Portfolio Media. Inc. | 111 West 19th Street, 5th floor | New York, NY 10011 | www.law360.com
`
`Phone: +1 646 783 7100 | Fax: +1 646 783 7161 | customerservice@law360.com
`
`Law360's Product-Hopping Cheat Sheet For 2015
`
`By Melissa Lipman
`
`Law360, New York (March 13, 2015, 4:45 PM EDT) -- Despite a decade of litigation over so-
`called product-hopping, the Second Circuit will become the first appellate court to weigh
`whether pharmaceutical companies' efforts to preserve profits from blockbuster brands
`facing expiring patents can amount to an antitrust violation.
`
`The Second Circuit is set to hear oral arguments April 13 over whether a federal judge erred
`in granting New York's attorney general a preliminary injunction forcing Actavis PLC and its
`Forest Laboratories LLC unit to keep selling an older version of the Alzheimer's drug
`Namenda until generic-drug challengers can enter the market.
`
`Whatever the appeals court concludes will have significant repercussions for the
`industry generally and for a handful of other pending cases making similar claims over
`drugmakers' efforts to move the market to a new version of a treatment to avoid the steep
`drop in profits that follows patent expiration and generic market entry.
`
`Here, Law360 takes a look at the key cases so far.
`
`Case: Abbott Laboratories et al. v. Teva Pharmaceutical Industries Ltd.
`Court: U.S. District Court for the District of Delaware, U.S. District Judge Kent Jordan
`Drug: TriCor, cholesterol treatment
`Was the old version pulled from the market?: Yes
`Status: Settled after motion to dismiss denied
`
`One of the biggest and most successful product-hopping cases targeted Abbott Laboratories
`and Fournier Industrie et Sante over their repeated reformulations of cholesterol treatment
`TriCor.
`
`Generic-drug makers the pair had sued for patent infringement as well as purchasers and
`eventually two dozen states accused the companies of cutting off sales of the original
`formulation of the drug and buying back remaining stocks in order to thwart automatic
`generic substitution for the treatment.
`
`In 2006, a Delaware federal judge refused to dismiss the antitrust claims over the
`reformulations, citing the landmark Microsoft Corp. monopolization case and the regulatory
`restrictions within the pharmaceutical market.
`
`The judge pointed out that even though the generic-drug makers could still sell their version
`of the original formulation of the drug, it was enough for the plaintiffs to allege that Abbott
`
`Exhibit 1082
`ARGENTUM
`IPR2017-01053
`
`000001
`
`

`

`and Fournier's reformulation and withdrawal of the old versions of the drug kept the
`generic-drug companies from offering substitutes for the current formulation of TriCor.
`
`Abbott eventually agreed to pay $250 million to settle the class actions and reached a
`$22.5 million deal with the states in 2010.
`
`Case: Walgreen Co. et al. v. AstraZeneca Pharmaceuticals LP et al.
`Court: District of Columbia, U.S. District Judge Richard W. Roberts
`Drug: Prilosec, heartburn treatment
`Was the old version pulled from the market?: No
`Status: Dismissed
`
`Private plaintiffs had far less success with suits challenging AstraZeneca PLC's switch from
`Prilosec, whose patent protection expired in 2001, to a similar drug called Nexium and an
`over-the-counter version of the older heartburn treatment.
`
`The U.S. Food and Drug Administration had granted AstraZeneca exclusive rights to sell
`Prilosec without a prescription from 2003 through mid-2006, and Nexium remained under
`patent protection until 2014.
`
`AstraZeneca, however, never pulled Prilosec from the shelves.
`
`Even though the plaintiffs in the Prilosec suit pointed once again to the Microsoft ruling and
`the TriCor decision, the D.C. federal judge overseeing the case found the analogy a failed
`one. The difference, the judge reasoned, was that because AstraZeneca continued to sell
`the older product it had done nothing to limit consumer choice.
`
`Case: Mylan Pharmaceuticals Inc. et al. v. Warner Chilcott PLC et al.
`Court: Eastern District of Pennsylvania, U.S. District Judge Paul S. Diamond
`Drug: Doryx, oral antibiotic acne treatment
`Was the old version pulled from the market?: Yes — but the judge didn't mention it in
`his ruling
`Status: Partially settled; pending summary judgment motion
`
`In 2013, a Pennsylvania federal judge refused to dismiss product-hopping claims
`against Warner Chilcott PLC brought by Mylan Pharmaceuticals and a host of purchasers
`over acne medication Doryx.
`
`The court voiced skepticism about the plaintiffs' claims that the multiple reformulations of
`the drug amounted to an antitrust violation but called efforts to nix the case premature and
`denied the defendants' motion to dismiss without prejudice. Warner pulled the older version
`of the drug from shelves, according to the plaintiffs, but the judge made no explicit mention
`of that in his order.
`
`After the indirect purchasers lost their bid for class certification in late 2013, both the direct
`and indirect purchasers ended up signing settlements. Warner, which is now owned by
`Actavis, agreed to pay the direct purchasers $15 million and the indirect purchasers $8
`million.
`
`Mylan, however, is still pursuing the case and is now fighting for summary judgment.
`The generics maker recently pointed the court to the preliminary injunction ruling in the
`Namenda case.
`
`000002
`
`

