FDA

Recent decline in case filings: Lex Machina ANDA Litigation

On Thursday, April 27th, legal data analytics firm Lex Machina released a Hatch-Waxman/ANDA litigation report detailing trends and key findings from pharmaceutical cases filed in U.S. district courts between January 1st, 2009, and March 31st, 2017. More than eight years worth of data shows that patent infringement case filings in response to abbreviated new drug applications (ANDAs) filed [...]

By |2017-09-07T17:57:10+05:30May 9th, 2017|International, IP Basics|0 Comments

Federal circuit clarifies on On-Sale bar

On April 6, 2001, before the critical date, Helsinn entered into two agreements with MGI Pharma, Inc., including a Supply and Purchase Agreement. The agreements were announced via press release, which included redacted copies (price and specific dosage formulations were omitted). The Supply and Purchase Agreement included a provision conditioning performance on favorable clinical [...]

By |2017-09-07T18:03:02+05:30May 8th, 2017|International, IP Interview|0 Comments

Win-Win for All: FDA Approves Olmesartan Generic

In the  1st week of November FDA approved generic versions of Olmesartan and its combinations with amlodipine and/or hydrochlorothiazide. The development would have been quite contempt but for the 180-day exclusivity granted to Mylan for its generic equivalents of Benicar® and Benicar® HCT drug products. As readers with even very little attachment to lawsuits [...]

By |2017-09-08T13:15:25+05:30December 28th, 2016|Patent, USA|0 Comments

FDA Approves Olmesartan Generics

As readers with even very little attachment to lawsuits on intersection of patent and FDA law would know that this drug product had been a subject of herculean tug o’ war between generic rivals- Mylan (Mylan N.V. is an American global generic and specialty pharmaceuticals company registered in the Netherlands, with principal executive offices [...]

By |2017-09-08T13:39:14+05:30December 23rd, 2016|Patent|0 Comments

Impact of patent expiration on Pharmaceutical Industry

Patents, an exclusive right granted to the inventor by the government of the country for exploitation of his invention by use, sell or licensing the patent. With patents, inventor tries to cover up and gain from the research inventor has already carried out. Patents are used by an inventor to protect his invention; invention [...]

By |2017-09-07T13:31:26+05:30October 8th, 2012|International, IP Basics|0 Comments
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