Strategic Considerations for Seeking Patent Term Extension (PTE) and Its Scope for Drug Products
Life science companies developing new therapeutics – both small molecule and biologic – know that obtaining long patent term for their products is a key driver of valuation and revenue. A particular challenge in this respect is minimizing the loss of patent term during drug development. Fierce competition in the marketplace often requires that innovators patent their drug products as early as possible in the development process, but because the clock on a United States (patent’s lifespan starts running the moment it is filed, years of valuable patent term are often lost as a product navigates the regulatory approval process. An important method to mitigate these losses can be found in the Patent Term Extension (“PTE”) provisions of 35 U.S.C § 156, which provide statutory compensation for the substantial time and resources expended by an innovator to bring a new drug to market. In a nutshell, PTE restores a portion of the patent term, up to five years, that is lost during the period a new drug or medicinal product is awaiting pre-market regulatory approval in the U.S.. When a new chemical entity (“NCE”) – either a small molecule or a biologic – is approved by FDA as a therapeutic, a patent claiming either the NCE or its method of use may be entitled to PTE.
The British Business Bank has opened the application process for the Future Fund, a new fund that provides financing to UK start-ups and scale-ups in the form of a convertible loan which is invested directly by the UK government.
Increasingly in China over the past decade, corporations in the pharmaceutical, biotechnology and medical device sectors have supplemented their own internal research and development and business development efforts by participating in the equity funding of start-up and early stage Chinese as well as other Asian, U.S. and European companies which have over time been able to provide the corporation’s business with potential strategic and sometimes even financial gain. In recent years, regulations in both China and abroad relating to currency controls, foreign investments into sensitive industries and other factors have complicated this strategy, but it has continued to be an important means by which innovation in the sector is advanced in China and more broadly throughout Asia and the world.
On 20 April 2020, the UK government (“Government”) announced the Future Fund, providing financing to UK companies (including to start-ups and scale-ups in the technology and life sciences sectors) in the form of a convertible loan which is invested directly by the Government alongside private investors.