BPCIA Patent Dance: Navigating the Biosimilar Litigation Landscape in 2020

2021-05-21T04:21:19-04:00

Since the beginning of 2019, the number of biosimilar litigation - particularly those concerning the Biologics Price Competition and Innovation Act (BPCIA) “patent dance” - has drastically increased. One of the notable BCPIA cases that are being closely watched, is Amgen’s legal battle with Novartis’ Sandoz arm over the Enbrel patent, in which the former intends to hold commercial exclusivity for Enbrel until 2029. The legal precedents established in this dispute are expected to impact the biosimilar market as well as the pending and future biosimilar patent lawsuits.

Trade Secrets Protection in the Pharmaceutical Industry: Exploring Best Practices

2021-08-23T03:58:50-04:00

As the world develops and distributes safe and effective vaccines against COVID-19, the pharmaceutical industry is confronted with additional trade secrets protection challenges. Issues include the increased the burdens of protecting their assets, the immense level of R&D, the substantial impact of remote work, and COVID-related legal restrictions. Pharmaceutical companies must implement effective trade secrets protection strategies to manage threats amidst this crisis.

The Revised USPTO Subject Matter Eligibility Guidance: What You Should Know

2021-05-25T05:06:53-04:00

In January 2019, the United States Patent and Trademark Office (USPTO) issued a revised guidance to be used when evaluating subject matter eligibility and updated same in October 2019. The revised and updated guidelines primarily focus on patent eligibility procedures involving patent claims and applications. By providing new guidance in identifying whether a patent claim or patent application claim is directed to a judicial exception, it aims to bring better clarity and predictability to Step 2A of the Alice/Mayo test.

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