Pfizer's Lyrica patent appeal fails in U.K., endangering bid to protect $5B med

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Pfizer’s divide-and-conquer approach to Lyrica in the U.K. just hit a wall. The Court of Appeal upheld a ruling that struck down key patent claims on Lyrica and cleared Actavis’ generic of infringing it.

The closely watched case centered on a “carve-out” approval for Actavis’ Lyrica generic, a type of regulatory nod that branded drugmakers see as a threat. Naturally, drugmakers want to prolong their monopoly access to patients, and they use follow-up patents to extend their protection past the time when IP coverage expires on the original compounds.

But some recent “skinny” regulatory nods--from the FDA as well as international regulatory agencies--that clear generics only for particular indications have complicated those efforts, because they give generics makers an entreé onto the market while so-called method-of-use patents remain in effect.

The patent at issue in this case covered Lyrica’s use as a pain treatment; the patent on pregabalin itself, the active ingredient in the $5.1 billion drug, had already expired. These days, Lyrica is used more often for pain than for its original indication as a seizure drug.

Actavis launched a competing generic in the U.K. aimed at the epilepsy market, but Pfizer fought back, saying the generic would encroach on the patented pain use as physicians prescribed the med off-label. The company sued for patent infringement on the grounds of “inevitable” off-label use of those generics.

A lower U.K. court struck down that patent and ruled in favor of Actavis, Pfizer appealed, and now the appeals court has upheld that lower-court ruling. The company hopes to now take its fight to the U.K. Supreme Court. “Pfizer maintains its strong belief in the validity and importance” of the patent, the company said in a statement.

Outside the patent suit, the drug giant moved to protect Lyrica from that competition. Its aggressive bid to protect the blockbuster med spawned a contentious battle with England’s National Health Service, a threat of legal action in a strongly worded letter to NHS physicians and pharmacists, and an eventual court order forcing the NHS to instruct doctors not to prescribe generic pregabalin to patients for pain. Pfizer ended up covering the expense for doctors to switch existing pain scripts to the brand.

In a September ruling, however, the lower-court judge, Richard Arnold, chastised Pfizer for threatening legal action against doctors who wrote pain-related generic scripts and the pharmacists who dispensed them, saying they were “groundless threats.” To Arnold's mind, some of those letters were "calculated to have a chilling effect on the willingness of pharmacies to stock and dispense generic pregabalin."

Now, in its judgment, the appeals court defines infringement on a secondary patent such as Lyrica’s coverage for pain. A generics maker can avoid infringement if it “takes all reasonable steps within its power” to prevent prescribing for the still-covered indication, Powell Gilbert, the law firm representing Actavis in the case, said in a statement.

“We welcome the Court of Appeal’s decision to uphold the trial judge’s findings and the guidance it has given on the infringement of second medical use patents,” Tim Powell, a partner at that firm, said Thursday. “The judgment offers a pragmatic way forward in seeking to strike a fair balance between the patentee’s right to a return for its investment in innovation and the generic manufacturer’s right to sell into the non-patented market.” 

After its acquisition of Actavis, Allergan’s generics unit, Teva now owns the U.K. business that launched that Lyrica copycat--though Teva inked a deal just days ago to sell that unit off to Indian drugmaker Intas.

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