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US Pharmaceutical sector

Anticompetitive practices

The US Court of Appeals for the Third Circuit offers misguided analysis of product hopping (Mayne / Warner Chilcott / Mylan)
Rutgers University
On September 28, 2016, the U.S. Court of Appeals for the Third Circuit issued a misguided ruling granting defendants’ motion for summary judgment and ignoring the regulatory framework relevant to “product hopping,” by which a drug company switches from one version of a drug to another, sometimes (...)

The US Court of Appeal for the Second Circuit reverses a price-fixing cartel verdict against Chinese defendants on international comity grounds (Vitamin C)
Cleary Gottlieb Steen & Hamilton (Rome)
Second Circuit reverses a price-fixing cartel verdict against Chinese defendants on international comity grounds* On 20 September 2016, the United States Court of Appeals for the Second Circuit (the “Appeals court”) in New York reversed a federal district court judgment in an antitrust lawsuit (...)

The U.S. FTC urges the Court of Appeals for the First Circuit to consider that a reverse payment need not be in cash (Loestrin)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC urges the Appeals Court to revive the Loestrin Suit* On December 7, 2015, during oral argument, the U.S. FTC urged the Court of Appeals for the First Circuit to revive the Loestrin suit. The case concerns a so-called reverse payment settlement. In 2009 Watson Pharmaceuticals agreed (...)

The US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)
Rutgers University
On February 22, 2016, in the second federal appellate drug patent settlement ruling since the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013), the U.S. Court of Appeals for the First Circuit vacated a lower court decision granting a motion to dismiss for defendants. Writing (...)

The US District Court for the Southern District of New York dismisses lawsuit over patent settlement where generics were granted early-entry licenses with acceleration clauses (Takeda Pharmaceuticals)
Siemens (New York)
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Patterson Belknap Webb & Tyler (New York)
Better Early than Never: SDNY Dismisses Lawsuit over Patent Settlement where Generics were Granted Early-Entry Licenses with Acceleration Clauses* On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three (...)

The US FTC subjects to public comment the consent agreement proposed by two pharmaceutical companies that implemented an unlawful agreement not to compete (Concordia and Par)
US Federal Trade Commission (FTC) (Washington DC)
Pharmaceutical companies settle ftc charges of an illegal agreement not to compete, which resulted in higher prices for generic version of ADHD drug* Pharmaceutical companies Concordia Pharmaceuticals Inc. and Par Pharmaceutical, Inc. have settled FTC charges that they entered into an unlawful (...)

The US District Court for the District of Massachusetts rejects a request for a new trial to challenge a “pay-for-delay” agreement (Nexium)
Wolters Kluwer (Riverwoods)
Judgment for Drug Companies Unlikely the End of the Road in Nexium Case* The federal district court in Boston has rejected a request from purchasers of AstraZeneca LP’s heartburn medication Nexium for a new trial to challenge a “reverse payment” or “pay-for-delay” agreement between AstraZeneca and (...)

The US District Court for the Northern District of California upholds assignment of antitrust claims to indirect purchasers (United Food / Teikoku Pharma)
Patterson Belknap Webb & Tyler (New York)
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Patterson Belknap Webb & Tyler (New York)
Northern District of California Upholds Assignment of Antitrust Claims to Indirect Purchasers* Portions of a reverse payment suit against Endo Pharmaceuticals and others were recently dismissed by Judge William H. Orrick of the Northern District of California. The case [1] was brought by (...)

The U.S. Court of Appeals for the Third Circuit concludes that the Actavis ruling applies to non-cash payments (Lamictal)
Rutgers University
On June 26, 2015, in the first federal appellate drug patent settlement ruling since the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013), the U.S. Court of Appeals for the Third Circuit overturned a lower court decision granting a motion to dismiss for defendants. Writing for (...)

The Court of Appeal for the District of Columbia rejects a challenge to an FTC rule that makes the HSR Act reporting requirements cover pharmaceutical patent licenses that transfer all commercially significant rights (PhRMA)
Jones Day (Washington DC)
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Jones Day (Washington DC)
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Jones Day (Chicago)
The D.C. Circuit has rejected a challenge by the Pharmaceutical Research and Manufacturers of America ("PhRMA") to an FTC rule that makes the HSR Act reporting requirements cover pharmaceutical patent licenses that transfer "all commercially significant rights." The rule, adopted in 2013, (...)

The US FTC reaches record $1.2 billion proposed “pay for delay” settlement and injunctive relief restricting future similar settlements of patent infringement cases (Cephalon)
Weil, Gotshal & Manges (New York)
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Weil, Gotshal & Manges (New York)
Federal Trade Commission Reaches Record $1.2 Billion Proposed “Pay for Delay” Settlement with Cephalon and Injunctive Relief Restricting Future Similar Settlements of Patent Infringement Cases* Last week, on the eve of trial, the Federal Trade Commission (“FTC”) reached a proposed settlement in (...)

The US FTC reaches a settlement with a pharmaceutical company and continues march “to set a standard for the industry” in pay-for-delay settlements cases (Cephalon)
Sheppard Mullin (Los Angeles)
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Sheppard Mullin (Washington)
Federal Trade Commission Continues March “to Set a Standard for the Industry” with Cephalon Settlement* On May 28, the Federal Trade Commission (“FTC”) announced it had reached a $1.2 billion settlement with Teva Pharmaceuticals, which acquired Cephalon in 2012, over reverse payment for its (...)

The US Court of Appeals for the Second Circuit addresses pharmaceutical “product hopping” in decision barring a producer from pulling older version of drug from shelves (Actavis)
Winston & Strawn (Washington)
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Winston & Strawn (Washington)
Few courts have addressed antitrust challenges to pharmaceutical “product hopping,” i.e., the practice of shifting customers from a drug nearing the end of its patent protection to a modified version that is covered by newer patents and thus is protected from generic competition for a longer (...)

The California Supreme Court delineates a structured rule of reason analysis for evaluating reverse payments or pay-for-delay settlements (Cipro)
Sheppard Mullin (Los Angeles)
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Sheppard Mullin (Washington)
California Supreme Court Delineates a Structured Rule of Reason Analysis for Evaluating Reverse Payment or Pay-for-Delay Settlements* On May 7, 2015, the California Supreme Court issued its long-awaited decision in In re Cipro Cases I & II, Case No. S198616 (May 7, 2015) (Cipro). Cipro (...)

The California Supreme Court crafts "structured rule of reason" test for evaluating pay-for-delay settlements (Cipro)
Siemens (New York)
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Patterson Belknap Webb & Tyler (New York)
Following Actavis, California Supreme Court Crafts “Structured Rule of Reason” Test for Evaluating Pay-for-Delay Settlements* Last Thursday the Supreme Court of California decided In re Cipro Cases I & II, No. S198616 (Cal. May 7, 2015), holding that reverse payment, or “pay-for-delay,” (...)

The US District Court for the Eastern District of Pennsylvania holds that Actavis does not require plaintiffs to meet any sort of “threshold burden” for establishing that a large reverse payment is unjustified to trigger analysis under the antitrust rule of reason (Modafinil)
Labaton Sucharow (New York)
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Arnold & Porter Kaye Scholer (Washington)
In re Modafinil Litigation Finds No “Threshold Burden” in Reverse Payment Suit* On Wednesday, January 28, in King Drug Company of Florence, Inc. v.Cephalon, Inc. (In re Modafinil), the US District Court for the Eastern District of Pennsylvania held that FTC v. Actavis, 133 S. Ct. 2223 (2013), (...)

