Patents
Infringement by experimentation: the demarcation line
Against a backdrop of global interest, David Gilat is helping the Pharma Standing Committee to harmonise an issue that affects healthcare for everyone.
This year’s Congress hosts a discussion on a Resolution from the Pharma Standing Committee, on a dilemma at least three decades in the making.
In the majority of countries ‘experimental use’ permits not only the non-commerical use of another’s patented invention for philosophical inquiry, curiosity, or amusement, but also other experiments aimed at promoting the social interests underlying patent laws eg the promotion progress.
In the context of pharmaceutics, in addition to the experiment exception/exemption doctrine, another exception comes into play. That is the so-called ‘Bolar-type exemption’, which concerns the exempting from infringement of acts performed for obtaining regulatory approval.
“While the purpose of experimental use is to explore the unknown, Bolar-type exemptions are not enacted for the purpose of providing tools for research or contributing to the promotion of technical progress, but rather to advance interests that are external to the patent laws,” explained David Gilat of AIPPI’s Pharma Standing Committee.
The inconsistent application of this rule was the point of discussion yesterday (Sunday), when the draft Resolution put forward by the Committee came under scrutiny.
“People are very interested because it is one of the cutting-edge legal issues, especially in the second decade of the 20th Century.”
David Gilat, AIPPI’s Pharma Standing Committee
Without harmonisation, conflicting situations may arise. In most countries the two exemptions are separate concepts but, in some jurisdictions, both exemptions are covered by the same provision of the law.
“These two exemptions are interconnected. For example, in the USA, the experimental use exemption is very, very limited. Activities that in other countries fall under the ‘experimental use’ exception, would fall in the USA under the Bolar exemption,” continued Gilat.
“The exemptions are not defined in the same way in all jurisdictions, and it was felt that the time has come to deal with these issues.”
New technologies such as Healthtech and ‘big data’ have also prompted people to think again about whether the old scheme of experimental use is still relevant and whether it should be broadened, he added.
Just how complex and topical the issue is was evidenced by the Pharma Standing Committee’s document on the matter, which, with contributions from all member groups, ran to more than 75 pages and engaged dozens of AIPPI members along the way.
“The work on collecting reports, analysing them, and the subsequent preparation of a draft Resolution was made by a common effort of many members who gladly volunteered. It generated a real team spirit,” said Gilat. “People are very interested because it is one of the cutting-edge legal issues, especially in the second decade of the 20th Century.”
The 1992 Tokyo Resolution
The last time AIPPI discussed the issue it resulted in a Resolution on the experiment exception (the Tokyo Experimental Use Resolution). It stated that such permitted experimentation should be subject to the overriding principle that the use must involve work on the subject of the patent.
“According to the Tokyo resolution, the raison d'être of the experimental use exception is the overarching principle that the patent system should provide tools for research and contribute to the promotion of technical progress; use merely to obtain the advantage of the invention disclosed by the patent is not considered ‘experimental use’,” explained Gilat.
With respect to the Bolar exemption, the Tokyo Resolution merely acknowledged the fact of its existence in certain jurisdictions and determines that such exemption is not experimental use.
Gilat noted that in Boston in 2008, the Bolar-type exception as an exception to exclusive patent rights applicable to medicines and other medical products was acknowledged (Public Health Resolution), and it was clarified that the Tokyo Resolution also addresses experiments whose ultimate goal is to develop commercial products. Since then, experimental use, as an exclusion from exclusive patent rights has not been studied by the AIPPI.
Now, 30 years after Tokyo and 15 years after Boston, AIPPI has re-examined the scope of these defences against patent infringement.
“Worldwide cooperation between entities has grown in an unprecedented manner, affecting the way experiments are conducted.”
Covid-19 and advancing public health
So why did the Pharma Standing Committee consider it time to revisit the issue? Advances in technology over the past decade and, crucially, the Covid-19 pandemic were key.
“During this time, worldwide cooperation between entities has grown in an unprecedented manner, affecting the way experiments are conducted,” said Gilat.
This is particularly true for medicines, he explained, which are subject to international trials for which corresponding patents in numerous jurisdictions, often with differences in the scope of protection, can be relevant.
Achieving harmonisation on this issue would benefit everyone.
Consistent and predictable experimental use exemptions are an important factor in advancing medicine and public health, providing investors, governments, and other stakeholders with certainty that the actions they take for the benefit of humans, are not infringing upon the legitimate rights of patent holders.
One issue that came up in previous discussions was the relevancy of the recent pandemic to the issue, revealed Gilat.
“At first, some participants commented that the outburst of Covid-19 pointed to the need to allow a broader exemption to encourage rapid access to new medicines in a time of crisis.
“However, it was agreed that the experimental use exemption is broad enough so as not to impede the rapid development of new vaccines or medicaments,” confirmed Gilat.
Geographical differences
The Pharma Standing Committee observed that with respect to the experimental use exemption the answers solicited from the member groups were more diverse, in comparison to the Bolar-type exemption.
Other differences were conceptual: for example, whether the experimental use exception covers experiments for commercial purposes, or whether it concerns academic research only.
“This has bearing, for example, on the question whether experiments with the patented invention should be exempted,” explained Gilat. “In Latin America, the tendency seems to limit the scope of the experiment exception to academic non-commercial research, and experimenting with the patented exception in such circumstances might be allowed in such jurisdictions.”
Allowed experimental activities were generally found to be in line with the Tokyo Resolution. These include:
(a) determining the properties of the invention;
(b) determining the scope of a claim relating to the invention;
(c) improving or modifying the invention;
(d) determining the validity of the patent or of a claim relating to the invention;
(e) determining whether the patent for the invention would be, or has been, infringed by the doing of an act.
“There are specific exceptions for agricultural biological inventions, such as in Italy and Colombia,” said Gilat.
“All countries allow experiments relating to the patented invention, and the law in the minority of countries afford for experiments with the patented invention, namely Belgium, Poland, Argentina, Columbia, Uruguay, El Salvador and Mexico.” Such countries would normally include in their laws a limitation that the experiments may not be commercial.
Bolar-type exemptions and compulsory licensing
Gilat explains that the Bolar-type exception and the institute of compulsory licensing share a common denominator. Gilat described compulsory licensing as “the yielding, in certain circumstances, of the exclusive patent right, which aims at globally diminishing suffering and promoting progress in the long run, before other public interests, usually local, whose target is to maximise public well-being at lower cost in the short term”.
The idea that the exclusive right of a patent may be restricted in favour of the public interest of more rapid introduction of generic drugs prompted the 1984 Hatch-Waxman Act, which struck a balance between the competing interests, and exempted from infringement experimental acts performed for obtaining a regulatory approval. It took more than a decade before the other countries aligned with the USA on this matter.
“Therefore, we see less variance in the global approach to the Bolar-type exemption, which was adopted by statutes in practically all jurisdictions,” he added. Nowadays, with the introduction of modern technologies, especially in bio-pharma, the Bolar-type exemption is not limited to generic drugs, and may be applicable to innovative drugs, eg, as in the case of biosimilars.
With such a concerted effort by the AIPPI community, perhaps Gilat’s wish for a “meaningful” Resolution “with the aim of consolidating the concept of experimental use worldwide in terms of globalisation and new technologies” will indeed become a reality.
The Plenary Session for Pharma Standing Committee (Experimental use/Bolar exemption) will take place on Wednesday, 25 October at 09:00-10:30 in the Grand Ballroom 3 & 4.
Image courtesy of Shutterstock / Fauzi Muda
Monday, October 23, 2023
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