The US Supreme Court last month (June 12, 2017) in Sandoz v. Amgen ruled unanimously in favor of generic that biosimilar companies will not have to wait an additional six months after FDA approval to launch their product. The case concern a biologic product filgrastim marketed by Amgen as Neupogen since 1991 and claims to hold patents on methods of […]
The Supreme Court of the United States in SCA Hygiene Prods. Aktiebolag, et al. v. First Quality Baby Prods., LLC, et al. dated March 21, 2017, has held that the equitable defense of laches is no longer a valid defense to patent damages claims brought within the six-year damages limitation period of 35 U.S.C. § 286. Section 286 “Except as otherwise […]
By judgement and order dated Mar. 08 2017, a single judge of the Delhi High court interpreted the Bolar provision in India (section 107 A). Whether the language of section 107 A of the Patent Act, 1970 permits exports from India of the patented invention, even if solely for uses reasonable related to the development and submission of information required […]
On October 20, 2016 federal court in Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc. addressed the effect of the supreme court decision in Cuozzo Speed, on the issue of whether termination of instituted inter partes review (“IPR”) proceedings based on a failure to meet the statutory filing requirements for a petition would be barred from review by 35 U.S.C. § 314(d) [under Cuozzo […]
Original New Drug Application (NDA and BLA) New molecular entity_ Approvals-May 2016 Active Ingredient(s); Drug name Company Approval Date FLUCICLOVINE; AXUMIN (NDA) BLUE EARTH DIAGNOSTICS LTD 27/05/2016 DACLIZUMAB; ZINBRYTA (BLA) BIOGEN 27/05/2016
India has decided against giving the compulsory licence for Anglo-Swedish drugmaker AstraZeneca’s key antidiabetes compound Saxagliptin sought by Hyderabad-based Lee Pharma. The Controller of Patents office rejected the application on the grounds that substitutes to the drug are readily available in the market and Lee Pharma’s claim that requirements of public with respect to the patented invention are not being […]
Indian Patent office in an Order Dated: 31/12/2015, has streamlined numbering system of Patent applications and also request for examination filed. This numbering system will be implemented from 1st Jan 2016. According to the new numbering system the patent applications shall have 12 characters length with format YYYYJTNNNNNN, where YYYY denotes year of filing, J denotes jurisdiction (1: Delhi 2: […]
New Molecular Entity and New Therapeutic Biological Product Approvals Drug Name Active Ingredient Date FDA-approved use on approval date Daklinza daclatasvir 7/24/2015 To treat chronic hepatitis C virus (HCV) genotype 3 infections Odomzo sonidegib 7/24/2015 To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation […]