St. Louis patent litigator Doug Robinson spoke to Ian Lopez of Bloomberg Law about a case that will go before the U.S. Supreme Court in March that could have significant effects on patent litigation and could harm generics makers’ ability to compete with larger pharmaceutical companies.

The trial in United States v. Arthrex will focus on whether the U.S. Court of Appeals for the Federal Circuit correctly found that Patent Trial and Appeal Board judges within the USPTO are powerful enough to be principal officers under the Constitution. If so, they would require presidential nomination and Senate confirmation, which they are not subject to currently.

If the Supreme Court upholds the ruling — finding that PTAB judges flout the Constitution — generics and biosimilar manufacturers fear that they will no longer have the ability to use the PTAB’s Inter Partes Review proceedings and that PTAB judges will be subject to changing political forces and pressures. 

Generics and biosimilar manufacturers are generally in favor of preserving IPRs as an attractive and efficient means of keeping drug prices low. By using IPRs to invalidate patents held by major pharma companies, generics makers can avoid the potential for costly patent infringement litigation.

For generic makers, Robinson says, “the idea that people have is that you’re more likely to succeed on a patent challenge in an IPR versus district court litigation. The timing limitations on IPRs are also more favorable to challengers, which, in this case, is the generics company.”

“Going the IPR route can clear the landscape for you faster than litigation,” Robinson adds. With fewer patents in the way, generics companies can also get their products to market faster.

Standing up for generics makers, the Association for Accessible Medicines warned the justices that “dismantling the entire system” would uphold patents that “serve as an illegitimate barrier to cheaper generic and biosimilar alternatives.”

If found unconstitutional, it is more likely that PTAB proceedings and IPRs would be paused rather than outright cancelled. Congress would then need to find a solution to the issue. The amount of time that could take is an open question.

At the center of the case is Arthrex Inc., a biotech company that is urging the justices to rule that IPRs are unconstitutional.

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