The U.S. District Court for the Eastern District of Pennsylvania sends second reverse-payment case to trial (Cephalon)
Rutgers University
On January 28, 2015, Judge Mitchell Goldberg of the U.S. District Court for the Eastern District of Pennsylvania denied defendants’ summary judgment motions, sending the second reverse-payment-settlement case to trial. In King Drug Company of Florence v. Cephalon, 2015 WL 356913 (E.D. Pa. Jan. (...)

A US appellate panel questions whether reverse payments need to be in cash to put the patent settlement under the scrutiny of antitrust laws (GlaxoSmithKline)
DLA Piper Weiss-Tessbach (Vienna)
Reverse payments can be non-cash according to appellate judges* On 19 November 2014 in a hearing regarding the possible reopening of a lawsuit over whether GlaxoSmithKline (GSK) unfairly extended the monopoly on its drug Lamictal, an appellate panel of the Third Circuit suggested that reverse (...)

The US District Court for the District of New Jersey reminds that even if a Court accepts the premise of a reverse non-monetary payment after Actavis, plaintiffs may have to allege facts to allow an estimate of the monetary value of that settlement or risk facing dismissal (Lipitor)
Siemens (New York)
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Patterson Belknap Webb & Tyler (New York)
Plausibly Alleging Non-monetary Settlements as Reverse Payments After Actavis* In In re Lipitor Antitrust Litigation, No. 12 Civ. 2389 (D.N.J.), U.S. District Judge Peter G. Sheridan has confirmed his prior ruling that under the Supreme Court’s decisions in Twombly, Iqbal, and FTC v. Actavis, (...)

The US FTC files a federal antitrust complaint for the Eastern District of Pennsylvania for entering into an agreement to maintain a monopoly over and restrain generic competition (AbbVie, Abbott, Besins Healthcare and Teva)
Skadden, Arps, Slate, Meagher & Flom (New York)
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Skadden, Arps, Slate, Meagher & Flom (Washington DC)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging (...)

The US FTC files a complaint before the District Court for the Eastern District of Pennsylvania asserting that reverse payments do not have to be cash or monetary in order to violate antitrust laws (AbbVie)
Constantine Cannon (New York)
Regulators Prescribing Higher Dose Of Pharmaceutical Antitrust Enforcement* Antitrust enforcers returned to their offices after Labor Day, refreshed and ready to tackle what they view to be anticompetitive practices by pharmaceutical companies to delay entry of lower-priced generic drugs. In (...)

The US FTC files a complaint against five pharmaceutical companies for pay-for-delay settlements (AbbVie)
Skadden, Arps, Slate, Meagher & Flom (New York)
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Skadden, Arps, Slate, Meagher & Flom (Washington DC)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging (...)

The U.S. District Court for the District of Rhode Island issues concerning ruling on drug patent settlements (Loestrin)
Rutgers University
On September 4, 2014, Judge William Smith of the U.S. District Court for the District of Rhode Island issued a concerning ruling on drug patent settlements. In In re Loestrin 24 FE Antitrust Litigation, 2014 WL 4368924 (D.R.I., Sept. 4, 2014), Judge Smith misapplied the Supreme Court’s landmark (...)

The US District Court for the Eastern District of Pennsylvania holds that a firm which has engaged in fraud on the patent office cannot stand on its patent to defend reverse payment antitrust claims (Cephalon)
Sheppard Mullin (San Francisco)
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Paul Hastings (Washington)
Last year in a landmark decision, the Supreme Court ruled that pharmaceutical “reverse payment” settlements in Hatch-Waxman Act “Paragraph 4” patent litigation are subject to challenge, departing from the rule that most Circuits had adopted. FTC v. Actavis, 133 S.Ct. 2223 (2013). In these cases, (...)

The US FTC files an amicus brief in the Court of Appeals explaining that commitment not to compete raises the same antitrust concerns as the reverse-payment patent settlements (King Drug / SmithKlineBeecham)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC files an amicus brief in the Court of Appeal urging to reverse the District Court finding in the Lamictal Direct Purchase Antitrust Litigation* On 28 April, 2014 the Federal Trade Commission (“FTC”) filed an amicus brief in the Court of Appeals for the Third Circuit in the (...)

The US Supreme Court holds that reverse-payment patent settlements should be reviewed under the antitrust rule of reason (Actavis)
Gibson Dunn (Washington)
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O’Melveny & Myers (Los Angeles)
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O’Melveny & Myers (Los Angeles)
But Decision Raises as Many Questions as it Answers The Supreme Court yesterday held that it may be unlawful under the antitrust laws for a brand-name drug manufacturer to resolve patent litigation against an allegedly infringing generic drug maker by paying the generic to forestall market (...)

The US Supreme Court rules that a payment by a patentee to a generic manufacturer may constitute an infringement of antitrust law (Actavis)
Orrick, Herrington & Sutcliffe (San Francisco)
Why FTC v. Actavis Won’t Shift the Border Between IP and Antitrust Law* The Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc., No. 12-416, ___ U.S. ___ (2013), has generated a lot of commentary recently. Some articles have suggested that the decision may expose certain (...)

The US Supreme Court issues first ruling on antitrust legality of reverse-payment drug patent settlements (Actavis)
Rutgers University
On June 17, 2013, in FTC v. Actavis, the U.S. Supreme Court for the first time examined the antitrust legality of agreements by which brand-name drug companies pay generics to delay entering the market. Justice Stephen Breyer wrote the majority opinion for five Justices, concluding that these (...)

The US Supreme Court rules that the “pay for delay” settlements in the pharmaceutical sector are to be analyzed under the rule of reason (Actavis)
European Commission - DG CNECT (Brussels)
Facts In 1999, Solvay Pharmaceuticals filed a New Drug Application (NDA) for a topical testosterone hormone drug, called Androgel. In 2003, Solvay obtained patent protection for it. Subsequently, the generic companies Actavis (before Watson Pharmaceuticals) and Paddock Laboratories filed an (...)

The US Supreme Court establishes a rule that blurs the lines between antitrust and patent law (Actavis)
Sheppard Mullin (Chicago)
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Sheppard Mullin (Washington)
FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?* On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade (...)

The US Supreme Court holds that patent protection does not confer immunity from antitrust attack (Actavis)
Ashurst (Milan)
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RSM US (New York)
U.S. Supreme Court reverses Eleventh Circuit opinion in FTC v. Actavis, Inc* On 17 June 2013, the U.S. Supreme Court (“the Court”) reversed a decision by the Court of Appeals (Eleventh Circuit). The Court of Appeals had upheld a dismissal of a complaint made by the Federal Trade Commission (...)

The US Supreme Court opens reverse payment patent settlement agreements to antitrust challenge (Actavis)
Wolters Kluwer (Riverwoods)
A “reverse payment” settlement agreement is not entitled to “near-automatic antitrust immunity” simply because its anticompetitive effects fall within the scope of the exclusionary potential of the patent, the U.S. Supreme Court ruled earlier this week in a five-to-three decision. Although such (...)

