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Posts Tagged: "michael carrier"

The Fifth Circuit Must Preserve the Patent-Antitrust Balance by Upholding Actavis

The pharmaceutical industry presents some of the most important and challenging issues lying at the intersection of the patent and antitrust laws. On the one hand, patents play a crucial role in the industry, which is unique in the cost and duration of reaching the market. But on the other, a complicated regulatory regime and the event of generic entry (which dramatically lowers price and which the brand firm has interest in delaying) opens the door for potentially anticompetitive behavior. One area where this tension has surfaced in recent years has involved the settlement of patent litigation. In 2013, in FTC v. Actavis, the Supreme Court held that agreements by which brand-name drug companies pay generics to settle patent litigation and delay entering the market could have “significant anticompetitive effects” and violate the antitrust laws.

The Supreme Court’s Actavis Decision, Or Why Pay-for-Delay Litigation Just Got More Active

In this case, the Supreme Court considered an arrangement by which brand firm Solvay paid generics Watson (now Actavis) and Paddock roughly $30 to $40 million to delay entering the market with generic versions of testosterone gel. The Eleventh Circuit upheld the activity, concluding that “absent sham litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent.” The court explained that “[p]atent holders have a ‘lawful right to exclude others from the market’” and that a patent “conveys the right to cripple competition.”

The Supreme Court reversed the Eleventh Circuit, concluding that, while a valid patent allows a patentee to charge “higher-than-competitive” prices, “an invalidated patent carries with it no such right.” The Court recognized the policy encouraging settlements. But for five reasons, it found that that policy did not dictate immunity for pay-for-delay settlements.

Supreme Court Agrees To Tackle Drug Patent Settlements

In the past several years, the Second, Eleventh, and Federal Circuits have upheld these settlements (known as “reverse payment” agreements since the money flows from the patentee to the alleged infringer rather than the other way around). These courts have focused on the benefits of settling cases and the presumption of patent validity, and they have explained that payments fall within the “scope of the patent.” In contrast, the Third Circuit recently applied more aggressive scrutiny, rejecting the scope test and finding that payments for delay were “prima facie evidence of an unreasonable restraint of trade.”

Reverse Payment Home Run for Pharma Antitrust Enforcement

One of the most complex issues in antitrust and patent law today involves agreements by which brand-name drug companies pay generics to delay entering the market. In the past decade, with the Supreme Court showing no interest in wading into the area, the Federal, Second, and Eleventh Circuits have upheld these agreements. And, with each court relying on its sister court, a momentum had developed that made it nearly impossible to discern a role for antitrust scrutiny. The Third Circuit just found that a reverse payment was “prima facie evidence of an unreasonable restraint of trade.”

A Special Thank You to Our Guest Contributors!

Over the years IPWatchdog.com has continued to try and add additional perspectives from a wide variety of guest contributors, ranging from well respected practicing attorneys and agents to high profile academics to inventors and pro-patent lobbyists. It is hard to imagine providing such depth of analysis on such an array of topics without having truly wonderful guest authors. So we take this moment to say a very special thank you and to shine the spotlight on them. Each deserve to share in any recognition of IPWatchdog.com. Without further ado, here are the guest contributors in alphabetical order, along with their contributions for 2011.

An Inconvenient Truth: Patents Do Not Deter Research

Carrier goes on to detail the comprehensive research of Professor John Walsh who in 2007 surveyed 1125 biomedical researchers in universities, government labs and nonprofit institutions. Walsh received 414 responses and the responses were overwhelmingly clear. Carrier explains that only 3% of respondents indicated that they stopped pursuit of a research agenda based on an excess of patents present in the space. Furthermore, Carrier explained that a mere 5% of respondents even regularly checked for patents related to their research and “no respondents reported that they had abandoned a line of research because of a patent.”

Hatch-Waxman at the Supreme Court: Supporting Cert. in Cipro

One of the most debated issues in patent and antitrust law today involves pharmaceutical patent settlements. Brand-name drug manufacturers pay generic firms to settle patent litigation and delay entering the market. How should the antitrust laws respond? The Cipro case presents an ideal vehicle for Supreme Court review. It involves a simple, undisputed payment from brand to generic to delay entering the market.