Patents in India

Introduction

A patent is a statutory monopoly granted by the State to an inventor, giving the inventor the exclusive right to make, use, sell, and import the invention for a limited period, in exchange for a full public disclosure of how the invention works. The bargain at the heart of patent law is disclosure in return for a time-limited monopoly: society gains new technical knowledge, and the inventor gains a temporary reward that lets them recover the cost of research and innovation.

In India, patents are governed by the Patents Act, 1970, which came into force on 20 April 1972 and replaced the older Indian Patents and Designs Act, 1911. The Act has been amended several times, most significantly by the Patents (Amendment) Act, 2005, which introduced product patents for pharmaceuticals, food, and chemicals to bring India into compliance with the WTO's TRIPS Agreement. The Act is administered by the Controller General of Patents, Designs and Trade Marks through the Patent Office and its branches.

The term of every patent is 20 years from the date of filing of the application (Section 53), subject to payment of the prescribed renewal fees.

What Can Be Patented: Meaning of "Invention"

Under Section 2(1)(j), an "invention" means a new product or process involving an inventive step and capable of industrial application. This definition breaks down into three cumulative requirements, all of which must be satisfied:

• Novelty: The invention must be new. It must not have been anticipated by prior publication, prior public use, or prior knowledge anywhere in the world before the priority date (the concept of "new invention" is defined in Section 2(1)(l)).
• Inventive step (non-obviousness): Defined in Section 2(1)(ja), an inventive step is a feature that involves technical advance compared to existing knowledge, or economic significance, or both, and that makes the invention not obvious to a person skilled in the art.
• Industrial application (utility): Defined in Section 2(1)(ac), the invention must be capable of being made or used in an industry.

Only when all three tests are met can a product or process qualify as a patentable invention.

What Cannot Be Patented

Even if something meets the definition of an invention, it may still be excluded from patentability. Section 3 lists inventions that are not patentable, and Section 4 bars inventions relating to atomic energy. Some important exclusions under Section 3 include:

• Frivolous inventions or those contrary to natural laws.
• Inventions whose commercial exploitation would be contrary to public order, morality, or which cause serious prejudice to human, animal, or plant life, health, or the environment.
• The mere discovery of a scientific principle or a naturally occurring substance.
• Section 3(d): The mere discovery of a new form of a known substance that does not result in enhancement of its known efficacy. This provision is central to India's approach to pharmaceutical patents and is designed to prevent "evergreening" (extending monopolies through trivial modifications).
• Methods of agriculture or horticulture.
• Methods of medical, surgical, curative, or diagnostic treatment of humans or animals.
• Plants and animals in whole or any part thereof (other than micro-organisms), and essentially biological processes for their production.
• Mathematical or business methods, computer programmes per se, and algorithms.
• Literary, dramatic, musical, or artistic works.
• Inventions relating to traditional knowledge.

Note: There is no separate statutory category of "conventional patents" versus "micro-organism patents." Micro-organisms are simply carved out as an exception to the plant/animal exclusion in Section 3, meaning they may be patentable if they otherwise meet the requirements of the Act.

The Patent Application Process

The journey from idea to granted patent typically involves the following stages:

1. Filing the application (Section 7): The application is filed in the prescribed form, either by the true and first inventor or by an assignee.
2. Provisional or complete specification (Sections 9 and 10): An applicant may first file a provisional specification to secure a priority date and must then file a complete specification within 12 months. Section 10 sets out what the specification must contain, including a full description of the invention and the claims that define the scope of protection.
3. Publication (Section 11A): The application is ordinarily published in the official journal after 18 months from the priority date. Only after publication is the application open to public inspection.
4. Request for examination (Section 11B): Examination is not automatic. The applicant (or an interested person) must file a request for examination within the prescribed period, failing which the application is treated as withdrawn.
5. Examination and objections (Sections 12 and 13): An examiner conducts a search for novelty and prepares a report. Objections raised are communicated to the applicant in a First Examination Report, and the applicant must respond and put the application in order for grant within the prescribed time.
6. Pre-grant and post-grant opposition (Sections 25(1) and 25(2)): Any person may oppose the grant before it is granted, and an interested person may oppose within one year after grant.
7. Grant of the patent (Section 43): If the application meets all requirements and is not successfully opposed, the patent is granted and its grant is published.

