Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Read More

Art Caplan on the Myriad Decision: Patenting natural DNA never made sense

Bill of Health contributor Art Caplan weighed in on the Supreme Court’s decision in the Myriad case with an opinion piece at NBC:

“The Supreme Court has finally done what should have been done years ago — declared that genes which naturally exist in all of us cannot be patented.  For years Myriad Genetics, the company that sells the genetic tests used by Angelina Jolie and thousands of other women to assess their risk of breast cancer and ovarian cancer, has held back the development of better tests and access for many women to testing by invoking their patent claims on key genes. Now the Supreme Court has rightly said that kind of patent is not valid.

“Patenting a naturally existing gene never made any sense. Sure, it takes work to figure out what genes do, but the rewards for that are publications, tenure, professional honors and even a Nobel Prize — not a patent. Patents should be given not for discovery, but for inventions: What genes can you change; what test kit can you build; what program can you run to screen genetic risks?

“The implications of the decision could be far broader than Myriad, whose stock price went up after the ruling. Many companies have taken out patents on genes not only those found in humans but in animals, microbes and plants.  All of these are now in question — which may cause some reevaluation of the worth of some companies who have been touting their ownership of genes to Wall Street.”

You can read the full piece here: Patenting natural DNA never made sense.