Module 2: Patent Law & Practice - Assessment

Section 2(1)(j) defines "invention" as a new product or process involving an inventive step and capable of industrial application. This requires novelty, non-obviousness, and utility.

The three essential criteria for patentability are: (1) Novelty - the invention must be new, (2) Inventive Step - must not be obvious to a person skilled in the art, and (3) Industrial Applicability - must be capable of being made or used in industry.

Under Section 2(1)(l), novelty requires that the invention has not been anticipated by publication in any document or used in India or elsewhere in the world before the priority date of the claim. India follows absolute novelty standard.

Section 2(1)(ja) defines inventive step as a feature that involves technical advance as compared to existing knowledge or having economic significance or both, that makes the invention not obvious to a person skilled in the art.

Under Section 53, the term of every patent is 20 years from the date of filing of the application. This is consistent with TRIPS Agreement requirements.

Prior art encompasses all publicly available information (patents, publications, public use, oral disclosures) before the priority date that is relevant to determining novelty and inventive step of an invention.

Section 3(a) excludes inventions that are frivolous or claim anything obviously contrary to well-established natural laws, as well as inventions whose primary or intended use would be contrary to public order or morality or which cause serious prejudice to human, animal, plant life or health or environment.

Section 3(b) excludes inventions the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.

Section 3(c) excludes the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature.

In Novartis v. Union of India, the Supreme Court upheld Section 3(d) and rejected the patent for Gleevec (imatinib mesylate beta crystalline form), holding that a new form of a known substance is not patentable unless it demonstrates significantly enhanced efficacy.

Section 3(d) excludes 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, including salts, esters, ethers, polymorphs, metabolites, etc.

Section 3(e) excludes substances obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance.

Section 3(h) excludes methods of agriculture or horticulture from patentability. However, agricultural implements and machinery may still be patentable.

Section 3(k) excludes mathematical or business methods, computer programs per se, and algorithms. However, software with technical application or effect may be patentable.

The three types of patent applications are: (1) Ordinary Application - filed directly in India, (2) Convention Application - claiming priority from an earlier foreign application, and (3) PCT National Phase Application - entering India through the PCT route.

Under Section 9, a complete specification must be filed within 12 months from the date of filing of the provisional specification. The period may be extended by up to 3 months on payment of prescribed fee.

Under Section 10, a complete specification must contain: title, description of the invention, claims defining the scope of protection, abstract summarizing the invention, and drawings where necessary.

Under Section 25(1), any person can file a pre-grant opposition after publication of the application but before grant of the patent. This is a representation to the Controller.

Under Section 25(2), post-grant opposition must be filed by any person interested within one year from the date of publication of grant of the patent.

Form 1 is the application form for grant of patent. Form 18 is for request for examination, and Form 7 is for opposition proceedings.

Under Section 11B, a request for examination must be filed within 48 months from the priority date or date of filing, whichever is earlier. Failure to file leads to deemed withdrawal of application.

FER stands for First Examination Report, which is issued by the Controller after examination, listing objections to the patent application that the applicant must address.

Under Rule 24B, the applicant must put the application in order for grant within 6 months from the date of the First Examination Report.

Under Section 11A, patent applications are published after 18 months from the priority date or filing date, whichever is earlier. Early publication can be requested.

The Controller General of Patents, Designs and Trade Marks is the head of the Indian Patent Office, responsible for administration of patent law including examination, grant, and maintenance of patents.

Expedited examination is available for eligible applicants including startups, MSMEs, female applicants, and applicants under PPH (Patent Prosecution Highway) agreements, allowing faster processing of applications.

Section 48 grants exclusive rights to prevent third parties from making, using, offering for sale, selling, or importing the patented product/process without consent. For processes, this extends to products directly obtained by the process.

Section 84 allows compulsory licensing after 3 years from grant on grounds: (1) reasonable requirements of public not satisfied, (2) invention not available at reasonably affordable price, or (3) invention not worked in India.

In Natco v. Bayer (2012), India's first compulsory license was granted to Natco for Bayer's cancer drug Sorafenib tosylate (Nexavar) under Section 84, as the drug was not reasonably affordable and not adequately worked in India.

Section 92 allows the Controller to grant compulsory licenses suo motu in cases of national emergency, extreme urgency, or for public non-commercial use, upon notification by the Central Government.

Sections 100-103 provide for government use of patents for purposes of the Government. The patentee is entitled to remuneration determined by the High Court if not agreed upon.

Section 107A(a) provides the Bolar exemption, allowing use of a patented invention for development and submission of information required for regulatory approval, enabling generic manufacturers to prepare for market entry upon patent expiry.

Patent infringement under Section 104 occurs when any person without authority of the patentee makes, uses, offers for sale, sells, or imports the patented product or uses the patented process.

Under Section 104, no suit for infringement shall be instituted in any court inferior to a District Court having jurisdiction to try the suit.

Section 108 provides remedies including injunction (interim and permanent), damages or account of profits (plaintiff's choice), and delivery up or destruction of infringing products and materials.

Valid defenses include: patent invalidity (Section 64 grounds), prior user rights (Section 107A(b)), experimental use, parallel imports, and Bolar exemption for regulatory submissions.

The doctrine of equivalents extends infringement beyond literal claim interpretation. A product infringes if it performs substantially the same function in substantially the same way to achieve substantially the same result.

Section 64 lists grounds for revocation including: wrongful obtaining, prior publication, prior claim, prior knowledge/use, obviousness, non-patentable subject matter, insufficient disclosure, and fraud.

Claims are the most critical part of a patent specification as they define the legal scope of protection. Everything outside the claims is in the public domain; infringement is determined by claim interpretation.

An independent claim stands alone and contains all essential elements (limitations) needed to define the invention. It does not reference any other claim and typically provides the broadest protection.

A dependent claim refers back to and incorporates all limitations of an earlier claim (independent or dependent) while adding additional limitations, making it narrower in scope.

Section 10(4) requires the specification to sufficiently and clearly describe the invention and its operation so that a person skilled in the art can make and use the invention - this is the enablement requirement.

The best mode requirement (Section 10(4)(b)) requires the applicant to disclose the best method of performing the invention known to them at the filing date, ensuring full disclosure to the public.

The preamble is the introductory phrase of a claim that identifies the general category of the invention (e.g., "A method of...", "A composition comprising...", "An apparatus for...").

PCT stands for Patent Cooperation Treaty, administered by WIPO, which provides a unified procedure for filing patent applications in multiple countries through a single international application.

Under the Paris Convention, the priority period for patents is 12 months from the first filing date. For industrial designs and trademarks, it is 6 months.

National phase entry must generally occur within 30 or 31 months from the priority date, depending on the designated/elected office. For India, it is 31 months from the priority date.

PPH (Patent Prosecution Highway) enables expedited examination in a second patent office based on positive examination results (allowed claims) from a first office, reducing prosecution time and costs.

Section 39 requires Indian residents to obtain a foreign filing license before filing patent applications outside India, unless a corresponding application has been filed in India at least 6 weeks earlier.

The International Searching Authority (ISA) conducts an international search of prior art and issues an International Search Report (ISR) and Written Opinion on patentability. India's Patent Office is an ISA.