In the aftermath of the recent US Supreme Court decision on gene patents, what is the likely effect on the UK biotech startup sector and life sciences in general?
This question was put to me in so many ways following the recent United States Supreme Court decision in the landmark case of “Association for Molecular Pathology v. Myriad Genetics, Inc” (hereinafter referred to as “Myriad”).
How could Myriad, seemingly a world away in America, possibly affect the future fortunes of nascent British biotech start-ups?
Well, British biotech companies spend a small fortune filing patents on their gene discoveries in what still is the largest market in the world for biotech products including gene testing products.
If a British company is to stand any chance of recuperating large investments in time, money and effort, then getting their patents allowed and thereby enforceable in the United States of America is absolutely essential. British companies in the ‘Brave New World’ of biotechnology live and die based on getting patents allowed in the USA.
Now back to Myriad, in which the Supreme Court decided isolated genes or DNA sequences, otherwise found in nature, are not patentable subject matter under United States Federal Law, in particular: Title 35 of the United States Code, Section 101, i.e., “35 USC §101”, which reads at least in part:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.”
In Myriad the patentable subject matter in question were the BRCA1 and BRCA2 genes, mutations in either of which are linked to increased risk of breast cancer in women.
The issues in Myriad took on more meaning in the eyes of the public when Angelina Jolie announced she had a preventive double mastectomy after learning (using Myriad’s technology) she had an 87% risk of developing breast cancer due to her body having a defective BRCA1 gene.
Beyond the celeb world of Angelina Jolie, Myriad created a climate of fear in the biotech investor community.
So here comes the hundred billion dollar question? What can be done to return confidence to the biotech investor community? That is, how do biotech companies ‘get around’ the Supreme Court’s decisions in Myriad?
Or rather, are there any clues found in Myriad that could help restore investor confidence?
The Supreme Court in Myriad ruled out claims focused only on claiming isolated DNA sequences or genes otherwise found in nature.
But modified DNA sequences not found in nature remain eminently patentable such as cDNA (complementary DNA), molecules that complement DNA sequences found in nature.
Also, the Court noted that there were no “method” patents before the court in Myriad – so method claims remain patentable under 35 USC § 101.
For example, patent claims that speak to claiming a method for detecting a disease are acceptable. So, a claim for a method of detecting a DNA sequence or aberration thereof that is linked to a disease in a living organism is still patentable under 35 USC § 101.
Of course, if Congress passes a new law that makes isolated DNA sequences and isolated genes patentable subject matter under 35 USC § 101 then patents that speak to claiming isolated DNA fragments or isolated genes will once again be regarded as patentable subject matter as a matter of law.
The matter can once again be challenged but it would be very unlikely that the U.S. Supreme Court would over rule Congress on Constitutional grounds given that the United States Constitution reserves to Congress the Commerce Clause, an enumerated power found in Article I, Section 8, Clause 3.
Will Congress reverse the U.S. Supreme Court on Myriad?
In the opinion of this author: ‘watch this space’ because its only a matter of time before K Street lobbyists successfully lobby key members of Congress to reverse Myriad; K Street is located in downtown Washington, DC.
What would a reversal by statute mean for the British biotech industry?
It would mean there would be a direct financial incentive to find and isolate DNA sequences per se – that is, as an end in itself. Put another way, it will mean the world for gene-driven British biotech startups.
For many of these aspiring start-ups, nothing less than a complete reversal of Myriad will do, and then the sky would be the limit with such an eventuality.
Dr Christopher Wood is a patent attorney at Premier Law Group, PLLC, a patent law firm in Washington, DC.
Photo by Svilen Milev, Bulgaria