The US Supreme Court holds that “reverse payment” patent settlements between brand-name drug manufacturers and would-be generic competitors should be reviewed under the antitrust rule of reason (Actavis)
Arnold & Porter Kaye Scholer (Brussels)
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Latham & Watkins (San Francisco)
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Arnold & Porter Kaye Scholer (Washington)
On Monday, June 17, the Supreme Court handed down a decision in FTC v. Actavis, Inc., bringing some clarity to the antitrust treatment of so-called reverse payment patent settlements between brand-name drug manufacturers and would-be generic competitors, but leaving many open questions as (...)

The US FTC asks the Eleventh Circuit to overturn a lower court’s decision to allow a reverse-payment settlement between branded and a generic pharmaceutical manufacturers (Watson Pharmaceuticals)
Vinson & Elkins (Washington)
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Reese Gordon Marketos
A growing consensus among federal courts that so-called “reverse-payment” settlements rarely violate antitrust law has not tempered antitrust enforcement authorities’ opposition to such deals. In the pharmaceutical industry, brand-name drug manufacturers may file patent infringement lawsuits (...)

The US Eastern District of New York Federal Court awards plaintiffs $162 million in first-ever civil price-fixing verdict against Chinese companies (Vitamin C Cartel)
Quinn Emanuel Urquhart & Sullivan (Brussels)
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Office of the New York State Attorney General (New York)
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Shearman & Sterling (New York)
On March 14, 2013, a federal jury in Brooklyn, New York returned a verdict in In re Vitamin C Antitrust Litigation, No. 1:06-md-1738 (E.D.N.Y.), finding that two Chinese companies had unlawfully fixed prices and controlled the supply of vitamin C exports from China to the United States. (...)

The US FTC files amicus curiae brief supporting generics’ claim in patent dispute (Actelion Pharms/Apotex)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC files amicus curiae brief supporting generics’ claim in patent dispute* On 11 March 2013 the U.S. Federal Trade Commission (“FTC”) filed an amicus curiae brief in the case Actelion Pharms Ltd. V. Apotex Inc. which is being heard in the U.S. District Court for New Jersey supporting the (...)

The US FTC releases a summary of its new report on pharma patent litigation finding an increase in "reverse payment" settlements based on expanded definition of "payments"
Jones Day (Washington DC)
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Jones Day (Washington DC)
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Jones Day (Chicago)
With the Supreme Court set to address the validity of "reverse payment" settlements of pharmaceutical patent litigation, the FTC released a summary of its new report, announcing that in 2012 drug companies entered "a record number" of such settlements. However, the underlying data and analysis (...)

The US Supreme Court grants certiorari to consider the legality of reverse payment settlements (Actavis)
Stanford University - Stanford Law School
U.S. Supreme Court grants certiorari to consider the legality of reverse payment settlements* On 7 December 2012 the U.S. Supreme Court granted a petition to consider whether reverse payment settlement agreements are per se lawful or presumptively anti-competitive. In the case (U.S. Federal (...)

The US Supreme Court reviews Eleventh Circuit’s decision regarding reverse payment patent settlements (AndroGel)
Gibson Dunn (New York)
Important U.S. Developments Relating to “Reverse Payment” Patent Settlements* There have been two key recent developments in the U.S. relating to the legal dispute over patent settlements including so-called “reverse payments.” First, the U.S. Supreme Court has agreed to review an Eleventh Circuit (...)

A US District Court holds that “No-AG” agreements are not “Reverse Payments” (Lamictal litigation)
Gibson Dunn (New York)
Important U.S. Developments Relating to “Reverse Payment” Patent Settlements* There have been two key recent developments in the U.S. relating to the legal dispute over patent settlements including so-called “reverse payments.” First, the U.S. Supreme Court has agreed to review an Eleventh Circuit (...)

A US Court of Appeals holds that although reverse payment settlements between brand-name and generic pharmaceutical manufacturers are not illegal per se, they are presumptively unlawful under the rule of reason (Schering-Plough)
Arnold & Porter Kaye Scholer (Washington)
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Hooper Hathaway
On July 16, 2012, in an opinion authored by Judge Sloviter, the Third Circuit issued its decision in the K-Dur “reverse payments” case, holding that although such settlements are not illegal per se, they are presumptively unlawful under the rule of reason. In so doing it rejected the approach (...)

The US Third Circuit, by adopting a quick look rule of reason analysis for evaluating the legality of reverse payment settlements, rejects the prevailing "scope of patent" test and creates a Circuit split on this issue (Louisiana Wholesale Drug Company, Schering, Upsher-Smith)
Gill Jennings & Every LLP
On 16 July 2012, the US Third Circuit Court of Appeals rejected the scope of the patent test used by the New Jersey District Court in concluding that the patent settlement agreements (“Agreements”), providing for payments from Schering-Plough Corporation (“Schering”) (subsequently acquired by Merck (...)

A US Court of Appeals rejects the “scope of the patent” test in favor of a “quick look” rule of reason analysis when reviewing reverse payment settlements between patent holders and would be generic competitors in the pharmaceutical industry (Schering-Plough)
Vinson & Elkins (Dallas)
Citing the dire consequences for companies seeking to comply with antitrust law in the wake of a direct circuit split, major pharmaceutical makers are asking the Supreme Court to review a Third Circuit decision that declared settlement payments by brand-name pharmaceutical companies to (...)

A US Court of Appeals applies a quick look rule of reason and rejects scope of the patent test when considering whether pharma patent settlement violates the antitrust laws (Schering-Plough)
Hyman, Phelps & McNamara
In our post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t). It’s only been about three weeks since that (...)

The US Court of Appeals for the Third Circuit rejects Scope-of-Patent test in antitrust challenge to patent settlements (K-Dur)
Wolters Kluwer (Riverwoods)
Third Circuit Rejects Scope-of-Patent Test in Antitrust Challenge to K-Dur Patent Settlement* Reverse payments settlements between patent holders and would-be generic competitors in the pharmaceutical industry should be reviewed under a “quick look” rule of reason analysis based on the economic (...)

A US Court of Appeals rejects the FTC’s latest “Pay-For-Delay” challenge (FTC v. Watson)
Mayer Brown (Washington)
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US Federal Trade Commission (FTC) (Washington DC)
On April 25, 2012, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s dismissal of the Federal Trade Commission’s (“FTC”) complaint against four pharmaceutical companies: Solvay Pharmaceuticals, Watson Pharmaceuticals, Par Pharmaceuticals, and Paddock Laboratories. The (...)

The US Court of Appeals for the 11th Circuit reaffirms that the “scope of the patent” test is the proper standard of antitrust review of the reverse payment settlements among pharmaceutical companies (Solvay/Watson/Paddock)
United First Partners
Introduction In FTC v. Watson Pharmaceuticals, Inc. (“Watson”), the Eleventh Circuit reaffirmed its long line of precedents and held that, absent sham litigation or fraud in obtaining the patent, the “scope of the patent” test should be used to evaluate antitrust challenges to the reverse payment (...)

A US Court of Appeals rejects FTC’s approach to "pay-for-delay" settlement between brand name and generic drug companies as an unlawful agreement not to compete under S. 5 of the FTC Act (Watson Pharmaceuticals)
Wolters Kluwer (Riverwoods)
Eleventh Circuit Rejects FTC’s Approach to Pay-for-Delay Settlements as “Turducken Task”* The U.S. Court of Appeals in Atlanta rejected on April 25, 2012 the Federal Trade Commission’s challenge to a patent litigation settlement between brand name and generic drug companies as an unlawful (...)

