The anatomy of CUSMA’s patent: Does it still reflect an equipoise?

The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics). Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.

Changing paradigm of supplementary protection of inventions in the national legislation of Ukraine

Key words: patent term extension, supplementary protection, supplementary protectioncertificate, drug patents, patent legislation reform The article is mainly aimed at distinguishingtwo mechanism: patent term extension which used to be applied inUkraine before the patent reform, and supplementary protection certificates whichwere introduced to national legislation in 2020.Patent term extension in the way it was provided in the Ukrainian Patent Law is arather simple mechanism that didn’t require much regulations. It used to provide additionalperiod of patent monopolies which was equal to the period which elapsed betweenthe date on which the patent application was filed and the date of the marketingauthorisation, not more than 5 years. Since there were no limitation on the type ofpatent (basic patent) or requirement of the first marketing authorization, this regimeprovided an opportunity to extend not only basic patent term, but also all secondarypatents related to one drug. This created a situation when duration of patent monopolyfor one drug exceeded 35 years.Provided that national pharmaceutical industry is oriented on manufacturing ofgeneric drugs, supplementary protection certificates are more appropriate forUkraine. Firstly, this is due to the limitation of effective patent life to 15 years whichis more feasible considering the national context. Another positive thing about SPCsis some uncertainty in relation to definition of the subject matter and scope of SPCprotection. That means that the country can have some freedom in determining theways of its interpretation. However, it should be noted that such indeterminacy is agrey zone. Thus, it is necessary to consider how the country can benefit from the supplementaryprotection regimen. Since the pharmaceutical sphere is very sensitive,the SPC issues have direct effect on public health and access to treatment. So, the articlejustifies the general idea that implementation of new legislation provisions shallbe aligned with both ensuring pharmaceutical innovations and guaranteeing that thepublic health needs are still a priority. Therefore, considering the long-term negativeeffect of the patent term extension regimen, the new SPC approach should be as balancedas possible.

Amend Patent Legislation to Expand Access to Pharmaceuticals during National Emergencies

As of February 2021, the COVID-19 pandemic has led to almost 109 million cases worldwide and over 486,000 American deaths (Johns Hopkins University 2021). With the federal government pouring more than $9 billion in taxpayer money to develop vaccines and treatments for COVID-19, accessibility to these taxpayer-funded products is a public concern (Witters 2020). Under current U.S. law, private entities of any size are allowed to keep patents funded by taxpayer dollars (Stevens 2004). Although government use of taxpayer funded patents exist in limited circumstances, there is little incentive beyond public and political pressure for pharmaceutical companies to forgo patent enforcement for public good. We recommend that Congress amend Title 35 of United States Code to allow patent term extensions when a patent holder agrees to forgo patent enforcement in times of presidentially declared public health national emergencies under the National Emergency Act.

A Comparative Study of Pharmaceutical Incentives to Patents in India, USA and Europe

Background:: Protection of Intellectual Property Rights is a clear incentive to innovations; yet, several countries have provided further incentives to patents in pharmaceuticals because the full patent term of 20 years is largely exhausted, before marketing authorization. Objective:: The purpose of this article is to describe the various incentives to patents in the form of financial support, data exclusivity and most importantly extended market exclusivities and comparison of various incentives to patents in the United States of America, European Union and India. Methodology:: The detail of incentives is collected from various articles, latest topics, books, and newspapers. Result:: These incentives create a positive surrounding to encourage the drug development process, strengthen economic growth and improve a balance between new pharmaceuticals in the market and access of that medicine to general public at a reasonable price. Conclusion:: European Union and the United States of America are leading in the field of incentives to patenting in phar-maceuticals as compared to India. Indian Patent Act, 1970, needs to be re-looked in terms of data exclusivity and patent term extensions.

Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for prescription drugs by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and market approval). This study investigates overall development time in Canada for different groups of drugs approved between January 1, 2009 and December 31, 2018 and how many of these drugs are eligible for up to 2 years of patent term extension. Based on a list of patents and dates of market approval, the change in overall development time for all drugs was calculated along with whether there were differences in development time between different groups of drugs. Using Canadian patent filing dates, overall development time for all drugs went from a mean of 2240 days (95% CI: 1832, 2648) in 2009 to 4197 days (95% CI: 3728, 4665) in 2018 (analysis of variance [ANOVA], P<.0001). Using first global patent filing dates, overall development time went from a mean of 4481 days (95% CI: 3053, 5908) in 2009 to 6298 days (95% CI: 4839, 7756) in 2018 (ANOVA, P=.0118). There was a statistically significant difference in the overall development mean time between small molecule drugs (3553, 95% CI: 3361, 3746) and biologics (3903, 95% CI: 3595, 4212), (t test, P=.0487) when using Canadian patent filing dates but not when first global patent filing dates were used. There was no statistically significant change in overall development time among drugs that were substantial, moderate or little to none additional therapeutic value compared to existing drugs. Out of 238 drugs, 218 (91.6%) would have been eligible for patent term extension with 195 (80.7%) eligible for the full 2 years. Patent term extension does not appear to be justified based on changes in overall development time, except possibly in the case of biologics. There are also trade offs in terms of increased expenditures that need to be considered if patent terms are lengthened.

Innovative Space Occupied By Indian Pharmaceutical Industry: Future Prospects

Through the 1984 Drug Price Competition and Patent Term Restoration Act, the Indian Pharmaceutical Industry has thrived in the US market by selling generic products at competitive rates. However, the traditional and conservative model is no longer sustainable as we head past the “patent cliff”. An innovative business model characterized by the development of “super-generics”, an improved version of an original drug product which has lost patent protection, is the next logical step as it is relatively less time consuming and less expensive compared to the development of a new chemical entity, while affording higher profit margins and potentially, better patient outcomes compared to generics. This presentation will highlight the current space occupied by these super-generics, why the traditional Indian Pharmaceutical Industry should transition to become more innovative as well as the regulatory, infrastructure and personnel requirements that such a transition would entail.