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Biogen triumphs; Lilly, Pfizer, Ipsen back; Court nixes; Mylan EpiPen recall

Apr 04, 2017

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Biogen triumphs in latest Tecfidera patent dispute

Biogen has prevailed in a patent squabble with Denmark’s Forward Pharma over multiple sclerosis med Tecfidera—but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward could not declare patent infringement by Biogen. The verdict kept Biogen’s Tecfidera IP intact and secured exclusivity through 2028. It’s an outcome that is worth about $5 of upside to Biogen’s stock. In January, Biogen hedged the outcome of the Forward challenge by agreeing to a $1.25 billion settlement with the Danish pharma. The deal would have allowed it to license Forward’s IP to shield Tecfidera had the PTAB ruling not gone its way. But now that its own IP shield can stay, Biogen will not need to use Forward’s IP, and it also will not owe a royalty contingent for that settlement worth 10% of U.S. sales.

Lilly, Pfizer, Ipsen back Sanofi and Regeneron in PCSK9 patent appeal, AbbVie doesn’t

Big Pharma is enthralled with the Amgen vs. Sanofi patent fight, as its outcome could affect their in-development meds. Amgen, which makes the cholesterol-fighting Repatha, is asserting an antibody patent that, if upheld, could give the California biotech the power to push Sanofi and Regeneron’s rival PCSK9 drug off the market. And it’s a type of patent that has the potential to allow Amgen—and other drugmakers in other fields—to stake out a claim to an entire class of therapies, or so Sanofi’s legal team said in a recent phone conference with reporters. And that’s why drugmakers have been weighing in with amicus curiae briefs at the U.S. Appeals Court for the Federal Circuit, which hears all patent appeals—Pfizer, Eli Lilly and Ipsen among them. The lone outlier, at least so far is AbbVie. AbbVie’s brief contends that antibodies are expensive to develop, and without strong patent protections that limit competition, wouldn’t be worth the expense. Patent protection may mean drugs cost more in the short run, but that’s the price of developing new and complex biologic treatments, the brief states.

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Court nixes Acorda patents, teeing up Ampyra generics

Acorda Therapeutics’ IP protection on Ampyra may have held up against pharma patent challenger Kyle Bass at the U.S. Patent and Trademark Office, but it didn’t do the same in court. A U.S. District Court stamped out four of the company’s five patents on the med for multiple sclerosis patients, dubbing them invalid on the grounds of obviousness. It kept just one—a sustained-release patent set to expire in mid-2018—meaning generic competition in 2018 is “realistic,” Leerink Partners analyst Paul Matteis wrote in a note to clients. Ardsley, NY-based Acorda, unsurprisingly, plans to appeal the decision, but it’s not going to sit back and wait for an about-face in court. The company has developed contingency plans for early Ampyra generics, and it “will provide an update after finalizing the implementation timeline”.

Mylan EpiPen recall goes global but company says it has plenty of replacements

A recall of potentially malfunctioning EpiPens that Mylan first announced for Europe, Japan and Asia has now gone global, including the U.S., with the company retrieving tens of thousands more. Mylan, however, says it has plenty of replacements to avoid any interruptions in supply. The drugmaker announced the expanded recall of late Friday after the markets closed. According to the FDA, Mylan is voluntarily recalling the 0.3 mg and 0.15 mg strengths of EpiPen and EpiPen Jr. Auto-Injector because of a problem that may keep them from activating. The recall does not include any of its Mylan’s new authorized generic EpiPens. The first recall was for Japan, Australia and some markets in Europe. Now it has been expanded to the U.S. as well as additional markets in Europe, Asia and North and South America.