The Eastern District Court of New York holds that Chinese law did not compel the defendants in a cartel case to reach agreements on price and output (Vitamin C cartel)
Sheppard Mullin (San Francisco)
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Paul Hastings (Washington)
In a recent, strongly worded federal antitrust decision, pleas for international comity by China’s nationalized vitamin industry and its regulatory overseer, China’s foremost trade industry, fell short in a showdown with U.S. domestic antitrust laws. The case indicates that foreign compulsion (...)

The US Supreme Court declines to review a Second Circuit ruling permitting a reverse-payment settlement between branded and a generic pharmaceutical manufacturers (Lousiana Wholesale Drug / Bayer)
Vinson & Elkins (Washington)
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Reese Gordon Marketos
A growing consensus among federal courts that so-called “reverse-payment” settlements rarely violate antitrust law has not tempered antitrust enforcement authorities’ opposition to such deals. In the pharmaceutical industry, brand-name drug manufacturers may file patent infringement lawsuits (...)

The California Supreme Court rejects "Pass-On" Defense for antitrust damages (Pfizer)
Jones Day (Los Angeles)
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Jones Day (Los Angeles)
In its July 12, 2010, decision in Clayworth v. Pfizer, Inc., the California Supreme Court rejected the « pass-on » defense for claims brought under California’s antitrust law, the Cartwright Act. Defendants have used the pass-on defense to argue that direct purchasers of goods sold by allegedly (...)

A US District Court allows the reverse payment suits to proceed finding that the agreements extended beyond the scope of the concerned patent (Provigil)
Stanford University - Stanford Law School
U.S. District Court allows Provigil reverse payment suits to proceed* On 29 March 2010 the U.S. District Court for the Eastern District of Pennsylvania rejected defendants’ motions to dismiss in suits concerning reverse payment settlements between the brand name manufacturer of the (...)

A US District Court dismisses antitrust claims on reverse payment on the pharma market (Androgel Antitrust Litigation)
Sheppard Mullin (Los Angeles)
FTC Gets Shut Down – Once Again – In Its Bid To Change How Courts View Reverse Payment Settlements* As previously reported on this blog, in January 2009, the Federal Trade Commission launched its latest challenge to the legality of reverse payment settlements in the pharmaceutical industry, this (...)

A US District Court dismisses the FTC’s "pay-for-delay" antitrust lawsuit ruling that the contested settlements are not an unreasonable restraint of trade (Androgel Litigation)
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
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Skadden, Arps, Slate, Meagher & Flom (Washington DC)
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The Brattle Group (New York)
On February 22, 2010, Judge Thomas W. Thrash, Jr. dismissed the Federal Trade Commission’s (FTC) antitrust lawsuit alleging that Solvay Pharmaceuticals (Solvay) conspired with generic drug makers Watson Pharmaceuticals (Watson) and Par Pharmaceuticals (Par) to delay generic competition for the (...)

A US District Court grants defendants’ motions to dismiss antitrust claims brought by the FTC as regards reverse payments settlements and related commercial arrangements (Androgel)
Stanford University - Stanford Law School
U.S. District Court dismisses AndroGel reverse payment antitrust claims* On 22 February 2010 the U.S. District Court for the Northern District of Georgia (Atlanta Division) granted defendants’ motions to dismiss antitrust claims brought by the Federal Trade Commission (“FTC”) among others that (...)

The US DoJ files amicus brief on reverse payment settlements on the market for broad spectrum antimicrobial medicines (Arkansas Carpenters Health/Bayer, Hoechst, Watson)
Stanford University - Stanford Law School
U.S. DOJ files amicus brief on reverse payment settlements* On 6 July 2009 the U.S. Department of Justice filed an amicus brief in a reverse payment settlement case on appeal before the 2nd Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation). The filing is in response of an (...)

US District Courts grapple with novel legal issues relating to Chinese companies sued in U.S. for antitrust violations (Vitamin C and Magnesite cartel)
Sheppard Mullin (San Francisco)
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Paul Hastings (Washington)
As the world economy grows increasingly interconnected, plaintiffs’ lawyers in the US are searching for ways to sue foreign companies in US courts for anticompetitive behavior. Several recent Sherman Act cases have been brought against consortiums of partially government owned Chinese (...)

The US Federal Circuit dismisses antitrust claims against reverse payment agreement between pharmaceutical companies (Ciprofloxacin Hydrochloride)
ArbJournal
On 15 October 2008 the Federal Circuit affirmed the grant of summary judgment by the Court for the Eastern District of New York that patent settlement agreements («Agreements») entered into between Bayer AG and Bayer Corp (collectively «Bayer») and several manufacturers of generic drugs providing (...)

A US Court of Appeals holds the use of cash payments to settle Hatch-Waxman patent litigation does not violate the antitrust laws if the settlement does not exceed the scope of patent and claim for patent validity is not a sham (Bayer/Barr)
Jones Day (Washington DC)
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Jones Day (Washington DC)
On October 15, 2008, the Federal Circuit joined the growing list of federal courts to hold that the use of cash payments to settle Hatch-Waxman patent litigation does not violate the antitrust laws as long as (1) the settlement excludes no more competition than would the patent itself and (2) (...)

A US District Court rejects the allegation according to which inducement by a drug wholesaler of a drug price publisher to inflate the wholesale price may constitute a per se violation (New England Carpenters Health Benefits Fund / McKesson)
Sheppard Mullin (Los Angeles)
Twombly Meets Leegin. Failure of Plaintiff to Allege “Plausible” Entitlement to Relief Constitutes Failure to Allege “Antitrust Injury.”* In New England Carpenters Health Benefits Fund v. McKesson Corp., 573 F.Supp.2d 431 (Aug. 26, 2008), the District Court for the District of Massachusetts (...)

The US Federal Trade Commission again moves forward against "reverse payment settlements" in pharmaceutical patent settlements (Cephalon)
Allen & Overy (New York)
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RPCK Rastegar Panchal
On February 13th, 2008 the Federal Trade Commission (“FTC”) filed a complaint in the U.S. District Court for the District of Columbia charging Cephalon, Inc. with illegally preventing competition to its branded drug Provigil. In its complaint the FTC alleges that Cephalon, through patent (...)

A US Court of Appeals holds that the reverse payment settlement between branded and generic pharma companies did not violate the antitrust laws because the exclusionary effect of the agreement did not exceed the scope of the patent (Tamoxifen Citrate)
Axinn Veltrop & Harkrider (Hartford)
Over the past decade, practitioners, policy makers and commentators have increasingly debated the issues involved when the antitrust laws intersect with patent rights. Both the antitrust and patent laws are designed to promote competition and, as a result, societal wellbeing. However, the (...)

A US District Court holds that a pharmacy benefits manager’s (PBM) contracts should be analyzed under the rule of reason (North Jackson Pharmacy, Caremark)
Jones Day (Washington DC)
The Northern District Court of Illinois, in a decision issued August 12, held that a PBM’s arrangements with health plan sponsors are not per se unlawful and should be analyzed under the rule of reason. North Jackson Pharmacy, an independent retail pharmacy, filed suit against Caremark Rx, a (...)

