One aspect that has gained notoriety in the current global headlines is the protection for IP-rights and other proprietary information bestowed upon the life sciences focused companies and organizations, research institutes etc. In the past weeks we have seen numerous headlines in various media claiming that the industry “must change” and that there is a “need for a system that prioritizes public interest over profits”.
Such one-sided arguments and opinions, however, fail to mention the various mechanisms already in place that aim to ensure a balancing of interests between necessary IP-protection to promote much needed innovation and R&D, and the public interest for equitable access to crucial drugs and treatments.
Patent pools for new medicines
Patent pools are an additional avenue already in place that facilitate better access to new medicines. Patent pools allow third parties to acquire non-exclusive licenses for the intellectual property needed to develop the relevant products. In order to improve access to antiretroviral treatment in low- and middle-income countries Unitaid established the Medicines Patent Pool in 2010 as the first public health patent pool. Later, the patent pool’s mandate was expanded to treatments for tuberculosis and hepatitis C. The patent pool has negotiated most of the licensing agreements with pharmaceutical companies that have enabled competitive generic manufacture of antiretrovirals in low- and middle-income countries before patent expiry.
Compulsory licensing for medicines
On the international level the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) aims to strike a balance between promoting access to existing drugs and promoting research and development into new drugs. Accordingly, under Art. 31 TRIPS allows for “other use without authorization of the right holder”. Compulsory licenses for patented inventions are being a prime example of such use.
TRIPS does not define or limit the circumstances under which patented inventions can be subjected to compulsory licensing. However, it does highlight certain conditions under which compulsory licenses are to be granted. One important condition being that a prospective licensee should have been unsuccessful within a reasonable period of time in negotiating to obtain from the patent holder authorization to use the patented invention “on reasonable commercial terms and conditions”. Aforesaid negotiations requirement, however, is waived in the cases of “national emergency” or “extreme urgency”.
The Swedish Patents Act also contains several stipulations on compulsory licenses. Under Chapter 6 Section 47, in a scenario in which there is a public interest and it is of extreme importance, anyone who desires to exploit an invention commercially for which another party holds a patent may obtain a compulsory license to that effect. Examples of such public interest include significant national health concerns, need for public access to medicines etc.
Research and Bolar exemptions
In addition to compulsory licenses, other available mechanisms limiting the scope of the exclusive patent rights is the exception for experimental use of an invention. Furthermore, there is the possibility under the widely used Bolar exemption for generic manufacturers – during the term of patent protection – to carry out studies, tests etc. necessary to secure marketing approvals.
In this context it can also be mentioned that while both these mechanisms have been enacted in the Swedish Patents Act their scope of use is even more generous and broader in several other European jurisdictions. For example in relation to clinical trials for other indications not covered by the patent or for innovative medical research.
The way forward
Patent pools, compulsory licenses and legal exemptions are just a few mere examples to provide some perspective in response to the ill-founded and biased claims of a “faulty” or “profit-driven” system. Contrary to these voices of gloom we see first-hand the tremendous effort in the life sciences community as a whole – be it big pharma or independent research institutes alike – to join in the global effort to combat COVID-19.
The Director General of International Federation of Pharmaceutical Manufacturers (IFPMA), Mr. Thomas Cueni, was recently quoted in the Financial Times stating that the industry realizes “we have a responsibility to find solutions and we are fully aware that with this pandemic we cannot expect to do business as usual.”
Already during this short period of time since the outbreak of the pandemic we have also seen numerous examples of such voluntary acts by the industry. Roche, for instance has made the formula of a key coronavirus test component available to the Dutch government. Gilead has donated close to 1.5 million individual doses of remdesivir, its investigational medicine for COVID-19. And Abbvie in turn will not be enforcing patent rights relating to kaletra as the drug is being evaluated to treat severe COVID-19 in several clinical trials.
While no system is perfect and improvements naturally can always be made we are of the firm belief that the current mechanisms in place are more than sufficient to ensure that that a fair and equitable balance is achieved between the need for IP-protection to incentivize crucial innovation and the public interest for access to life-saving medicaments and treatments. This fact is even more evident in this current era where Corporate Social Responsibility (CSR) is not just a mere catch phrase but rather essential for maintaining a long-term profitable enterprise.
Christopher Tehrani, Head of Patent Litigation, Cirio Law Firm
Sanna Wolk, Head of IP & Corporate Sustainability, Cirio Law Firm
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