Patent vs. Trade Secret Considerations for Cell and Gene Therapies
- Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are complex and rapidly evolving. Careful consideration of the risks and benefits... ›
Establishing Unexpected Results: PTAB Highlights Pitfalls for Rule 132 Declarations
By: Qiwen Zhong Ph.D. and Lisa N. Silverman Ph.D.
A recent decision by the Patent Trial and Appeal Board (PTAB) sheds light on certain pitfalls patent applicants may encounter when submitting declarations under 37 C.F.R. § 1.132 (“Rule 132 Declarations”). Rule 132 Declarations are frequently used in life sciences patent prosecution to submit... ›Beyond Final Rejection: What’s Next for Patent Prosecution After USPTO Terminates its After Final Consideration Program?
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On October 1, 2024, the United States Patent and Trademark Office (USPTO) announced that it is terminating its After Final Consideration Pilot Program 2.0 (AFCP 2.0), which is set to expire on December 14, 2024. The expiration follows a brief extension from September 30,... ›Under lock and key – Private sales may not qualify as public disclosure
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product.[1] The Leahy-Smith America Invents Act provides exceptions for certain disclosures that would otherwise be considered prior... ›Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers
By: Paige N. Chandler Ph.D., Meghan McLean Poon Ph.D. and Matthew A. Chivvis
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would... ›Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories
By: Jeffrey W. Schmidt Ph.D., Meghan McLean Poon Ph.D. and Karen G Potter Ph.D.
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 obviousness-type double patenting (ODP) in the... ›The PTAB Axes Skin Treatment Patent Under Amgen
By: Mark D. McBriar Ph.D.
The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. ( See Forte Biosciences Inc v. University of Massachusetts , PGR2023-00014.) The PTAB found UMass’s claims... ›Federal Circuit Wades Into Article III Standing in Patent Cases Once Again
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
Article III standing can differ from the statutory requirements of 35 U.S.C. § 281 in patent cases. In certain instances, a secured creditor can obtain rights that become actionable only upon default, which may include the ability to license or enforce a patent. However, these rights... ›USPTO Considers Changing Terminal Disclaimer Practice to Require Agreement Regarding Enforceability
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies. Specifically, the USPTO proposes amending the patent rules “to require that a terminal... ›- - Corporate + Venture Capital, Employment, Financing, Global, Intellectual Property, Litigation, Privacy + Data Security, Regulatory, Startup
When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets
By: Kate Driscoll, Nathaniel R. Mendell and Jim Krenn
MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. The podcast features interviews with legal experts who share insights and advice you just might... ›