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The 'Skinny Labels' Case Will Have A Huge Impact On The Affordability Of Healthcare

I wish staying healthy could be cheaper.

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pills money medicine prescription drug prices cash moneyWhat’s in a label? Turns out a lot, actually. Illnesses come in all types of flavors and symptoms — figuring out how to alleviate, let alone cure some of them, can require companies to spend huge amounts of time and money in research and development. Naturally, companies want to recoup costs and have nice profit margins to boot once the medicine hits market. People suffering though the illness generally want their problems dealt with cheaply and effectively. In come generics. Because they don’t have to suffer through the R&D phase and can typically skirt around patent fees, companies selling generics can usually undercut the company that sells the original medicine. The companies with the patents for the drug generally find this… less than desirable. A fierce battle between Teva and GSK could give some clarity on when generics are able to enter the market — the Biden administration, along with anyone else who likes being able to afford to be sick and live, would really like some clearer guidelines. But first, we have to know what “skinny labeling” is, and Commonwealthfund has a great definition:

Congress created an approval pathway called “skinny labeling.” This permits a generic manufacturer to seek approval for only the unpatented uses of the drug — allowing the generic to avoid any existing use patents altogether instead of waiting until expiration or attempting to invalidate them in court as would normally be required by a generic drug application. The generic version, if successful, is then able to avoid infringing existing patents and is only approved for the unpatented uses.

Skinny labeling is an exception to the FDA requirement that generic labeling be identical to the brand-name drug’s labeling as the generic manufacturer must “carve out” — or exclude — from the labeling, diseases or patient populations that remain protected by use patents.

The practice can facilitate another process that patent-holding companies are willing to go to court for. Patent infringement. From Fierce Pharma:

As the generic industry seeks clarity on so-called “skinny” drug labels, the United States’ top lawyer is calling on the Supreme Court to take up the long-running feud between Teva and GSK…In a 29-page filing, the Biden administration’s solicitor general Elizabeth Prelogar told the justices that the case—which centers on GSK’s off-patent blood pressure med Coreg and Teva’s generic version—is a “suitable vehicle” to address the argument over skinny labels.

In this case, Teva launched its generic version of GSK’s Coreg in two of the branded med’s three indications in 2007.

Four years later, the FDA told Teva to include the third indication for congestive heart failure in the generic’s label, despite GSK holding a patent on that use through 2015. That prompted GSK to sue its generics rival in 2014. For its part, Teva argued it was simply following the FDA’s instructions.

GSK holds the upper edge in the litigation after winning a $235 million verdict in 2017 and getting that ruling upheld in appeals.

Teva petitioned the Supreme Court last summer to overturn the verdict. In October, the Supreme Court reached out to the Biden Administration for advice on whether or not to hear the case.

Two positions, Teva’s “I was just doing what the FDA told me to do” and GSK’s “Run me my money” is a proxy for skinny labeling at large. The outcome of this case will have large consequences regardless of the outcome. If GSK wins, patent holders will be able to keep drug prices higher for longer, hurting consumers.  Producers of generics will be less speedy in their deployment of cheap meds as the risk of patent infringement cases will rise. If Teva wins, patent holders could suffer such a reduced profitability window that R&D becomes a financial hurdle that is no longer worth jumping which, mind you, would also hurt consumers waiting on the development of new treatments.

Skinny Labeling: A Pathway for Timely Generic Drug Competition [Commonwealthfund]
In Teva vs. GSK skinny label feud, Biden Admin Urges Supreme Court To Weigh In [Fierce Pharma]

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Chris Williams became a social media manager and assistant editor for Above the Law in June 2021. Prior to joining the staff, he moonlighted as a minor Memelord™ in the Facebook group Law School Memes for Edgy T14s.  He endured Missouri long enough to graduate from Washington University in St. Louis School of Law. He is a former boatbuilder who cannot swim, a published author on critical race theory, philosophy, and humor, and has a love for cycling that occasionally annoys his peers. You can reach him by email at cwilliams@abovethelaw.com and by tweet at @WritesForRent.

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