FDA Law Update - JD Supra
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FDA Law Update FDA Law Update
Posted at 1:06 1:06 PM PM on on June June 15, 15, 2009 2009 by by Sheppard Sheppard Mullin Mullin Posted at
Reverse - Hot Button Issue Issue ReversePayments Payments - Hot Button issue of of aa patent patent litigation litigation settlement The issue settlement in in the the form form of ofpayments payments by byaa brand brand name name drug company to the defendant to delay marketing a generic version of its brand name is company to the defendant to delay marketing a generic version of its brand name counterpart counterpart is heating up this summer. summer. Indeed, it is is currently currentlyboth bothbefore beforethe theSupreme Supreme Court Court and and Congress. Congress.
A filed aa petition A group group of of indirect indirectpurchasers purchasers filed petition with withthe the Supreme Supreme Court seeking review of the Federal Circuit’s Circuit’s decision decision in in In Re:Ciprofloxacin finding million payment Federal finding that that Bayer’s $398 million payment to Barr and Hoechst Hoechst Marion Marion Roussel (now Sanofi-Aventis) to delay marketing a generic version of Roussel (now Sanofi-Aventis) to delay marketing a a drug did not not violate violate federal federal antitrust antitrust laws. laws. Arkansas Arkansas Carpenters Carpenters Health and Welfare Fund Fund is asking the court to determine whether reverse payments to settle patent litigation are per asking the court to determine whether reverse payments to settle patent litigation are per se se lawful without lawful withoutregard regardto tothe the amount amount paid paid or or strength strength of of the the underlying underlying patent patent challenge. This is the third time been brought brought to to the the Supreme Supreme Court. Court. The The Court Court the third time the the issue issue of of reverse reverse payments payments has has been refused to to hear the prior prior two refused hear the twocases. cases.
Supreme Court Court decide decide to to hear hear this this case, case,its itsdecision decisionwill will resolve Should the the Supreme resolve a current split among among the Circuit Circuit Courts regarding the legality of reverse payments. The U.S. Court of Appeals for the Courts regarding legality of reverse U.S. Court Sixth Circuit illegal; the Sixth Circuithas has held heldthat thatsuch such payments payments are are illegal; the Second Second and and Federal Circuits have have upheld them. The Eleventh Circuit adopted a more nuanced stance, holding that reverse upheld them. The Eleventh Circuit adopted a more nuanced stance, holding that reverse under the the antitrust antitrust rule of payments should be analyzed under of reason. reason.
casefor for which which Supreme Supreme Court Court review review is sought, Federal Circuit Circuit concluded In the the present present case sought, the Federal concluded that that reverse payments to settle patent litigation do not violate antitrust law as long as (1) the suit is reverse payments to settle patent litigation do not violate antitrust law as long as (1) the suit is not a sham or or otherwise otherwise baseless; and (2) (2) the the settlement settlement does does not not impose impose restrictions restrictions on not a sham baseless; and on the the alleged infringer that extend beyond the scope of the patent. It remains to be seen whether alleged infringer that extend beyond the scope of the patent. It remains to be seen whether the the Supreme Court Court will will grant Supreme grant the the petition petition to to review review this this decision decision and and settle the current split. Recently, payment Recently, private private class class action action suits suits also also have have been been filed filedagainst against these these reverse reverse payment
settlements. Themost most recent class action against companies marks 11thsuit settlements. The recent class action against thesethese companies marks the 11th the private private suit concerning this reverse payment settlement agreement. The United Food and Commercial concerning this reverse payment settlement agreement. The United Food and Commercial Workers Union Midwest Health Union and and Employers Midwest Health Benefits Benefits Fund Fund filed filed aa putative putative class class action suit in the District District of Minnesota, seeking to recover what it called overcharges stemming from the of Minnesota, seeking to recover it called overcharges “unlawful “unlawfuldelay delayand and exclusion” exclusion”of ofgeneric generic AndroGel. AndroGel.The Theunlawful unlawfuldelay delayand and exclusion exclusion was was a result of Unimed making payments to Watson, Par, and Paddock in exchange for keeping their result of Unimed making payments to Watson, Par, and Paddock in exchange for keeping their less expensive generics genericsoff off the the market. market. Prior Prior to this class class action, action, the the FTC FTC and and state stateof of California California less expensive
Document hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=ec9ce2f7-f990-421a-b1f1-17be196ccc2c
