Patent of Second Medical Use for COVID-19 Pandemic

Indonesia has been striving with Corona Virus Disease 2019 (COVID-19) pandemic and the cases has been rapidly increase since early March 2020. Due to the urgency in combating the pandemic, scientists are now developing new efficacy discovery of known drugs without have to wait a long time period to discover new substances. Hence, the exclusion of second medical use from the Law No. 13 year 2016 on Patent (“Patent Law”) should be exempted by the Government. 

Legal Framework

Article 4 Paragraph 1 Point f of the Patent Law stipulates that Invention does not include discovery in the form of:

1. new usage of existing and/or known products; and/or

2. new form of existing compounds which do not produce significant increases in efficacy and there are known differences in the chemical structure of compounds.”

According to the elucidation of Patent Law, existing and/or known products are including tools, goods, machines, compositions, formulas, methods, uses, compounds, and systems that are still protected by Patents or those are already become a public domain. The law clearly stated the exclusion of second medical use. Such exclusion applies, among others, to pharmaceutical compositions that are later discovered to have a second or further medical use. The failure of compliance to Article 4 may render the Patent deletion (entirely or partially) by third party claim based on court order. 

Medical Use Patents

Pharmaceutical products can have more than one use. Firstly, drug discovered to treat one problem could be found to treat other problems by research. Most famous examples are:

1. Viagra developed as a heart treatment, but later found more useful for Erectile Dysfunction (ED) treatment; and

2. Aldara is a treatment for warts, but also very effective for basal cell skin center treatment.

Second, different dosage regimens may also improve treatment. For clarity, if molecule or compound in question is already generic (either because the patent right has expired or never be patented), then once a new treatment is discovered, it cannot rely on patent for the molecule to stop use for the new treatment. Research and discovery that a pharmaceutical product or a different dosage regimen can be used to disease treatment bear highly cost. Nevertheless, without patent protection, there is no incentive for pharmaceutical companies to conduct necessary research and development for new treatments or dosage regimens.

Swiss form claims (Europe) allows the protection for this invention, but is now replaced by direct purpose use claim (For example, substance X or composition comprising X for use in treatment of Y (medical condition). Direct purpose use claim protected in most European Patent Convention member states.

The Government Implementation

Drug re-purposing is the re-purposing of an approved drug for the treatment of a different disease or medical condition than that for which it was originally developed. Gilead Sciences Inc. is now developing COVID-19 repurposing drug research for Remdesivir, which currently is in late stage of clinical trials. The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Remdesivir to treat COVID-19 on May 2020. Even though remdesivir was granted for emergency use, there are still several ongoing clinical trials testing whether it is effective in stopping the COVID-19 from replicating. Remdesivir patent application is still pending at Directorate General of Intellectual Property of Republic of Indonesia under patent application No. P00201703424. Article 6(1) point b of Patent Law allows the use of patented medicines for research and development purposes. Thus, the generic companies and research institutes are free to use these patented medicines during clinical trial.

Article 109 – 120 of Patent Law regulates the implementation of patent by the Government under certain circumstances. According to Article 109 (1), the Government may implement a patent by themselves in Indonesia under the following considerations:

a. Its relation to the State defense and security; or

b. Urgent needs for the public interest

Such use of a patent shall be limited, to fulfil domestic needs and are non-commercial. Article 111 point a further stipulates the implementation of patent by Government shall include Pharmaceutical and/or biotechnology products which are expensive and/or required to cope with diseases which may cause unforeseen death of people in large numbers and significant disability, and constitute Public Health Emergency of International Concern (“PHEIC”).

Voluntary Patent Licensing

On the other hand, United States-based pharmaceutical company, Gilead Sciences Inc. has signed non-exclusive voluntary licensing agreement with generic pharmaceutical manufactures based in Egypt, India and Pakistan to expand the supply of Remdisivir. The licensing agreements also permit the distribution of Remdesivir to 127 countries including Indonesia. A state-owned Indonesian pharmaceutical company, Kimia Farma, is now looking to cooperate with Gilead Sciences Inc. Under the licensing agreements, the licensees are entitled to receive a technology transfer of the licensor’s manufacturing process for Remdesivir to enable them to boost the production more quickly. The licenses are royalty-free until WHO declares the end of the PHEIC with regard to COVID-19, or until a pharmaceutical product other than Remdesivir or a vaccine is approved for COVID-19 treatment.

Written by: Threeas Novayanti