The latest in Teva Pharmaceutical’s feud with GlaxoSmithKline LLC (GSK) could have big ramifications for the entire generics industry.
On May 15, 2023, the U.S. Supreme Court rejected Teva Pharmaceutical’s certiorari petition in the skinny label case between Teva Pharmaceuticals USA and GlaxoSmithKline LLC, despite the recommendation from the federal government. Previously, in October 2020, a federal circuit court had ruled that Teva infringed on GSK’s patent related to the GSK drug Coreg, despite using a skinny label, and granted damages of $235 million. These decisions might have thrown a curveball to the generics industry and its widespread practice of using skinny labels.
What are skinny labels?
In 1984, the US Congress introduced the Hatch-Waxman Act which created a regulatory framework for generic drugs to operate under can be credited with the launch of the generic industry in the US. This act created a regulatory framework for generic drugs to operate under and allowed drug companies to seek FDA approvals for their generic drugs even before the patented protection for the brand name drugs has expired.
Generic manufacturers remove, or carve out, from their labels any specific uses of the drugs that are still covered by the brand company’s patents and only seek FDA approval for the unpatented indications of the drug. This practice allows the generics manufacturer to avoid infringing any existing patents and the generic drug application is only approved for the unpatented uses of the drug. This practice is known as skinny labelling and has become quite common since the introduction of the Hatch-Waxman Act.
The main benefit of the practice of skinny labelling is that it lowers the overall cost of treatment by fast-tracking the market entry of generic drugs, thereby making healthcare more accessible to all.
Teva Pharmaceuticals USA V. GlaxoSmithKline LLC
The case is related to GSK’s drug, Coreg®, with the active ingredient carvedilol, used to treat high blood pressure and heart failure. Teva sells a generic version of that product, using a skinny label to exclude the heart failure indication for several years.
GSK launched Coreg in 1997 for three indications: hypertension, congestive heart failure (CHF) and left ventricular dysfunction (LVD). The drug was covered by GSK’s US patent numbers 4,503,067 and 5,760,069.
In 2002, Teva Pharmaceutical filed for FDA approval of carvedilol under under Paragraph III of the HatchWaxman Act with the ANDA (Abbreviated New Drug Application) as a treatment for heart failure and hypertension. They expected to receive tentative approval in 2004, but their product could not be launched until the ’067 patent expired in March 2007.
In 2007, after the expiration of GSK’s ’067 patent, Teva received FDA approval for its generic drug for only the unpatented indications – LVD and hypertension. Teva’s approved skinny label did not list CHF as it was still covered by the ‘069 patent which hadn’t expired.
In 2011, on the expiration of the ‘069 patent, the FDA required Teva to amend its label to include CHF indication as well.
But GSK filed for reissue of the ‘069 patent in 2008, which was granted by the USPTO as Reissue Patent No. RE40,000, with a slight modification of the CHF indication stated in italic font.
- A method of decreasing mortality caused by congestive heart failure in a patient in need thereof which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of an angiotensin converting enzyme inhibitor (ACE), a diuretic, and digoxin, wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months. ‘000 patent, col. 8, ll. 30–40 (emphasis added). On expiration of the ’067 patent in 2007, Teva launched its generic carvedilol. Teva’s label dated “8/2007” states:
In 2014, GSK filed a suit in a district court in Delaware against Teva for infringing Coreg’s patent. Teva Pharmaceuticals presented defences in terms of patent invalidity and non-infringement in the case. Teva’s argument was that they had excluded, or “carved out,” the indication and prescribing information for the treatment of congestive heart failure from their initial label in 2007. They cited the carve-out authorization in 21 U.S.C. § 355(j)(2)(A)(viii), which allowed them to omit certain information from their label for the generic version of Coreg. Teva contended that, as a result, they could not be held responsible for inducing prescribing physicians to infringe the ‘000 patent until they amended their label to include all the FDA-approved information for Coreg.
In 2017, the Delaware district court ruled in favour of GSK and awarded them a $235 million verdict.
This verdict was subsequently overturned by another district court, But, a U.S. appeals court again restored the verdict in 2020.
Teva appealed to the Supreme Court in 2022 and the Supreme Court had asked for a recommendation from the federal government on whether to review the case before rejecting Teva’s petition last month.
Should generics manufacturers be worried?
While the Teva case grabbed a lot of headlines, there are other cases recent cases related to skinny labels that reaffirm that generic manufacturers could continue to rely on the practice of skinny labelling to avoid infringements. There were two recent skinny label cases – Amarin Pharma vs Hikma Pharma and Genentech vs Sandoz, where the courts decided to favour generics manufacturers and ruled that their activities did not induce infringement. Undoubtedly’ the generics manufacturers would have to be more careful about deciding what activities could potentially be construed as inducing infringement, but these recent court rulings have indicated that it is not the end of the road for skinny labels. As of now, skinny labels remain the most preferred pathways for introducing cost-effective alternatives to brand-name drugs, providing competition, and making healthcare more cost-effective and inclusive.
In conclusion, the practice of skinny labeling has created challenges for the generic pharmaceutical industry. As generics manufacturers navigate the complexities of patents, the demand for specialized patent services has increased. MCRPL your trusted patent service provider offers comprehensive support, including patent validity assessments, infringement analyses, and strategic counseling. By partnering with us, generics manufacturers can make informed decisions, mitigate legal risks, and maximize their market potential. As the demand for affordable alternatives to brand-name drugs continues to grow, MCRPL plays a crucial role in facilitating the development and accessibility of cost-effective medications while ensuring compliance with intellectual property regulations.