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,
Proskauer in Life Sciences
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Federal Circuit Clarifies Reach of “Artificial” Act of Patent Infringement
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…
PTAB Has Authority to Issue Decisions After Statutory Deadline
By Erin Short
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…
Duty of Candor Continues Before the PTAB or Does it?
By Fangli Chen & Lingyun Jia
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…
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…
The Supreme Court Kept the Door Open to Genus Claims
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…
Is an Appeal Time Well-Spent? For Patents, That Depends . . .
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 would-be biosimilar competition. But “if…
BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers
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…
Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”
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…