Litigators in the life sciences field are no doubt familiar with the so-called “artificial” act of infringement established by 35 U.S.C. § 271(e)(2)(A)-(B): namely, that a party can be sued for patent infringement by merely filing an Abbreviated New Drug Application (“ANDA”) for a generic drug or a Biologics License Application (“BLA”) for a biosimilar drug. The filing of such an action can allow for, among other things, the resolution of patent infringement disputes before the generic (or biosimilar) drug enters the market.  Read the full post on Proskauer’s Minding Your Business blog ..read more

Recently, in Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc., the Federal Circuit held for the first time that the Patent Trial and Appeal Board (“the Board”) has the authority to issue a Final Written Decision even after the statutory deadline has passed. Congress introduced post grant review (“PGR”) and inter partes review (“IPR”) in 2011 as part of the America Invents Act (AIA). Parties can use these processes to ask the Board to review the patentability of a patent’s claims. Under the AIA, the Board must provide a Final Written Decision within one year of instituting the PGR ..read more

In an unprecedented PTAB decision involving Spectrum Solutions LLC and Longhorn Vaccines & Diagnostics, the Board found all five challenged patents invalid and imposed sanction against patent owner Longhorn for failure to meet the duty of candor and fair dealing. The board determined that Longhorn selectively disclosed testing results to support its claim construction and misled its technical expert with incomplete laboratory data, thereby failed to meet its duty of candor and fair dealing in its actions before the Board. Read the full post on the Minding Your Business blog ..read more

Life Sciences is an area ripe for trade secrets misappropriation litigation. In recent news, Merz Pharmaceuticals, LLC filed a lawsuit under the North Carolina Uniform Trade Secrets Act alleging that its former director of federal accounts, Andrew Thomas, stole trade secrets relating to Merz’s flagship botulinum toxin drug Xeomin®. Those secrets purportedly included drug pricing strategies, marketing plans, market share data, and potential customer lists, all of which were intended to grow Xeomin®’s presence in the government market sector — a key therapeutic sector for Merz’s drug ..read more

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 ..read more

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. Prosecution of a patent application can stall for any number of reasons, including challenging examiners, lack of bright-line rules, and funding. Appeals to the Patent Trial and Appeal Board (the “Board”) and the federal courts are often effective tools for resolving sticky issues and moving an app ..read more

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 Jud ..read more

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 sec ..read more

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 ..read more

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. At ..read more