The door may now be open for additional challenges to patents covering mRNA vaccine technologies, paving the way for increased competition in the mRNA vaccine space.
On Wednesday, March 5, 2025, the United States Patent...more
Kilpatrick attorneys Yifan Mao and Stuart Pollack recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis...more
In the aftermath of Amgen v. Sanofi, courts continue to invalidate genus claims for lacking enablement. Baxalta Incorporated v. Genentech Inc.2 shows that it is nearly impossible to meet the enablement requirement for claims...more
Kilpatrick Townsend recently held its semi-annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) in California. Firm attorneys led two days of interactive discussions with clients on the latest developments in...more
Novartis and Accord Healthcare, Inc. are embroiled in a patent infringement suit concerning Novartis’ blockbuster multiple sclerosis drug Gilenya. Our previous articles Sound of Silence: Claiming Negative Limitations, and...more
United States courts have recently tightened the written description requirements for antibody claims. The scope of issued claims is now often limited to antibodies with specific sequences of the CDR and the heavy chain and...more
Article 76 of the Fourth Amendment1 to the Chinese Patent Law links regulatory approval of a generic drug and patent protection of the brand-name drug. It establishes a legal framework for resolving drug patent disputes...more
To satisfy the written description requirement under 35 U.S.C. 112, a patent specification must describe the claimed invention in such sufficient detail that a person of skilled in the art (POSA) can reasonably conclude that...more
On August 16, 2021, the Federal Circuit handed down two rulings related to patents issued to Teva, which involve therapeutic antibodies targeting a calcitonin gene-related peptide (“CGRP”). In both cases, the Federal Circuit...more
Many of today’s top-selling drugs worldwide are therapeutic antibodies thus antibody-related inventions can be extremely valuable. Developing antibody therapeutics requires significant resources and time, so it is paramount...more
Approval Processes -
The regulatory approval pathway for a new “biological product” submitted as a Biologics License Application (BLA) under the Biologics Price Competition and Innovation Act (BPCIA), is now separate from...more
For several years, China has been evaluating changes to its drug approval system to promote drug innovation and patient access to medicines. The year 2020 saw China begin taking steps towards adopting some of those changes....more