Another busy BIO conference has finished for the year.
Amongst the 15,000 – or thereabouts – attendees were many IP lawyers from all over the world and the talk of the town was the ever growing divergence in patent practices before the EPO and the USPTO. So what messages can our Irish and European clients take home from this?
Whilst the issues of patenting natural products in the US have found some leniency and clarity with the recent Nature-Based Product Examples of the USPTO Interim Guidelines, the patenting of inventions in the diagnostic space is another story. This has been compounded by the recent ARIOSA v Sequenom CAFC decision. This decision held that despite the invention (US 6,528,540) being a breakthrough in the field of non-invasive prenatal diagnostics, it related to a naturally occurring principle which is not patent-eligible subject-matter and, as such, had to be rejected on the basis of Supreme Court precedents.
Thus, at present patenting diagnostic inventions which rely on a naturally occurring principle in the US is fraught with uncertainty and additional costs for Applicants as they adopt different claim strategies to cover their diagnostic method inventions and aim to keep their applications pending until the Courts reverse these decisions or there are further reforms of the US patent system.
Over at the EPO, it is business as usual where both natural products and diagnostic inventions remain patentable once they fulfill the usual patentability criteria of novelty and inventive step. Furthermore, the recent EPO Enlarged Board of Appeal decisions G 2/13 and G 2/12 have provided clarity that the plant products of essentially biological processes are patentable (see our recent article here). So providing applicants do not encounter any added subject-matter issues (which is admittedly applied stringently by the EPO – see out recent article here), the EPO is regularly granting patents in these fields.
Our advice for clients working in these areas is always to seek guidance in advance. Patent law is constantly evolving and account of these diverging practices needs to be taken at the initial patent drafting stages to ensure a patent application is in the best form possible for prosecution before the various Patent Offices.
As an aside, we see that “BIO” itself is rebranding itself from the Biotechnology Industry Association to the Biotechnology Innovation Organization in 2016. BIO’s President and CEO, Jim Greenwood notes
“This is a great move that will help clarify for policymakers, and the public, the heart of our industry – scientific innovation that will help to heal, feed and fuel the world. Each day, our members use cutting edge science and technology to deliver game-changing products, therapies and cures to improve the human condition.”
Our hopes are that the Patent Offices and Courts worldwide recognise the importance of these innovations and the pendulum swings back in favour of granting protection to these valuable scientific innovations.
After all, what is the alternative for these inventions which are not patent-eligible subject-matter? Is keeping a technology a trade secret really a good and plausible commercial option? Perhaps, as one US patent attorney colleague remarked, copyright for synthetic DNA needs to be revisited.