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.

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

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

CRISPR patents continue to face priority challenges in Europe. Following an earlier revocation of CRISPR patent EP2771468 based on a successful priority challenge, another foundational CRISPR patent EP3241902, co-owned by University of California Berkeley (UCB), was revoked in its entirety last month by the European Patent Office (EPO) based on an invalid priority claim. This is the first significant loss of UCB’s CRISPR patent rights in Europe.

In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed

The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA approval or market their new product. These considerations might lead a company to take a license, seek to invalidate a competitor’s patent, or some combination of the two. The Patent Trial and Appeal Board (“PTAB”) is a popular venue for challenging patent validity and in 2020, Bio/Pharma and Chemical Patents accounted for 12% of petitions filed at the PTAB.

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.

But how does the FDA reach that conclusion? A newly filed case may shed some light on the Agency’s decision-making process.