Tag: clinical trials

Applying for a patent is a race against time to secure the earliest priority date (i.e., the date of the first filing of a patent application). As a result, patent applications are often filed with accompanying data that do not always capture all the facets of the invention. In such cases, using post-filing data to support the applications is often the only course available. ......

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. ...

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....