Patent

The total cost for bringing a new prescription drug to market is about USD 2 to 3 billion (DiMasi et al.). A significant portion of this cost is incurred in conducting clinical trials. The global clinical trials market size is expected to reach USD 69.8 billion by 2027, exhibiting a 5.1% compound annual growth rate (‘CAGR’) during the forecast period. ...

An Indian court has held that in the absence of a patent, common law rights or agreements protecting know-how cannot be a means to circumvent the patent process. In its judgement in Prof. Dr. Claudio De Simone & Anr v. Actial Farmaceutica Srl. & Ors. (17.03.2020, Delhi High Court), a Single Judge dismissing a suit for permanent injunction said that the right to an injunction could only be invoked under Section 48 of the Patents Act, 1970, and no right exists in common law to restrain others from commercially exploiting the know-how of an invention. ...

On 16 January 2020, the European Patent Office (EPO) Board of Appeal revoked a patent related to CRISPR/Cas9 technology, and in doing so delivered one of the most anticipated decisions in the field of biotechnology patents in recent times. This gene-editing technology, which is the subject of a bitter battle for intellectual property rights between two rival parties - The Broad Institute and the University of California (UC), Berkeley, is revolutionizing research in biotechnology....

Artificial Intelligence (AI) is changing the way we live and engage with the world. Besides smart devices (phones, speakers), and self-driving cars, AI is also set to revolutionize biotechnology and the health sector. Deep learning algorithms are being used in areas such as genomic data analysis, cellular profiling and characterisation which find use, for example, in cancer diagnosis, drug design and pharmacology, genome sequencing, and protein structure prediction. ...

The Government of India recently announced draft amendments to the Design Rules and Patent Rules with the primary objective of encouraging startups and small entities to protect their intellectual property. The proposed changes include new definitions of “startups” in the design rules (to align with corresponding changes on the patents and trademarks side), and significantly reduced filing and prosecution fees for startups and small entities. ...

On November 21, 2019, the Ministry of Commerce and Industry (Department for Promotion of Industry and Internal Trade, or DPIIT) issued a notification notifying the approved Bilateral Patent Prosecution Highway (PPH) Programme between the Indian Patent Office (IPO)and the Patent Offices of other interested countries/regions. As of now, the PPH programme has been agreed upon and signed between the IPO and the Japan Patent Office. ...

In a world where science and technology evolve at an exponential pace, it is essential that the institutional systems that support the evolution of these industries also keep up with the pace. But the Indian patenting system has been often criticized over the years for its slow and long drawn out processing time. This processing pace naturally affects the quality and quantity of applications as well, and it is possible that foreign innovators or entities may be losing interest in filing for patents in India for this reason....

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. ...