Dive Brief:

• The eyes of the biopharma industry are on a case being heard at the Supreme Court, that of Oil States Energy Services LLC v Greene’s Energy Group LLC et al. The aim is to determine whether the inter partes review (IPR) process violates the U.S. Constitution, on the basis that patents are property rights that need a judicial process for termination.
• The court has had a number of briefs filed, according to a BioCentury report. On one side, pharma companies are stating that IPR is unconstitutional, and on the other side, the generics trade body, generic companies and technology companies are seeking the preservation of IPR as another means to expedite generics to the market.
• The ruling is expected before the end of the current term in June 2018, and could have a major impact on the future of the entire IPR process.

Dive Insight:

The inter partes review process, put in place in 2012 as part of the America Invents Act, allows challenges to the patentability of one or more claims in a U.S. patent.

While the process has been a thorn in the side of big pharma as it has tried to extend the lifecycle of its key blockbuster drugs, the IPR process has been little understood. Although, its existence and the drawbacks it creates have been thrust into the light by a recent deal inked between Allergan and the Saint Regis Mohawk Tribe.

The specialty pharma company sold patents for its blockbuster eye drug Restasis (cyclosporine ophthalmic emulsion) to the Native American tribe, which in turn licensed the patents back to Allergan for an upfront payment and slice of the profits, allowing the company to be shielded from the IPR process due to the tribe's sovereign immunity. 

The tribe then filed a motion to dismiss Mylan N.V.'s IPR on Restasis' patentability, launched in December 2016 over six Restasis patents.

Restasis net revenues were $382.3 million in the third quarter of 2017, a 2.9% increase year-on-year. This made it the company's second-best selling drug, bringing in 9.5% of the company's income in the quarter. Losing this would knock a major hole in the company's balance sheet. In response, Allergan has been fighting the generic threat against Restasis since 2014, when the patents expired. Late in 2014 it argued that bioequivalence standards couldn't guarantee the equivalence of a Restasis generic. The deal with the Saint Regis Mohawk Tribe was a more unorthodox attempt to skirt generic competition.  

This move has been highly controversial, and Senator McCaskill (D-MO) introduced a bill last month to abrogate this immunity. Allergan claims, however, that it's not an "attempt to shield" the patents; rather it is a strategy to combat the IPR process, which it sees as unfair. The attempt may have backfired. It has dented Allergan's reputation, and despite all the efforts, a federal court judge has invalidated four of the patents. This means that generics could enter the market as soon as late 2018 or early 2019.