Finding The Right Balance Between IP And Access To Science

STRASBOURG, FRANCE – As UN Special Rapporteur Farida Shaheed prepares to finalise a second consecutive report on the connection between the right to science and culture and patent policy, two well-known academics took the floor at the University of Strasbourg Centre for International Intellectual Property Studies (CEIPI) recently to share their views and hopes for this long-awaited paper.

Shaheed’s mandate comes in the context of her current three-year mandate in the field of cultural rights set by the Human Rights Council under Resolution 19/6. The report from Shaheed is expected to be submitted to the UN General Assembly in October 2015.

The roundtable entitled, “Intellectual Property And Access To Science And Culture: Convergence or Conflict?” was organised by CEIPI on 11 May, under the lecture series called “Rethinking Intellectual Property, Fundamental Questions And New Perspectives.” CEIPI Director Christophe Geiger played the role of moderator for the different sessions.

IPRs Have Appropriated Portions of Scientific Knowledge

Under the title, “Appropriation and Free Access to Scientific Knowledge: Limiting the Scope of IPRs,” Carlos Correa, professor and director of the Centre for Interdisciplinary Studies on Industrial Property Law and Economics at University of Buenos Aires, argued in its panel that certain developments of intellectual property law have today stifled access to scientific knowledge.

He recalled the idea that science should not be subject of appropriation, noting, “science is an essential part of public domain.” In an example, he said that imagining that Millstein had applied for a patent for his discovery of monoclonal antibodies, many research projects in the domain of cancer treatment would have been delayed.

While Correa admitted that there are now blurred frontiers between science and technology, especially in biotechnology, the role of patents remains the same, namely, promoting innovation and creation – and there is no room for protecting “something just discovered,” he said.

However, with an example, Correa showed the ever-increasing scope of patentability in both the United States and Europe, in particular over gene sequences.

A few decades ago, the US Supreme Court opened the way in Diamond v. Chakrabarty, asserting that, “anything under the sun that is made by man is patentable,” he said. This precedent was the starting point for allowing the grant of patents for living organisms – including the patenting of parts of human body, such as gene sequences.

From that time, a patent application simply identified an isolated natural gene and at least one of its functions was sufficient to be considered as an invention at the US Patent and Trademark Office. That was based on the controversial theory of isolation, considering a simple isolation of a gene from its natural setting equivalent to an invention under US patent system, Correa said.

However, the landmark case Association for Molecular Pathology v. Myriad Genetics, Inc, in June 2013 – related to human genes patents relevant for breast cancer – marked a relatively important change. The Supreme Court ruled that a natural DNA sequence – even isolated – was ineligible for patent, he said.

Yet, “the Court did not really go far,” said Correa, and uphold the patentability of complementary DNA, i.e., c-DNA, in which many scientists do not perceive a significant difference with natural DNA. “A more scientific approach would have been preferable,” he said.

When it comes to Europe, Correa considers Article 52 §2 of the European Patent Convention is “the correct approach,” stating that, “discovery shall not be regarded as invention.” However, he wondered whether this clear-cut distinction between invention and discovery is preserved in the EU Biotech Directive 98/44/EC, in particular under Article 3.

In his view, these two provisions are in conflict and Article 3 is a sad reflection of the old US theory of isolation, he said.

Among the interesting attempts to narrow down the scope of this provision, he mentioned that under French law, claims directed to human gene sequences are strictly limited to the specific functions disclosed in the patent application, he said.

Although, this option has also been followed by General Advocate of the European Court of Justice in Monsanto Technology LLC v. Cefetra BV case, “that is not enough to make the science accessible,” said Correa. “More serious correction need to be introduced.”

Hopefully, some countries have chosen a different approach, he said, such as Brazil, where the law itself states that, “isolation is not an invention.”

The second example, given by Correa to illustrate obstacles brought by intellectual property developments, is the on-going trend in US, Europe, Japan and Australia to implement a regime of “data exclusivity,” i.e., a form of time-limited intellectual property right.

In the context of pharmaceutical industry, it is usually required that in order to get permission to place new drugs on the market, companies need to undertake extensive clinical test data for ensuring the safety, quality and efficacy of their new products, he said.

While the results generated by these clinical test data are simply “empirical” and “not an invention at all” said Correa, there has been an attempt by pharmaceutical industries and developed countries to prevent the use of such data by third parties on the grounds of intellectual property law. In US, for instance, the period of exclusivity under this regime is of 5 years.

This issue, according to Correa, largely derives from a misinterpretation of Article 39.3 of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which requires member states to protect these clinical test data on the basis of unfair competition law. But, it is not an invitation to create a new intellectual property right for test data, he said.

Therefore, via these two examples, Correa showed the current conflicts between some trends of intellectual property law and the right to access to science. The former “went eventually too far,” he said, and today “that is a dangerous trend,” which needs to be addressed.

Thus, through the prism of the human right to access to science, it is time to redraw a sharp line between the concepts of “invention” and “discovery,” adding that a careful regard need to be posed on the real subject matter as well as the nature of the information, sought to be protected by the patent applicant and thinking whether the outcomes of such scientific researches can rightly be appropriate.

