INTRODUCTION
Intellectual Property Rights (IPR) provides the creator or owner of any work or invention with exclusive monopoly rights over the respective work or invention. In today’s commercialized market, protecting the intellectual property (IP) of any company or business is of utmost importance as IP essentially amounts to one of the pivotal assets of any company or business.
As per the Government’s Annual Report of 2021, the pharmaceutical industry in India is the world’s 3rd largest pharmaceutical industry by volume and 14th largest by value. Hence, in the light of the foregoing, the patent protection of pharmaceutical inventions comes into play.
A patent is an IPR that provides protection over any unique innovation and also provides the patent-owner exclusive rights to sell, transfer, use, create or manufacture the patented work or invention.
New and improved drugs are being manufactured and introduced in the market every year and especially in the backdrop of the Covid-19 pandemic, the demand and supply for new and improved drugs have increased. It is necessary to protect such invention in order to negate the possibility of replication or counterfeiting.
LEGAL FRAMEWORK: GOVERNING PATENTS
In India, patents are governed by the Patents Act, 1970 (the Act). The Act was amended in 2005 in order to comply with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.
Vide the Patents (Amendment) Act, 2005, the patent protection of drugs and pharmaceutical products was amended and product patents have been made available for inventions pertaining to pharmaceutical products, agrochemicals, and foods. The aforementioned amendment omitted Section 5 of the Act which stated that pharmaceutical inventions would only be entitled to process or product patent protection.
As a signatory to the TRIPS agreement, India has to comply with the minimum standards as stipulated in the TRIPS agreement. Besides TRIPS, India is a signatory to several other international agreements which provide for patent protection of pharmaceutical products such as the Paris Convention, the Patent Cooperation Treaty, the Convention on Biological Diversity and the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.
Internationally, TRIPS is one of the most comprehensive multilateral agreements on IPR which governs the patentability of pharmaceutical inventions. The TRIPS agreement enlists a uniform provision regarding patentability of all inventions, whether product or process, across all fields of technology, wherein such invention meets the standard criteria for patentability, i.e., novelty, inventive step and industrial applicability.
The term of patent protection in India and as per TRIPS is twenty years from the date of filing the application, subject to renewal in certain jurisdictions.
PATENT PROTECTION IN THE PHARMACEUTICAL INDUSTRY
The pharmaceutical industry around the globe has undergone major changes influenced by technology and digitisation. With the advent of improved medicines being produced and introduced in the market, pharmaceutical patents have become fairly common. Besides safeguarding the work, pharmaceutical patents also aid in generating huge amount of revenues.
Any pharmaceutical innovation requires a prolonged period of research and development (R&D) and the companies incur huge amount of costs during the same. Pharmaceutical patents help to regain the investments and costs that are incurred during the R&D stage.
Patent Filing Process in India
1. Filing
Patent filing can be done either physically or electronically. The applicant is required to do the filing in the appropriate Patent Office in accordance with the jurisdiction. There are four Patent Offices situated across India in four cities, namely, Kolkata (Head Office), Chennai, Mumbai and New Delhi.
2. Publication
Once the application is submitted in the Patent Office, the patent is thereafter published in the Patent Journal approximately after a period of 18 months. In the event any applicant wants to submit a request for early publication, the same can be done by submitting Form 9.
3. Examination and Pre-Grant Opposition
In order to patent any invention, the applicant should ensure that such invention is novel, non-obvious and must be useful in the industry. The Patent Office examines the application and the patent thoroughly in accordance with the parameters laid down in the Act. After due examination, the examiner issues a report which is called the First Examination Report (FER).
India being a member to the World Trade Organisation (WTO) has incorporated the concept of oppositions. Any company or entity can file a pre-grant opposition and challenge the patent application till the date of the grant of the application. The procedure for pre-grant opposition is enumerated in Section 25(1) of the Act.
4. Grant and Publication of Application
Once the examination is completed and the objections, if any, are resolved, the patent is granted and thereafter published.