`

`Case: In re: Suboxone Antitrust Litigation
`Court: Eastern District of Pennsylvania, U.S. District Judge Mitchell Goldberg
`Drug: Suboxone, opiate addiction treatment
`Was the drug pulled from the market?: Yes
`Status: Pending motion for reconsideration on motion to dismiss
`
`Filed in 2013, this multidistrict litigation brought by private purchasers accuses Reckitt
`Benckiser Inc. of using product-hopping to thwart generic-drug competition for opiate
`addiction treatment Suboxone.
`
`The company reformulated the drug from a tablet to a film, withdrew the old product from
`the market just as generics were able to begin sales and started claiming the tablets had
`safety issues, according to the plaintiffs.
`
`Even though Reckitt didn't have a patent on the drug, the FDA deemed the product an
`orphan drug and granted the company seven years of exclusivity. The company then began
`developing and seeking patents for a film formulation of the drug, according to the suit.
`
`In December, Judge Goldberg refused to dismiss the case, saying that allegations that
`Reckitt paired its introduction of the reformulated product with sufficiently "coercive"
`measures that limited consumer choice were enough for the case to go forward. The judge
`has not yet ruled on Reckitt's motion for reconsideration.
`
`The Federal Trade Commission is also looking into whether Reckitt abused its monopoly
`to switch the market to the new version of the drug and filed sham petitions with the FDA.
`
`Case: New York v. Actavis PLC et al.
`Court: Second Circuit
`Drug: Namenda, Alzheimer's treatment
`Was the drug pulled from the market?: Yes — that was the plan
`Status: Awaiting oral argument
`
`New York Attorney General Eric Schneiderman sued Actavis and Forest in September,
`saying that they planned to pull the drug from the market after few patients initially made
`the transition from the twice-a-day immediate release version of the Alzheimer's treatment
`to a once-a-day extended release version.
`
`Forest initially said in early 2014 that it would discontinue Namenda IR entirely in August
`but eventually shifted its plan amid the state investigation and supply problems with
`Namenda XR so that the older version of the drug would only be available through a
`specialty mail-order pharmacy with a prescription and a doctor's statement that it was
`medically necessary for the patient to keep using it.
`
`In December, however, U.S. District Judge Robert W. Sweet intervened, granting the
`state a preliminary injunction requiring the companies to keep the immediate release
`version of the drug on the market. Once again, the court looked to the Microsoft ruling
`among others to justify ruling for the plaintiffs.
`
`The court noted that just because the companies no longer planned to fully withdraw the
`drug from the market didn't mean they weren't restricting generic competition.
`
`Case: In re: Opana ER Antitrust Litigation
`Court: Northern District of Illinois, U.S. District Judge Harry D. Leinenweber
`
`000003
`
`

`

`Drug: Opana ER, painkiller
`Was the drug pulled from the market?: Yes
`Status: Consolidated into multidistrict litigation
`
`The most recently filed case combines pay-for-delay allegations with product-hopping
`claims.
`
`Six putative class actions accusing Endo Pharmaceuticals Inc. of paying Impax Laboratories
`Inc. more than $112 million to delay a generic version of Endo's opioid pain medication
`Opana ER were consolidated in Illinois in December.
`
`The suits maintain that the settlement gave Endo enough time to move the market to a
`newer version of the drug. With the additional two-year delay in generic launch from the
`pay-for-delay deal, Endo had enough time to secure approval for Opana ER CRF — a more
`crush-resistant form of the drug — and to stop selling the older version of the product to
`force doctors to start prescribing the newer, protected version, according to one complaint.
`
` A
`
` consolidated complaint has not yet been filed.
`
`
`--Additional reporting by Linda Chiem and Kelly Knaub. Editing by Katherine Rautenberg
`and Brian Baresch.
`
`Correction: A previous version of this article incorrectly stated the original form of the
`product at issue in the Doryx case. The error has been corrected.
`
`
`All Content © 2003-2018, Portfolio Media, Inc.
`
`
`
`000004
`
`