Watson, Par, Par, Paddock, Paddock,and andUnimed Unimedin in California California claiming both sued sued Watson, claiming that that the the reverse reverse payment payment was unlawful. The case was subsequently transferred to the Northern District of Georgia, was unlawful. The case was subsequently transferred to the Northern District of Georgia, where where caseisis still still pending. the case
Notably, its Notably, its not not just just the the Judiciary Judiciary that that is is currently currentlygrappling grapplingwith withthe thereverse reversepayment payment issue. issue. The issue is is also also now now before before Congress. Congress.The TheHouse HouseJudiciary JudiciaryCommittee’s Committee’s Courts Courts and and Competition Competition issue Policy Policy Subcommittee Subcommitteeheld heldaa hearing hearingon on June June 3, 3, 2009 2009 regarding regarding reverse reverse payments payments and and the the proposed Protecting Protecting Consumer ConsumerAccess AccesstotoGeneric GenericDrugs DrugsAct Actof of 2009 2009(H.R. (H.R. 1706). 1706). At At this proposed hearing, FTC Bureau Bureau of of Competition Competition Director Director Richard A. A. Feinstein Feinstein testified testified in in support support of of the the bill bill hearing, FTC Access to to Generic Generic Drugs Drugs Act Act stating the Commission strongly strongly supports supports the the Protecting Consumer Consumer Access of 2009 (H.R. 1706), which would prohibit these reverse settlement (“anticompetitive which would prohibit these reverse settlement (“anticompetitive stated that that this this legislation legislation would “subvert settlements”). Feinstein further opined stated “subvert the the goals of the Hatch-Waxman Act, which was designed to prevent weak patents from obstructing lower-cost Act, which was designed patents from competition.” Over generic competition.” Overthe theyears, years, the the Federal Federal Trade Trade Commission Commission has has consistently consistently opposed opposed reverse payments but its court challenges of them have been unsuccessful. reverse payments but its court challenges of them have been unsuccessful.
Also testifying at atthe theJune June3rd3rd Congressional hearing, T. Donatiello, Vice Also testifying Congressional hearing, Guy Guy T. Donatiello, Vice President of President of Intellectual Property at Endo Pharmaceuticals, voiced opposition to the bill stating H.R. 1706 Intellectual Property at Pharmaceuticals, voiced opposition to the bill would in patent that they would discourage discourage settlement settlement and and instead instead force force companies companies to to engage engage in patent disputes disputes that they otherwise would not, costing consumers. Bret M. Dickey, Senior Vice President of Economic consumers. Bret M. Vice President Consulting firm firmCompass Compass Lexecon, concurred with Donatiello Donatiello and and testified testified that that patent patent settlements can benefit consumers by keeping litigation costs and risk of litigation low. settlements can benefit consumers by keeping litigation costs and risk of litigation low. Notably, the House House Judiciary Judiciary Committee Committee hearing, Notably, on on the the same same day day as as the hearing, the the House House Energy Energy and and Commerce Committee, Commerce, Commerce, Trade, Trade, and and Consumer Protection Subcommittee Subcommittee approved approved same bill bill (H.R. 1706) with a 16 to 10 vote, vote, sending sendingitit to to the thefull full Committee for further this same action. Subcommittee members did, however, express concern that thebill bill could could inadvertently inadvertently action. Subcommittee members did, however, express concern that the result in to generic generic drugs. drugs. Representative Representative Joseph Joseph R. R. Pitts Pitts (R-Pa.) (R-Pa.) said said brand brand drug drug result in less less access access to companies will have no incentive to settle cases, thus further expressing concern that, generic companies will have no incentive to settle cases, thus further expressing concern that, generic companies may may only only challenge challenge aapatent patentifif aapositive positive outcome outcomeisishighly highly likely. likely. An companies An amendment amendment proposed by Representative George P. Radanovich (R-Calif.) and approved by a voice vote of of proposed by Representative George P. Radanovich (R-Calif.) and approved by a voice vote Subcommittee, requires requires the theGovernment GovernmentAccountability Accountability Office the Subcommittee, Office to to conduct conduct aa study two two years years after the legislation is enacted to analyze the impact of the legislation on patent litigation. The enacted to analyze the impact of the legislation on patent litigation. will be and if if analysis will be focused focused on on whether whether generics generics actually actually enter enter the the market market earlier earlier as as a result and there are are any any resulting resulting harm harm or or benefits benefits to to consumers. consumers.The Thebill bill will will now go to the Energy and now go to the Energy and Commerce Committee for markup.