A US Court of Appeals holds that the reverse payment settlement between branded and generic pharma companies did not violate the antitrust laws because the exclusionary effect of the agreement did not exceed the scope of the patent (Schering-Plough)
Axinn Veltrop & Harkrider (Hartford)
Over the past decade, practitioners, policy makers and commentators have increasingly debated the issues involved when the antitrust laws intersect with patent rights. Both the antitrust and patent laws are designed to promote competition and, as a result, societal wellbeing. However, the (...)

The US Supreme Court rules that the Sherman Act does not apply to claims arising solely out of the foreign effect of a global cartel (Hoffman-LaRoche / Empagran)
Jones Day (Washington DC)
As economic globalization marches on, one question that emerges repeatedly is how far the U.S. legal system can and should reach beyond its own borders. Answering that question has become particularly urgent in antitrust enforcement, as the effects of cartels and business practices increasingly (...)

A US Court of Appeals holds that antitrust law is not implicated provided that the terms of “pay for delay” settlements between the brand name and generic pharma companies are within the scope of the patent (Valley Drug/Abbott Laboratories)
Hill, Kertscher & Wharton (Atlanta)
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Sutherland
A recent 11th Circuit case, Valley Drug Co. v. Geneva Pharmaceuticals, Inc., sheds light on the complex intersection of patent and antitrust law in the context of a settlement agreement between a name brand pharmaceutical manufacturer and two allegedly infringing generic manufacturers that (...)

The US Court of Appeals for the 11th Circuit holds that a reverse payment agreement between a brand-name pharmaceutical company and a generic would-be competitor should be analyzed under the “scope of the patent” test to determine antitrust liability (Abbott/Geneva/Zenith)
United First Partners
Introduction In Valley Drug Co. v. Geneva Pharm., Inc. (“Valley Drug”), the Eleventh Circuit adopted the “scope of the patent” test to evaluate validity of reverse payment agreements between a brand-name pharmaceutical manufacturer and generic would-be competitors. The court viewed the case in (...)

A US Court of Appeals holds that a reverse payment agreement between a brand-name pharmaceutical manufacturer and a generic would-be competitor is a per se antitrust violation because the agreement exceeded the scope of the patent (Cardizem CD Antitrust Litigation)
United First Partners
Introduction In re Cardizem CD Antitrust Litigation (“Cardizem”) is one of the first in a long line of cases challenging the so-called reverse payment or pay-for-delay settlement agreements between the pharmaceutical companies. In Cardizem, the U.S. Court of Appeals for the Sixth Circuit held (...)

The US FTC publishes a report on generic drug entry prior to patent expiration raising issues on patent-shortening settlement agreements
White & Case (Washington)
The Federal Trade Commission’s recent report, Generic Drug Entry Prior to Patent Expiration (Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study, July 2002, ("FTC Report")), raises a number of competition issues that merit further discussion and research. This (...)

A US Federal Circuit Court finds that the district court exceeded its authority in shortening the statutory stay of entry by a generic competitor which was challenged by a pharmaceutical patent-holder manufacturer in a patent infringement suit (Andrx/Biovail)
Cabot (Boston)
Judges: Dyk (author), Bryson, and Linn In Andrx Pharmaceuticals, Inc. v. Biovail Corp., No. 01-1650 (Fed. Cir. Jan. 17, 2002), the Federal Circuit vacated and remanded a lower court’s order (1) shortening the statutory thirty-month delay of FDA approval of Andrx Pharmaceuticals, Inc.’s (“Andrx”) (...)

The US Supreme Court holds it is per se illegal for a manufacturer to set minimum resale prices in agreements with independent resellers (Dr. Miles Medical / John D. Park & Sons)
Baker Botts (Washington)
In 1911, the U.S. Supreme Court in Dr. Miles Medical Co. v. John D. Park & Sons Co. held that a manufacturer’s setting the minimum prices at which independent resellers may resell its products was unlawful under the common law and Section 1 of the Sherman Act.That result spawned the (...)

Unilateral Practices

The US Court of Appeals for the Third Circuit rules on bundling in pharmaceuticals sector (Eisai / Sanofi Aventi)
Constantine Cannon (New York)
Third Circuit Shows No Love For Lovenox® Bundling Theory*Citing the well-known maxim that the antitrust laws are concerned with “the protection of competition, not competitors,” the U.S. Court of Appeals for the Third Circuit on Wednesday affirmed summary judgment for Defendant Sanofi Aventis on (...)

The FTC seeks to secure first disgorgement in nearly a decade (Cardinal Health)
Womble Carlyle Sandridge & Rice (Charlotte)
FTC Seeks to Secure First Disgorgement in Nearly a Decade* The FTC announced yesterday that Cardinal Health, Inc. (“Cardinal”) has agreed to pay $26.8 million to resolve its investigation into the company’s alleged anticompetitive behavior. If approved by a federal court, the settlement would (...)

A US district court dismisses claims of conspiracy to protect a monopoly by "product hopping", citing risk to slow or halt pharmaceutical innovation (Mylan / Warner Chilcott)
BakerHostetler (Philadelphia)
Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical Innovation* A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. (...)

Louisiana’s Attorney General sues a pharmaceutical company for violating antitrust rules by filing baseless citizen petitions to the US Food and Drug Administration in order to delay the entry of a generic medicament in the market (GlaxoSmithKline)
DLA Piper Weiss-Tessbach (Vienna)
Louisiana’s Attorney General sues GlaxoSmithKline over delay of generic nasal spray* In December 2014 Louisiana’s attorney general (AG) filed a complaint against GlaxoSmithKline (GSK) alleging that GSK engaged in an anticompetitive scheme to delay the entry of a generic version of its Flonase (...)

A US District Court allows “product hopping” claims to proceed based on allegations of removal of prior formulation and disparagement of generic competition (Suboxone)
Patterson Belknap Webb & Tyler (New York)
,
Patterson Belknap Webb & Tyler (New York)
Court Allows “Product Hopping” Claims to Proceed in Suboxone Litigation Based on Allegations of Removal of Prior Formulation and Disparagement of Generic Competition* We’ve previously discussed antitrust claims related to “product hopping”—allegations that pharmaceutical manufacturers have (...)

A US Court of Appeals rules that one firm’s ability to break into the relevant market does not foreclose the possibility that another company monopolized or attempted to monopolize said market (Lenox / Medtronic)
Wolters Kluwer (Riverwoods)
Monopoly Claims Can Survive Summary Judgment: Medtronic Must Defend Conduct in “Bone Mill” Market* One firm’s ability to break into the market for “bone mills” used in spinal-fusion surgery did not foreclose the possibility that medical device company Medtronic monopolized or attempted to (...)

A US District Court allows a bundling claim to proceed under Sherman Act Section 1, even after dismissing other claims for lack of market or monopoly power (Schuylkill Health Systems / Cardinal Health)
University of Michigan
Can Bundled Discounts Be Illegal If Offered by a Firm Without Market Power?* Bundled discounts are common marketing schemes that normally benefit consumers and competition; however, courts and commentators have found certain circumstances when they might be illegal monopolization. The line (...)

