“Innovation without access does not make sense,” says Dr Carlos Correa, Executive Director of the South Centre and a seasoned voice on intellectual property rights (IPR), at a recent discussion on the subject.
In fact, the tightrope walk between innovation and access is the central theme of the first report from the International Generic and Biosimilar Medicines Association (IGBA), titled ‘Gaming the system’, which gives an overview of “originator companies’ evergreening strategies used to hinder access to generic and biosimilar products”.
Outlining “multiple forms” of evergreening strategies, the report points to “patent thickets, patent linkage, elimination of skinny labels, product hopping, pricing strategies, denigration and misuse of regulatory procedures”, and the material impact they could have on the timing of generic product launches.
Abuse of the patent system is a globalised phenomenon, says Correa, adding that the use of evergreening to delay generics was evident not just for drugs from chemical synthesis but also biologics, given their importance as treatment therapies and the high prices they command.
“No region is immune to practices delaying the launch of safe, effective, cost-effective, and quality-assured medicines,” observes Archana Jatkar, Chair of the IGBA International Trade and IP Committee.
“Practices previously seen in the US and Europe are increasingly observed in emerging markets. This leads to lost savings and jeopardises future investments in medicine development,” she adds.
‘800’ patent families
The report shares examples of attempts to delay generics: “For MabThera (rituximab) or Glivec (imatinib), the originator company used the same evergreening strategies in parallel across multiple jurisdictions; for other medicinal products, such as Gilenya (fingolimod) or Xalatan (latanoprost), the originator company used multiple strategies in combination in the same jurisdiction.”
Citing a World Intellectual Property Organisation global report, Sergio Napolitano, Vice-Chair of the IGBA International Trade and IP Committee, points to the patent landscape of ritonavir (in 2011), which is used to treat human immunodeficiency virus (HIV).
“From the first filing for this compound in July 1994, to the present filings — in which additional patent families attempt to protect subsequent innovations to the compound, variants and derivatives, combinations with other chemicals, methods of production, methods of use — there are over 800 patent families directed to ritonavir,” the report says.
Prof Brook Baker of Northeastern University, calls for tech transfer over trade secret protection. Twenty years of exclusivity granted by a patent makes the wait for life-saving medicines too long for poor people, he says, adding that the system is not balanced. Those from rich countries can access medicines faster, since insurance pays for it.
The problem needs to be addressed through “enhanced collaboration among competition authorities, patent offices, and health authorities to share information on practices leading to delayed access,” adds Napolitano.
Pointing to legal tools to support access, Erika Dueñas, Access to Medicines and Health Products Division, IP Lead, World Health Organization, says it includes voluntary licences (though it could limit access to certain markets), TRIPS (trade-related aspects of intellectual property rights) flexibilities, and strict patentability criteria.
In fact, GR Raghavender, Senior Consultant, Department for Promotion of Industry and International Trade (Commerce Ministry), points to India’s patent regulatory framework, including Section 3 (d), which does not allow incremental modifications, besides other features.
Speaking in his personal capacity, Wolf Meier-Ewert, Counsellor IP Division, World Trade Organization, points to tools that countries could adopt to implement rules and strike the balance between IP rights and obligations, which helps to safeguard public health.
Patent quality
Stressing the significance of ‘quality patents’, the report says, “Litigating the question of whether a patent is valid and infringed across major markets worldwide can cost well in excess of 10 million USD.”
Patent offices should be “properly resourced, not rewarded for granting poor quality patents, constantly trained and updated on the science in the relevant field by independent experts and fully empowered to require full and honest answers from patentees,” it says. It also calls for “a robust, well-resourced and consistent way to challenge patents at the local patent office, such as pre- and post-grant oppositions”.
Only a balanced IP system fosters innovation while ensuring access to affordable medicinal products, it says.