Why the fuss over assigning a drug patent to a tribe?

| Sep 17, 2017 | Patent Law

Patent law is not one of those areas of practice that has garnered a great deal of media attention over the centuries. That’s changed a lot in recent decades. Many readers are surely familiar with the long-running battle between Apple and Samsung over patents related to their respective smartphones.

Another likely factor in elevating patent disputes into the limelight happened in 2011 when Congress passed the America Invents Act. With its enactment, the Patent Trial and Appeal Board was created – a forum meant to make it easier, faster and less expensive to resolve patent claims seeking to invalidate existing exclusivity rights. Many companies, especially in the tech sector, like the law. Many patent holders do not, and the split in opinions is sparking some interesting fireworks.

Making headlines in recent days is the fact that a major drug manufacturer has taken a step to try to have one of its patented products taken out of the traditional purview of the Patent and Trademark Office – including the PTAB. What happened is that Allergan Plc assigned its patent for the drug Restasis to a Native American tribe in New York. Under terms of the announced deal, the tribe will hold the patent and license rights to it back to Allergan for ongoing payments.

Patents usually protect the holder from competition for as much as 20 years. But generic companies often challenge the patents early. If they win, the door opens for generic drug competition. Allergan’s action comes as it faces patent challenges on Restasis. There are suits underway in federal court and claims before the PTAB.

Allergan’s CEO says he’s not trying to dodge the battle over the patents. He says the patent shift to the tribe is simply an effort to avoid what he considers to be the “double jeopardy” that the suits and the PTAB claims represent.

Adding to the furor are concerns of patient advocates and generic drug makers that other firms will follow Allergan’s lead and the result will be higher prices on drugs because of reduced availability of generics.

Whether the patent handoff strategy survives what seems to be certain legal challenges is anyone’s call at this point. What this story reflects, we think, is that patent law doesn’t warrant the “boring” stereotype that some choose to apply.