Panel Looks At Patentability Criteria In Public Health

A recent workshop on patentability criteria illustrated how countries are using the policy space provided by international trade rules to calibrate their patent law. In particular, incremental innovation remains a trying issue for national legislators, speakers said.

The technical workshop was organised on 27 October, back-to-back with the annual trilateral event co-organised by the World Trade Organization, World Health Organization, and World Intellectual Property Organization. The trilateral meeting focussed on public health, intellectual property, and the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on 28 October (IPW, WTO/TRIPS, 30 October 2015).

The technical workshop too was jointly organised by the three organisations, and was focused on the impact of patentability criteria on public health.

What Does TRIPS Say

According to Roger Kampf, counsellor, WTO Intellectual Property Division, speaking on the panel, the mandate of the WTO is not to interpret the provisions of any of the WTO agreements, including the TRIPS agreement, and not to assess how it is implemented at country level.

The TRIPS agreement includes five patentability criteria, he said. In order to be patentable, an invention needs to be a patentable subject matter, be novel, present an inventive step and be non-obvious, be able to have an industrial application, and that the invention be sufficiently disclosed.

Article 27 of TRIPS covers patentable subject matter, he said, and a footnote to that article makes room for some flexibility about the definition of the terms “inventive step” and “capable of industrial application.” The footnote says members can find those terms to be synonymous with the terms “non-obvious” and “useful”. Often in countries, patentable subject matter is defined through a positive or negative list, that is to say what is patentable and what is not, he said.

Key terms are not defined in this provision, providing for policy space, he said, For example, the provision does not tell what constitutes an invention, or when is an invention new, inventive and capable of industrial application, he said.

On the disclosure requirement under TRIPS Article 29 (Conditions on Patent Applicants), he said there is limited guidance as to what and how to disclose, and the article is silent with respect to disclosure of genetic resources or traditional knowledge.

Issues that are often mentioned with regard to patentability are the patentability of material existing in nature, and incremental and adaptive innovations, including new dosage forms, new formulations, and new forms of delivery. There are concerns that the patenting of such innovations can delay access to medicines and innovation. The challenge is how to distinguish between innovations that really confer improvements and those which do not, he said.

WHO: Patentability Criteria, Incremental Innovation “Tricky”

Peter Beyer, senior advisor at the WHO Department of Essential Medicines & Health Products, talked about the impact of patentability criteria on public health. We should not take patentability criteria as something that is written in stone, he said, as countries can define it in their national legislations.

For WHO, it is a “tricky” issue, he said, “because we often complain that we do not see the innovation we want to see, and we don’t see the fixed-dose combination produced. We don’t see the paediatric formulations. … We don’t see the heat-stable products that we want to see for use in Africa.”

“We are often the first ones to complain, ‘Why is industry not developing the drugs that we want to use in these countries?’,” he said.

Those are examples where the WHO is seeking incremental innovation, he said, which can make a huge difference in terms of public health. “We have to acknowledge that of course the interest of industry… is to keep generic competition off the market as long as they can by using the patent system,” he said.

One issue is how to deal with incremental innovations within the patent system, he said. “If we want companies to do those incremental developments, would they do so if they did not get a patent?” he asked. Maybe the system should be more flexible, he said.

Countries are struggling with where to draw the line between what is actually incremental innovation that merits a patent and what is mere life cycle management, he said.

“We see that Argentina, India and the Philippines follow new approaches in the pharmaceutical area to limit secondary patents,” Beyer said. And other countries are considering similar rules.

On the other hand, there is the United States which does not share the same approach. There are different trends, and unfortunately in WIPO it does not seem that these things are discussed in substance any more, he said.

The definition of patentability criteria is impacting health budgets, Beyer said. From a health perspective, it would be important to remunerate what is incremental innovation when it is actually useful, but traditionally the patent system has been neutral on that regard and countries are trying out new approaches.

This is a question for policymakers: whether all incremental improvements actually merit a 20-year patent or whether a more flexible system would be more appropriate to reflect the level of inventive step that is required between developing a whole new drug and improving the drug, and moving for example from intravenous to subcutaneous (under the skin).

Balance Between Protection and Evergreening

Markus Engelhard, German Patent attorney, European patent and trademark attorney for Boehmert & Boehmert, presented some mechanisms by which patents in the pharmaceutical, medical and biotechnological field are granted.

In most jurisdictions, the three main patentability requirements which decide the grant or rejection of a patent application are novelty, inventive step, sometimes also referred as to non-obviousness, and industrial applicability, as summarised in his presentation.

Most patent acts also include certain exceptions and exclusions from patentability, “which means that specific subject matter such as discoveries, scientific theories, aesthetic creations, inventions against morality etc. cannot be patented,” he said in his summary.

Some countries provide for particular exceptions in the pharmaceutical area. In the workshop, he cited Section 3(d) of the India Patent Act, which excludes the “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

“Generally speaking, pharmaceutical subject matter can be divided into physical entities, such as substances, compounds, compositions and formulations, on the one hand, and activities, such as methods of synthesis, methods of manufacture and uses, on the other hand,” he said in his summary.

Typically, once a pharma company has identified a promising lead compound as an invention which has pharmacological activity, it will try to build up a patent portfolio around the invention which allows the company to achieve and maintain protection around the invention for a considerable period of time, he said in the summary.

“The patent portfolio will initially focus on the class of compounds to which the promising lead compound belongs, and may then focus specifically on specific compounds which are particularly good in terms of their pharmaceutical property.”

While a company will try to get patent protection for as long as possible to recoup investment costs, the legislator will seek to strike a balance between the monopoly awarded to patent owners and preventing an “evergreening” of patent protection, which might prevent access to affordable medicines, he said in his summary.

Different jurisdictions use different approaches for evaluating inventive step, he said at the workshop. For example, he said in his summary, “if an invention succeeded in showing a technical problem where others failed for longer periods of time or if an invention had surprising and unexpected, possibly synergistic effects that were not envisaged in the prior art, this may help in establishing non-obviousness/inventive step.”

Patentability Criteria Key In Patent Law, WIPO Says

Tomoko Miyamoto, head of the Patent Law Section at WIPO, said at country level patentability criteria is a very important requirement of patent law. National laws describe the formality requirements, the form and content of patent applications and which kind of documents should be provided by applicants.

Patentability criteria is at the core of the patenting procedure, she said. Countries use very similar language on certain requirements, such as inventive step, in that case many countries refer to the non-obviousness of the invention. Also the principle of novelty is described in a very similar manner in different jurisdictions, she said.

 

Image Credits: Flickr – Patents – Michael Neubert – Patent 573907