The past thirty days have given those who follow developments in innovation policy quite a bit of material. First, on March 29th, a US district court (SDNY) held that neither isolated genes nor methods of analyzing or comparing genes were patentable subject matter in Association for Molecular Pathology v. US Patent and Trademark Office (USPTO). Then, recently, the very controversial and secret Anti-Counterfeiting Trade Agreement (ACTA) was officially released in draft form (available here).
First, in the case of genes, the ACLU is calling the court’s decision “a huge victory for womens' health and scientific freedom.”
The case centered around Myriad Genetics’ patents over BRCA1 and BRCA2, genes which are associated with breast and ovarian cancer. The plaintiffs challenged these patents as invalid, arguing that genes are not patentable under the “product of nature” exemption from patentable subject matter (35 USC s. 101).
Seemingly an obvious argument by the plaintiffs, the defendant bio-tech industry has argued (successfully) that genes – in their “isolated” or “purified” form – were not a product of nature and hence, a patentable invention. The defendants’ lawyers repeated this argument before the court in this case, arguing for the patentability of Myriad’s claims over BRCA1 and BRCA2.
However, the judge did not agree in the least bit with the defendants. Judge Sweet held that a purified form of a natural product (e.g. a gene) must have "markedly different characteristics" than the unpurified form of that product to be patent eligible subject matter. Then, citing in re Bilski (US Court of Appeals for the Federal Circuit), a decision which could invalidate thousands of business method patents if upheld by the US Supreme Court, the judge held that the method for analyzing the genes for cancer were not patentable either.
If upheld on appeal, the BRCA case will have broadly sweeping implications. The implication for health are clear – when available, doctors will be able to provide gene based tests, results and treatments at a lower cost, thereby increasing access and potentially lowering national health-care costs.
However, the case could also have implications for the food, biofuel, and other bio-based industries. For example, patents over isolated genes and methods for their analysis are also found in many commercially viable transgenic plants (a.k.a GM crops/foods, GMOs, etc), owned by Monsanto, Syngenta and others in the very concentrated agriculture biotech industry. For example, see Monsanto’s patent over “DNA constructs and Methods to Enhance the Production of Commercially Viable Transgenic Plants” (US pat. no 7,575,917).
Regarding genes and biofuels, see DuPont’s patent over genes for polyunsaturated fatty acid production using transgenic algae, bacteria, yeast and/or fungi (US pat. no. 7,695,950). Algae is a second-generation (non-food crop) biofuel, which can be used to produce biodiesel and other biofuels. Biodiesels are long chain esters, such as the polyunsaturated fatty acids produced by the transgenic algae claimed in DuPont's patent. The US Dept of Energy claims that algae-based biodiesels are the only viable alternative energy source for automobiles, and thus it is no surprise that Exxon Mobil is investing heavily in algae biofuels.
Turning to ACTA, negotiating parties to the Agreement (US, EU, Japan, New Zealand, and others) – which is basically a new IP treaty in a thinly-veiled disguise – appear to have bowed to pressure from civil society, officially releasing the ACTA Draft. Knowledge Ecology International (KEI), a leading NGO in advocating for transparency in ACTA negotiations, has stated that the disclosure comes far to late and is incomplete, lacking information on the negotiating parties‘ positions.
ACTA negotiators are fudging the meaning of counterfeit, confusing copied products, where the consumer is aware of the authenticity of products such as generic medicine and audio/video reproductions, with actually counterfeit products – those which are intended deceive consumers. Counterfeit medicines are very dangerous and a serious problem. Awareness should be raised on this issue, but not by equating low-cost generic medicines to deadly counterfeit medicines. This is the issue that has been at the heart of the ongoing dispute over the EU’s seizure of generic medicines that were in transit from India to Africa through EU ports.
Medecins Sans Frontieres (aka, Doctors Without Borders) is concerned that the key elements of the ACTA – injunctions, border measures, criminal penalties and enforcement practices – may obstruct and deter legitimate generic competition. MSF is also concerned about another anti-counterfeiting measure – the 2008 Kenyan Anti-Counterfeiting Legislation, which could not only impact the supply of anti-retroviral medications in Kenya, but throughout the African continent, given the influence of Kenya's laws on the legislative activities of other African countries. Of particular concern are provisions in the Kenyan legislation on enforcement, and the vague definition of "counterfeit." For more opinion and information, also see Michael Geist's blog and website on the ACTA (thanks Philip).
Under current international IP and Trade agreements, TRIPS and the GATT, goods in transit – such as the generic medicines that were seized by the EU- are exempt from IP laws, which are territorial, while the goods are in transit. In other words, under current international law, a Dutch patent on XYZ drug compound is inapplicable to a generic copy of that drug whose final destination is not in the Netherlands. The enforceable patents in importing territory are what is applicable. However, as suspected for some time, the draft ACTA agreement has the potential to go beyond current international IP norms and limiting access to medicines, depending on how the final negotiations shape up (see Dr. Henning Grosse Ruse-Kahn’s analysis of the ACTA text here)
So, are IP norms and laws moving towards a more balanced, a less “one-size-fits-all” approach? In the case of gene patents, it depends what happens with the BRCA case on appeal, which might in turn depend on what the US Supreme Court has to say about the Federal Circuit Court of Appeals opinion in Bilski. In the case of ACTA, in the end it will depend on what negotiators agree upon as the final text, which could depend on how much transparency is provided in the negotiations. We'll see if US Trade Representative Ambassador Ron Kirk is correct when he said "people will walk away from the table" if the ACTA negotiation is made public.