Usually, when generic copies of a branded drug hit the market, that's the end of the line for scrapping over patent protection. And usually, when drugmakers are trying to protect their patents, they don't go to doctors to do so.
But these are unusual circumstances, or so says Pfizer ($PFE), which has written doctors in the U.K. warning them not to prescribe Lyrica knockoffs to treat neuropathic pain. Seems the company still has a live patent covering Lyrica's use against that type of nerve pain. Generics are specifically approved to treat generalized anxiety disorder and epilepsy.
So, Pfizer still wants to protect its turf--ostensibly till July 2017, when the neuropathic pain patent expires. Hence the letter, which, according to PatentDocs, was dispatched to pharmacists and hospital administrators in addition to (or perhaps instead of) doctors.
According to the letter, which was published by PatentDocs on its website, Pfizer says it's seeking to "inform" recipients about "relatively unusual issues" affecting Lyrica exclusivity, "so that you can take necessary action to prevent patent infringement by your organization."
"Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the U.K. would infringe Pfizer's patent rights," the letter states, going on to urge addressees to make sure prescribers know about the pain patent and advise clinicians to prescribe Lyrica by brand when using the drug to treat neuropathic pain.
It's not just friendly advice. The letter closes with a not-so-veiled threat of legal action. "[I]nstructing or encouraging the usage of generic pregabalin in pain would amount to procurement of patent infringement (an unlawful act)," the letter states. "Pfizer therefore reserves all of its legal rights in this regard."
Pfizer's missive is somewhat similar to KV Pharmaceuticals' attempts to quash cheap compounded versions of an old hormonal preterm labor treatment it had won FDA approval to sell in standardized form. The agency gave KV market exclusivity as a reward for running trials of its manufactured version, dubbed Makena. But after an outcry over Makena's $1,500-per-injection price, the FDA said it wouldn't go after compounding pharmacies that turned out the injections on a patient-by-patient, prescription-by-prescription basis (at the much lower price of $20 per injection). KV, on the other hand, sent letters to compounding pharmacies warning of FDA action if they did so.
Whether Pfizer's attempt to keep Lyrica partially protected will work remains to be seen. KV, however, ended up in hot water over its threatening letter. The agency said KV's threats of an agency crackdown were absolutely false. KV later slashed its price on Makena to $595. Even later, the company found itself in bankruptcy. But the FDA did go after one compounding pharmacy making Makena--not on exclusivity grounds, but for purity problems.
Pfizer has plenty of incentive to keep Lyrica's brand sales as high as possible. It's the company's third-best-selling drug, with $4.6 billion in 2013 sales. Its fourth-best seller, Celebrex, just got generic competition sooner than expected. Plus, time could be running out on its ability to twist doctors' arms on Lyrica in the U.K. Two generics makers, including Actavis ($ACT) , have challenged the use patent covering neuropathic pain, with a trial expected in June. In the U.S., however, Pfizer won a court ruling last year protecting Lyrica from generics till December 2018.
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