Minding Your Business

Proskauer’s perspective on developments and trends in commercial litigation.

Tag Archives: life sciences

UC Berkeley CRISPR Patent Revoked in Europe Due To Invalid Priority Claim

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priority challenge, another foundational CRISPR patent EP3241902, co-owned by University of California Berkeley (UCB), was revoked in its entirety last month by the European Patent Office (EPO) based on an invalid priority claim.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 … Continue Reading

When Is Less Really More for a Patent Licensee?

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 … Continue Reading

Generic Competition for Withdrawn Drug Products

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 A generic cannot be approved if, in the FDA’s view, the product was withdrawn for “safety and effectiveness” reasons.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? … Continue Reading

CAFC Tightens Enablement Standard for Functional Claiming of Antibodies

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that … Continue Reading

Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine. This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, … Continue Reading
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