Rights Conferred by a Patent

The exclusive rights of a patentee are set out in Section 48. Where the patent is for a product, the patentee has the exclusive right to prevent third parties, without consent, from making, using, offering for sale, selling, or importing that product in India. Where the patent is for a process, the patentee can prevent others from using the process and from using, offering for sale, selling, or importing a product obtained directly by that process.

These rights are property rights. A patent can be assigned (transferred outright) or licensed (permission granted to another to use it) under the provisions of the Act, and such assignments and licences must be recorded with the Controller to be effective.

Limitations on Patent Rights

Patent monopolies are not absolute. The Act balances the patentee's interests against the public interest through several mechanisms:

• Working requirement (Section 83): The Act declares as a general principle that patents are granted to encourage inventions to be worked in India on a commercial scale, and not merely to enable patentees to enjoy a monopoly for importation.
• Compulsory licensing (Section 84): After three years from the grant of a patent, any interested person may apply for a compulsory licence on grounds that the reasonable requirements of the public have not been satisfied, that the patented invention is not available to the public at a reasonably affordable price, or that the invention is not worked in India.
• Revocation for non-working (Section 85): Where a compulsory licence has been granted, the patent may in certain circumstances be revoked for non-working.
• Government use and acquisition (Sections 100 and 102): The government may use or acquire a patented invention for its own purposes or in the public interest.
• Revocation (Section 64): A patent may be revoked by the Appellate Board or a High Court on a petition by an interested person, or as a counter-claim in an infringement suit, on grounds such as lack of novelty, obviousness, insufficiency of disclosure, or wrongful obtaining of the patent.

Infringement and Remedies

Infringement occurs when a person, without the patentee's authority, does any act that falls within the exclusive rights conferred by Section 48 during the term of the patent. Suits for infringement are filed in a District Court, or in a High Court where a counter-claim for revocation is made (Section 104).

The reliefs a court may grant in an infringement suit are provided in Section 108 and include:

• Injunction: An order restraining the defendant from continuing the infringing acts. Courts may grant interim (temporary) injunctions pending trial and permanent injunctions on final decree.
• Damages or account of profits: At the option of the plaintiff, the court may award either damages (compensation for the loss suffered) or an account of the profits made by the infringer. The two are alternatives, not cumulative.
• Seizure, forfeiture, or destruction of infringing goods and the materials used to make them.

A defendant commonly meets an infringement suit by challenging the validity of the patent itself, and Section 107 allows any ground of revocation under Section 64 to be raised as a defence.

Landmark Case

Novartis AG v. Union of India (2013): In this landmark decision, the Supreme Court of India refused a patent for the beta-crystalline form of imatinib mesylate (marketed as the cancer drug Glivec/Gleevec). The Court held that the new form did not demonstrate enhanced therapeutic efficacy over the known substance and therefore failed the test of Section 3(d). The judgment is a leading authority on the scope of Section 3(d) and India's policy against "evergreening" of pharmaceutical patents.

Key Takeaways

• Patents in India are governed by the Patents Act, 1970; the term of a patent is 20 years from the filing date.
• An "invention" (Section 2(1)(j)) must be new, involve an inventive step, and be capable of industrial application.
• Sections 3 and 4 list what cannot be patented; Section 3(d) restricts patents on new forms of known substances lacking enhanced efficacy.
• Section 48 confers the exclusive rights of the patentee; these are limited by compulsory licensing (Section 84) and revocation (Section 64), among other provisions.
• Remedies for infringement (Section 108) include injunctions and, at the plaintiff's option, damages or an account of profits.