Authored by: Arianna B. B. Chernove (202) 772-5361 [email protected] [email protected] and and
Deborah M. Shelton
Document hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=ec9ce2f7-f990-421a-b1f1-17be196ccc2c
(202) 772-5351 [email protected]
FDA Law Update FDA Law Update
Posted at 1:06 1:06 PM PM on on June June 15, 15, 2009 2009 by by Sheppard Sheppard Mullin Mullin Posted at
Reverse - Hot Button Issue Issue ReversePayments Payments - Hot Button issue of of aa patent patent litigation litigation settlement The issue settlement in in the the form form of ofpayments payments by byaa brand brand name name drug company to the defendant to delay marketing a generic version of its brand name is company to the defendant to delay marketing a generic version of its brand name counterpart counterpart is heating up this summer. summer. Indeed, it is is currently currentlyboth bothbefore beforethe theSupreme Supreme Court Court and and Congress. Congress.
A filed aa petition A group group of of indirect indirectpurchasers purchasers filed petition with withthe the Supreme Supreme Court seeking review of the Federal Circuit’s Circuit’s decision decision in in In Re:Ciprofloxacin finding million payment Federal finding that that Bayer’s $398 million payment to Barr and Hoechst Hoechst Marion Marion Roussel (now Sanofi-Aventis) to delay marketing a generic version of Roussel (now Sanofi-Aventis) to delay marketing a a drug did not not violate violate federal federal antitrust antitrust laws. laws. Arkansas Arkansas Carpenters Carpenters Health and Welfare Fund Fund is asking the court to determine whether reverse payments to settle patent litigation are per asking the court to determine whether reverse payments to settle patent litigation are per se se lawful without lawful withoutregard regardto tothe the amount amount paid paid or or strength strength of of the the underlying underlying patent patent challenge. This is the third time been brought brought to to the the Supreme Supreme Court. Court. The The Court Court the third time the the issue issue of of reverse reverse payments payments has has been refused to to hear the prior prior two refused hear the twocases. cases.
Supreme Court Court decide decide to to hear hear this this case, case,its itsdecision decisionwill will resolve Should the the Supreme resolve a current split among among the Circuit Circuit Courts regarding the legality of reverse payments. The U.S. Court of Appeals for the Courts regarding legality of reverse U.S. Court Sixth Circuit illegal; the Sixth Circuithas has held heldthat thatsuch such payments payments are are illegal; the Second Second and and Federal Circuits have have upheld them. The Eleventh Circuit adopted a more nuanced stance, holding that reverse upheld them. The Eleventh Circuit adopted a more nuanced stance, holding that reverse under the the antitrust antitrust rule of payments should be analyzed under of reason. reason.
casefor for which which Supreme Supreme Court Court review review is sought, Federal Circuit Circuit concluded In the the present present case sought, the Federal concluded that that reverse payments to settle patent litigation do not violate antitrust law as long as (1) the suit is reverse payments to settle patent litigation do not violate antitrust law as long as (1) the suit is not a sham or or otherwise otherwise baseless; and (2) (2) the the settlement settlement does does not not impose impose restrictions restrictions on not a sham baseless; and on the the alleged infringer that extend beyond the scope of the patent. It remains to be seen whether alleged infringer that extend beyond the scope of the patent. It remains to be seen whether the the Supreme Court Court will will grant Supreme grant the the petition petition to to review review this this decision decision and and settle the current split. Recently, payment Recently, private private class class action action suits suits also also have have been been filed filedagainst against these these reverse reverse payment
settlements. Themost most recent class action against companies marks 11thsuit settlements. The recent class action against thesethese companies marks the 11th the private private suit concerning this reverse payment settlement agreement. The United Food and Commercial concerning this reverse payment settlement agreement. The United Food and Commercial Workers Union Midwest Health Union and and Employers Midwest Health Benefits Benefits Fund Fund filed filed aa putative putative class class action suit in the District District of Minnesota, seeking to recover what it called overcharges stemming from the of Minnesota, seeking to recover it called overcharges “unlawful “unlawfuldelay delayand and exclusion” exclusion”of ofgeneric generic AndroGel. AndroGel.The Theunlawful unlawfuldelay delayand and exclusion exclusion was was a result of Unimed making payments to Watson, Par, and Paddock in exchange for keeping their result of Unimed making payments to Watson, Par, and Paddock in exchange for keeping their less expensive generics genericsoff off the the market. market. Prior Prior to this class class action, action, the the FTC FTC and and state stateof of California California less expensive
Document hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=ec9ce2f7-f990-421a-b1f1-17be196ccc2c
