The high court upholds the constitutionality of a patent appeals process that the health insurance industry says will help to negate stall tactics used by brand name drug makers.
A U.S. Supreme Court ruling this week that upholds the constitutionality of a patent review process is being hailed as a win for consumers by the health insurance industry.
America’s Health Insurance Plans says the high court’s 7-2 decision in Oil States v. Greene’s Energy Group upheld the inter partes review process as a way to prevent drug manufacturers from inappropriately prolonging patent monopolies past the time intended by Congress.
“Patients had a lot at stake in the Supreme Court’s determination. Congress designed inter partes review as a quick and cost-effective way to weed out weak patents – including patents for branded prescription drugs,” AHIP said in prepared remarks.
Nicole S. Longo, senior manager of public affairs at Pharmaceutical Research and Manufacturers of America (PhRMA), said the ruling “was narrowly tailored, finding only that IPR is constitutional, not that it is efficient or fair.”
Longo pointed to another Supreme Court ruling this week, SAS Institute v Iancu, that raises concerns about the patent review process.
“SAS Institute v Iancu makes clear there are problems with the IPR process that need to be addressed. This decision points toward reforms to IPR, something stakeholders have raised time and again to the Patent and Trademark Office and members of Congress,” she said.
“Given this narrow decision, we call on Congress and the PTO to take steps to address the Supreme Court’s ruling in SAS Institutes v Iancu and concerns raised by stakeholders, and we stand ready to work with policymakers to make the IPR process more fair for all.”
According to Reuters, Congress created the reviews in 2011 to handle the perceived high number of flimsy patents issued by the patent office in prior years. Since then, the agency’s Patent Trial and Appeal Board has canceled all or part of a patent in about 80% of its final decisions.
The health insurance lobby said that the ruling ensures that millions of people will have faster access to affordable medicine.
“By upholding a faster and less costly patent review process, the Supreme Court has protected an important pathway that allows generic prescription drugs to get to patients faster. Generic drugs increase competition and choice in the market, which helps to lower drug prices,” AHIP said.
Longo said PhRMA has raised significant concerns with the IPR process because it requires drug makers to defend patents in multiple venues under different standards and with procedural rules that are less fair to patent owners than a federal court.
“This creates significant business uncertainty for biopharmaceutical companies that rely on predictable intellectual property protections to justify long-term investments needed to discover new treatments and cures,” Longo said.