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

In Sawstop Holding LLC v. Vidal the Federal Circuit confirmed what many practitioners suspected— the Patent and Trademark Office will only award a patent term adjustment to offset a delay caused by appellate review of a patent prosecution if the appeal results in allowable claims ready for issuance. Continue Reading Is an Appeal Time Well-Spent? For Patents, That Depends . . .

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 AbbVie made 132 inventions,” Judge Easterbrook asked rhetorically, “why can’t it hold 132 patents?”  As he noted, Thomas Edison alone held 1,093 patents. Having lots of patents shouldn’t be an antitrust issue, according to Judge Easterbrook. It’s how you use the patents.

The case is Mayor and City Council of Baltimore et al. v. AbbVie Inc. et al. Importantly, the plaintiffs did not challenge the validity of the 132 patents, nor did they allege fraud on the Patent Office.  Instead, plaintiffs argued the 132 patents are too weak for AbbVie to exclude others from the Humira market, and to allow AbbVie to challenge the entrance of biosimilars in court. But, according to the Court, there really is no such thing as a “weak” patent. Patents are valid or invalid, and valid patents can be broad or narrow in scope. A narrow patent is just as valid as a broad one, according to the Court, and the First Amendment protects the right to assert presumptively valid patents in court, as long as the claim is not otherwise baseless.

Unable to challenge obtaining the 132 patents or their assertion in court, plaintiffs turned to the outcome of those assertions: settlements with potential entrants setting the entrance dates at various points in 2023, well before the last of the 132 patents expires in 2034. The Court concluded, however, that these were not reverse payment settlements. AbbVie did not make a payment to any of the defendants. Plaintiffs claimed the settlements reflected a conspiracy between AbbVie and its competitors to allocate the market to AbbVie through 2022. Judge Easterbrook addressed that claim with simple logic: “If this is a cartel…, then all settlements of patent cases violate the Sherman Act.” The settlements did what settlements are supposed to do: compromise.

This does not spell the end of patent thicket claims. A thicket of invalid or inapplicable patents might be a different story. But one thing is clear: plaintiffs will need to come up with more than just the sheer number of patents, because there really is no answer to the question, “When is one more patent too many?”

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

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s attempt to obtain a patent for an invention created by his AI system called DABUS (“Device for Autonomus Bootstrapping of Unified Sentence). Most recently, we considered Thaler’s appeal of the September 3, 2021 decision out of the Eastern District of Virginia, which ruled that under the Patent Act, an AI machine cannot qualify as an “inventor.” Continuing this series, we now consider the USPTO’s recently filed opposition to Thaler’s appeal. Continue Reading Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”

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

Our previous blog posts, Artificial Intelligence as the Inventor of Life Sciences Patents? and Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor,” discuss recent inventorship issues surrounding AI and its implications for life sciences innovations. Continuing our series, we now look at the appeal recently filed by Stephen Thaler (“Thaler”) in his quest to obtain a patent for an invention created by AI in the absence of a traditional human inventor.  Continue Reading Update on Artificial Intelligence as a Patent Inventor

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