Watson, Par, Par, Paddock, Paddock,and andUnimed Unimedin in California California claiming both sued sued Watson, claiming that that the the reverse reverse payment payment was unlawful. The case was subsequently transferred to the Northern District of Georgia, was unlawful. The case was subsequently transferred to the Northern District of Georgia, where where caseisis still still pending. the case
Notably, its Notably, its not not just just the the Judiciary Judiciary that that is is currently currentlygrappling grapplingwith withthe thereverse reversepayment payment issue. issue. The issue is is also also now now before before Congress. Congress.The TheHouse HouseJudiciary JudiciaryCommittee’s Committee’s Courts Courts and and Competition Competition issue Policy Policy Subcommittee Subcommitteeheld heldaa hearing hearingon on June June 3, 3, 2009 2009 regarding regarding reverse reverse payments payments and and the the proposed Protecting Protecting Consumer ConsumerAccess AccesstotoGeneric GenericDrugs DrugsAct Actof of 2009 2009(H.R. (H.R. 1706). 1706). At At this proposed hearing, FTC Bureau Bureau of of Competition Competition Director Director Richard A. A. Feinstein Feinstein testified testified in in support support of of the the bill bill hearing, FTC Access to to Generic Generic Drugs Drugs Act Act stating the Commission strongly strongly supports supports the the Protecting Consumer Consumer Access of 2009 (H.R. 1706), which would prohibit these reverse settlement (“anticompetitive which would prohibit these reverse settlement (“anticompetitive stated that that this this legislation legislation would “subvert settlements”). Feinstein further opined stated “subvert the the goals of the Hatch-Waxman Act, which was designed to prevent weak patents from obstructing lower-cost Act, which was designed patents from competition.” Over generic competition.” Overthe theyears, years, the the Federal Federal Trade Trade Commission Commission has has consistently consistently opposed opposed reverse payments but its court challenges of them have been unsuccessful. reverse payments but its court challenges of them have been unsuccessful.
Also testifying at atthe theJune June3rd3rd Congressional hearing, T. Donatiello, Vice Also testifying Congressional hearing, Guy Guy T. Donatiello, Vice President of President of Intellectual Property at Endo Pharmaceuticals, voiced opposition to the bill stating H.R. 1706 Intellectual Property at Pharmaceuticals, voiced opposition to the bill would in patent that they would discourage discourage settlement settlement and and instead instead force force companies companies to to engage engage in patent disputes disputes that they otherwise would not, costing consumers. Bret M. Dickey, Senior Vice President of Economic consumers. Bret M. Vice President Consulting firm firmCompass Compass Lexecon, concurred with Donatiello Donatiello and and testified testified that that patent patent settlements can benefit consumers by keeping litigation costs and risk of litigation low. settlements can benefit consumers by keeping litigation costs and risk of litigation low. Notably, the House House Judiciary Judiciary Committee Committee hearing, Notably, on on the the same same day day as as the hearing, the the House House Energy Energy and and Commerce Committee, Commerce, Commerce, Trade, Trade, and and Consumer Protection Subcommittee Subcommittee approved approved same bill bill (H.R. 1706) with a 16 to 10 vote, vote, sending sendingitit to to the thefull full Committee for further this same action. Subcommittee members did, however, express concern that thebill bill could could inadvertently inadvertently action. Subcommittee members did, however, express concern that the result in to generic generic drugs. drugs. Representative Representative Joseph Joseph R. R. Pitts Pitts (R-Pa.) (R-Pa.) said said brand brand drug drug result in less less access access to companies will have no incentive to settle cases, thus further expressing concern that, generic companies will have no incentive to settle cases, thus further expressing concern that, generic companies may may only only challenge challenge aapatent patentifif aapositive positive outcome outcomeisishighly highly likely. likely. An companies An amendment amendment proposed by Representative George P. Radanovich (R-Calif.) and approved by a voice vote of of proposed by Representative George P. Radanovich (R-Calif.) and approved by a voice vote Subcommittee, requires requires the theGovernment GovernmentAccountability Accountability Office the Subcommittee, Office to to conduct conduct aa study two two years years after the legislation is enacted to analyze the impact of the legislation on patent litigation. The enacted to analyze the impact of the legislation on patent litigation. will be and if if analysis will be focused focused on on whether whether generics generics actually actually enter enter the the market market earlier earlier as as a result and there are are any any resulting resulting harm harm or or benefits benefits to to consumers. consumers.The Thebill bill will will now go to the Energy and now go to the Energy and Commerce Committee for markup.
Authored by: Arianna B. B. Chernove (202) 772-5361 [email protected] [email protected] and and
Deborah M. Shelton
Document hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=ec9ce2f7-f990-421a-b1f1-17be196ccc2c
(202) 772-5351 [email protected]
