Lucas van der Hoeven
SOUTHNEWS No. 313, 17 March 2020, Link
How to examine pharmaceutical patent applications to ensure access to affordable generic medicines while rewarding genuine pharmaceutical inventions, in accordance with the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), was the focus of two training workshops organized by the South Centre at the Indian Patent Offices in Kolkata and Chennai on 10-11 February and 13-14 February, respectively. These activities were part of the collaboration between the South Centre and the Indian Patent Office under a Memorandum of Understanding with the Department of Industry and Internal Trade, Ministry of Commerce and Industries, Government of India. Patent examiners and controllers in the pharmaceuticals and biotechnology sections of the patent offices exchanged views with experts from the South Centre on possible approaches to the examination of various types of typical claims in pharmaceutical patent applications.
Key Issues on Intellectual Property and Access to Medicines
Dr. German Velasquez, Special Advisor on Policy and Health of the South Centre, introduced the participants to the basic issues relating to intellectual property (IP) and access to medicines. He pointed out that almost one-third of the world’s population did not have access to medicines, as medicines have been regarded in practice as similar to merchandise products and not a public good. The research and development agenda for new medicines is set according to potential markets and not according to health problems. In this context, Dr. Velasquez pointed out that the number of pharmaceutical patent applications are far higher than the number of new molecules that are introduced every year. Moreover, high prices of patented medicines have been a major barrier to access to treatments. Before the adoption of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), countries could exclude medicines from the grant of patents or could limit the grant of patents to processes for the manufacture of pharmaceutical products. Even the term of such patents could be limited. After the adoption of the TRIPS Agreement, all WTO members are required to grant patents to pharmaceutical products for a minimum term of 20 years. The TRIPS Agreement also limited the scope of exceptions and limitations to patent rights that could be included in national patent laws. In 1996, the World Health Assembly (WHA) of the World Health Organization (WHO) adopted resolution WHA 49.14 on the ‘Revised Drug Strategy’ which called upon the WHO to address the interface between trade and public health, including the public health implications of the TRIPS Agreement, and in 1997 the WHO published a report on the implications of the WTO TRIPS Agreement on access to medicines, recommending developing countries to make full use of the flexibilities contained in the TRIPS Agreement to promote access to medicines. However, attempts to use the flexibilities in the TRIPS Agreement by developing countries were in some cases met with political and commercial threats.
When South Africa amended its law to allow parallel importation of generic medicines in order to meet the challenge of the HIV/AIDS crisis, 39 multinational pharmaceutical companies mounted a legal challenge to the law. While the case in South Africa was ruled in favour of the government, this also led to a demand, notably by the African Group, to clarify the freedom of WTO members to use the TRIPS flexibilities.
The WTO Doha Ministerial Declaration on the TRIPS Agreement and Public Health reaffirmed the right of WTO members to make use of the flexibilities of the TRIPS Agreement in a manner that is supportive of public health objectives. In this context, the patent offices play a very critical role in making use of such flexibilities to determine the patentability of a claim on a pharmaceutical product or process. Patent examination is a key element that can contribute to or undermine access to medicines.
While the adoption of permissive standards have contributed to the proliferation of pharmaceutical patent grants of questionable validity in many countries, adoption of robust guidelines for the examination of pharmaceutical patent claims in some countries has led to the grant of substantially lesser number of pharmaceutical patents. Such countries include Argentina and other MERCOSUR countries, Ecuador, Egypt and India. In this context, Dr. Velasquez introduced a set of guidelines prepared by WHO, the United Nations Conference on Trade and Development (UNCTAD) and the International Centre for Trade and Sustainable Development (ICTSD) on the examination of pharmaceutical patents which has largely been inspired by the practice of India.
These guidelines focus on typical claims made in pharmaceutical patent applications and analyse the patentability of such claims against rigorous criteria of novelty, inventive step and industrial applicability.
TRIPS Flexibilities Related to Patentability Standards
Dr. Carlos Correa, Executive Director of the South Centre, introduced the participants to the flexibilities available under the TRIPS Agreement related to implementation of patentability standards by patent offices. Dr. Correa pointed out that in addition to the three general criteria of patentability – novelty, inventive step and industrial applicability – some patent offices also regard sufficiency of disclosure as an additional requirement that should be satisfied in order for a patent claim to be granted. Dr. Correa also observed that in accordance with article 27.1 of the TRIPS Agreement, patents are only required to be granted for inventions, a term that is not defined in the TRIPS Agreement. Thus, certain patent claims, e.g., for microorganisms, genes, computer programmes, business methods, or polymorphs, could not be considered as inventions and, hence, not patentable under the patent law of a country.
Another important consideration for patent offices with regard to pharmaceutical patents is whether claims on new uses of existing medicines can be considered to be patentable, as they are equivalent to methods of treatment and lack industrial applicability.
