Patent

The Government of India has proposed a slew of amendments to the rules governing Geographical Indications (GIs), particularly with regard to the rights of authorised users under the law. On September 16, 2019, the Ministry of Commerce and Industry (Department for Promotion of Industry and Internal Trade, or DPIIT) issued draft rules, which propose various amendments to the Geographical Indications of Goods (Registration and Protection) (Amendment) Rules, 1999....

In a major decision that is likely to impact evergreening of pharmaceutical patents in India, the Delhi High Court vacated interim injunctions granted to AstraZeneca, a big pharma multinational, against three generics manufacturers, Micro Labs, Natco Pharma, and Dr. Reddy’s Laboratories. The case involved allegations of infringement of AstraZeneca’s three patents, for offering a generic version of AstraZeneca’s drug-TICAGRELOR for sale under the brand name BRILINTA....

Pharmaceutical industry is one of the most intensively regulated sectors and as a result of these challenges, returns on R&D investments in the pharmaceutical industry have decreased. One feasible alternative to address these challenges is to adopt strategies to reduce development costs and maximize profit. One such strategy is Product Differentiation. Product Differentiation is innovating an existing product, i.e., creating a product with better features, performance, or efficacy. Most blockbuster drugs have gone off-patent, and more are expected to go off-patent in the near future. ...

The Patent Rules, 2003 are proposed to be amended by Draft Rule 21 Sub-rule (2) and Sub-rule (3), Draft Rule 131 Sub-rule (2), and updated Form-27. Draft Rule 21 Sub-rule (2) reduces the high cost previously borne by applicants for the translation of priority documents. This Draft Rule restricts the requirement for submitting verified English translations of priority documents in accordance with Rule 51bis.1(e) of regulations under the Patent Cooperation Treaty (PCT). ...

In its latest proposed amendments to the Patent Rules, 2003, the government of India has proposed to overhaul the antiquated Form 27 (which seeks details of the commercial working of patents), among other procedural clarifications. ...

Patents are granted for inventions that are new, include an inventive step and are capable of industrial application. An element of human contribution and “inventiveness” are required for patentability. The body of scientific knowledge received by any generation is a combination of invention and discovery, but there is a fine line between the two, and the distinction is not always clear. In this note, we examine the patentability of discoveries in Europe, the United States, and India to understand this distinction in the context of “naturally occurring substances”. ...

Over the years, a large number of patents have been granted for antibodies all over the world. The world is also seeing a shift towards biologic based drugs. Most of the top-selling drugs in 2018 were monoclonal antibodies with HUMIRA® leading the list. With the progress in the art and growing case law in this area, the criteria for patentability of antibodies are becoming increasingly strict, with restrictions on the scope of the claims. ...

The Madras High Court earlier this year rejected a writ petition filed against a patent owned by Kibow Biotech Inc. for a dietary supplement that aids in the carrying out of the kidney function, for reasons, among others, that there was no expert evidence led to support the case. The validity of the patent was challenged primarily under Section 3(e) of the Patents Act, i.e., on grounds that it was “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance”....

The Department of Industrial Policy and Promotion under the Ministry of Commerce and Industry have issued draft rules to amend the Patent Rules, 2003 (available here: See). The following major changes have been proposed in these draft rules: ...