AJPark

Last week, Judge Sweet of the US District Court for the Southern District of New York ruled in Association for Molecular Pathology vs The USPTO that the seven Myriad patents in suit were invalid.

Judge Sweet found that the invention Myriad’s patents protect—the BRCA1 and BRCA2 genes associated with breast cancer—was not patent-eligible subject matter.  Judge Sweet ruled that the purified or isolated BRCA1 and BRCA2 gene sequences are “products of nature” and are therefore patent-ineligible.

Isolated genes vs genes per se

The US courts and the USPTO have long considered that isolated genes could be patented. The act of isolating the DNA encoding the gene(s) and determining its sequence distinguishes the isolated gene from its natural form. The isolated gene is, therefore, fundamentally different to anything that occurs in nature.

However, in Judge Sweet’s view: “[m]any, however, including scientists in the fields of molecular biology and genomics, have considered this practice a ‘lawyer’s trick’ that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result”.

Judge Sweet held that the isolation of DNA does not alter its fundamental quality as it exists in the body, nor does it alter the information it encodes. The result? Isolated genes are no different to those occurring in nature—indeed, they are “products of nature”—and so are unpatentable.

This result is at odds with the prevailing case law in the US, and with the position taken by other jurisdictions. It mirrors, however, the plantiffs’ view that gene patents “put up unacceptable barriers to the free exchange of ideas”.

Gene patents stifle innovation, don’t they?

Opponents of the patent system trumpet the argument that patents stifle innovation. They argue that gene patents prevent fundamental biological research.

However, in most Commonwealth jurisdictions ‘research exemptions’ provide researchers with a defence to patent infringement.  Researchers studying a gene to understand more about its biology—its structure and function, factors affecting its expression, it’s variation across populations—are able to assert this defence.  Additionally, most Commonwealth jurisdictions exclude from patent infringement any use of a patented invention in order to generate information for regulatory approval. Significant research programmes can therefore be undertaken, within some limits.

Clearly, it is important to distinguish between innovation and commercialisation.  Gene patents do not stifle innovation, but they can stop others from exploiting the fruits of one’s labour.

Just compensation for innovation

It is important to remember that Myriad’s BRACAnalysis test, and the patents that protect it, are the result of an enormous amount of basic research, clinical trials and regulatory approval, development work—not to mention vast expenditure.  This research had to recognise that various candidate genes may determine genetic risk of cancer, to correctly identify the BRCA1 and BRCA2 genes from a great number of dead ends, sequence them (in the days before genomic-scale sequencing technologies were available) to identify mutations, and correlate those mutations with a statistically significant risk of cancer in a range of patient populations.

Myriad undertook this to prove that their test works to the satisfaction of the regulators in order to gain registration for their test—a test that would not exist otherwise.

Would Myriad have undertaken this work (and would the BRACAnalysis test exist) if there was no opportunity to reap some reward? Even the most altruistic must accept they would not.

Into uncharted waters . . .

Importantly, AMP vs USPTO does not mean that any, and all, uses to which genes, mutations or polymorphisms within them, or the products they encode are put are unpatentable. 

Furthermore, AMP vs USPTO will almost certainly be appealed—Myriad has promised to do so.  That appeal will be of such significance that there is a good chance it will be considered by a full Court of Appeals bench.  It will also be the first time that a specialist patent court deliberates on the substantive issues, and has an opportunity to provide some certainty on the patent-eligibility of this fundamental building block of the biotech industry.

Also—all eyes on Bilski case

One other ongoing US case of interest to the biotech sector is the Bilski case currently being deliberated by the United States Supreme Court. This case hopefully will determine the patentability of business method inventions.  It may, however, also influence the availability of patent protection for diagnostic methods, methods of disease prediction, genetic testing, and methods for designing and monitoring treatment regimes.  At this point it is impossible to say exactly how Bilski will be applied to the biotech sector.

These are two cases that the biotech sector must watch.

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  John Mansell

  Senior Associate