The practice of serially filing continuation applications through a patent’s lifetime has come under increased pressure in recent years from newly implemented continuing application fees to expanded case law on non-statutory obviousness-type double patenting. A somewhat new interpretations of the doctrine of prosecution laches emerging from Sonos, Inc. v. Google
Novo Nordisk v. Mylan: Method of Treatment Claims Must Be Aligned with Label
Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of Delaware’s recent decision in Novo Nordisk v. Mylan is another reminder that the scope of method of treatment claims must be aligned with an FDA approved drug label.
A New Dawn for Patent Owners? Breaking Down the PERA and PREVAIL Acts of 2025
In a move that could reshape the U.S. patent landscape, Congress has reintroduced two major pieces of legislation: the Patent Eligibility Restoration Act (PERA) of 2025 and the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL) Act. Both bills purport to restore clarity, strength and global competitiveness to the U.S. patent system—longstanding priorities for patent owners across industries.
Here we break down what each bill proposes and what it could mean for innovators if passed in its current form.
Beyond the Deal: How are Expiring Patents Fueling M&A in the Life Sciences Industry?
Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our lawyers assess the evolving landscape, share insights on the impacts of strategic deals and explain how
The Broad Impact of Edwards v. Meril on the Safe Harbor Provision
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
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
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?
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
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 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 . . .
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.