Apotex, Inc. v. Cephalon, Inc.

321 F.R.D. 220, 2017 WL 2215262
CourtDistrict Court, E.D. Pennsylvania
DecidedMay 19, 2017
DocketCIVIL ACTION No. 2:06-cv-2768
StatusPublished
Cited by11 cases

This text of 321 F.R.D. 220 (Apotex, Inc. v. Cephalon, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Apotex, Inc. v. Cephalon, Inc., 321 F.R.D. 220, 2017 WL 2215262 (E.D. Pa. 2017).

Opinion

MEMORANDUM OPINION

Goldberg, District Judge

This antitrust ease involves allegations that four reverse-payment settlement agreements entered into by a brand-name drug manufac[224]*224turer and four generic drug companies constitute antitrust violations under the Sherman Act.1 Apotex, Inc,, a generic competitor, and other Plaintiffs claim that these settlement agreements were created and signed with the purpose of delaying the market entry of generic versions of the brand-name pharmaceutical, Provigil. Defendants maintain that the agreements were legitimate settlements of Hatch-Waxman patent litigation and contained procompetitive terms.

A liability trial is currently scheduled for June 5, 2017. As a result of various settlements and the procedural postures of the other related cases, the only plaintiffs in that trial are Apotex and a group of owners and operators of retail pharmacies who filed them own separate actions. Over the course of this litigation, these plaintiffs have been referred to as “Individual Plaintiffs,” “Retailer Plaintiffs,” “Opt-Out Plaintiffs” and “Merchant Plaintiffs.” The only defendants in the June trial are Mylan and Ranbaxy.

This Opinion addresses Mylan and Ran-baxjfs motion challenging the damages analysis set forth by Apotex’s expert, Dr. Hal Singer, under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1998).2 For the reasons that follow, Defendants’ motion will be granted in part and denied in part.

I. FACTUAL AND PROCEDURAL BACKGROUND

A. Hatch-Waxman Administrative Framework

The Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, commonly known as the Hatch-Wax-man Act, is designed to encourage the development and marketing of generic versions of approved drugs. It allows generic manufacturers to file an Abbreviated New Drug Application (“ANDA”) when seeking approval from the Food and Drug Administration (“FDA”) to market a generic version of an approved drug. See Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1282 (Fed. Cir. 2008).

ANDA filers must submit one of four certifications addressing any and all patents covering the brand-name drug, certifying either: (1) that the relevant patent information has not been filed with the FDA; (2) that such patent has expired; (3) the date that such patent will expire; or (4) “that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.” Id. at 1282-83 (quoting 21 U.S.C. § 355(j)(2)(A)(vii)). “If a generic drug company seeks to market a generic version of a listed drug before the expiration of the Orange-Book-listed patents3 covering that drug, it must file a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), i.e. a ‘Paragraph IV certification.’” Id. at 1283 (citing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990)).

Filing a Paragraph IV ANDA constitutes an act of patent infringement, often prompting the patent holder to file a lawsuit. However, as an incentive to generic companies to challenge weak patents, the first applicant to file an ANDA with a Paragraph IV certification is entitled to a 180-day period of exclusivity for its generic drug beginning on the first day it markets its drug commercial[225]*225ly. Federal Trade Commission v. Actavis, Inc., 570 U.S. 136, 133 S.Ct. 2223, 2228-29, 186 L.Ed.2d 343 (2013).

When a patent holder files an infringement lawsuit within forty-five days of a Paragraph IV ANDA filing, the FDA is barred from approving the generic company’s ANDA for a period of 30 months. 21 U.S.C. § 355(j)(5)(B)(iii). If the case is resolved during the 30-month stay, the FDA will take action on the ANDA consistent with the court’s judgment. Actavis, 133 S.Ct. at 2228. If the case is still ongoing at the end of the 30-month period, the FDA may grant final approval on the ANDA, at which point the generic company will have to decide whether to sell its drug “at risk” of incurring damages should the Paragraph IV litigation result in a judgment favorable to the patent holder. Id.

B. Factual History

In 1997, Cephalon was issued U.S. Patent No. 5,618,845, covering specific formulations of modafinil, the active pharmaceutical ingredient (“API”) in Provigil. Cephalon was granted a reissue patent on modafinil, U.S. Patent No. RE 37,516 (“the RE ’516 patent”), in 2002, which was scheduled to expire October 6, 2014.4

Modafinil is a wakefulness-promoting agent used to treat narcolepsy and other sleep disorders. On December 24, 2002, the Generic Defendants each filed an ANDA seeking to market generic versions of Provi-gil, and each filed a Paragraph IV certification with the FDA indicating that Cephalon’s RE ’516 patent was either invalid or the generic products did not infringe the patent. Because each of the Generic Defendants filed ANDAs on the first possible day, all were eligible to share the 180-day first filer exclusivity. On March 28, 2003, Cephalon sued the Generic Defendants for patent infringement, (the “Paragraph IV litigation”), triggering an automatic thirty-month stay on the approval of their ANDAs.

The Paragraph IV litigation between Ce-phalon and the Generic Defendants settled between December 2005 and February 2006, while the Generic Defendants’ motions for summary judgment were pending. All of the settlement agreements included a provision by which Cephalon granted the Generic Defendants a license to market their generic modafinil products on a “date certain” — April 6, 2012. Aso, all of the settlement agreements provided that the Generic Defendants could enter the market earlier than the date certain if: (1) Cephalon licensed any other generic manufacturer to market generic mo-dafinil prior to the date certain; (2) another generic decided to launch “at risk”; or (3) if a judgment declared that generic modafinil may be sold without infringing the RE ’516 patent (“the Contingent Launch Provisions”). Through a series of contemporaneous agreements reached at or around the time of settlement, Cephalon paid the Generic Defendants a total of approximately $300 million.

Apotex alleges that had the Paragraph IV litigation continued, the RE ’516 patent would have been declared invalid, not infringed by the Generic Defendants’ products, and unenforceable due to Cephalon’s fraud in the procurement of the patent. Apotex explains that due to the Generic Defendants maintaining the 180-day first filer exclusivity while agreeing to stay off of the market through 2012, a “bottleneck” was created, preventing Apotex and other generic drug companies from entering the market.

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321 F.R.D. 220, 2017 WL 2215262, Counsel Stack Legal Research, https://law.counselstack.com/opinion/apotex-inc-v-cephalon-inc-paed-2017.