Eurand, Inc. v. Impax Laboratories, Inc.

504 F. App'x 900
CourtCourt of Appeals for the Federal Circuit
DecidedFebruary 1, 2013
DocketNo. 2012-1280
StatusPublished
Cited by2 cases

This text of 504 F. App'x 900 (Eurand, Inc. v. Impax Laboratories, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Eurand, Inc. v. Impax Laboratories, Inc., 504 F. App'x 900 (Fed. Cir. 2013).

Opinion

O’MALLEY, Circuit Judge.

Impax Laboratories, Inc. (“Impax”) appeals from the November 8, 2011 decision of the United. States District Court for the District of Delaware explicitly adding Im-pax to a preliminary injunction originally entered in May 2011. The injunction barred all generic versions of AMRIX® from the market. Because Impax was subject to the May 2011 injunction and failed to file a timely appeal, we lack jurisdiction over Impax’s appeal of the district court’s November 8, 2011 order clarifying that injunction. Impax also complains of the district court’s failure to require Ce-phalon to post a bond in its favor upon entry of the injunction. Because we have no jurisdiction over Impax’s appeal from the injunction which bars its entry into the market for generic AMRIX®, we also have no jurisdiction to assess the niceties thereof. Impax next appeals from the district court’s refusal to modify or discontinue the injunction prospectively, following a motion asking that it do so. While we have jurisdiction over that aspect of Impax’s appeal, we affirm the district court’s conclusion that Impax failed to justify its request for modification. Impax finally appeals from the district court’s March 15, 2012 decision that Impax’s right to enter the generic market for extended-release cyclobenzaprine hydrochloride had not been triggered under the terms of Impax’s settlement agreement with Plaintiffs Ap-talis Pharmatech, Inc., Cephalon, Inc. and Anesta AG (collectively “Cephalon”). Because the district court correctly interpreted the agreement, however, we affirm.

I.

We only recite the facts necessary to address the current issues on appeal. A more detailed history of the underlying action appears in In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063 (Fed.Cir.2012).

Cephalon manufactures and sells AM-RIX®, an extended-release formulation of cyclobenzaprine hydrochloride. Cephalon is the owner of U.S. Patent Nos. 7,387,793 and 7,544,372 (collectively “patents-in-suit”), that cover the formulation of and method of administering AMRIX®. The United States Food and Drug Administration (“FDA”) approved Cephalon’s New Drug Application (“NDA”) for AMRIX® in 2007.

Shortly thereafter, Impax, Mylan Inc. and Mylan Pharmaceuticals, Inc. (collectively “Mylan”), and Par Pharmaceutical, Inc. (“Par”), among others, filed Abbreviated New Drug Applications (“ANDAs”) seeking FDA approval to make and sell generic versions of AMRIX®. Mylan, as the first party to file a complete Paragraph IV certification, was granted a 180-day exclusive marketing period for its generic product. See 23 U.S.C. § 355(j)(2)(A)(vii)(IV) (2006). Cephalon sued for patent infringement and proceeded to trial against Mylan, Par, and Impax, with Impax only participating in the validity portions of the trial.1 On the last day of [903]*903trial, Cephalon and Impax settled (“Ce-phalon-Impax Settlement Agreement”).

Cephalon granted Impax a non-exclusive license to the patents-in-suit as part of the parties’ agreement. Section 3.2 of the Ce-phalon-Impax Settlement Agreement controls the timing of Impax’s entry date into the generic market. Section 3.2 is entitled “License Effective Date,” and provides five different “triggering events,” upon the earliest of which Impax may enter the generic market. The first, and baseline date, is one year prior to the expiration of the '793 patent. Another trigger is when and if Cephalon grants a license to, or authorizes, a third party entitled to first-to-file exclusivity to sell a generic product following expiration of the exclusivity period. Im-pax would also be granted a right to enter the generic market should Cephalon license or authorize a third party, not entitled to first-to-file exclusivity, to sell a generic product. And, Impax may enter the market on the same date an ANDA filer with first-to-file exclusivity enters pri- or to that party obtaining a final non-appealable judgment of non-infringement, invalidity, or unenforceability of the patents-in-suit, otherwise known as an “at-risk” launch. Finally, Impax may enter the market if a third party obtains a final, non-appealable judgment of invalidity, un-enforceability, or non-infringement of the “Orange Book Patents,” following the expiration of any applicable first-to-file exclusivity period.

Upon the occurrence of a triggering event, Impax may choose to market either its own ANDA product, or an authorized generic supplied by Cephalon. Impax and Cephalon, however, also signed an attendant “Transfer Price Agreement” (“TPA”) on the same day as the settlement agreement. Impax, via the TPA, essentially surrendered its right to produce its own ANDA product and concedes that Cephal-on will be its sole and exclusive manufacturer of generic AMRIX®, unless Cephal-on fails to deliver the product. In other words, for all intents and purposes, Impax agreed not to pursue the sale of its own ANDA product in the near term, absent narrow circumstances. In return, Cephal-on agreed to, and did begin to, supply its generic product to Impax in anticipation of a possible triggering event by which Im-pax could enter the market with that product.

In addition to settling with Impax, Ce-phalon also made contingency plans to launch its own generic version of AM-RIX® should Mylan and the other defendants prevail at trial. As is common industry practice, Cephalon partnered with a generic company to gain access to generic distribution channels and marketing expertise. In May 2011, Cephalon entered a “Sales Agent Agreement” (“Cephalon-Watson Agreement”) naming Watson its sales agent for authorized generic versions of AMRIX® should the litigation result in an ANDA filer launching “at-risk.”

Watson was given the authority to solicit orders for Cephalon’s generic version of AMRIX®. Watson was required to notify customers that it was acting as Cephalon’s sales agent. The agreement stated that Cephalon maintained title of the generic drugs at all times, even when in Watson’s possession, until the drugs were transferred to the ultimate customer. The generic versions were also to be sold solely under Cephalon’s trademarks and product labeling. Watson was also foreclosed from marketing or selling any other generic ex[904]*904tended-release cyclobenzaprine hydrochloride product.

After the bench trial, on May 12, 2011, the district court issued an order finding the asserted claims of the patents-in-suit invalid as obvious. Mylan launched “at-risk” the next day. That same day, Ce-phalon instructed Watson to begin soliciting orders for Cephalon’s authorized generic version of AMRIX®. On May 24, 2011, the district court enjoined Mylan and Cephalon, along with all persons “acting in active concert or participation” with them, from selling generic versions of AMRIX® so as to maintain the status quo pending the outcome of any appeals from its invalidity ruling. In other words, the district court sought to prohibit all generic versions of AMRIX® from entering the market while its order effectively authorizing such entry was affirmed on appeal. Ce-phalon appealed the invalidity finding. Mylan appealed the injunction.

After the May 24, 2011 injunction, neither Mylan, Cephalon/Watson, nor Impax sold or offered to sell any generic extended-release cyclobenzaprine product.2 This court heard oral argument in the pending appeals on September 7, 2011 and took the matter under advisement.

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Bluebook (online)
504 F. App'x 900, Counsel Stack Legal Research, https://law.counselstack.com/opinion/eurand-inc-v-impax-laboratories-inc-cafc-2013.