A common strategy adopted by pharmaceutical companies is to claim selection patents i.e., claiming patents by specifically selecting a compound from a range of compounds disclosed in a previous patent. Such claims are based on a legal fiction adopted by the European Patent Office that the specific compound claimed in a selection patent application was not specifically disclosed in a generic claim in an earlier patent. Selection patent claims can be dismissed on the ground of lack of novelty. Moreover, patent offices also need to consider the admissibility of Markush claims i.e., patent claims on a range of compounds (trillions of compounds can be claimed in a single application) while only specifically providing detailed examples for a few of the claimed compounds.
In the case Novartis vs. Union of India, the Indian Supreme Court rejected the contention that the claim for coverage can be wider than the disclosure, enablement or teaching in the patent application, and held that such a practice would be contrary to a fundamental rule underlying the grant of patents.
In determining the level of inventive step in a patent application, the patent examiners need to place themselves as a person skilled in the art to determine whether the invention would be obvious to such a person. The person skilled in the art cannot be considered to be a dullard but as an expert with a modicum of creativity and possessing technical skills to perform experiments with his/her knowledge. This test would enable the application of an adequate threshold of non-obviousness that must be demonstrated by a claimed invention.
Dr. Correa also pointed out the trend towards increasingly filing and granting ‘secondary’ pharmaceutical patents with the aim of extending (or ‘evergreening’) the term of an original patent. However, both developing countries such as India as well as developed countries face the challenge of the effect of the grant of secondary patents on the availability of affordable generic medicines. In this regard, Dr. Correa presented examples of section 3(d) of the Indian Patents Act and the observation by the US Government Accountability Office that courts tend to invalidate almost half of the patents that are challenged in the US. He also referred to initiatives taken by Australia and the European Parliament to improve the quality of patents granted.
Dr. Correa suggested that in view of the considerable scope of the TRIPS flexibilities to determine the patentability of a claimed pharmaceutical invention, developing countries should introduce robust patentability thresholds either in the patent statutes or through the adoption of patent examination guidelines.
Typical Claims Made in Pharmaceutical Patent Applications
Dr. Carlos Correa and Ms. Srividya Ravi discussed some of the typical claims made in pharmaceutical patent applications and how such claims could be viewed under rigorous patentability standards. The examiners and controllers engaged in intensive technical discussions on the different types of claims including formulations, compositions, combinations, salts, ethers, esters, polymorphs, enantiomers, prodrugs, metabolites, etc. Different possible approaches to the admissibility of these types of claims under the patentability criteria were discussed with a focus on exploring the best possible approach from a public health perspective, while being fully compliant with the requirements of the national law and the TRIPS Agreement. Participants also engaged in group exercises to discuss examples of pharmaceutical patent claims and how those would be assessed in accordance to the law and examination guidelines in India.
Mr. Nirmalya Syam gave a presentation to the participants introducing them to the World Intellectual Property Organization (WIPO) and the relevant discussions in the WIPO Standing Committee on the Law of Patents and the Patent Cooperation Treaty Working Group.
Access to Generic Drugs of Biological Origin
Dr. German Velasquez addressed the issue of access to generic drugs of biological origin (biosimilars). Pointing to the growing importance of biological drugs worldwide for the treatment of various health conditions, differences in the terminology used to refer to generic biological drugs have created confusion about how regulatory standards should be set on such drugs. Generic drugs of biological origin are not identical drugs but are therapeutically equivalent to the originator biologic drug, as they cannot be exact copies given the biological nature of the drug. What should be more relevant from a patient perspective is whether the drug would have a similar therapeutic effect as the originator drug. By 2020 almost half of the originator biological drugs will go off patent. In this scenario, the large biological drug manufacturers have been arguing that there cannot be a biogeneric (or biosimilar) as a complex biological product cannot be replicated to manufacture an identical product. However, many experts have refuted this view by showing that two biological products can be comparable even if not identical. Indeed, the 2006 European Union (EU) Guidelines for the Evaluation of Competitor Therapeutic Proteins recognizes that demonstration of comparable or equivalent therapeutic effect of a biosimilar product on the patient will be sufficient for the approval of the drug. Access to biosimilars is often blocked through various strategies including settlement payments by patent holders to potential generic competitors to delay their entry into the market, the promotion of unnecessary high regulatory standards, misleading doctors and patients about the safety and efficacy of biosimilars and through measures impeding their importation. In the WHO, proposals have been made to develop a biological qualifier (BQ) to give individual identity to each biological product, premised on the ‘innovators’ industry’s argument that biosimilar products cannot exist. This would put an additional barrier to the marketing of biosimilar products and reduce access to needed treatments.
Author: Nirmalya Syam is Senior Programme Officer of the Health, Intellectual Property and Biodiversity (HIPB) Programme of the South Centre.
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