Mylan N.V. announced that the United States District Court for the District of Delaware has issued a decision in favor of the company pertaining to claims related to Teva Pharmaceutical’s TEVA Copaxone 40mg/mL.
The court declared all claims of four Orange Book-listed patents relating to Copaxone 40 mg/mL as invalid.
We note that the invalidated patents are United States Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development Co. Ltd. and licensed to Teva Pharmaceuticals Industries.
The news is expected to boost Mylan’s investors’ sentiments. As per IMS Health estimates, Copaxone generated sales of approximately $3.3 billion for the 12 months ending Nov 30, 2016 in the U.S.
Hence, a favorable ruling for the drug bodes well for Mylan.
We note that Momenta Pharmaceuticals MNTA is also looking to get approval for its generic version of 40-mg thrice-weekly formulation of Copaxone.
Earlier, in Dec 2016, the U.S. Patent and Trademark Office's U.S. Patent Trial and Appeal Board (PTAB) reaffirmed a prior decision that three of these patents ('250, '413 and '302) are unpatentable in its inter partes review (IPR) proceedings initiated by Mylan. In addition, Mylan also challenged the '776 patent in an IPR proceeding. The PTAB is expected to issue its institution ruling on the '776 patent IPR by May 16.
Per a report from Bloomberg, Mylan is facing an antitrust investigation in the U.S. related to competitive practices for EpiPen.
We remind investors that Mylan has been under immense pressure since Aug 2016. The increase in price of EpiPen, which it acquired in 2007, drew immense criticism from lawmakers, consumers and the common people alike.
Nevertheless, shares of Mylan have performed better than the Zacks categorized Medical-Generic Drugs industry in the past one year with the stock losing 30.6% compared to the industry’s decline of 32.5%.
Mylan currently carries a Zacks Rank #4 (Sell).
Key Pick in the Sector
Sucampo Pharmaceuticals, Inc. SCMP is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.58 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in the four trailing quarters with an average beat of 35.5%.
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