Less than two months after CVC made the surprising move to revoke two of its seminal European CRISPR patents, Sigma-Aldrich has done it too. While the facts that led to Sigma’s “self” revocation may be different than CVC’s, this en vogue trend of avoiding final decisions is troubling because it
To Be Or Not To Be: Self-Revocation of Seminal European Patents Creates New Uncertainty In CRISPR IP Space
By Fangli Chen & Nicholas C. Prairie on
There is no shortage of surprises and twists in the decade-long fight over the control of dominant IP in the CRISPR space. The newest one is the self-revocation of two seminal CRISPR patents in Europe by the team led by two Nobel Laureates Emmanuelle Charpentier and Jennifer Doudna (aka “CVC”). …
The Broad Impact of Edwards v. Meril on the Safe Harbor Provision
By Fangli Chen, Erik Milch & Nicholas C. Prairie on
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…
Federal Circuit Clarifies Reach of “Artificial” Act of Patent Infringement
By Gourdin Sirles & Baldassare Vinti on
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…
PTAB Has Authority to Issue Decisions After Statutory Deadline
By Erin Short on
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…
Duty of Candor Continues Before the PTAB or Does it?
By Fangli Chen & Lingyun Jia on
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…
Alleged Theft of Drug Pricing Trade Secrets Could Cost Both Victim and Thief
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, which is primarily known for its aesthetic effects.
The Supreme Court Kept the Door Open to Genus Claims
By Fangli Chen, Lawrence Frank & Nicholas C. Prairie on
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.
Is an Appeal Time Well-Spent? For Patents, That Depends . . .
By Nicholas C. Prairie on
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.
The Seventh Circuit Asks, “What’s Wrong With Having Lots of Patents?”
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…