Infringement Of Repurposed Drug Patents And Skinny Labelling ' Where Does The Balance Lie In The United States Today?

Published date03 November 2022
Subject MatterFood, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
Law FirmDehns
AuthorMr Daniel Rowe

Repurposed drugs - what are they and why are they important?

The time and financial expense of bringing a novel drug to market is enormous and the process is fraught with risk. Very often, a putative novel chemical entity showing promising efficacy in pre-clinical or animal models will fail to reach the clinic due to unforeseen toxicology or dosing issues. As such, the repertoire of usable drugs in the clinic is finite and comparatively limited.

On the other hand, if a drug which has successfully negotiated the approval process and has reached the clinic can be found to have other clinical uses, the risks, timescales and costs of obtaining regulatory approval for such uses is significantly less. Thus, there is strong impetus in the pharmaceutical industry to repurpose their existing medicinal products to the treatment of second or further medical conditions (or "indications"), thereby expanding their drug portfolio in the most efficient way. As a result, more therapies can be made available to the public in a shorter period of time.

Classic examples of repurposed drugs include aspirin (a non-steroidal anti-inflammatory repurposed as an anticoagulant useful in preventing heart attack, stroke and DVT), thalidomide (a treatment for leprosy repurposed as a treatment of multiple myeloma), viagra (a treatment for angina repurposed as a treatment for erectile disfunction) and, more recently, remdesivir (a hepatitis C medicament repurposed to treat COVID-19). The latter example really shows the potential power of the system - a life-saving drug for a novel respiratory disease was in use in the clinic within a matter of months rather than the decade or so it sometimes takes to develop a new treatment from scratch.

Repurposed drug patents - potential for conflict

Society at large is keen to have as many pharmaceutical treatments available as possible. To further incentivise the pharmaceutical industry to investigate new indications for known medicaments and bring those discoveries to the clinic, governments worldwide allow such new uses to be patented, thereby providing a 20 year monopoly protection for the further medical use of the drug. The conventional wisdom is that this monopoly gives the pharmaceutical company the chance to recover the costs of bringing a new therapy to the market and so encourages investment.

However, critics point out that this system is overly generous - giving the same compensation to the development of the original drug as the new use - and, if left unfettered, open to abusive practices by innovator companies who can game the system to "evergreen" patent protection for their original medicament and build patent thickets around their drug to keep generic competition off the market.

In the US, second or further medical uses of known compounds are claimed in patents as straightforward method of treatment claims. This means such claims must overcome inherency hurdles, which second medical...

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