Duplicative patents in pharmaceuticals make it harder to bring generic drugs to market, driving up higher costs for patients and insurers, America's Health Insurance Plans (AHIP) said in an amicus brief pushing for the Supreme Court to review the issue.
Specifically, AHIP is weighing in on the case of Mylan Pharmaceuticals v. UCB, Inc. In that case, generic drugmaker Mylan challenged several patents taken out on the same antiepileptic drug by drugmaker UCB.
The patchwork of patents prevented generic drugs companies from bringing alternatives to market, "creating a monopoly on the manufacture of the drug stretching over a quarter of a century," AHIP argued.
"There certainly is an appropriate monopoly inherent in the patent granted for innovation, but there are various ways in which branded pharmaceutical companies have extended their patent monopolies through actions taken with those patents, or through, in this case, duplicative patenting. So obtaining multiple patents applying to a single drug—or a drug that's very close to another drug and there's no real innovation between the two—and using those patents or patent estates to ward off generic competition for many years," explained Mike Spector, AHIP's senior counsel who led the amicus brief, in an interview with FierceHealthPayer.
On its website, top drug manufacturing group PhRMA points to the Hatch-Waxman Act (PDF), a law to allow increased generics competition which passed in 1984. "With the help of the Hatch-Waxman Act, the United States can remain a leader in medical innovation, while balancing innovation and affordability and promoting competition," the group said.
Duplicative patenting certainly isn't unique to the UCB antiepileptic drug. For example, the popular drug Humira has over 100 patents on it to prevent competitors from coming to market. (Humira isn't involved in Mylan's suit, however.)
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These duplicative patents are generally difficult to challenge in federal circuit courts because those courts consistently use rigid legal tests to assess the obviousness of the duplication. AHIP said that since the Supreme Court has already expressed disagreement with that process, this case could be a chance for the high court to get at the problem.
"You have to get through this test before you get to the question then of obviousness—of is this, you know, truly a novel item that meets the requirement of the patent laws (of being nonobvious). So it's our view that the Supreme Court has expressed a preference for substance over form, and these kind of preliminary tests that keep either courts or patent examiners from doing a full examination ... are not beneficial, and according to the Supreme Court, not appropriate," Spector said.
If the Supreme Court takes the case, it would be an opportunity to enable courts and patent examiners to really get to work challenging redundant patents, AHIP said. But until then, the surging drug costs resulting from these types of patent loopholes will continue to make their mark on the insurance pricing structure.
"This is part of our advocacy with this amicus brief. It's to continue to address these bigger loopholes that are allowing big pharma to exploit this stuff for their own bottom line, their own financial gain," Cathryn Donaldson, AHIP's director of communications, told FierceHealthPayer. "We want people to be able to afford their medications, and right now if a drug is priced at $100,000, that's obviously going to affect the rest of the pricing chain. So, that includes insurers, right? And that will include premiums, deductibles, etc."