Life Sciences

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The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. § 271(e)(1). The Federal Circuit’s ruling, and the subsequent denial of Edwards’s petition for rehearing en banc, underscores the breadth of the safe harbor, putting to bed the question of whether “solely” means “only” in the context of the safe harbor.

Proving access to and use of trade secrets are core elements in a trade secrets misappropriation case.  Recent rulings in a trade secrets action filed by Allergan against its competitor Revance Therapeutics (“Revance”) provide helpful guidance on what is sufficient to plead these elements. There, the court explained what facts are—and are not—sufficient to infer access to and use of trade secrets allegedly misappropriated. The court also explained how examining the similarity of design may help in this analysis. Finally, the court clarified that the ability to reverse engineer alone may not always preclude trade secret protection.  

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. 

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 or IPR; this can be extended for good cause for an additional six months.

In an unprecedented PTAB decision involving Spectrum Solutions LLC (“Spectrum”) (Petitioner) and Longhorn Vaccines & Diagnostics (“Longhorn”) (Patent Owner), 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. The claims and substitute claims in all five patents asserted by Longhorn were unpatentable due to its sanctionable misconduct. Longhorn was also ordered to provide Spectrum compensatory expenses including attorney fees. On one hand, it is a reminder that duty of candor is a continuing obligation that cannot be ignored even during the IPR proceeding.  On the other hand, it does raise the question whether the PTAB has the authority to invalidate a patent for misconduct. 

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…

With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that increased demand is a good problem to have, a recent case involving Ozempic shows that pharmaceutical companies with popular drugs might face increased competition, without the ability to obtain legal remedies against their competitors.

Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up.

Recently, Fate Therapeutics and the Whitehead Institute sued Shoreline Biosciences in the Southern District of California for allegedly infringing six patents directed to composition and methods relating to induced pluripotent stem cells (iPSCs) directly under 35 U.S.C. §§ 271(a) and (g), and for inducing infringement. Fate’s infringement theories included both literal infringement and infringement under the Doctrine of Equivalents. The court granted summary judgment of noninfringement to Shoreline for all asserted claims.