[Ip-health] UPDATE 1-Pfizer loses UK patent case over use of Lyrica drug in pain

Tahir Amin tahir at i-mak.org
Thu Sep 10 09:07:51 PDT 2015


By Ben Hirschler

(Reuters) - Pfizer suffered a major setback in Britain on Thursday when the
High Court in London ruled that claims of patent protection for the use of
its $5 billion-a-year drug Lyrica as a pain treatment were invalid.

Lyrica, known generically as pregabalin, was originally developed for
epilepsy. However, further research showed it could also help patients
suffering from neuropathic pain and most prescriptions are now written for

While the original patent on pregabalin expired last year, Pfizer was
awarded a secondary patent covering pain, valid until July 2017, and the
U.S. drugmaker had been fighting to protect this lucrative section of the

The expiry of the basic patent allowed generic drugmakers including
Actavis, now renamed Allergan, to launch cut-price versions of the
medicine, which carried a so-called "skinny label" limiting their use to
epilepsy and general anxiety disorder.

But Pfizer still sued, arguing it was inevitable that the copycat versions
would be dispensed for pain as well as non-pain conditions.

The issue was further complicated by the fact that British doctors, who
typically write prescriptions using a drug's generic name, were told by the
National Health Service (NHS) to only prescribe branded Lyrica for pain,
angering some medics.

In the event, the court decided that generic companies had not infringed
Pfizer's secondary patent and its patent claims directed generally to pain
and neuropathic pain were invalid.

"Pfizer is liable for making groundless threats of patent infringement
proceedings," the court said in a lengthy judgment.

In a statement, Pfizer said it maintained its strong belief in the validity
and importance of the second medical use patent for pain and it intended to
appeal the ruling.

Since four out of five prescriptions for the drug in Britain are written
for pain, the setback is significant for Pfizer. The NHS spent nearly 250
million pounds ($386 million) on the medicine last year, or around 7.5
percent of Lyrica's worldwide sales of $5.2 billion.

The case is specific to Britain and has no direct implications for other
markets, where Pfizer also has secondary patent protection for Lyrica in

Pfizer argues such secondary patents are essential if companies are to
investigate and spend research dollars in novel uses of drugs, which may
bring important benefits to society.

In the case of Lyrica, Pfizer said it had conducted more than 50 clinical
studies involving some 12,000 patients specifically to assess the efficacy
and safety of Lyrica in neuropathic pain, a chronic condition involving
nerve damage. (Editing by Mark Potter

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472

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