The first gene patent was granted in 1982 for the sequence encoding insulin. Today ~ 20% of the human genome is patented. And the controversy is as alive as ever as we discuss in this month’s editorial.
Gene patents have supporters who see them as essential for the development of diagnostic and therapeutic products and detractors who see them as hindering research directly and indirectly.
We think that Myriad Genetics’ patents on BRCA 1 and 2, and how these patents have been upheld in court challenges in the US, illustrate how gene patents can elicit cases of preemptive obedience which is problematic for patients and researchers alike.
While it is not clear that Myriad’s patents on BRCA 1 and 2 are infringed by technology that does not rely on isolated cDNA, such as next generation sequencing (NGS), no company in the US seems to be willing to take that risk. AmbryGenetics, for example, a company offering an NGS-based test for mutations in 14 breast cancer related genes, specifically excludes BRCA 1 and 2.
For patients in the US with a family history of breast cancer this is bad news, since it leaves them with Myriad as the only provider for mutation testing in BRCA. And there is no way to obtain a second opinion, particularly for negative results.
Not so in the UK. There Myriad holds fewer and more restricted patents and NewGene, a company owned by the Newcastle Hospitals NHS Foundation Trust and Newcastle University, offers full sequencing of the BRCA1 and 2 coding regions and some introns. We are not saying that NewGene’s test is superior to Myriad’s, though it is certainly cheaper. But it shows that the latest technology can quite rapidly be translated into the clinic, if there are no legal hurdles.
To understand the impact of the many different mutations in the BRCA genes researchers need to have access to a large patient population. For this purpose the NIH founded the Breast Cancer Information core (BIC) mutation database to gather such patient data.
Myriad as the sole provider of BRCA mutation tests acquires large amounts of patient data and until about 2006 the company contributed variants to BIC. Then they decided to keep them proprietary. Researchers were not happy about losing access to such valuable information. In response Robert Nussbaum from UCSF started an initiative to gather mutations directly from physicians. He is asking them to black out a patients identity and forward the mutation report Myriad provides so it can be incorporated into BIC. This information, together with many international contributions, has led to over 14 000 variants in the database.
With personalized medicine on the rise and many people interested in having their genome sequenced restricting who can look at a particular gene makes little sense and the much coveted $1000 genome will hopefully not be rendered ineffective by patent laws.
As always we are keen to hear your views.
Over the past 30 years the ties between academic research and commercial enterprise have increased enormously. Much of this increase has involved attempts by universities to capitalize on the intellectual property created by their research scientists using the US patent system. The Editorial in the October issue of Nature Methods discusses this change and the challenges facing academics interested in commercializing their innovations.
The America Invents Act was signed into law on September 16 by President Obama as the Nature Methods Editorial went to press. As discussed in the Editorial, this law introduces a fundamental change in US patent law that impacts how US academics and their technology transfer offices will handle their intellectual property once the law goes fully into effect a year from now.
Overall, the harmonization of US patent law with the rest of the world should greatly simplify patent claims. But it also presents challenges and fails to fix some aspects of patent law that make little sense, like forcing the same 20-year patent lifetime on classes of inventions that display huge disparities in the time and cost of moving from patent filing to commercial product and the corresponding difference in commercial lifetimes. The implementation of different patent lifetimes for different classes of inventions, for example pharmaceuticals versus computer technology and processes, would help correct severe imbalances in the current system. But given the years required to obtain passage of the America Invents Act, further significant changes are likely years away.
The links below have additional information and commentary on patent law and commercialization in academia.
US switch to first-to-file patents could cause minor shake-up Nat. Med. 17, 906 (4 Aug 2011)
New models emerge for commercializing university assets Nat. Biotechnol. 29, 774 (8 Sept 2011)
Patent reform on the brink Nat. Biotechnol. 29, 778 (8 Sept 2011)
The Effects of the America Invents Act on Technological Disclosure Patently-O Blog (8 Sept 2011)
Patent reform bill passes US Congress – September 09, 2011 Nature newsblog (9 Sept 2011)
Patents Directed to Human Organisms Patently-O Blog (9 Sept 2011)
Guest Post – To Promote Progress in Science and Job Creation Patently-O Blog (12 Sept 2011)
Patent medicine Nature 477, 249 (14 Sept 2011)
New Patent Law Could Change How Academics Commercialize Discoveries ScienceInsider (14 Sept 2011)
Patent Reform Shuffles Who Is First in Line Science 333, 1559 (16 Sept 2011)
Guest Post: Preclusive Inventor Disclosure Under Leahy-Smith Patently-O Blog (22 Sept 2011)