The Patents Act, 1970 notes — Unit 2

A patent is an exclusive statutory right granted by the State for an invention that is new, involves an inventive step, and is capable of industrial application.

⇒The Grand Bargain (Quid Pro Quo)

A patent is a social contract. The inventor discloses the secret details of their invention to the public (adding to human knowledge). In exchange, the government grants the inventor a 20-year monopoly to commercially exploit it. After 20 years, the invention falls into the public domain for anyone to use.

Not every good idea gets a patent. To get a patent under the Indian Patents Act, an invention must satisfy a strict three-part test:

⇒1. Novelty (New Invention)

The invention must not have been published in any document or used in the country or elsewhere in the world before the date of filing. (Absolute global novelty). If you publish a paper about your invention before filing a patent, you destroy its novelty.

⇒2. Inventive Step (Non-Obviousness)

This is the hardest hurdle. Section 2(1)(ja) defines it as a feature that involves technical advance as compared to existing knowledge, AND makes the invention not obvious to a person skilled in the art.

(Example: If you take a known chair and just paint it red, it's new, but it's obvious to any carpenter. No patent).

⇒3. Industrial Application

The invention must be capable of being made or used in an industry. Abstract theories or perpetual motion machines that defy physics cannot be patented.

Even if an invention is new, non-obvious, and useful, India explicitly bans certain things from being patented for public policy reasons.

⇒Key Exclusions under Section 3:

• 3(b): Inventions contrary to public order or morality (e.g., a gambling machine, a biological weapon).
• 3(c): The mere discovery of a scientific principle or the discovery of any living thing occurring in nature (You can't patent a new species of frog you found).
• 3(k): A mathematical or business method or a computer program per se or algorithms. (Software is usually protected by Copyright in India, not patents).
• 3(i): Any process for the medical, surgical, or curative treatment of human beings or animals. (Doctors must be free to save lives without paying royalties for a surgical method).

Section 3(d) is India's most famous and globally controversial patent provision, designed to protect cheap generic medicines.

⇒The Concept of 'Evergreening'

When a 20-year patent on a drug is about to expire, pharma companies often make minor, trivial changes to the molecule (like turning it into a salt) and apply for a new 20-year patent, artificially extending their monopoly. This is evergreening.

⇒The Section 3(d) Filter

Section 3(d) states that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is NOT patentable.

Novartis, a Swiss pharma giant, applied for a patent in India for 'Glivec', a life-saving blood cancer drug. The Indian patent office rejected it under Section 3(d), arguing it was just a new form (beta crystalline form) of a previously known substance (Imatinib).

⇒Supreme Court's Decision

Novartis argued that the new form was more stable and easier to store. The Supreme Court rejected the patent. The Court ruled that under Section 3(d), for medicines, "efficacy" strictly means "therapeutic efficacy" (it must cure the disease significantly better). Better storage stability is not therapeutic efficacy.

(This monumental judgment prevented evergreening and saved India's generic pharma industry, keeping cancer drugs affordable worldwide).

Getting a patent is a long, bureaucratic process involving the Indian Patent Office.

• 1. Filing the Application: An inventor files a provisional or complete specification detailing the invention.
• 2. Publication: The application is published in the official journal after 18 months, making it public knowledge.
• 3. Request for Examination: The patent office doesn't examine it automatically; the applicant must explicitly request examination within 48 months.
• 4. Examination: A Patent Examiner checks if it meets the criteria (novelty, inventive step) and issues a First Examination Report (FER) raising objections.

India allows the public (usually rival companies or health NGOs) to oppose the grant of a patent.

⇒Pre-Grant Opposition (Sec 25(1))

Any time after publication but before the patent is granted, any person can file an opposition (e.g., claiming the invention is already known or falls under Sec 3). This is a democratic safeguard to stop bad patents before they are born.

⇒Post-Grant Opposition (Sec 25(2))

After the patent is granted, a person "interested" (like a rival manufacturer) has a 1-year window to file a formal opposition to get the patent revoked.

Once granted, the patentee has the exclusive right to prevent third parties, who do not have their consent, from the act of:

• Making the patented product.
• Using the patented product.
• Offering for sale or selling it.
• Importing that product for those purposes.

⇒Term of Patent

The term of every patent granted in India is 20 years from the date of filing the application. (Once the 20 years expire, anyone can manufacture it).

What if a company invents a life-saving drug, gets a patent, but sets the price at Rs. 2 Lakhs per pill, letting millions die? The law has a built-in safety valve.

⇒The Concept

A Compulsory License (CL) is an authorization given by the government to a third party (a generic manufacturer) to produce the patented product without the consent of the patent owner, provided they pay a reasonable royalty to the owner.

⇒Grounds for CL (After 3 years of grant):

• The reasonable requirements of the public with respect to the patented invention have not been satisfied.
• The patented invention is not available to the public at a reasonably affordable price.
• The patented invention is not worked in the territory of India.

India's first ever Compulsory License was granted in 2012, shaking the global pharma industry.

⇒The Facts

Bayer (a German company) held a patent for 'Nexavar', a kidney cancer drug. Bayer priced a month's dosage at roughly Rs. 2.8 Lakhs. An Indian generic company, Natco, applied for a CL, offering to sell the same drug for Rs. 8,800 a month.

⇒The Decision

The Controller of Patents granted the CL to Natco. He ruled that Rs. 2.8 Lakhs was not a "reasonably affordable price" for the Indian public, satisfying Section 84. Natco was ordered to pay a 6% royalty on net sales to Bayer.

⇒Premium Advice for Top Marks

• Section 3(d) & Novartis: This is an almost guaranteed question. Do not just write the section; explain the purpose (stopping evergreening) and the Novartis ruling (therapeutic efficacy). This shows advanced understanding of Indian IP policy.
• Compulsory Licensing: When writing about CL, structure it logically: (1) The definition/TRIPS flexibility, (2) The grounds under Sec 84 (affordable price/public requirement), and (3) You MUST cite the Natco v. Bayer case to ground your answer in reality.
• Criteria for Patentability: Memorize the triad: Novelty, Inventive Step (non-obviousness), and Industrial Application. Explain that 'Inventive step' is the hardest to prove because it requires showing technical advancement over existing knowledge.