Mylan Pharmaceuticals Inc v. Warner Chilcott Public Limited, 2016 U.S. App. LEXIS 17599

Mylan filed Sherman Act §§1, 2 and tortious interference claims against Warner Chilcott and Mayne; the district court granted some motions and denied others, ultimately granting summary judgment for defendants on antitrust claims.
Hatch-Waxman framework allows generics to rely on a brand NDA via ANDA with AB-rating, enabling substitution under state laws and affecting competition dynamics.
Doryx proceeded from capsules to tablets; defendants implemented a series of product changes (hops) starting in 2005 to shift market dynamics toward newer formulations.
Mylan pursued generic versions (capsule and later tablets); FDA approvals and exclusivity periods affected timing and competitive entry.
Defendants’ four identified hops altered dosage forms or scoring, triggering new AB-rating requirements for generics and potentially affecting substitution advantages.
District Court held the market broader than Doryx alone and that defendants never held monopoly power exceeding about 18% in the relevant market; this influenced the disposition of both §1 and §2 claims.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether defendants had monopoly power in the relevant market under §2	Mylan asserts market power in a Doryx-focused market.	Market is broader (oral tetracyclines for acne) and defendants never surpassed a dominant share.	No monopoly power; market broader and share capped at ~18%.
Whether defendants engaged in attempted or actual monopolization under §2	Product hops were intended to delay generic entry and raise barriers.	Hops served non-pretextual, procompetitive purposes with reasonable justification.	No anticompetitive monopolization or attempted monopolization proven under Microsoft framework.
Whether defendants’ product hops violated §1 restraint of trade	Aggregated hops constituted unlawful collusion to restrain trade.	No illegal restraint; changes were procompetitive or non-anticompetitive.	No §1 violation; no anticompetitive conduct established.
Whether the case should be decided under a Microsoft framework balancing procompetitive and anticompetitive effects	Microsoft framework should reveal anticompetitive product redesign.	Framework not satisfied; broader market context and affordability arguments negate liability.	Court affirms grant of summary judgment; no anticompetitive product hopping found.

Broadcom Corp. v. Qualcomm Inc., 501 F.3d 297 (3d Cir. 2007) (monopoly power shown via direct/indirect evidence; power to control prices and exclude competition)
United States v. Grinnell Corp., 384 U.S. 563 (U.S. 1966) (monopoly power elements under §2)
Microsoft Corp. v. United States, 253 F.3d 34 (D.C. Cir. 2001) (Microsoft framework for rule-of-reason antitrust analysis)
New York ex rel. Schneiderman v. Actavis PLC (Namenda), 787 F.3d 638 (2d Cir. 2015) (cadence on patent cliffs and substitution impacts; relevance to product-hopping theory)