Last week, the BIA wrote to the US Patent and Trademark Office (USPTO) to raise concerns about the increasing divergence between US patent law and that of other major jurisdictions around the world.  The intervention is the latest action led by the BIA’s Intellectual Property Advisory Committee (IPAC), which has been following developments in the US closely to monitor how they might affect the UK biotech sector.

A widening schism in international patent law

Over the past six years, the US Supreme Court has issued a series of decisions – Bilski, Mayo, Myriad, and Alice – that have significantly impacted the legal definition of what is eligible for patenting and what is ineligible (see page 5 of this document for an in-depth background).

As a result, patents involving abstract ideas, laws of nature, and natural phenomena have become prone to challenge in the courts. In biotechnology, this has resulted in a range of diagnostic patents being declared invalid, and even the patent for Dolly the Sheep.

The BIA recently hosted a seminar with Dr Konstantin Linnik from US firm Nutter McClennen & Fish LLP. His slides are an excellent introduction to the implications of the Supreme Court’s decisions, with helpful guidance on how companies should write their patents to gain greater protection.

A consistent and harmonised patent eligibility framework across the globe allows inventors to determine with predictability whether to rely on patent protection (and therefore to disclose their inventions) or, instead, withhold their discoveries and rely on trade secret as an alternative form of IP protection. These two forms of protections are mutually exclusive – one cannot maintain a trade secret in one jurisdiction while obtaining a patent in another.

This can hamper innovation as ideas aren’t shared, and at worst can prevent innovations being developed at all – the risk of losing exclusivity to a technology puts off many investors, meaning companies can’t develop them. As the US is the largest market in the world for medical innovations, their laws will influence decisions made by biotechs and investors everywhere.


BIA interventions in the US

This threat to innovation and the importance of the US market for UK biotechs has prompted the BIA to intervene in court cases across the Atlantic where there was opportunity for the case law to be better aligned with that of Europe and other jurisdictions.

In 2015, we petitioned – with support from Dr Linnik – the US Federal Circuit to reassess its decision in Ariosa vs. Sequenom, a case in which the case ruled that the PCR-amplified foetal DNA detected by Sequenom’s diagnostic test represented a natural phenomenon. The court didn’t change its view and so Sequenom sought review in the Supreme Court. The BIA submitted a friend of the court brief urging it to accept the review; this time we were joined by several other industry associations, illustrating the global importance of this issue: EuropaBio, AusBiotech, Swiss Biotech Association, HollandBIO, BIOTECanada, and Japan Bioindustry Association. Unfortunately, the Supreme Court didn’t accept the case and so the law remains at odds with that of other countries.

A potential new opportunity to address the schism?

The USPTO has recently launched a public debate exercise, calling for comments on “the legal contours of eligible subject matter in US patent law” and hosting public roundtables. They are also asking for feedback on guidance they have produced.

The BIA has now written to the USPTO raising our concerns and highlighting the international support that the friend of the court brief received from other biotech associations. We hope this demonstrates to the US authorities the importance of the issue not only to US innovators, but those around the world also.

The USPTO is only facilitating a public debate at this stage, but we hope it could be a useful step towards a process that can address the increasing schism in international patent law. The BIA’s IP Advisory Committee will continue to monitor the issue and look for further opportunities to ensure the UK and the international biotech community’s voice is represented in the US.