Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Oct. 18 — Mylan Pharmaceuticals Inc. has asked a federal appeals court to rehear its appeal in a case alleging that other drugmakers tried to monopolize the market for its branded antibiotic Doryx ( Mylan Pharm., Inc. v. Warner Chilcott Pub. Ltd. , 3d Cir., No. 15-2236, rehearing sought 10/14/16 ).
The case involves product hopping, a practice in which branded pharmaceutical companies extend a branded drug’s patent protection by patenting minor modifications to the drug, then move the market to the reformulated version of the drug.
In a petition for rehearing filed with the U.S. Court of Appeals for the Third Circuit Oct. 17, Mylan said the appeals court panel’s September decision, finding that Mylan’s product-hopping claim against Mayne Pharma and Warner Chilcott (now part of Allergan) didn't allege an antitrust violation, conflicts with prior Third Circuit and U.S. Supreme Court precedent.
If the panel’s decision is allowed to stand, Mylan says, it could cost prescription drug purchasers billions of dollars by delaying consumer access to cheaper generic drugs.
In September, the panel affirmed a district court’s dismissal of Mylan’s product-hopping claim, finding no antitrust violation. Even though Mayne and Warner engaged in “hops” to exclude generics from the market, the Third Circuit panel said Mylan failed to show their behavior harmed competition or even kept Mylan from making “generous profits” on generic Doryx (doxycycline hyclate).
The panel also expressed reservations about the validity of product-hopping as an antitrust claim, putting itself at odds with a recent Second Circuit opinion upholding similar claims involving Namenda, an Alzheimer’s treatment drug.
While petitions for rehearing aren’t granted very often, David Balto, an antitrust lawyer in private practice, and former policy director at the Federal Trade Commission, told Bloomberg BNA Oct. 18 that Mylan’s petition “hit a grand slam.”
Mylan’s petition addresses all the essential points the Third Circuit would care about, Balto said. Those points include Mylan’s argument that the panel’s decision is inconsistent with its own precedent and precedent in other circuits and the significant financial impact of the decision on consumers.
Balto, who filed a consumer groups’ amicus brief in the case supporting Mylan, says the Third Circuit will probably decide whether to require a reply brief in the case in the next week or so. He’s optimistic that the Third Circuit might rehear the case, especially given that court's expertise in pharmaceutical antitrust cases and the split between the Third Circuit and the Second Circuit on the viability of product-hopping claims.
Antitrust lawyer John W. Treece with Sidley Austin LLP’s Chicago office had a different take, telling Bloomberg BNA Oct. 18 that “it’s unlikely the Third Circuit will agree to rehear a case in which the decision was unanimous and turns on the specific detailed factual findings of the district court.”
Moreover, Treece said, even if the appellate court agrees to rehear the case, the evidentiary record in the case “suggests it would not change the outcome.”
To contact the reporter on this story: Dana A. Elfin in Washington at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
The petition is available at http://src.bna.com/jsE.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)