The US Supreme Court reverses the judgment of the 11th circuit and leaves the structuring of the rule of reason antitrust litigation to the lower courts (Actavis)
Cleveland-Marshall School of Law
Just What on Earth Did Actavis Really Say? And Does It Mean Something for Section 1 More Broadly?* It’s going to be a strict, nearly-per-se quick look rule, folks, in more or less every reverse-payment case likely to be brought from here on out. Dollars-to-donuts. A few weeks have gone by, (...)

A US District Court denies a motion to dismiss an antitrust counterclaim in a patent infringement action in the wake of defendant having filed an ANDA with the FDA (Shionogi Pharma / Mylan)
Sheppard Mullin (Los Angeles)
ANDA Automatic Stay of FDA Approval Does Not Defeat Standing in Sham Litigation Antitrust Counterclaim* The District of Delaware recently denied a motion to dismiss an antitrust counterclaim in a patent infringement action in the wake of defendant Mylan, Inc. ("Mylan") having filed an (...)

A US District Court dismisses indirect purchaser class actions challenging proposed reverse payment agreements as anticompetitive on an allegation of preventing a cheaper generic medicine to enter the market sooner (Plavix Indirect Purchaser)
Sheppard Mullin (San Francisco)
Indirect Purchaser Plavix Class Actions Tossed for Lack of Antitrust Standing* On January 31, 2011, the District Court for Southern District of Ohio granted defendants’ Rule 12(b)(6) motion, dismissing indirect purchaser class actions that challenged proposed reverse payment agreements as (...)

The US Court of Appeals for the Second Circuit states that direct purchasers of antidiuretic medicine have antitrust standing in patent infringement suit (DDAVP)
Stanford University - Stanford Law School
2nd Circuit finds DDAVP purchasers stated Walker Process and related claims and had antitrust standing* On 16 October 2009 the Court of Appeals for the Second Circuit held (In re: DDAVP Direct Purchaser Antitrust Litigation) that direct purchasers of desmopressin acetate tablets, sold under (...)

A US District Court holds that a drug manufacturer rebates to pharmacy benefits managers (PBM) for exclusive formulary listing do not violate the Sherman Act (Wyeth, J.B.D.L)
Jones Day (Washington DC)
A U.S. District Court in Ohio granted summary judgment for defendants in a class action suit alleging that a drug manufacturer’s rebates to pharmacy benefit managers in order to obtain an exclusive listing in the PBMs’ drug formulary violated Section 1 of the Sherman Act. The plaintiffs, (...)

Mergers

The FTC challenges a merger in regional markets for sterilization of products using radiation based on future competition concerns (Steris / Synergy Health)
Doyle, Barlow & Mazard (Washington DC)
FTC Challenges Deal Based on Future Competition Concerns* On May 29, 2015, the Federal Trade Commission (“FTC”) issued an administrative complaint alleging that Steris Corporation’s (“Steris”) proposed $1.9 billion acquisition of Synergy Health plc (“Synergy”) would violate the antitrust laws by (...)

The US FTC issues final changes to the premerger notification rules that require companies in the pharmaceutical industry to report certain proposed acquisitions of exclusive patent rights to the FTC and the DoJ for antitrust review
University of Michigan
Is the FTC Picking on the Pharmaceutical Industry Through New HSR Rules?* Effective December 16, 2013, Hart-Scott-Rodino (HSR) coverage of exclusive licenses of patents will change. As HSR practitioners know well, the Federal Trade Commission’s Premerger Notification Office (PNO) has (...)

The US FTC proposes revisions to the premerger notification rules for pharmaceutical patent licensing transactions
Crowell & Moring (Washington)
The FTC’s Proposed Revisions to the Premerger Notification Rules for Pharmaceutical Patent Licensing Transactions* Recent developments On August 13, 2012, the Federal Trade Commission (“FTC”) released proposed amendments to the Hart-Scott-Rodino (“HSR”) premerger notification rules relating to the (...)

US antitrust agencies propose new Hart-Scott-Rodino merger control rules to require enhanced reporting of pharma, biological and diagnostic licenses
Thompson Hine (New York)
New FTC/DOJ position will require heightened regulatory reporting of pharma, biological and diagnostic licenses* The Federal Trade Commission and Department of Justice recently announced revisions to the Hart-Scott-Rodino (HSR) Act’s premerger notification rules to require enhanced reporting of (...)

The US Court of Appeals for the 8th Circuit upholds a lower court’s finding that the FTC failed to show the relevant market in a case concerning the acquisition of two drugs treating a similar heart defect (Lundbeck)
Scharf Banks Marmor (Chicago)
What Is a Relevant Market Anyhow?* The Eight Circuit, in FTC v. Lundbeck, Inc., No. 10-3458/3459 (Aug. 19, 2011), upheld the district court’s finding that the FTC failed to show a relevant market, and thus was unable to challenge the acquisition of the drug NeoProfen. It already owned a drug (...)

A US Court of Appeals rejects the FTC’s attempt to identify a relevant product market in a pharmaceuticals related merger (Lundbeck)
Cleveland-Marshall School of Law
FTC v. Lundbeck: Why, God, Why?* What really has the world come to when a merger to monopoly followed by a 1300% price increase survives Section 7 challenge? That, sadly, seems to be the final result in Federal Trade Commission v. Lundbeck, which the Eighth Circuit affirmed last Friday. (...)

A US District Court denies FTC request for a preliminary injunction in medical laboratory merger case (LabCorp)
Skadden, Arps, Slate, Meagher & Flom (New York)
,
Skadden, Arps, Slate, Meagher & Flom (Palo Alto)
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Kirkland & Ellis (New York)
In a decision broadly critical of the Federal Trade Commission’s case challenging the acquisition of Westcliff Medical Laboratories, Inc., a medical laboratory company, by Laboratory Corporation of America (LabCorp), Judge Andrew Guilford of the U.S. District Court for the Central District of (...)

A US Court of Appeals rejects antitrust lawsuit that challenged premerger planning and information exchanges between two health insurers (Omnicare/UnitedHealth)
Jones Day (Washington DC)
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Jones Day (Houston)
This article has been selected for the business category, mergers section of the 2012 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. Last week the U.S. Court of Appeals for the Seventh Circuit rejected an antitrust lawsuit by institutional pharmacy (...)

The US FTC and the State of Minnesota appeal the district court’s decision on relevant market issue in a pharmaceutical merger case (Lundbeck)
Cleveland-Marshall School of Law
Some Reflections on the Lundbeck Appeal: Will Pharmaceuticals Get a Blanket Antitrust Immunity? And Is Quality Competition No Longer Protected by Antitrust?* A decision to watch for this year is the Eighth Circuit’s pending consideration of FTC v. Lundbeck, Inc., 2010-2 Trade Cases ¶77,160; 2010 (...)

The US District Court for the District of Minnesota dismisses FTC complaint seeking divestiture and disgorgement remedy in consummated acquisition in the healthcare industry (Lundbeck)
Jones Day (Washington DC)
,
Jones Day (Washington DC)
,
Jones Day (Washington DC)
In a decision that was filed under seal in late August but released publicly just last week, the U.S. District Court for the District of Minnesota dismissed with prejudice the complaint filed by the Federal Trade Commission (FTC) and the State of Minnesota challenging the already-consummated (...)

