Two weeks ago I told you that the FDA approved a generic version of Lyrica® (pregabalin) made by Lupin Limited, but I wasn't able to find out when it might actually be available on the market. Now I know why I couldn't find that information. Apparently Lupin was awaiting a court decision as to whether or not on Pfizer Inc.'s patents for Lyrica were valid.
That decision came down last Thursday, July 19, 2012. Judge Gregory M. Sleet of the U.S. District Court of Delaware upheld the validity of Pfizer's patents for Lyrica, giving them exclusive rights to the medication until December 30, 2018. In addition, Judge Sleet ordered the FDA to stop approving generic forms of pregabalin until Pfizer's patents expire.
The Story Behind the Decision
In 2009, Pfizer filed a lawsuit charging patent infringement against Israel's Teva Pharmaceutical Industries, India's Sun Pharmaceutical Industries, and U.S. firms Mylan and Watson Pharmaceuticals, who all sought FDA approval to market generic versions of Lyrica.
Pfizer has three separate patents for Lyrica that were at issue in this case:
U.S. Patent No. 6,197,819 covers the active ingredient pregabalin and expires December 30, 2018.
U.S. Patent No. RE 41,920 covers methods for using pregabalin to treat pain and expires December 30, 2018.
- U.S. Patent No. 5,563,175 covers a method for using pregabalin to treat seizure disorders and expires October 8, 2013.
The Court's decision affirms the strength of Pfizer's patents and prevents the generic manufacturers from marketing their generic versions of Lyrica in the U.S. before the patents expire, pending a possible appeal by the generic companies. Litigation on the same patents remains pending against other generic companies, but no trials have been scheduled in these later cases.
"The Court's decision recognizes the infringement and validity of our Lyrica patents and affirms the value of Lyrica as a distinct and important innovation for patients," said Amy Schulman, Executive Vice President and General Counsel for Pfizer. "Protecting our intellectual property is vital to our ability to develop new medicines that save and enhance patient lives."
When I first read that a generic for Lyrica had received FDA approval, I was surprised because it didn't seem like Lyrica had been on the market for that long. Lyrica was first approved to be marketed in the U.S. in 2004. But since the length of time between FDA approval and patent expiration can vary quite a bit, I didn't think too much more about it.
Although I'm disappointed for fibromyalgia and other chronic pain patients who would benefit by having a less expensive version of Lyrica available, I can't disagree with the court's decision. Pfizer does have a legal right to exclusively market their product until the patents expire.
I did find it interesting that the judge prohibited the FDA from approving any more generic versions of Lyrica until Pfizer's patents expire. I just learned that in addition to approving Lupin's pregabalin earlier this month, the FDA also approved pregabalin applications for Teva Pharmaceutical and Watson Labs on the same day.
I'm not a legal expert so I don't know why so many generic manufacturers thought they could market pregabalin before the patent expirations. But as it stands now, a generic form of Lyrica will not be available in U.S. markets until at least early 2019.
Pfizer, Inc. press release. July 19, 2012. Anson, P. (2012, July 20). Judge upholds Pfizer's patent on Lyrica. American News Report.