The Legal Infrastructure of Business: The gene patent debate: Why I ...

The recent Federal Appeals Court?s ruling in the Association of Molecular Pathology vs. U.S. Patent and Trademark Office has brought the gene patent debate right back into focus. At the center of this controversy is Myriad Genetics, a gene testing company that filed patents for BRCA1 & BRCA2- genes associated with high breast and ovarian cancer risk in women. But should genes really be patentable? The Federal Appeals court seems to think so as in August this year it reaffirmed that gene patents are indeed legal.

The controversy surrounding gene patens is that genes are naturally occurring law of nature. As per Section 101 of the patent law in order to pass the patent examination procedure, the subject must either be a process, a machine, manufacture or composition of matter (here, composition refers to being made up of two or more substances). In particular the patent code specifies three exceptions to patent eligibility, namely: laws of nature, physical phenomenon and abstract ideas. Naturally occurring genes are not processes, machines, manufacture or composition of matter and hence not eligible to be patented. Secondly, the subject/invention must be novel, useful and non-obvious. With rapid progress in gene analysis techniques, the non-obviousness of genes is also questionable.

However, not all parties agree to this school of thought. Advocates of gene patents such as biotech firms allege that if microorganisms can be patented, then so should genes. The parties here are referring to the landmark Diamond vs. Chakrabarty (1980) case where the courts concluded that microorganisms are not excluded from patent protection. However the key difference between this case and the one involving Myriad is that the microorganisms in question were genetically engineered and hence produced as a direct result of human intervention. Thus, they could not be classified exclusively as product/law of nature. Similarly, although artificial gene mutations should be patentable, naturally occurring genes such as BRCA1 & 2 should be classified as scientific discoveries rather than inventions and hence, excluded from patent production.

The ruling of the Myriad case implies that whenever a woman in the United States is tested for gene mutations correlated with high risk of breast or ovarian cancer, her test samples would be sent to Myriad Genetics Inc. This is so as the firm now owns the patent rights to BRCA1 & BRCA2 and hence, is the sole controller of all associated test and research conducted in the country. This only serves to monopolize the firm and hinder further progress.

It may hence, not be far fetched to state that the patent might be unconstitutional in spirit. The patent clause in Article 1, Sec 8 of the constitution provides the congress the power to ?to promote the progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries?.? Thus the gene patent awarded to Myriad serves only to slow scientific advancement because although there is no invention, there are severe restrictions placed on any future progress and discovery, as these genes are the building blocks of research itself.Thus, the courts should have sough to protect novel gene testing techniques or research methods rather than granting gene monopoly to firms. It is hardly surprising that Myriad charges $3000 for screening tests on BRAC mutations.

Examining further, the patent is also in direct conflict with the First Amendment of the United States constitution, which protects freedom of thought expression, scientific enquiry and knowledge exchange.

• Researcher rights are violated, as the patent holder?s permission is needed to conduct any further research on the gene. Researchers are also exposed to risks including the possibility of being denied research permission or/and being exposed to high economic costs.
• Genetic practitioner rights are violated, as they are now unable to freely conduct testing of BRCA1 & BRCA2 and have to apply for testing licenses that may or may not be granted.
• Patient rights are violated as individuals now have limited choice and restricted access to medical information and care e.g. patients seeking genetic testing on breast and ovarian cancer only have one option - Myriad.

A few years back, the Congress anticipated these future concerns and did try to implement corresponding measures. Two proposed acts that stand out are the Genomic Science and Technology Innovation Act and Genomic Research and Diagnostic Accessibility Act. The former (act) sought to involve the Office of Science and Technology Policy to study the impact of the intellectual property (IP) policy on genomic science. The aim was to consider alternate levels of IP protection if the current/proposed protection resulted in barriers to future research or increased licensing costs for stakeholders.

The latter act in particular sought to exempt from patent infringement, individuals using the gene for non-commercial research purpose and medical personnel using gene for assessment and cure of ailments/diseases

Unfortunately, no further action has been taken after the bill was referred to the House Science Committee and the House Judiciary Committee. Thus until the court decision is revised, whether we like it or not, a vital part of our genes now actually belong to somebody else!

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References

http://www.lexology.com/library/detail.aspx?g=ca7c90f9-9d20-4825-9600-672e71df89e9

http://www.aclu.org/free-speech/brca-genes-and-patents

http://www.cbsnews.com/8301-18560_162-6354069.html

http://news.yahoo.com/aclu-asks-supreme-court-reconsider-gene-patenting-case-193652861--finance.html

http://www.uspto.gov/web/offices/pac/mpep/s2106.html

http://olpa.od.nih.gov/legislation/107/pendinglegislation/9gene.asp

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Source: http://picker.typepad.com/legalinfrastructure/2012/11/the-gene-patent-debate-why-i-believe-that-genes-should-not-be-patentable.html

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