Stronger Intellectual Property for Emerging Economies

The second panel entitled, “Aiding Technological Development: Tailoring Intellectual Property Law To Stimulate Emerging Economies,” was presented by Rochelle Dreyfuss, Professor of Law at New York University School of Law, who brought a more nuanced approach on the role of intellectual property in the context of the emerging economies currently blooming all around the globe.

First of all, Dreyfuss explained that at the time of the implementation of the TRIPS Agreement, countries that were not at the right technological frontier, almost instinctively sought to maximize access. This was “probably the right approach,” she said, taking the notable example of India, which made, for instance, maximum use of the TRIPS flexibilities over the years.

However, “the strategy has now been questioned,” she said. The so-called BRICS (Brazil, Russia, India, China, South Africa) countries are thriving; the next generation is closely behind, and empirical literature suggests “that they may benefit from stronger intellectual property protection.” Referring to a recent paper of Keith Maskus, Professor of Economics at the University of Colorado, Dreyfuss explained that developing countries with stronger patent protection appear to be creating more jobs and opportunities for training, “which can make them more likely to move to the technological frontier.” Too much emphasis on flexibilities and access could actually undermine the ability of these countries to strike a balance that promotes domestic innovation.

Dreyfuss gave the example of suggestions that countries limit the scope of patents to the use disclosed in the patent applications and that they bar patents on new uses of known products.

Such provisions would put many discoveries into the public domain. However “this combination removes any patent incentives to find new uses for products that are already available.” Given that emerging countries especially likely to make this kind of incremental innovation (for example, to tailor a product to local needs), she opined that implementing the two suggestions simultaneously may not be in their best interest.

The adoption of an international exhaustion rule would also be “a devastating problem” for development, she said. Segmentation of the market is, in fact, “the key to ending bilateral and plurilateral pressure on emerging and developing countries to duplicate the level of protection offered in developed countries.” International exhaustion will also affect global prices.

As an example, she posited the recent US Supreme Court decision in Kirtsaeng v. John Wiley & Sons, which held that the first-sale doctrine applies to copies of copyrighted works lawfully purchased abroad. “John Wiley & Sons is not going to sit around and watch its US market evaporate,” she said. Rather, “they will set an international price that will make books cheaper for American students but more expensive for students in Thailand.”

Therefore, Dreyfuss encouraged emerging countries to opt for an economic approach suiting their needs and then to consider how to withstand Northern pressure to increase protection. Furthermore, they must pay attention to how the approaches they choose are implemented on the ground.

She mentioned a book she edited with César Rodríguez-Garavito, Balancing Wealth and Health: The Battle over Intellectual Property and Access to Medicines in Latin America, where a group of experts analysed the implementation of international obligations regarding patent law in Latin America, with the purpose of understanding why some countries have managed to maintain access to low-cost medicines and others have not. The countries, Brazil, Argentina, Chile, Colombia, Ecuador, and six in Central America were chosen to provide comparisons that would help identify the factors that lead to good outcomes. Some factors were obvious. They included the size of the market, proximity to the United States, and experience in the international arena. Others were more subtle. Among those, Dreyfuss mentioned: (1) expertise, (2) the role of civil society, (3) institutional competence, and (4) strong normative commitments, such as human rights.

The last factor, i.e., a robust view of the right to health, could easily be thought of as the most important consideration, acting like “insulation against pressure.” However, the results turned out to be much more complicated. “The right to health … is not necessarily about access to medicine,” Dreyfuss noted. It can instead mean the right to see doctors and to be treated in a hospital. Moreover, in countries that recognize a right to healthcare that does include access to medicine, the governments usually procure and pay for the needed drugs. In those cases, the general public often does not pay close attention to price, leading to “a lot of room for kickbacks from companies to government officials,” thus diverting the money that could be used for further development. Language also matters.

In her study, Molly Land, Professor of Law at the University of Connecticut School of Law, observed that the move to recast the relevant human right as “access to knowledge” (A2K) “actually hurt.” Human rights remain “very evocative for people,” whereas, “access to knowledge not so much” because it often comes across as a right to education or books rather than to medicine. According to Dreyfuss, movements that failed to pay attention to the local vernacular “didn’t do so well.”

As a bottom line, the experts stressed the importance of global administrative law. Procedural principles such as right to notice, access to documents, transparency, participation, and effective assistance of counsel are keys for economic development, she said.

In short, Dreyfuss strongly welcomes the second report by the UN Special Rapporteur, hoping that it will propose a sturdy menu of options that deal with all the different stages of development, so that “countries can move from one stage to another.” She added that such a development in intellectual property law would create an “IP acquis,” an accumulated body of knowledge that would inform the evolution of international intellectual property law and the adjudicators of international disputes.

The menu must also “take into account the need for scientists to innovate.” It must also recognize that patents are not the only way to incentivize innovation. Potential users of new innovations (“user-innovators”) often have internal incentives to innovate and do not need another regime; peer production divides work up so that no one developer needs the sort of incentives the patent system provides. Other external incentives include prizes, public procurement, and tax preferences.

Lastly, Dreyfuss warned of “a new danger:” many bilateral investment treaties (including some very old ones), regional, and plurilateral agreements provide for investor-state dispute resolution. As both Canada and Australia are finding out, these threaten both the South and the North. Because private investors are not under the same geopolitical and internal restraints as states, they can make claims that go to the heart of sovereign authority to regulate.

 

Image Credits: Dennis Wilkinson via Flickr Creative Commons, CEIPI