The role of Intellectual Property in the pharmaceutical industries are essential, with ensuring the protection of the rights of creation, it is one of the main driving force for the continued birth of new medicines and innovations in healthcare. This article will be focusing on the application of patents in the pharmaceutical industries as it provides the most economic value to the pharmaceutical companies as well as the main guard for innovation. Although some might assume that patents provide a positive right with the legal basis of exclusivity and commercial monopolisation in actuality, patent is a negative right; as it gives the owner of the patent the right to restrict and prevent others from making, selling the innovation without the permission of the owner.
With the rise of the novel Corona Virus since 2019, it had claimed the lives of over 50,000 people, the demand for a cure has never been more crucial. Scientists, medical and health professionals have been rushing to find a cure to treat the victims of the Covid-19. As of date, 35 companies and organizations are racing to create any forms of cures and vaccines to treat this new disease and Malaysia has been chosen by WHO in a global research initiative for possible Covid-19 cure.
However, aside from researching for new cures, the most probable approach by pharmaceutical companies and organizations is to utilize the patented literature which acts as a goldmine for information that could provide insights on contemporary drugs that are currently being used in clinical studies in treating the strains of coronaviruses. In the pursuit of global research efforts, It is important to identify the drugs being used to combat Covid-19. At this juncture, it is the most opportune moment for pharmaceutical companies to utilize their patented drugs that are being used in treating coronaviruses. Pharmaceutical companies that owns the patented drugs that are currently being utilized in clinical trials against the coronaviruses should be quick to enforce their patents and licensing agreements. Identifying which of the patented drugs are being reproduced to combat the strains of coronaviruses or any one of its symptoms is the first essential step in taking control of the patent assets. This establishes leverage for further development and/or commercialization to protect one from other competitors in the market.
Furthermore, when a potential candidate drug has been identified from the patented literature, what pharmaceutical companies should also do is collaborate with the local authorities and/or governments in licensing their patented drugs for its generic uses and availability for compensations and considerations. Rather than wait for a compulsory licensing policy by the government for compassionate use and non-commercial usage, pharmaceutical companies should take the first initiative in embracing the mass licensing phase of their patented drugs provided their usage of their patents are well compensated. Aside from that, the repurposing of the molecules in the patented drugs is also one of the main approaches in current clinical trials of the global efforts by WHO, patent obstacle makes it hard for generic companies to proceed with clinical trials unless they have gotten licensing or government interventions. The demand for proper usage is essentially a demand for licensing, and pharmaceutical industries should see this as an alternative investment and a new market.
For our local pharmaceutical and biotech companies in Malaysia taking part and being at the forefront of the research for the possible cure, the need for the patent protection of future innovations is imminent. However, before one can procure any patent protection, it is vital to ensure the patentability of the innovations made in pursuit of the cure. Malaysia’s patent is governed under the Patents Act 1983 and regulated under Patents Regulation 1986. To ensure the patentability of any innovations it must qualify these three conditions; it must be novel, it must involve an inventive step and it must also be industrially applicable. To ensure the novelty of the patent, the knowledge or concept that ensures the novelty of the innovation must not exist in the realm of public knowledge. An inventive step essentially correlates to the specific part of the innovative nature of the patent. Therefore, a newly invented pharmaceutical product should have these three requirements to ensure patentability.
However, pharmaceutical companies seeking patent protection must ensure that their inventions are not included in the list of non-patentability inventions set forth in Section 13 of the Patents Act which excludes these inventions from being patented:-
Discoveries, scientific theories and mathematical methods (section13(1)(a)).
Plant, animal varieties or essentially biological processes for the production of plants or animals other than man made living microorganism, micro biological processes and the products of such microorganism processes (section13(1)(b)).
Schemes, rules or methods for doing business, performing purely mental acts or playing games (section13(1)(c)).
Methods for the treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body, except for products used in any such methods (section13(1)(d)).
Inventions where their performance would be contrary to public order or morality (section 31(1)).
A closer look at section 13(1)(d), since the method of treatment for human and animal concerns the pharmaceutical industries it is worthy to note that section 14(4) of the Patents Act states that Where a substance or composition is part of the prior art but a new medicinal or veterinary use of that product is found, the mere fact that the product is not novel will not stop the novelty of the use of that product for a method of medical treatment”. Although the method of treatment are excluded from being patented, Section 14(4) provides the legal basis for the use of a substance or composition in a method of treatment to be patented. Therefore, in the pursuit of finding a cure for the Covid-19, if you were to find a medicinal use for a certain type of herbs or a chemical composition that could be used to treat Covid-19 patients, the herb and/or chemical composition is considered to be novel and can be patented even though the method of treatment is non patentable. To take it a step further, any new inventions to solve the lack of ventilators and Covid-19 test kits that are currently haemorrhaging the hospitals all over the world can also be patented.
Once we have determined the patentability of the innovations, the next step is to apply to the Patent Registration Office of the Intellectual Property Corporation of Malaysia (MyIPO). For more information of the processes and patents application, you can visit the MyIPO official portal at www.myipo.gov.my/en/home. In summary, the process of patent application can be laid out as follows:-
Firstly you must start with filing an application with the prescribed forms for the grant of a patent to above mentioned Patent Registration Office, it can be done by hand or mail. The filing requires you to also file a “Patent Specification” document that contains the descriptions of your invention along with an abstract and drawings or technical features of your invention. The next phase is the preliminary examination of the application and for
filing and preliminary examination, if there is non-compliance with the Patents Act, three months is given to submit corrections). After 18 months after the priority date or filing date, the details of the patent application will be made available for public inspection. The next step that comes after the public inspection is to request for a substantive examination which must be made within two years from the date of the filing application. This gives the chance for the applicant to respond and address any objections made by the examiners. Lastly, a Certificate Grant of the patent will be issued, and the particulars of the patent together with the abstract will be published in the Government Gazette.1
Once you have successfully applied and registered for a patent for your innovation, you have exclusive right to your innovation provided that you pay the annual fee to keep the patent in force. Any other pharmaceutical companies or organization that wishes to utilise your innovation must require your agreement which can be applied using a licensing agreement. It is best to keep in track of the regulatory bodies and legislations when it concerns the medicinal and pharmaceutical products. The Drug Control Authority handles the registration of pharmaceutical products as well as the licensing premises of importers, manufacturers and wholesalers. For a drug-medical product, where the primary mode of action is based on pharmacological, immunological or metabolic action in/on the body, the National Pharmaceutical Regulatory Agency (which is a subsidiary of The Drug Control Authority) is the main agency regulating the product and an application for registration must be submitted to it under the Sale of Drugs Act 1952. Any drug substances used as ancillary to the medical device that are listed as a scheduled poison are regulated by the Poisons Act whereas if it is listed as dangerous drugs or substance are regulated by the Dangerous Drugs Act 1952.2
- Li, Lee Lin, and Lim Jing Xian. “Pharmaceutical IP and Competition Law in Malaysia: Overview.” Thompson Reuters Practical Law, uk.practicallaw.thomsonreuters.com.
- Lee, Lee Lin, and Lim Jing Xian. “Medicinal Product Regulation and Product Liability in Malaysia: Overview.” Thompson Reuters Practical Law, Practical Law, uk.practicallaw.thomsonreuters.com
