IP Law Daily, TOP STORY—FedCir: Injunction Against Generic Post-Menopause Osteoporosis Drug Manufacturers Denied, (Oct 12, 2012)

By Jody Coultas, J.D.

The federal district court in Newark, New Jersey did not err in refusing to grant drug manufacturer Hoffmann-La Roche, Inc. a preliminary injunction against generic drug manufacturers because Hoffman-La Roche was unlikely to succeed in overcoming the defendants’ obviousness challenge, according to the U.S. Court of Appeals for the Federal Circuit (Hoffmann-La Roche Inc. v. Apotex Inc., October 11, 2012, Lourie, A.).

Hoffman-La Roche, Inc. (“Roche”) held U.S. Patents 7,410,957 (the '957 patent) and 7,718,634 (the '634 patent), which cover the osteoporosis drug Boniva®. Both patents disclose and claim methods of treating osteoporosis by orally administering once a month a tablet that contains about 150 mg of a salt of ibandronic acid, which is the active ingredient in Boniva®.

The district court found that Roche failed to prove a likelihood that it would succeed in defending against obviousness challenges and refused to issue a preliminary injunction. While Roche’s instant appeal was pending, the court on summary judgment concluded that claims 1-8 of the '634 patent would have been obvious to those of skill in the art, relying on the prior art submitted during the motion for preliminary injunction as well as three additional references.

In order to establish a right to a preliminary injunction, a party must show a reasonable likelihood of success on the merits; irreparable harm if a preliminary injunction is not granted; the balance of hardships tipping in its favor; and the impact of the injunction on the public interest.

In order to prove a likelihood of success, Roche needed to show that the patents were valid and not obvious. Although the ultimate determination of obviousness is a question of law, it is based on several underlying factual findings, including (1) the scope and content of the prior art; (2) the level of ordinary skill in the pertinent art; (3) the differences between the claimed invention and the prior art; and (4) evidence of secondary factors, such as commercial success, long-felt need, and the failure of others.

The district court did not err in refusing to grant the preliminary injunction, according to the Federal Circuit. Roche argued that the district court erred by applying an “obvious to try” standard because the prior art taught multiple possible dosing regimens with unpredictable results and pointed to evidence that its success was not predictable. It was not clear error for the district court to find that the prior art disclosed every claim limitation and that, while uncertainties remained, the field was trending towards intermittent dosing based on the total dosing concept, including a once-monthly dose of 150 mg. Roche’s argument that the district court erred by failing to consider evidence of unexpected results also lacked merit because Roche failed to submit the secondary evidence as part of the motion to dismiss. The court noted that it owed the district court deference on review of the grant or denial of a preliminary injunction unless the district court abused its discretion or made clearly erroneous findings that affected the exercise of its discretion.

Dissent

A dissenting opinion, filed by Judge Newman, took issue with the majority panel’s considerations of the evidence and failure to evaluate the equitable factors of hardship and public interest. Judge Newman alleged that the majority took into account only that evidence which weighed on the side of invalidity, ignored the contrary evidence, and discarded the effect of the burden of proof.

In Judge Newman’s view, the outcome of the case was uncertain at the preliminary stages and the court should have taken into consideration the other factors necessary for a preliminary injunction. The fact that a patent examiner considered and rejected the asserted prior art weighed strongly against a preliminary finding that the patents were likely to be ruled obvious as a matter of law. The district court also apparently refused to consider Roche’s evidence of unpredictable results when it refused to issue the injunction. The equities in this case weighed on the side of preserving the status quo during the litigation as Roche’s successful product was the result of heavy risk-laden investment that the defendants now seek to benefit from without bearing the costs or risks.

The cases are Nos. 2012-1270, 2012-1271, and 2012-1272.

Mark E. Waddell (Loeb & Loeb LLP) for Hoffman-La Roche Inc. Deanne M. Mazzochi (Rakoczy Molino Mazzochi Siwik LLP) for Apotex Inc.

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