Posts Tagged: "patent term extension"

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today in In re Cellect holding that patent term extension (PTE) and patent term adjustment (PTA) are not the same for purposes of an obviousness-type double patenting (ODP) analysis. Specifically, the court said that “ODP for a patent that has received PTA, regardless whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.” The opinion was authored by Judge Lourie.

A letter sent to the United Kingdom’s International Business and Trade Secretary today urged scrapping proposals that health groups say would undermine the generic medicines industry in India. The letter refers to a leaked document that indicates the UK will be asking India to agree to a number of patent provisions as the two countries negotiate a trade deal today.

Patent Term Adjustment (PTA) was designed to serve an important purpose – to compensate patentees for time lost during examination due to U.S. Patent and Trademark Office (USPTO) delays. Most industries rely heavily on their patent portfolios to drive business strategies that ultimately impact their bottom line. The impact of patent term is especially acute in the pharmaceutical and biotechnology industries, where companies spend billions of dollars to develop new drugs. For these companies, every day that their patent is in force matters, generating millions in additional revenue. With so much at stake, companies strive to accrue all the patent term they are entitled to under the current statutory regime, including by way of PTA.

Section 156 of the Hatch-Waxman Act provides for restoring some of a patent’s term consumed during clinical testing and Food and Drug Administration (FDA) review of a New Drug Application (NDA) for a product covered by the patent. The extension afforded under Section 156 is of great importance to a drug manufacturer given that development of a new drug from discovery through FDA approval often takes a decade or more (10-15 years), leading to the loss of a significant portion of the term of a patent covering the drug. The dispute in Biogen International Gmbh v. Banner Life Sciences LLC, No. 2020-1373 (Fed. Cir. April 21, 2020) (Biogen v. Banner) centers around the very meaning of the term “product” as used in Section 156.

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from their efforts. However, in the pharmaceutical industry, the practical duration of protection is often substantially shorter since obtaining a patent is just one piece—albeit a critical one–of bringing a drug to market.