Patentability: Novelty, Inventive Step and Industrial Application in India, the UK and the US

1. The statutory definition

Section 2(1)(j) of the Patents Act, 1970: “invention” means a new product or process involving an inventive step and capable of industrial application. Section 2(1)(m) and (n) define patent and patentee; s.2(1)(ta) defines “pharmaceutical substance” as a new entity involving one or more inventive steps. The requirements are cumulative; the Controller and courts examine each.

2. Novelty

Section 2(1)(l): a “new invention” means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the patent application with complete specification, that is, the subject matter has not fallen in the public domain or does not form part of the state of the art. India therefore applies absolute (worldwide) novelty for documents and, after 2005, for use as well.

Anticipation. An invention is anticipated by a prior publication, prior claim in an Indian specification with an earlier priority date, prior public knowledge or prior public use (ss.13, 25, 64). A single prior disclosure must contain every element of the claim and enable a skilled person to perform it: the “clear and unmistakable directions” test of the English cases (General Tire v. Firestone, CA 1972), and the two requirements of disclosure and enablement set out by the House of Lords in Synthon BV v. SmithKline Beecham plc (2005). Novelty cannot be destroyed by combining documents (mosaicing), which belongs to inventive step.

Exceptions (ss.29–34): publication without the applicant's consent, disclosure at a government-notified exhibition or before a learned society within twelve months before filing, and reasonable trials, do not anticipate.

3. Inventive step

Section 2(1)(ja): “inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both, and that makes the invention not obvious to a person skilled in the art. The test is non-obviousness; technical advance and economic significance are indicators, not substitutes.

In Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries, 1978 INSC 258, the patent claimed a method of making brass utensils (dekchis) by fixing the job on a lathe in a particular way. The Supreme Court held it invalid: the alleged invention was a mere workshop improvement known to the trade, involving no inventive step. The Court explained that a patentable invention must be a manner of manufacture that is new and useful, that it must involve some real advance beyond what is known and not a mere workshop improvement, and that the test of obviousness is whether the advance would have been obvious to a person skilled in the art in the light of the prior art. It also held that grant raises no presumption of validity (s.13(4)).

The Delhi High Court has adopted a structured approach drawn from the English Windsurfing and Pozzoli cases (for example in F. Hoffmann-La Roche v. Cipla, Division Bench, 2015): identify the inventive concept of the claim, the skilled person and his common general knowledge, the differences between the prior art and the claim, and whether those differences would have been obvious without hindsight. Secondary indicators include long-felt need, commercial success, failure of others and unexpected results.

4. Industrial application

Section 2(1)(ac): “capable of industrial application” means that the invention is capable of being made or used in an industry. The requirement replaced the older “useful” test. It excludes inventions that cannot be made (perpetual motion, s.3(a)) and purely abstract or speculative claims. In biotechnology it requires a specific, substantial and credible use to be disclosed; a gene sequence with no known function fails. Lack of utility remains a separate ground of revocation (s.64(1)(g)).

5. Subject matter and disclosure

The invention must not fall within s.3 (what are not inventions) or s.4 (atomic energy); see the next note. The specification must disclose the invention fully and the best method of performing it, with claims fairly based on the disclosure (s.10). Insufficiency is a ground of opposition and revocation.

6. The United Kingdom

The Patents Act 1977 implements the European Patent Convention (EPC, 1973). Section 1(1): a patent may be granted only for an invention that is new, involves an inventive step, is capable of industrial application, and is not excluded by s.1(2)–(3) or s.4A.

• Novelty (s.2; EPC Art 54): not part of the state of the art, which includes everything made available to the public anywhere before the priority date, and earlier-filed applications published later.
• Inventive step (s.3; EPC Art 56): not obvious to a person skilled in the art. The Court of Appeal's four steps in Windsurfing International v. Tabur Marine (1985) were restated in Pozzoli SpA v. BDMO SA (2007): (1)(a) identify the notional person skilled in the art and (b) his common general knowledge; (2) identify the inventive concept of the claim; (3) identify the differences between the prior art and the concept; (4) ask whether, without knowledge of the alleged invention, those differences would have been obvious. The EPO uses the problem-solution approach: closest prior art, objective technical problem, and whether the skilled person would have arrived at the solution.
• Industrial application (s.4; EPC Art 57): can be made or used in any kind of industry, including agriculture. Human Genome Sciences v. Eli Lilly (UKSC, 2011) held a gene sequence with a plausible disclosed use industrially applicable.
• Exclusions (s.1(2); EPC Art 52(2)–(3)): discoveries, scientific theories, mathematical methods, aesthetic creations, schemes and methods for mental acts, games, business, and computer programs, and presentations of information, “as such”.

7. The United States

• Subject matter and utility (35 U.S.C. §101): any new and useful process, machine, manufacture or composition of matter, or improvement. Judicial exceptions are laws of nature, natural phenomena and abstract ideas. Diamond v. Chakrabarty (1980) allowed a patent on a genetically engineered bacterium, relying on the congressional reports that patentable subject matter includes “anything under the sun that is made by man”. Mayo v. Prometheus (2012) and Alice Corp. v. CLS Bank (2014) set the two-step test: is the claim directed to an exception, and if so, does it add an “inventive concept” amounting to significantly more. Association for Molecular Pathology case (US Supreme Court, 2013), on the BRCA gene patents, held isolated natural DNA unpatentable but synthetic cDNA patentable.
• Novelty (§102): since the America Invents Act, 2011 (effective March 2013), the US is first-inventor-to-file; prior art is anything patented, published, in public use, on sale or otherwise available to the public before the effective filing date, with a one-year grace period for the inventor's own disclosures.
• Non-obviousness (§103): Graham v. John Deere Co. (1966) set the factual inquiries: scope and content of the prior art, differences from the claim, level of ordinary skill, and secondary considerations. KSR International v. Teleflex (2007) rejected a rigid “teaching, suggestion or motivation” test and allowed common sense and predictable combinations to show obviousness.
• Disclosure (§112): written description, enablement and definite claims; Amgen v. Sanofi (2023) held that broad functional antibody claims must be enabled across their full scope.

8. Comparison

How this is examined

Q2 of 2024. India first (definitions with section numbers, Biswanath), then UK (Windsurfing/Pozzoli, Synthon), then US (§§101–103, Graham, KSR, Alice), then the table. Keep the s.3 detail short here and refer to the exclusions note.