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 The Supreme Court decision is a blow for the U.S. drugmaker -- which
had sought to affirm a secondary medical use patent for the product
-- and a win for generic drug companies Actavis, now renamed
Allergan, and Mylan.
Lyrica, known generically as pregabalin, was originally developed
for epilepsy but further research showed it could also help patients
suffering from neuropathic pain, which soon became its main market.
In a bid to protect this lucrative section of the market, Pfizer
secured a secondary patent, valid beyond the life of the original
one.
The Supreme Court, however, ruled that the secondary patent claims
relevant to neuropathic pain were invalid.
For Pfizer, the legal fight had become a point of principle,
following years of battles in lower courts, since its key secondary
pain patent has now expired in Europe.
Pfizer said it was disappointed by the ruling and the decision would
have a significant impact on incentives for innovation in public
health.
"The period that a medicine is under patent is a critical phase in
its lifecycle that fuels innovation -- as science evolves and
knowledge grows, patients increasingly benefit from ongoing research
into new uses for existing medicines," the company said.
"As situations such as these are expected to become more common,
it's important for patients that pharmaceutical companies are able
to protect patents, including second medical use patents."
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The expiry of the basic patent on Lyrica five years ago had allowed
generic drugmakers to launch cut-price versions of Pfizer's
medicine, which carried a "skinny label" limiting their use to
epilepsy and general anxiety disorder.
Pfizer sued, arguing it was inevitable that the copycat versions
would be dispensed for pain as well as other conditions.
The U.S. group took the case to the Supreme Court after a appeal in
the case was rejected in 2016. Since then Pfizer's secondary
neuropathic pain patent in Britain has also expired, in July 2017.
In the United States, by contrast, Pfizer is only expecting generic
competition to Lyrica in 2019.
The Supreme Court is the final court of appeal in Britain for civil
cases. Pfizer said it was "too early" for it to determine or comment
on any possible next steps.
(Reporting by Ben Hirschler; editing by Jason Neely and Jane
Merriman)
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