The following intervention on patents and health was delivered by KEI during the 21st session on WIPO’s Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.
Statement of Knowledge Ecology International (KEI)
Item 7: Patents and health
Part 1
Thank you Mr. Chairman and as this is the first time I am taking the floor, I would like to congratulate you upon you re-election. We thank the Secretariat for preparing document SCP/21/9 on the “Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents”. In particular, we take note of paragraph 48 of the study which states:
48. Ministries of Health, procurement agencies and humanitarian organizations may be interested in knowing the patent status of medicines in order to check the validity of patents, negotiate price or license with the patent holder or to consider the possible use of compulsory licenses or governmental use. A comprehensive INN keyword search function would facilitate a search for relevant patents and their legal status without the need for specialized skills for searching pharmaceutical substances. Similarly, the possibility of a more thorough patent search for particular pharmaceutical substances through an INN keyword search may aid health policy advocates and patent landscape service providers.
Since disclosure of INN relevance for patents is useful, the SCP should find ways to make this work.
Part 2
On the broader issues of patents and health, KEI notes that the reason why there is a conflict right now is because patents are typically implemented as an exclusive right, and the monopoly leads to very high prices. This is particularly true in the area of cancer, where new drug prices are often more than $100,000 per year, and sometimes more than twice that.
In the past five years, there has been an explosion of news reports and academic journal articles detailing one outrage after another as regards high prices for life saving drugs, including not only for cancer, for but autoimmune diseases, gout, hepatitis C, and a host of other diseases and conditions.
One response to these high prices is to avoid granting patents that extend and broaden monopolies, or to grant compulsory licenses when prices are unreasonable or unaffordable. But another approach, worth exploring, is to delink the patent from the notion of an exclusive right, and make the patent a mechanism to establish a claim on innovation inducement prizes, and are given as a reward for innovation – as a substitute for the grant of a monopoly. This approach allows the patent system to play a constructive role, without being in conflict with access to drugs, which would be prices as generics, from competitive suppliers. The patent would be used to establish the ownership of the innovation inducement prizes.
The US Senate and the US National Academies have proposed a study of delinkage, as an alternative to drug monopolies, following this model that changes the benefits of obtaining a patent.
In September 2014, the US White House issued a statement asking to explore delinkage in the context of antibiotic drug development, an approach endorsed by some of the leading European R&D focused drug companies. The World Health Organization is also experimenting with delinkage drug development models, for a wide range of diseases for which market failures exist.
KEI suggests the SCP undertake a review or ask for a study of the provisions in national patent laws that would enable full delinkage of drug prices and R&D costs. We note that SCP/12/5 (paragraph 85) identified Alternative models for innovation as part of the non-exhaustive list of issues for consideration by the Committee.
We underscore our support for the African Group and Development Agenda Group proposal on patents and health, in particular paragraph 14:
14. Develop a technical assistance module that explicitly demonstrate the difference between compulsory licenses that are granted under the procedures of Part II of the TRIPS Agreement, concerning patent rights, and those granted under Part III of the Agreement, concerning the remedies for infringement of those rights. These technical assistance programs would explain both approaches, and focus on the flexibilities afforded to both systems, noting that under the structure of the TRIPS Agreement, Article 44 compulsory licenses are not subject to the restrictions that exist for Article 30 and 31 of the Agreement.
At the General Assembly in 2014, the United States objected to the development of this technical assistance module as they viewed that this was beyond the mandate of WIPO. To the United States and those who object to the development of this technical assistance module, we recall Article 4 of the Agreement Between the World Intellectual Property Organization and the World Trade Organization which explicitly provides WIPO the mandate to provide legal technical assistance relating to the TRIPS Agreement.
In conclusion, our written submission will include a compilation on state practice on compulsory licensing from Europe and the United States.
Annex: Not read
KEI Research Note: Recent European Union Compulsory Licenses, 1 March 2014
/wp-content/uploads/Annex_B_European_Union_Compulsory_Licenses_1Mar2014_8_5x11_0.pdfKEI Research Note: Recent United States Compulsory Licenses, 7 March 2014
/wp-content/uploads/Annex_A_US_Compulsory_Licenses_7Mar2014_8_5x11.pdfKEI’s comments on Special 301, 7 March 2014 which includes a compilation of academic articles and news stories describing the high cost of cancer drugs: https://www.keionline.org/node/1976
Some news stories on cancer prices: /node/2113