The Pulse Of IP In International Pharma Today

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High-level policymakers, industry leaders, law professors and other stakeholders came together in Geneva recently to discuss the how the role of intellectual property is evolving when it comes to developing, protecting, and providing medicines.

The University of Geneva held the conference entitled, “Intellectual Property in the Pharmaceutical Industry,” on 10 February as part of its annual series of conferences on intellectual property law. University of Geneva Professor Philippe Ducor chaired the event.

From patent limitations and regulatory data protection to mandatory disclosure requirements and new customs regulations, conference speakers provided concrete examples of industry challenges as well as the trajectory of policymaking related to pharmaceutical products.

Addressing how patents fit into the access to medicines debate, Peter Beyer, senior advisor in the Department of Public Health, Innovation, and Intellectual Property at the World Health Organization, emphasised that patents are only one part of the equation. Pointing to the WHO Framework for Access to Essential Medicines, he said that beyond affordable prices (and patents), sustainable financing, a reliable supply system and selection and use are equally important in providing access to essential medicines.

But when it comes to achieving affordable prices, he said that progress has been made in the past ten years, especially when it comes to antiretroviral medications. He emphasised the importance of the patent flexibilities provided to countries under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

At-Risk Generics?

Additionally, Beyer highlighted the important role that generics play in getting essential medicines to the people who need them. In fact, 80 percent of the generic ARVs purchased with donor funds for the developing country market come from India. But he said that with the changes in Indian patent law, the future of this model is uncertain.

“The big question mark is that India introduced patent protection in 2005 and that has changed the situation,” said Beyer. “They have used a couple of flexibilities [allowing non-application of IP rights under international trade law]. But will we still be able to rely on Indian generic ARVs in the future?”

He also said that the role of the Medicines Patent Pool, created in 2010 to negotiate licence agreements on ARVs to increase access to treatment, has been key in achieving affordable prices. Even the pharmaceutical companies that have refused to enter into negotiations with the Pool feel pressure to expand the scope of their corporate responsibility programmes, he said, especially through non-exclusive voluntary license agreements and non-assert declarations.

“The Medicines Patent Pool has given an additional kick to companies to look at what they could improve,” said Beyer. “And following the creation of the Pool, companies have been signing more licence agreements, with more products, and to more countries.”

Representing the World Intellectual Property Organization (WIPO), Hans Georg Bartels, senior program officer in the Global Challenges Division, discussed some of the challenges in balancing rights and obligations and protecting and promoting the public interest. From how a generic producer can or cannot use a copyright protected package insert to whether or not biosimilars should be treated the same way as the originator, IP cuts across many areas affecting both the pharmaceutical industry and public health.

In the same way, questions related to IP and public health also intersect with questions related to trade. Antony Taubman, director of the Intellectual Property Division of the World Trade Organization (WTO), said that a comprehensive approach to policymaking is essential today. He outlined some of the ways in which the WTO, WIPO and the WHO are working together to optimise their efforts, citing the trilateral study currently underway, called “Promoting access and medical innovation: intersections between public health, intellectual property and trade.”

On the Brink of Genetic Resource Norm-Setting

For pharmaceutical companies, trends in genetic resources, patents and benefit sharing are gaining increasing importance. Ahmed Abdel Latif, senior programme manager in innovation, technology and intellectual property at the International Centre for Trade and Sustainable Development (ICTSD), discussed how the policymaking related to biological diversity is evolving. The Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore (IGC), convening at WIPO through 22 February, is mandated to move toward an agreement on an international legal instrument this year.

The face and scope of what such an agreement would like is in the balance. Latif says that the debate is no longer a North-South issue, and there are many different examples of national legislation and free trade agreements (FTAs) that include IP-related biodiversity provisions to draw upon.

Although it’s still a highly contested question, especially in the pharmaceutical industry, “biodiversity disclosure requirements have gained wider acceptance over the past decade,” Latif said. As policymakers near norm-setting, all eyes are on Switzerland, a country that requires declaration of the source of genetic resources on patent applications, to see what kind of effect the requirement has on patent filings.

In an interview with Intellectual Property Watch, Latif said, “I think that there is a way to preserve the role of the patent system in promoting innovation while ensuring it makes a positive contribution in respect of access and benefit sharing principles through the incorporation of biodiversity related disclosure requirement in patent applications that are not excessively burdensome for patent applicants.”

Moving Beyond the Blockbuster Model

Andrew Jenner, director of innovation, IP and trade at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), set the scene for the pharmaceutical industry, discussing current and future IP challenges that companies are facing. Widely known, the blockbuster business model is not what it once was. Many of the blockbuster medicines (drugs that generate more than $1 billion of revenue per year) are coming out of patent and the pipeline of replacements is drying up.

At the same time, Jenner explained, the cost of developing new drugs is increasingly expensive, risky, and timely. He underlined the need for new innovation models, working in partnership with governments, and aligning business with society’s needs. In terms of areas for innovation, he pointed to biotherapeutics, generics, diagnostics, and the personalised medical space.

Both Prof. Philippe Ducor and Trevor Cook, president of the UK Group of the International Association for the Protection of Intellectual Property (AIPPI), discussed IP protection beyond patents. Prof. Ducor laid out the various forms of protecting a medicine, including patent clusters and secondary patents claiming new formulations and processes.

Cook honed in on regulatory data protection and marketing exclusivities, which he said are becoming increasingly important. “Patents are becoming a poor proxy for what people actually want to protect in the pharmaceutical industry,” he said. “Patents protect ‘invention’ when what society actually wants is the demonstration of the efficacy and safety of the product.”

What’s in a Name?

Hans-Freidrich Czekay put forth the challenges the pharmaceutical industry faces in the creation of brand names. An incredibly involved process, the price tag on a single trademark project can run up to a half million Swiss francs. A multi-disciplinary process, developing the name of a medicine involves branding agencies, name screening, market testing and more. Companies count on the name to establish the product’s distinctiveness and memorability in a global market.

Manon Rieger-Jansen, partner at the law firm Bird & Bird, presented another key facet of trademark issues: protection and enforcement. Focusing on trademark law in the European Union, Rieger-Jansen talked about the broader protections that trademark on design can provide, especially as a tool in the fight against counterfeit medicines. She said that goods in transit are an area of particular interest with changes in regulations affecting how customs can intercept suspected counterfeit goods and procedures on how to process them.

Another speaker at the conference, Prof. Jean-Christophe Galloux of the Université de Paris II and director of the Institut de Recherche en Propriété Intellectuelle, spoke about European patent law as it relates to the pharmaceutical industry. University of Geneva Law School Dean Christian Bovet gave opening remarks along with University of Geneva Professor of Law Jacques de Werra, who organised the conference.

Rachel Marusak Hermann may be reached at info@ip-watch.org.

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