By Peter Loftus
A federal judge has upheld the validity of a U.S. patent covering Merck & Co.'s (>> Merck & Co., Inc.) Vytorin cholesterol-lowering drug, which could stave off competing generic copies for several years.
In an opinion released Friday, U.S. District Judge Jose Linares in federal court in Newark, N.J., said a patent for Vytorin was valid and enforceable.
Merck, based in Whitehouse Station, N.J., said in a recent regulatory filing it expects its U.S. exclusivity for Vytorin and a related drug, Zetia, to expire in April 2017.
Mylan Inc. (MYL) had applied for U.S. Food and Drug Administration approval to sell a generic version of Vytorin before its patent protection expired, arguing that the patent was invalid and unenforceable.
Schering-Plough, which was acquired by Merck in 2009, filed a patent-infringement lawsuit against Mylan in late 2009, seeking to block Mylan's product. A trial was held in December 2011, leading to Judge Linares's opinion Friday.
On a conference call with analysts Friday morning, Merck Chief Executive Kenneth Frazier said he was anticipating a favorable decision. "We believe this is a patent that is valid and enforceable," he said.
A Mylan spokeswoman couldn't immediately be reached.
Earlier Friday, Merck reported first-quarter Vytorin sales of $444 million and Zetia sales of $614 million.
Merck previously reached a settlement of patent litigation for Zetia with generics manufacturer Glenmark Pharmaceuticals. The pact will allow Glenmark to sell generic Zetia in December 2016, subject to final regulatory approval.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; [email protected]