5. Post-Grant Opposition
Any company can challenge the patent and file a post-grant opposition after the patent application has been granted and published. Section 25(2) of the Act lays down the grounds for post-grant opposition. Once a post-grant opposition is filed, an Opposition Board comprising of 3 members is constituted by the Controller. After conducting the proceedings and hearing both the parties and the recommendations of the Opposition Board, the Controller decides the case.
Therefore, in order to safeguard any invention via patent protection, all the pharmaceutical companies need to undergo the abovementioned procedure. In addition to the above, Section 92A of the Act stipulates that compulsory license shall be available for the manufacturing and export of patented pharmaceutical products to any country which does not have the said product or the capacity to manufacture the said product.
The Covid-19 pandemic imposed a massive pressure on the pharmaceutical industry around the globe. The industry witnessed an uncontrollable demand for several medicines and other pharmaceutical products. Subsequently, several companies came up with new products and improved drugs. However, it is pertinent to note that majority of the companies were unable to safeguard their inventions due to the urgency of the situation.
KEY PRECEDENTS
Novartis AG v. UOI [(2007) 4 MLJ 1153]
In this case, the Supreme Court dismissed the claim of patentability by the Appellant and held that the Appellant failed the test of invention and patentability as stipulated in Sections 2(j), (ja), (l) and Section 3(d) of the Act. The Novartis case is a landmark judgment pertaining to pharmaceutical patents as the Supreme Court discussed the importance of balancing the rights of the patent holder and the public.
The pivotal takeaway from the said judgment is that the Supreme Court held that the aim of the Act is not just entitling the patent holder to create monopolistic rights or exploitation of the general public when it comes to medicines and drugs.
Hoffmann-La Roche Ltd. v. Cipla Ltd. [148 (2008) DLT 598]
This judgment is one of the landmark decisions in the arena of pharmaceutical patents. Even though prima facie the case deals with patent infringement, however moving forward, it discussed the concept of public interest in consonance with patenting of drugs and medicines. While interpreting the rights of the patent holder, it is also important to keep in mind the interest of the common people.
The Roche case is one of the key cases in the jurisprudence of infringement of pharmaceutical patents and laid down detailed guidelines regarding patent infringement.
Natco Pharma Limited v. Bayer Corporation [(Order No. 45 of 2013)]
In this case, the Intellectual Property Appellate Board (IPAB) upheld the decision of the Controller of Patents and granted India’s first compulsory license to the Appellant. The IPAB considered the three conditions enumerated in Section 84(1) of the Act.
In the light of the foregoing, the IPAB also held that the following parameters should be adhered with while deciding such appeals:
- The grant of such patent shall not impede protection of the health of the general public
- The grant of patents must strike a balance between the rights and obligations of the patent holder
- The patent holder must make the benefits of a patented invention available at an affordable price to the general public.
Merck Sharp & Dohme Corporation v. Glenmark Pharmaceuticals Ltd., [(2015) 63 PTC 257]
In this recent decision, the Delhi High Court passed an injunction against the Respondent and held that the Respondent had infringed on the patent rights of the Appellant, and caused irreparable injury to the Appellant.
The Glenmark case is a classic case of infringement of pharmaceutical patents with regards to manufacturing of generic drugs.
AMLEGALS REMARKS
Besides safeguarding the inventions and other IP assets, the pharmaceutical industry has the responsibility of providing medicines and drugs to the common public at reasonable costs and thrive for improving the healthcare system.
The Covid-19 pandemic was a portrayal of the well-known proverb “necessity is the mother of invention”. In order to battle the pandemic, the pharmaceutical sector came up with an array of pharmaceutical inventions. Such inventions should be patented by the respective pharmaceutical companies and organisations at the earliest in order to safeguard the IP assets of the said company or organisation.
Furthermore, as pharmaceutical patents involve a lot of technicalities, the filing of such patent applications for registration shall be done with due diligence as the same can be subject to pre or post grant opposition as discussed above.
The pharmaceutical companies or the patent holder should always ensure the protection of public interests and health and strike a balance between their rights as a patent holder and the greater good, i.e., public health.
For any query or feedback, please feel free to connect with chaitali.sadayet@amlegals.com or mridusha.guha@amlegals.com.
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