as feared.
Continue Reading The Supreme Court Kept the Door Open to Genus Claims

The answer? Not much, in itself. If one patent is good, 132 is probably fine too. That was Judge Easterbrook’s reasoning in a recent decision addressing indirect purchasers’ antitrust challenge to AbbVie’s so-called “patent thicket” of 132 patents around the blockbuster drug Humira, arguing the sheer number of patents blocked would-be biosimilar competition. But “if…

BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes involved in the timing of the FDA review of a new drug application (“NDA”) or biologic license application (“BLA”). While the purchase of a voucher can help a drug’s sponsor shorten the time to market, it can also put immediate cash in the hands of the voucher seller seeking to tide itself over, particularly during a period of flagging investor interest in the biopharma sector.
Continue Reading BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers

Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification should be devoted to something that is not supposed to be part of the claim? The answer may be none at all according to a recent Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc. The key, according to the decision, is that the specification should not describe the negative limitation in a manner inconsistent with how it is used in the claim.
Continue Reading “Negative” Patent Claim Limitations—May They be Adequately Described by Omission?

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand scrutiny under the new patent court.
Continue Reading Preparing for Europe’s Unified Patent Court

In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs (the “GSK decision,” discussed here and here), Judge Richard Andrews in the District of Delaware held that plaintiff Amarin Pharma (“Amarin”) failed to plead facts sufficient to show that Hikma Pharmaceuticals’ (“Hikma”) carved-out product label and/or public marketing statements induced infringement of Amarin’s patents. The holding suggests that carved-out labels (so-called “skinny labels), despite the GSK decision, continue to provide some measure of protection from liability based on induced infringement.
Continue Reading Skinny Labels May Not Be Dead: Delaware District Court Distinguishes GSK, Dismisses Induced Infringement Claim

In the United States, the scale of trade secret theft is estimated to be between $180 billion and $450 billion annually. Among the targets of this theft are pharmaceutical companies, which are some of the most research-intensive institutions in the world. Pharmaceutical research generally requires extensive work and often generates proprietary data that is pivotal to shaping pharmaceutical development. Because that data may be very attractive to threat actors, pharmaceutical companies employ various measures to protect their proprietary information, these measures may sometimes fall short. A November 2021 trade secret misappropriation suit brought by Venn Therapeutics (“Venn”) against Corbus Pharmaceuticals (“Corbus”) in the District Court for the Middle District of Florida highlights the issues that can arise despite a company’s best efforts to protect its trade secrets.
Continue Reading When Nondisclosure Agreements and Pharmaceutical Trade Secrets Intersect

The Federal Circuit recently reversed a jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno Therapeutics, Inv. v. Kite Pharma, Inc.. This case further builds on the application of the written description requirement to claims that recite functional limitations, and is instructive to patent prosecutors.
Continue Reading Juno v. Kite: Written Description and Claiming Antibodies and Chimeric Antigen Receptors—Lessons for Patent Prosecutors

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s perceived role in shaping the pharmaceutical pricing landscape.
Continue Reading Calls for USPTO to Adopt Policies to Modulate Drug Pricing

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for?

By way of background, a sponsor can obtain orphan drug exclusivity when the FDA approves an application for a drug that has first been designated under 21 U.S.C. § 360bb of the Orphan Drug Act (ODA) for a “rare disease or condition.”  Id. § 360cc(a).  Except in any of three statutorily prescribed circumstances (§§ 360cc(b), (c)), the FDA cannot approve another application for the “same drug” for “the same disease or condition” for seven years after the first approval.Continue Reading In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra