It was interesting to hear attorneys at a recent biotech conference I attended get very excited about the millions of additional dollars a patent term adjustment can bring in.

Panelists at the BIO IP Counsels Committee Conference in Charleston, S.C., Nov. 13 described how patent terms can be extended as a result of delays by the U.S. Patent and Trademark Office in issuing a patent. The applicant can request a PTA from the PTO and, if the applicant disagrees with the PTO's calculation under the statute, the company can ask the court to recalculate the PTA.  

The complaints to the U.S. District Court for the Eastern District of Virginia may not be that imposing. They are usually no more than seven pages long. But Jennifer Johnson of Finnegan, Henderson, Farabow, Garret &  Dunner, LLP, Washington, said that a drug that has revenues of $1 billion a year brings in over $2 million a day. “Even for non-blockbuster drugs, the additional daily revenue adds up. Any time you can add to the tail end of your patent is worth fighting for when it can be worth millions of dollars in revenue,”  she said  

The excitement about PTAs was partly precipitated by the Eastern District of Virginia ruling just two weeks before the conference in Exelixis Inc. v. Kappos that the PTO's calculations of PTAs in certain situations had been incorrect.  Just before and just after the conference, on Nov. 9 and Nov. 16, the U.S. District Court for the District of Columbia agreed with the Exelixis ruling in its decisions in University of Massachusetts v. Kappos and Novartis AG v. Kappos.  

This is an area in which there is a lot happening.