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Pfizer Loses U.K. Patent Case Over Lyrica
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LONDON—A U.K. High Court judge ruled against Pfizer Inc. in a closely watched patent case involving its blockbuster drug Lyrica, leaving generic-drug makers free to sell cheap copycats of the drug.

The New York-based drug maker had hoped for a ruling that would protect the exclusive use of Lyrica for pain, even though the patents for two other uses—general anxiety disorder and epilepsy—have already expired. Lyrica was originally developed for those two indications, but Pfizer later discovered it could also be used in pain and got a secondary patent to cover that use. The original patent expired last year, but the secondary patent is intact until 2017.

Generic-drug makers including Actavis PLC, now Allergan PLC; and Mylan NV launched copycat versions of Lyrica when the first patent expired but sought approval only for use in general anxiety disorder and epilepsy.

Pfizer claimed the companies had nonetheless breached Lyrica’s secondary patent because U.K. doctors typically use the active ingredient rather than the brand name when prescribing medicines. Thus, in practice, generic versions of Lyrica would be dispensed for pain.

However, Justice Richard David Arnold found that the secondary patent was invalid, except in a handful of specific types of pain, and hadn’t been infringed by the generic companies.

The ruling is an important milestone in a battle that has raged for months. Pfizer took the unorthodox step of writing to physician groups in the U.K. to warn that prescribing generic Lyrica for pain amounted to a patent infringement. Pfizer later scored a victory when Justice Arnold ordered the U.K.’s National Health Service to issue guidance to physicians asking that they use the brand name Lyrica when prescribing the drug for pain “so far as reasonably possible.”

The industry has followed the case closely because it is increasingly common for pharmaceutical companies to obtain secondary patents for old drugs in a bid to extend their lifespans.

Dr. Berkeley Phillips, medical director at Pfizer’s U.K. unit, said secondary patents were important because they encouraged future investment in research and development. “The desire to protect second medical-use patents is in recognition of their importance in ensuring patients are able to benefit from future medical innovations,” he said.

Although he ruled Pfizer’s secondary patent invalid, the judge said the U.K. government needed to establish a system that would minimize the potential for similar disputes involving other companies’ secondary patents.

Pfizer said it maintained its “strong belief in the validity, and importance, of the second medical-use patent for the use of Lyrica in pain” and that it planned to appeal the ruling.

Write to Denise Roland at

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September 10, 2015 15:35 ET (19:35 GMT)

Copyright (c) 2015 Dow Jones & Company, Inc.

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