A US district court rules against the FTC holding that it has failed to prove the relevant market in pharmaceutical merger case (Lundbeck)
Wolters Kluwer (Riverwoods)
FTC Loses Suit against Drug Maker over 2006 Acquisition* The Federal Trade Commission recently suffered a significant setback in its merger enforcement efforts when the federal district court in Minneapolis rejected an action brought by the agency along with the State of Minnesota against (...)

The US DoJ and FTC issue new merger guidelines suggesting increased focus on deals in high tech and pharmaceutical sectors
Gibson Dunn (New York)
New U.S. Merger Guidelines Suggest Increased Focus on Deals in High Tech and Pharmaceutical Sectors* In August 2010, the U.S. antitrust agencies released the final version of their revised Horizontal Merger Guidelines, which they use to analyze the competitive implications of mergers between (...)

A US District Court reaffirms importance of market definition in antitrust merger analysis (Golden Gate Pharmacy / Pfizer)
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
Skadden, Arps, Slate, Meagher & Flom (New York)
On April 16, 2010, Judge Maxine M. Chesney of the U.S. District Court for the Northern District of California dismissed a complaint raising a private antitrust challenge to the merger of Pfizer, Inc. and Wyeth Pharmaceuticals, because she concluded that the complaint failed sufficiently to (...)

The US FTC imposes remedies before clearing a merger affecting multiple markets for animal health and pharmaceutical products (Pfizer / Wyeth)
Akin Gump Strauss Hauer & Feld (Dallas)
The FTC entered into a consent agreement with Pfizer Inc. and Wyeth, requiring divestiture of one entity’s U.S. operations in over 20 markets for various animal health and pharmaceutical products. The consent order, established on January 25, 2010, sets forth the divestiture of Wyeth’s U.S. (...)

The US FTC files a complaint to stop a proposed merger between two leading producers of plasma-derivative protein therapies (CSL / Talecris)
Jones Day (Washington DC)
Just two weeks after the FTC filed a complaint seeking an injunction to stop the proposed $3.1 billion acquisition by Australia-based CSL Limited of Talecris Biotherapeutics Holding Corporation, the parties have withdrawn their plans for a merger. The announcement, made on June 8, 2009, came (...)

The US FTC seeks disgorgement remedy in challenge against pharma company for illegally acquiring drugs used to treat premature babies with life-threatening heart condition (Ovation)
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
The Brattle Group (New York)
Continuing a trend of increasing aggressiveness in antitrust enforcement, the Federal Trade Commission (FTC) is seeking disgorgement in a challenge to Ovation Pharmaceutical Inc.’s acquisition of the drug NeoProfen®, filed in the Minnesota District Court on Dec. 16, 2008. In the past, the FTC has (...)

The US FTC places a price cap on intra-company prices as a condition precedent to clearing a merger in the market for iron sucrose administrated intravenously (Fresenius / Daiichi)
Weil, Gotshal & Manges (Washington)
,
US Federal Trade Commission (FTC) (Washington DC)
On September 15, 2008, the FTC announced that it challenged a manufacturing, distribution, and supply agreement between Fresenius Medical Care Ag & Co. KGaA (Fresenius) and Daiichi Sankyo Company, Ltd. (“Daiichi”) based on allegations that the proposed transaction would violate U.S. (...)

The US FTC seeks divestiture of rights and assets to five different medications before approving a merger, which would affect the markets for generic injectable pharmaceuticals (Hospira / Mayne)
Akin Gump Strauss Hauer & Feld (Dallas)
The FTC entered into a consent decree with Hospira Inc. and Mayne Pharma Ltd. on May 21, 2007 imposing divestitures on the firms prior to clearing their merger. The consent decree required Mayne to divest its current business in one type of generic pharmaceuticals, as well as the assets (...)

The US FTC employs an uncommon remedy to resolve the anticompetitive concerns of a merger-to-monopoly by requiring the merged firm to license a generic form of its breakthrough cancer pain drug to a third party (Cephalon/CIMA)
US Department of Justice
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BakerHostetler (Washington)
,
Pillsbury Winthrop Shaw Pittman (New York)
In two recent decisions involving pharmaceutical mergers – Cephalon/Cima, in August 2004, and Genzyme/Novazyme, in January 2004, a divided Federal Trade Commission was accused by dissenting Commissioners of breaking with precedent and allowing acquisitions involving innovator pharmaceuticals (...)

The US FTC requires divestiture of three brand drugs in order to grant approval to a merger between two pharmaceutical companies (Sanofi-Synthelabo/Aventis)
US Department of Justice
,
BakerHostetler (Washington)
,
Pillsbury Winthrop Shaw Pittman (New York)
In two recent decisions involving pharmaceutical mergers – Cephalon/Cima, in August 2004, and Genzyme/Novazyme, in January 2004, a divided Federal Trade Commission was accused by dissenting Commissioners of breaking with precedent and allowing acquisitions involving innovator pharmaceuticals (...)

The US FTC imposes divestiture of assets for one product and licensing of patents for two other products prior to approving a merger in the pharmaceuticals industry (Amgen / Immunex)
Akin Gump Strauss Hauer & Feld (Dallas)
Amgen Inc. and Immunex Corporation entered into a consent decree with the FTC on September 3, 2002 in order to proceed with the merger of the two pharmaceutical giants. To obtain clearance from the FTC, Amgen and Immunex agreed to divest Immunex’s business concerning the production of one (...)

Procedures

The US Supreme Court says that judges who determine foreign law in federal courts are not strictly bound by foreign government’s statements (Animal Science Products / Hebei Welcome Pharmaceutical)
Bona Law (San Diego)
In an antitrust case deciding a non-antitrust-specific issue, the US Supreme Court held in Animal Science Products, Inc. v. Hebei Welcome Pharmaceutical Co.(the Vitamin C Antitrust Litigation) that to determine foreign law in federal courts, judges are not strictly bound by that foreign (...)

The U.S. Court of Appeals for the Third Circuit applies an appropriate post-Actavis pleading standard (Lipitor)
Rutgers University
On August 21, 2017, the Third Circuit overturned a decision that had applied excessive pleading standards against plaintiffs challenging reverse-payment settlements. Writing for a unanimous panel, Chief Judge Smith held that, in the wake of FTC v. Actavis, 133 S. Ct. 2223 (2013), courts should (...)

The U.S. Court of Appeals for the Federal Circuit renders a split decision regarding sham patent litigation (Tyco Healthcare / Mutual Pharmaceutical)
Jones Day (Washington DC)
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Jones Day (Cleveland)
,
Jones Day (Washington DC)
The U.S. Court of Appeals for the Federal Circuit has remanded for further consideration antitrust claims accusing a patent holder of filing a sham infringement suit and a sham citizen petition with the Federal Drug Administration. The case is Tyco Healthcare Group LP v. Mutual Pharmaceutical (...)

The US District Court for the Northern District of Georgia refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine, since such a conclusion would have contradicted the decision of the Supreme Court finding that a reverse payment settlement agreement should be subject to antitrust scrutinity (Actavis)
Sheppard Mullin (Los Angeles)
FTC v. Actavis on Remand: A New Chapter* District Court refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine. In re AndroGel Antitrust Litigation (No. II), MDL No. 2084 (re Federal Trade Commission v. Actavis, Inc., No. 1:09-CV-955-TWT) (N.D. GA April 21, 2014). In (...)

