In the week leading up to an important meeting of the Senate Judiciary Committee on September 19, PIRG and our allies worked to educate lawmakers about how two pieces of legislation could undermine some of Congress’ previous work to address the high costs of prescription drugs.
The PREVAIL Act and the Patent Eligibility Restoration Act (PERA) both propose reforms to the U.S. patent system which would make it harder than ever for generic and biosimilar drugs to compete on the market. These alternatives to brand name drugs save patients money. An FDA study demonstrated that with even one generic competitor , the average manufacturer’s price is reduced by up to 39%. Entry of four generics improves competition so much that prices are 79% less than the brand drug price before generic entry.
We need generic drug competition sooner. That means only valid patents should stand.
Too often, pharmaceutical companies apply for dozens of patents on one drug, even years after the original patent. They build a “patent thicket” – piles of patents which prevent generic competitors from selling their products. And allowing the brand name company to keep raising their prices.
That’s why we can’t afford to change the patent law as proposed in these two bills.
We should not expand the universe of what can be patented.
PERA expands the kinds of things that can get a patent. Changing what is eligible to be patented would significantly alter America’s patent system. PERA would open the door to allow patents for compounds that exist in nature which nobody invented, but are newly discovered. This dramatic change could have devastating effects on drug pricing by expanding the universe of items that can have a patent, meaning it will be easier than ever for drug companies to build patent thickets which keep competitors off the market.
We need to protect the public’s right to challenge a weak patent.
The PREVAIL Act removes key tools that allow the public to question and challenge weak patents. Today the PTO is dealing with thousands of patent applications and just one drug might have dozens of patents. We would hope the patent examiners always get it right, but there are bound to be mistakes. PREVAIL takes away the public’s right to ask the Patent Office to take a second look at a patent that should not have been given in the first place. If we can’t get bad patents revoked, we have a smaller chance of riding our system of weak patents. And that means those patent thickets will continue to stand in the way of patients getting access to lower cost generics and biosimilars in a timely way.
Ultimately, we raised enough questions that the vote on these two bills were delayed until this week, September 26. If one of your Senators serves on the Senate Judiciary committee, let them know you want them to vote NO on PERA and PREVAIL. And tell your Representatives to help on this issue too, by using our action link below, to pass the Affordable Prescriptions for Patients Act.