The United States Patent and Trademark Office (USPTO) recently implemented a new pilot program that allows certain applicants to defer responding to subject matter eligibility rejections under 35 U.S.C. §101 during prosecution.  This program, which is effective from February 1, 2022 to July 30, 2022, is intended to evaluate whether deferring applicant responses to subject matter eligibility rejections can improve prosecution efficiency and patent quality.

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The use of open source software (OSS) in modern technical innovations is increasingly prevalent. For example, incorporation of OSS in innovations within the life sciences has become a relatively common practice as life sciences companies pursue technology-based solutions in the expanding personalized healthcare market. These solutions at the interface of life sciences and hi-technology can range from software-based products to evaluate whether a patient will benefit from a particular therapy to systems that monitor patient compliance with prescribed therapies. OSS can provide companies with quick and cost-effective solutions to many software-related objectives, which can be appealing to those racing to bring products to a competitive market. Companies considering the use of OSS must, however, be aware of the consequences associated with incorporating OSS into a product’s code, particularly with respect to the licenses attached to OSS which often create limitations on associated intellectual property rights. Failure to adequately recognize and address the intellectual property issues raised by the utilization of OSS and their associated licenses can greatly diminish a product’s commercial value.

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A recent decision from the U.S. Court of Appeals for the Federal Circuit serves as a reminder of the importance of 35 U.S.C. §112’s written description requirement in both patent litigation and patent drafting. In Biogen Int’l GMBH v. Mylan Pharms., 18 F.4th 1333 (Fed. Cir. 2021), the Federal Circuit affirmed a West Virginia district court’s ruling that patent claims directed to a method of treatment with a specific drug dosage were invalid for lack of written description—even though the patent specification explicitly recited the dosage as part of a dosage range. The decision highlights the importance of considering invalidity under the written description requirement as a potential defense in litigation—particularly in ANDA cases, in which therapeutic efficacy for specific conditions, and drugs dosage amounts, may be at issue—and for patent applicants to remain mindful of written description pitfalls throughout patent prosecution.

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*This article was previously published on February 3, 2022 in the New York Law Journal. 

In case you missed it, here is a recap video of our February 2022 Intellectual Property Report that looked at: