Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more
7/8/2025
/ Biotechnology ,
Clinical Trials ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Regulatory Requirements ,
USPTO
On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in ImmunoGen, Inc. v. Stewart, in which the court clarified its standards for determining...more
Earlier this month, the Federal Circuit decided a subject matter eligibility case closely watched in the pharmaceutical industry. The case involved composition-of-matter claims reciting measured results. Reversing the...more
On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024) clarifying the scope of...more
On March 18, 2024, the USPTO issued a memorandum to its Examiners reminding them of the resources and proper analysis for interpreting limitations under 35 U.S.C. § 112(f), which are commonly referred to as...more
On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.
The guidelines clarify that the...more
Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated...more
Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in...more
The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have...more
USPTO Clarifies Subject Matter Eligibility with New Guidance -
The USPTO rang in the new year by releasing new Examiner Guidance that could potentially benefit patent applicants who have previously encountered difficulty...more
The United States Patent and Trademark Office (PTO) issued a Notice today extending the Cancer Immunotherapy Pilot Program (Pilot Program), also known as “Patents 4 Patients.” The Pilot Program, which accelerates the...more
The United States Patent and Trademark Office (USPTO) recently provided updated guidance regarding the patent eligibility of subject matter related to natural products. The updated guidance may be of interest to companies...more