The following statement was issued by David Mitchell, a cancer patient and the Founder of Patients For Affordable Drugs, regarding today’s House Judiciary Subcommittee hearing about drug company patent abuse and the inter partes review (IPR) process:
“Today’s hearing touches on the heart of the problem with high drug prices.
“One reason drug corporations enjoy prolonged monopoly pricing power is because they abuse America’s patent system. They build a thicket of patents to block cheaper generics from coming to market.
“Congress sought to encourage faster and cheaper challenges to phony patents by enabling the inter partes review process. Drug corporations hate it because it directly threatens their patent schemes and monopoly status. We need IPR as a vehicle to challenge and invalidate weak and unmerited patents.”
BACKGROUND:
After the international drug conglomerate, Allergan, attempted to transfer ownership of its patents for Restasis to the Saint Regis Mohawk Tribe, we spoke to dozens of patients suffering under Allergan’s scheme.
- Ann Neilson of Madras, OR: “I have been on Restasis for dry eyes for many years. There are still no generics which I don’t understand. The charge for my last 3-month prescription was $1,205.”
- Joseph Landi of Boca Raton, FL: “I’m a retired police officer. My doctor prescribed Restasis for chronic dry eye. I expect to spend at least $1,000 this year for Restasis and there is no cheaper generic. I have had to stop taking other drugs I need to pay for Restasis. How much do these drug companies need to make on the backs of patients?”
Allergan transferred its patents to the St. Regis Mohawk Tribe under the guise of a suffocating inter partes review process. But the anti-competitive and unprecedented move was rebuked by Federal Judge William Bryson. He wrote:
- “The Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed. The essence of the matter is this: Allergan purports to have sold the patents to the Tribe, but in reality it has paid the Tribe to allow Allergan to purchase — or perhaps more precisely, to rent — the Tribe’s sovereign immunity in order to defeat the pending IPR proceedings…What Allergan seeks is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits through the administrative mechanism for canceling invalid patents.” (Link)
According to a new study from the University of California Hastings College of Law:
- Every year, at least 74 percent of the drugs associated with new patents in the FDA’s records were not new drugs coming on the market, but existing drugs.
- The report said: “Rather than creating new medicines, pharmaceutical companies are recycling and repurposing old ones. Adding new patents and exclusivities to extend the protection cliff is particularly pronounced among blockbuster drugs. Of the roughly 100 best-selling drugs, almost 80% extended their protection at least once, with almost 50% extending the protection cliff more than once.”
Drug companies like Allergan claim they use patents to protect intellectual property. The fact is that they abuse our patent system to plunder American patients, consumers, and taxpayers with outrageous prices for existing drugs. In fact, the price of Restasis has more than doubled since 2008.