How Non-Product-Specific Manufacturing Patents Block Biosimilars

by Chorong Song

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Abstract

A new class of drugs called biologics has potential to finally cure previously untreatable conditions such as cancer and Alzheimer’s disease. But there is a catch: these innovative drugs are expensive. On average, prices range from $10,000 to $30,000 per year, and the most expensive ones exceed $500,000. The Biologics Price Competition and Innovation Act (“BPCIA”) was passed in 2010 to lower prices by providing a new regulatory pathway in approving biosimilars––copies of brand-name biologics. Yet, the BPCIA’s promised regulation of drug prices has not materialized partly due to brand-name companies’ vast patent portfolios, also known as patent thickets. This Note analyzed all BPCIA patents disputed in BPCIA litigations and found that over half of the asserted patents are manufacturing method patents, many of which were filed years after FDA approval. Given the nonproduct-specific nature of these patents and stringent FDA requirements, these inventions are not only unnecessary, but are also unlikely to be practiced when producing brand-name biologics. Regardless of their actual worth, these patents are extremely valuable to brand-name manufacturers because even a patent of marginal improvement can foreclose biosimilar access entirely. This Note proposes that brand-name manufacturers should be required to disclose related patents at the time of the FDA approval and share the FDA license application with biosimilar manufacturers. Further, Congress should eliminate the availability of injunctive remedies for these problematic assertions of patents.

How Non-Product-Specific Manufacturing Patents Block Biosimilars

by Chorong Song

Click here for a PDF file of this article

Abstract

A new class of drugs called biologics has potential to finally cure previously untreatable conditions such as cancer and Alzheimer’s disease. But there is a catch: these innovative drugs are expensive. On average, prices range from $10,000 to $30,000 per year, and the most expensive ones exceed $500,000. The Biologics Price Competition and Innovation Act (“BPCIA”) was passed in 2010 to lower prices by providing a new regulatory pathway in approving biosimilars––copies of brand-name biologics. Yet, the BPCIA’s promised regulation of drug prices has not materialized partly due to brand-name companies’ vast patent portfolios, also known as patent thickets. This Note analyzed all BPCIA patents disputed in BPCIA litigations and found that over half of the asserted patents are manufacturing method patents, many of which were filed years after FDA approval. Given the nonproduct-specific nature of these patents and stringent FDA requirements, these inventions are not only unnecessary, but are also unlikely to be practiced when producing brand-name biologics. Regardless of their actual worth, these patents are extremely valuable to brand-name manufacturers because even a patent of marginal improvement can foreclose biosimilar access entirely. This Note proposes that brand-name manufacturers should be required to disclose related patents at the time of the FDA approval and share the FDA license application with biosimilar manufacturers. Further, Congress should eliminate the availability of injunctive remedies for these problematic assertions of patents.