A US District Court dismisses an antitrust class action against two pharma producers regarding an agreement to postpone the production of a generic epilepsy and bipolar disorder drug because no reverse payment with cash was involved to keep the rival off the market (GSK / Teva)
DLA Piper Weiss-Tessbach (Vienna)
U.S. District Court holds that Actavis requires monetary payments for antitrust scrutiny to be applicable* On January 24, 2014 U.S. District Judge William H. Walls dismissed an antitrust class action against GlaxoSmithKline LLC (“GSK”) and Teva Pharmaceutical Industries Ltd. (“Teva”) regarding (...)

The US Court of Appeals for the 3rd Circuit vacates class certification order on ascertainability grounds in consumer false advertising case (Carerra/Bayer)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Purchasers of a diet supplement brought a class action asserting that Bayer falsely claimed that the supplement enhanced metabolism by including a green tea extract. The district court certified a class of purchasers in Florida. The Third Circuit vacated the class certification order and (...)

The US District Court for the Southern District of New York certifies class for liability purposes only in a lawsuit brought against retail chain pharmacy (Jacob/Duane Reade)
Cohen Milstein (Washington)
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Cohen Milstein (New York)
Pharmacy store managers brought suit against a retail chain pharmacy, asserting that the pharmacy failed to compensate them for overtime in violation of the Fair Labor Standards Act. The district court concluded that certification of the class for all purposes was inappropriate, under Comcast, (...)

The US Southern District of New York certifies a class for liability purposes only (Jacob/Duane Reade)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Pharmacy store managers brought suit against a retail chain pharmacy, asserting that the pharmacy failed to compensate them for overtime in violation of the Fair Labor Standards Act. The district court concluded that certification of the class for all purposes was inappropriate under Comcast. (...)

The US Central District of California denies class certification on California law claims and grants class certification on New York law claims (Guido/L’Oreal)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Purchasers of a hairstyling product (“Serum”) from L’Oreal brought a class action, asserting that the product was flammable, that its flammability was not adequately disclosed, and that class members would not have bought the product had they known that it was flammable. On that basis, they (...)

The US District Court for the Eastern District of Tennesse denies motion to dismiss in antitrust case brought against drug makers (Skelaxin -Metaxalone- Antitrust Litigation)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Plaintiff drug purchasers brought suit under federal and state antitrust laws, contending that the defendants had engaged in an unlawful scheme calculated to raise and maintain the prices of the drug Skelaxin through sham litigation, the filing of sham citizen petitions and unlawful horizontal (...)

A US Court of Appeals applies “consumer-or-competitor” rule to deny antitrust standing to foreign manufacturer of drug marketed in US by licensee (Ethypharm/Abbott)
Wolters Kluwer (Riverwoods)
Third Circuit Holds the Line on Antitrust Standing* In order to assert an antitrust injury, a plaintiff needs to be a consumer or a competitor in the restrained market, the U.S. Court of Appeals in Philadelphia ruled on January 23, 2013. If a company makes the choice not to compete, then it (...)

US Eastern District Court of New York approves class settlement in a price-fixing lawsuit brought against Vitamin C manufacturers (Vitamin C Antitrust Litigation)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
In determining whether to finally approve a class settlement reached with one defendant, the court considered the objections of several members of the proposed indirect purchaser settlement class regarding class counsel’s decision to forego a monetary distribution to the class and instead make a (...)

The US Northern District of Georgia applies objective baselessness and subjective baselessness (Androgel Antitrust Litigation)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Especially in pharmaceutical antitrust class actions, many efforts have been made in recent years to rest cases on Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (1993)("PRE"), which requires that for a claim of so-called "sham litigation" to remove (...)

The US Supreme Court issues a decision addressing the pharmaceutical “use codes” and their impact on generic drugs approval process (Caraco)
Gibson Dunn (New York)
New U.S. Supreme Court Decision Addresses Pharmaceutical “Use Codes”* The U.S. Supreme Court recently issued a decision that provides generic pharmaceutical manufacturers with the ability to challenge the “use codes” listed by brand name manufacturers in filings made with the U.S. Food and Drug (...)

The US Supreme Court denies petition for certiorari brought by a drug manufacturer with respect to federal jurisdiction over antitrust class action claims (Lorazepam & Clorazepate Antitrust Litigation)
Wolters Kluwer (Riverwoods)
Antitrust Decision from Supreme Court Unlikely During Current Term* It is beginning to look like the U.S. Supreme Court will not be taking up any antitrust cases in the current term. Last week, the Court denied six petitions for review in antitrust-related matters. Just yesterday, the Court (...)

The US Eighth Circuit rejects FTC’s market definition (Lundbeck)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
In this case, the Eighth Circuit affirmed a trial court’s rejection of a case brought by the Federal Trade Commission based on rejection of the FTC’s proposed market definition, even in the face of clear evidence that the challenged conduct had in fact led directly to vastly increased prices, and (...)

The US District Court for the Eastern District of Pennsylvania adopts "scope of patent" test for analyzing Hatch-Waxman patent settlements (Cephalon)
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
The Brattle Group (New York)
On March 29, 2010, Judge Mitchell S. Goldberg upheld antitrust lawsuits filed by the Federal Trade Commission (FTC) and private plaintiffs against drug maker Cephalon, Inc. (Cephalon), alleging that Cephalon conspired with four generic drug manufacturers to delay generic competition for the (...)

A US Court of Appeals holds that American courts have authority to hear antitrust claims brought by foreign plaintiffs against foreign defendants over foreign conduct (Empagran)
Hughes Hubbard & Reed (Washington)
The twenty years since the enactment of the Federal Trade Antitrust Improvements Act (the FTAIA) in 1982 have seen steady progress in the cooperation of antitrust authorities worldwide. Prior to the FTAIA’s passage, the US’s extraterritorial application of its antitrust laws created international (...)

Regulatory

The US Food and Drug Administration (FDA) makes it possible for incremental pharmaceutical innovation to foreclose generic competitors and thereby cause antitrust concerns
CRA International (Toronto)
Incremental pharmaceutical innovation and antitrust concerns* Many pharmaceutical innovations are improvements on existing drug therapies as opposed to entirely new molecular or biologic entities. Such “incremental innovation” has been at the center of a range of legal disputes in the (...)

The US FTC issues a report on pharmaceutical patent settlements scrutinizing their interplay with authorized generics
Gibson Dunn (New York)
U.S. FTC Scrutinizes Interplay Between Authorized Generics and Patent Settlements* The U.S. Federal Trade Commission has recently released two reports relating to the pharmaceutical industry. A significant theme in both reports is a concern that brand name pharmaceutical companies are using (...)

The US FTC issues a report on authorized generic drugs expressing concern that they are being used to delay generic competition
Gibson Dunn (New York)
U.S. FTC Scrutinizes Interplay Between Authorized Generics and Patent Settlements* The U.S. Federal Trade Commission has recently released two reports relating to the pharmaceutical industry. A significant theme in both reports is a concern that brand name pharmaceutical companies are using (...)

The US FTC issues its final report on the effect of authorized generic drugs (AGs) on competition in the prescription drug market
Wilson Sonsini Goodrich & Rosati (Washington)
This article has been selected for the business category, general antitrust section of the 2012 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. On August 31, the Federal Trade Commission (FTC) issued its final report on the effect of authorized generic (...)

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