India-Style Patent Laws Targeted In Trans-Pacific Trade Negotiations
This article was originally published in The Pink Sheet Daily
Executive Summary
Draft intellectual property chapter of the Trans-Pacific Partnership includes a provision prohibiting signatories from denying patents solely because a product did not show enhanced efficacy over a known product.
A draft text of the intellectual property chapter of the Trans-Pacific Partnership (TPP), released by WikiLeaks on Nov. 13, includes a provision that would prohibit signatories from denying a patent on a product that is incrementally different from an existing entity.
According to the document, the U.S. and Japan propose that a patent cannot be denied “solely on the basis that the product did not result in enhanced efficacy” over a known product if the applicant has shown that “the invention is new, involves an inventive step, and is capable of industrial application.” The other 10 negotiating countries oppose the provision.
The clause appears designed to prevent the kind of situation that has occurred in India, which amended its Patent Act in 2005 to prevent the patenting of incremental innovations that do not show “enhanced efficacy.” In April the Indian Supreme Court denied Novartis AG’s request to patent its cancer drug Gleevec/Glivec (imatinib), which had been rejected on such grounds (Also see "India’s Supreme Court Dismisses Novartis’ Glivec Patent, Finding Bioavailability Alone Does Not Create New Product" - Pink Sheet, 1 Apr, 2013.).
The draft IP text created an outcry among nongovernmental organizations, including Public Citizen and Knowledge Ecology International, who contend that it expands the IP rights of the pharmaceutical industry.
“It strengthens, lengthens and broadens the pharmaceutical monopoly, which blocks access to medicines in developing countries, including life-saving medicines, and it locks US consumers into bad rules here,” Peter Maybarduk, director of Public Citizen’s global access to medicines program, said in an interview.
Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said PhRMA could not comment on the draft since it does not know if the document is the correct chapter.
Countries Disagree On Patenting Of Microorganisms, Surgical Procedures
A main point of contention in the agreement is how many years of test data exclusivity to provide biologics. That issue remains undecided as the draft IP chapter includes a placeholder for a specific provision applying to biologics. The pharmaceutical industry has pushed for 12 years of exclusivity while the Generic Pharmaceutical Association has objected to the inclusion of biologics provisions in any trade agreement (Also see "Trans-Pacific Trade Agreement: GPhA, NGOs Oppose Proposed IP Provisions" - Pink Sheet, 25 Jul, 2011.).
Negotiations over the TPP agreement began in 2010. In addition to the U.S., the other 11 negotiating countries are Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam. Nongovernmental organizations have sharply criticized the secrecy of the negotiations, noting that 28 advisory committees to the government get access to the information while others do not. PhRMA and the Biotechnology Industry Organization are among the members of the Industry Trade Advisory Committee on Intellectual Property Rights.
The terms of the TPP are particularly important as the agreement is expected to provide a framework for future trade agreements and take precedence over existing trade agreements between the U.S. and individual TPP partners. Last year, former US Trade Representative Charlene Barshefsky said the intent behind the TPP is to come up with a gold standard. She added that there is no area where this is more important than Asia, which has been “difficult to penetrate” (Also see "Trans-Pacific Partnership Agreement Hits Turbulence Over Pharma IP Provisions" - Scrip, 4 Sep, 2012.).
The negotiating parties have indicated that they would like to finalize the agreement by the end of the year. Chief negotiators and key experts will meet in Salt Lake City Nov. 19-24 where the latest version of the document is to be discussed.
The text indicates provisions that are being proposed by the negotiating countries and indicates where there is disagreement. The U.S. proposes that patents be available for plants and animals while 10 countries propose that microorganisms be excluded from patentability.
The U.S. also proposes that diagnostic, therapeutic, and surgical methods for the treatment of humans or animals be patentable “if they cover a method of using a machine, manufacture, or composition of matter.” Japan oppose such patents.
The U.S. also proposes that the negotiating countries “provide that a patent may be cancelled, revoked or nullified only on grounds that would have justified a refusal to grant the patent.”
The U.S. and Japan also oppose allowing a patent to be cancelled, revoked or nullified on the basis it is determined to be anti-competitive.
Among other provisions, the draft IP chapter specifies that each party shall provide patent applicants with at least one opportunity to make amendments, corrections and observations in their applications; that the patent term be adjusted for unreasonable delays in the granting of the patent (i.e. more than four years from the date of filing or two years after a request for examination of the application); and that patent applications be published within 18 months after filing or from its priority date.