GSK v. Teva* Is A Big Win For Brand Pharma Companies; A Glimmer Of Hope For Generics

• Published date: 02 September 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Taft Stettinius & Hollister
• Author: Mr Andrew M. Alul, Stephen R. Auten and Roshan P. Shrestha, Ph.D.

On Aug. 5, the Federal Circuit reaffirmed its 2-1 prior decision that Teva's sales of carvedilol, a cardiovascular drug, induced infringement of GSK's method of treatment patent, even though Teva had filed a section viii statement to carve out the infringing uses from its product label. The majority called its decision a 'narrow, case-specific review' that would not affect other cases with section viii carve out, but its impact on the industry has yet to be seen and may in fact be far-reaching.

The court reinstated the $235 million patent infringement jury verdict against Teva, again finding that Teva encouraged doctors to prescribe the generic carvedilol for infringing uses that it had carved out in its Abbreviated New Drug Application (ANDA). The majority opinion, authored by Chief Judge Moore and Judge Newman, found that there was substantial evidence to support the jury verdict during the period Teva was marketing its product with a skinny label because, the majority found, the evidence showed that Teva's attempted carve-out was ineffective. Specifically, the majority found that one of the indications Teva left in its label, to reduce cardiovascular mortality in patients suffering from left ventricular dysfunction following myocardial infarction ('the post-MI LVD indication'), promoted (along with other portions of the label) the method of decreasing mortality caused by congestive heart failure claimed in GSK's patent ('CHF patent'). Former Chief Judge Prost dissented, finding that GSK's CHF patent could not cover the post-MI LVD indication because GSK never identified that indication to FDA as being covered by its CHF patent when it submitted that patent to the Food and Drug Administration (FDA), in accordance with the Hatch-Waxman Act and Federal regulations implementing the Act. For the full-label period (the period Teva marketed its product with the indication covered by GSK's CHF patent), Judge Prost also dissented from the majority's opinion finding substantial evidence supporting the jury's infringement verdict because, in Judge Prost's opinion, there was no evidence in the record supporting the jury's finding that Teva's actions actually caused physicians to prescribe Teva's product in an infringing manner.

What the Ruling Means

Section 505(j)(2)(A)(viii) of the Food, Drug, and Cosmetic Act, which is also known as the 'section viii carve out' or a 'skinny label' protects generic drug companies from infringement lawsuits as long as the uses...