{"id":21510,"date":"2013-06-27T14:26:56","date_gmt":"2013-06-27T18:26:56","guid":{"rendered":"http:\/\/www.iposgoode.ca\/?p=21510"},"modified":"2013-06-27T14:26:56","modified_gmt":"2013-06-27T18:26:56","slug":"splitting-the-difference-between-antitrust-and-intellectual-property-ftc-v-actavis","status":"publish","type":"post","link":"https:\/\/www.yorku.ca\/osgoode\/iposgoode\/2013\/06\/27\/splitting-the-difference-between-antitrust-and-intellectual-property-ftc-v-actavis\/","title":{"rendered":"Splitting the Difference Between Antitrust and Intellectual Property: FTC v Actavis"},"content":{"rendered":"

The dividing line between intellectual property and antitrust laws was further clarified last week when the Supreme Court of the United States (SCOTUS) settled a debate<\/a> on the illegality of Reverse Payment Agreements (RPAs) in Federal Trade Commission (FTC) v Actavis<\/em>. In so doing, the Court split the difference between the FTC\u2019s assertion that RPAs are \u201cpresumptively illegal\u201d and the \"Brand-name\" position that RPAs should be \u201cimmune from antitrust scrutiny\u201d if formed under a valid patent.<\/p>\n

<\/b><\/p>\n

What is a Reverse Payment Agreement (RPA)?<\/b><\/p>\n

As has previously been discussed on this blog<\/a>, an RPA is a settlement agreement that has come to be known as a \u201cpay-for-delay deal\u201d.\u00a0 In such an agreement, a patent holder pays the allegedly infringing generic drug company to delay entering the market until a particular date, thus delaying litigation on the patent. The payment is \u201creverse\u201d because the money flows in the opposite direction from a typical exchange between licensee and patent holder.

<\/p>\n

In some ways, RPAs make economic sense for all companies involved. \"Brand-names\" can maintain market exclusivity, while \"Generics\" potentially generate more revenue than if they had released the product into the market.\u00a0 Consumers, however, are arguably short-changed because the prices of pharmaceuticals remain high as a result of this delayed competition.

<\/p>\n

The AndroGel \u201cReverse Payment\u201d<\/b><\/p>\n

In 2000, Solvay\u2019s patent for a formulation of testosterone - AndroGel - was approved.\u00a0 In 2003, Watson and Paddock filed their intent to manufacture generic versions of AndroGel with the FDA, alleging that Solvay\u2019s patent was invalid.\u00a0 In response, Solvay sued for patent infringement.\u00a0 Instead of allowing litigation to determine the validity of the patent, the parties settled<\/a>. The settlement involved a payment from Solvay to Watson of $19-30 million annually until 2015.\u00a0 During that time, Watson would not sell its version (unless another generic entered the market) and would assist Solvay in marketing AndroGel to urologists.

<\/p>\n

The FTC Argument: RPAs Illegally Allow \"Brand-Name\" Manufacturers to Extend Patent Monopolies<\/b><\/p>\n

The FTC argued that these agreements had little actual value to Solvay, and that the real purpose of the settlement was to protect Solvay\u2019s patent from being challenged and delay generic entry into the market. As a result, the FTC believed that Solvay had unlawfully extended its monopoly on AndroGel through payments to its competitors.\u00a0 This sort of agreement is a prima facie <\/i>violation of US antitrust laws, because the agreement between Solvay and the generic manufacturers resembled a horizontal agreement to suppress competition and extend a monopoly.\u00a0 Thus, the FTC argued that settlements involving RPAs should be made presumptively illegal.

<\/p>\n

The \"Brand-Name\" Response: A Valid Patent Should Immunize RPAs from Antitrust Scrutiny<\/b><\/p>\n

In response, the pharmaceutical companies argued that the existence of a valid patent should immunize settlements involving RPAs from antitrust scrutiny.\u00a0 Since the settlement agreement allowed Watson to enter the market 65 months\u00a0before<\/i>\u00a0Solvay\u2019s patent ended, and since patents are legitimate exercises of market exclusivity, the \"Brand-names\" argued that RPAs are a legitimate exercise of their patent rights and there should be no concern about abuse of monopoly power.

<\/p>\n

They further argued that unless the companies took action outside the \u201cscope of the patent\u201d (for example, by extending market exclusivity past the patent expiration date or expanding the scope of the exclusivity beyond the patent claims), the fact that Solvay held a valid patent should allow it to choose to exclude others from the marketplace at its discretion, including by settling cases with potential competitors using RPAs.

<\/p>\n

The Supreme Court\u2019s Decision in FTC v Actavis<\/i>: The FTC Has the Right to Prove Antitrust Claim<\/b><\/p>\n

Writing for the majority in a 5-3 decision<\/a>, Justice Stephen Breyer held that a broad allowance of all RPAs under a registered patent was an improper outcome given that the patent itself may be invalid.\u00a0 At the same time, Justice Breyer did not find RPAs to be so unjustifiable that they should be evaluated under the \u201cpresumptively illegal\u201d framework proposed by the FTC.\u00a0 Instead, Breyer J struck a balance and held that the FTC has the right to be given an opportunity to \u201cprove its antitrust claim.\u201d

<\/p>\n

The Dissent <\/b><\/p>\n

In a dissenting opinion, Chief Justice John Roberts supported the \"Brand-name\" position.\u00a0 He argued that so long as the parties held a valid patent, the patent itself\u00a0<\/i>gave the owner the right to choose who could use their property. \u00a0This right includes the use of reverse payments to settle litigation.\u00a0 While Chief Justice Roberts acknowledged that antitrust laws are intended to encourage competition, he\u00a0<\/i>worried that the majority opinion would discourage settlements in patent litigation.\u00a0 He wondered whether the costs of protracted litigation would lead fewer \"Generics\" to challenge \"Brand-name\" patents in the first place.

<\/p>\n

The Impact of the Decision<\/b><\/p>\n

While the majority decision seems to strike a balance between two extreme positions, one wonders if SCOTUS has not opened a new can of worms with this decision. By allowing the FTC to make an antitrust case against RPAs, courts are now faced with the difficult task of deciding which agreements are anti-competitive. Justice Breyer does provide some guidance on this assessment by stating that the anti-competitive nature of an RPA would be based on \u201cits size, its scale in relation to the payor\u2019s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification.\u201d He also warned against \u201clarge and unjustified\u201d RPAs. It is worth noting, however, that the merits of the patent were not part of Breyer\u2019s consideration.

<\/p>\n

Only time will tell if this decision will prevent truly anti-competitive practices or if it will prevent legitimate agreements that would have allowed innovators of beneficial drugs to recoup their costs.


<\/i><\/p>\n

Beatrice Sze is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.<\/em><\/div>\n","protected":false},"excerpt":{"rendered":"

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