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The Medicines Company’s ( MDCO - Analyst Report) shares dropped 15.48% after the U.S. District Court of Delaware found that Hospira Inc.’s generic version of The Medicines Co.’s Angiomax (bivalirudin) does not infringe the patents. Angiomax is used as an anticoagulant in patients undergoing coronary angioplasty.
What Does Trial Opinion Say?
Although a final judgment has not been released by the Court, on Mar 31, 2014, Judge Andrews in the U.S. District Court of Delaware issued his trial opinion regarding the generic Angiomax related case between The Medicines Co. and Hospira.
The Court found The Medicines Co.’s patents (U.S. Patent Nos. 7,582,727 and 7,598,343) to be valid and Hospira had failed to prove that the patents were anticipated and/or obvious. Additionally, the Court was of the opinion that the patents satisfied the written description requirement, were enabled and were not indefinite. The '727 and '343 patents are set to expire in Jul 2028 excluding a six-month period of pediatric exclusivity.
However, the Court found that Hospira's abbreviated new drug applications for its generic version of Angiomax did not meet the efficient mixing claim limitation and did not infringe the above mentioned patents. How Does it Affect The Medicines Co.?
Angiomax is the company’s lead product, with U.S. sales accounting almost 80% of total revenues in 2013. Sooner-than-expected entry of Angiomax generics would be a huge setback for the company.
While the company settled its patent infringement lawsuit with Teva Pharmaceutical Industries Ltd. ( TEVA - Analyst Report) and APP Pharmaceuticals (a division of Fresenius Kabi), other generic makers continue to seek approval for their generic versions of the product. As per the settlement agreement, generic versions of Angiomax could hit the market as early as May 1, 2019.
The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Gilead Sciences Inc. ( GILD - Analyst Report) . The stock carries a Zacks Rank #1 (Strong Buy).