Pfizer Inc. announced today that the United States District Court for
the District of Delaware upheld its composition of matter patent and
pain and seizure use patents covering LYRICA® (pregabalin) capsules CV.
With this decision, Pfizer will exclusively provide pregabalin as LYRICA
to patients through December 30, 2018 in the U.S., pending generic
company appeal and further litigation.
“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.”
The Court’s decision affirms the strength of our 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. Pfizer and Northwestern University, which owns
the patents covering the active ingredient pregabalin and the use for
treating seizure disorders, filed suit in 2009 against the generic
companies that applied to the FDA to market a generic version of LYRICA®
prior to the expiration of the patents covering pregabalin and its use.
Litigation on the same patents remains pending against other generic
companies, but no trials have been scheduled in these later cases.
Three separate patents are 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. 5,563,175 covers a method for using pregabalin
to treat seizure disorders and expires October 8, 2013; U.S. Patent No.
RE 41,920 covers methods for using pregabalin to treat pain and expires
December 30, 2018.
LYRICA® is currently approved for various indications in 120 countries
and regions globally. In the United States, LYRICA® is indicated for
diabetic nerve pain, post herpetic neuralgia (pain after shingles),
fibromyalgia, neuropathic pain associated with spinal cord injury and
partial onset seizures in adults with epilepsy who take one or more
drugs for seizures. Antiepileptic drugs (AEDs) including LYRICA®
increase the risk of suicidal thoughts or behavior in patients taking
AEDs for any indication. There have been post-marketing reports of
angioedema and hypersensitivity with LYRICA®. Treatment with LYRICA® may
cause dizziness, somnolence, dry mouth, edema and blurred vision. Other
most common adverse reactions include weight gain, constipation,
euphoric mood, balance disorder, increased appetite and thinking
abnormally (primarily difficulty with concentration/attention).
For LYRICA® prescribing information, please visit www.lyrica.com.
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