BIO submits comments on Australian Senate Patent Amendment

The Australian Senate has proposed the Patent Amendment (Human Genes and Biological Materials) Bill 2010 that aims to ban ‘gene patents’. 

From the BIO Submission to Australian Senate Legal Committee on Patent Amendment:

This amendment would exclude from patent protection “any” biological material, whether a human gene or otherwise, that is substantially identical to a naturally-occuring biological material.  Specifically, the amendment states that the following materials would be catergorically declared unpatentable:

            “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.”

“Biological materials” broadly “include,” but apparently not limited to, such fundamental biotechnology building blocks as “DNA, RNA, proteins, cells and fluids.”

As almost any biological material can be said to be “substantially identical” to some other natural biological material, this change would have the effect of banning large swaths of previously patentable innovative biological discoveries – thus, removing the protection needed to incentivize investment in biotechnology-related innovation in drugs and biological therapies, preventative treatments such as vaccines, animal healthcare products, renewable energy production and other “green” technologies, environmental mitigation and remediation, biodiversity, farming, food, nutrition, household cleaners, and industrial fermentation for food and fuel production.

BIO and its members believe that excluding biological inventions from patent protection is inconsistent with the demonstrated evidence of social benefit from isolating and purifying active compounds from previously ineffective mixtures occurring in nature. For example, the invention of isolated polymerase from certain thermophilic bacteria has provided valuable methods for amplifying DNA that enables forensic DNA analysis to establish guilt or innocence of crimes, the development of life-saving medical diagnostics, and molecular breeding for improved plants. If the amendment had been law, it would have prevented the patenting – and thus development – of significant advances in human health, like purified insulin, adrenaline, and antibiotics; vitamin D and B-12 compositions; human growth hormone; erythropoietin, and numerous vaccines and anti-cancer treatments on the market today.

Accordingly, BIO believes that this amendment, if adopted, would fail to affect its intended purpose of advancing medical and scientific research and the diagnosis and cure of human illness and disease. Indeed, it would slow such progress immeasurably. The public demands continuing the patent incentive for such biologic innovation.

 

 

 

 

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Is the Myriad Case Decision and/or the DOJ Brief TRIPS Compliant?

Judge Sweet seemed to dismiss Myriad’s constitutional taking and TRIPS claims by indicating:

“Finally, Myriad’s suggestion that invalidating the patents-in-suit would constitute an unconstitutional taking in violation of the Fifth Amendment of the Constitution or a violation of the United States’ obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is unpersuasive. Myriad’s novel taking argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent. Similarly,Articles 8.1 and 27.3 of TRIPS permit governments to incorporate public health concerns into their intellectual property law and to exclude from patentability diagnostic, therapeutic, or surgical methods as well as particular inventions on the grounds of public interest. As a result, invalidation of the patents-in-suit would constitution neither a constitutional violation nor a conflict with the Untied States’ treaty obligations.” Pages 106-107. Emphasis added.

Alnylam’s Appellate Brief to the Circuit Court in the Myriad case argues that “excluding certain “compositions of matter” from patent-eligibility would violate the United States’ treaty obligations under the TRIPS Agreement.” pg. 17  The Brief goes on to discuss this legal issue as well as international policy implications.  pg. 18-19

Questions for thought:

1.  Would ‘isolated DNA’ even constitute an “invention” under TRIPS Article 27.1?  How do other nations view patentability of ‘isolated DNA’ and how does that affect a TRIPS analysis? See European Union Biotechnology Directive and WIPO’s “Information provided by WIPO Member States Concerning Practices Related to the Protection of Biotechnology Inventions.”

According to practice, a Dispute Panel would use the ordinary meaning of the word (probably from the Oxford English Dictionary) and look at common practice around the world.  Isolated DNA seems to meet the definition of ‘invention’ and the resources mentioned above seem to back up the assertion. 

2.  What about Alnylam’s “discriminatory… as to the field of technology” argument?  Does Judge Sweet’s opinion discriminate against DNA based patents and/or the Biotechnology Industry?  How does the DOJ’s Brief fare? 

Based on a WTO Dispute Panel analysis on discrimiation in a similar context (see CANADA – PATENT PROTECTION OF PHARMACEUTICAL. PRODUCTS), it seems that both Judge Sweet and the DOJ Brief are discriminating against DNA based patents and the biotechnology industry.  Judge Sweet creates a patentability exemption for ‘isolated DNA’ and DNA based inventions (to an unknown point).  The DOJ seem to create a new ‘isolation’ test which implicates much more than ‘isolated DNA’.  Both approaches specifically target the biotechnology ‘field of technology’ and have devastating effects on the industry.