Fernando Muzzio, Principal Consultant
Acumen BioPharma, LLC
- Many formulation and process patents for pharmaceutical products are vulnerable to various form of invalidity attack
- Formulation patents often include reference to ingredients by function – but many ingredients can have multiple functions – and sometimes the function of an ingredient is poorly defined term (example “wetting agent”). This can create opportunities for indefiniteness, anticipation, and obviousness challenges.
- Formulation patents often contain claim language that refers material properties. Lack of specificity about how the property is supposed to be measured creates opportunities for indefiniteness and lack of written description challenges. If language is not sufficiently specific, or is not defined clearly in the patent, claim construction can significantly change the scope of the claim.
- Process patents might define the process too narrowly (thus failing to provide sufficient protection) or too broadly (thus facilitating anticipation and obviousness challenges). Often the language defining the process is not specific enough.
- Generic companies often include admit infringement in their own ANDA documents.
Daniel A. Rubé, Ph.D., Attorney
Troutman Sanders LLP
1) Strategies for patenting CAR-T and other cellular therapies in US and internationally.
a) protection of the CAR-T itself
b) protection of cells expressing CAR-T
c) protection of methods of treatment using CAR-T
2) Issues concerning patenting antibodies in US and internationally
Brian M. Gummow, Ph.D., Counsel
Haley Guiliano LLP
- Life Sciences Methods – A Section 101 Update
- Diagnostic Methods—a discussion of the en banc decision in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC and what the Supreme Court’s denial of certiorari means for diagnostic method claims.
- Methods of Treatment—a discussion of post-Vanda method of treatment cases
- Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC
- Endo Pharm. Inc. v. Teva Pharm. USA, Inc.
- Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc.
- Methods of preparing—a discussion of Illumina, Inc. v. Ariosa Diagnostics, Inc. and the patent eligibility of preparing samples for a diagnostic test.