Patent

The Delhi High Court recently adjudicated on the issue of whether generic companies can export patented products for experimental purpose, in an expansive interpretation of Section 107A of the Indian Patents Act, 1970 (the ‘Act’). Section 107A, which relates to what is referred to as ‘the Bolar Provision’, was introduced via the Patents Act (Second Amendment) Bill, 1999. The provision sought to ensure the prompt availability of patented products, particularly generic drugs, immediately after the expiry of the patent term....

Micro, Small, and Medium Enterprises (MSMEs) are key drivers of economic growth, and the Government of India has been especially cognizant of their demands and concerns, by supporting and encouraging startups and MSMEs through various schemes and incentives introduced from time to time. ...

New rules for patent filing were introduced in India recently, which have made the application process considerably easier, such as waiving the requirement for filing originals, allowing applicants such as women and small enterprises to apply for expedited examination, and removing the transmittal fees for international applications. The Patent (Amendment) Rules 2019 came into force on September 17, 2019. ...

An application for a patent can be filed by a ‘true and first inventor’, or the inventor’s assignee. In cases where the application is filed by the assignee, the assignee is required to submit a ‘proof of right’, as per Section 7(2) of the Patents Act, 1970 (the “Act”). ...

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. ...