Patent Law Practice Center

FTC charges Endo Pharmaceuticals with “pay for delay” antitrust violation

On March 30, 2016, the Federal Trade Commission filed a complaint in the United States Federal District Court for the Eastern District of Pennsylvania alleging that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using “pay for delay” agreements to block consumers’ access to lower-cost generic versions of Opana ER and Lidoderm. The complaint also names Allergan plc, the parent company of Watson, and Endo International plc, the parent company of Endo Pharmaceuticals Inc. According to the FTC, this enforcement action is the first FTC case challenging an agreement not to market an authorized generic – often called a “no-AG commitment” – a form of reverse payment. A no-AG (“no authorized generic”) commitment involves a branded firm agreeing that it will not launch its own generic alternative when the first generic begins to compete. Because introduction of an authorized generic from the branded company would cut into the revenues of a competing generic, a no-AG commitment can induce the generic company to delay its entry.

This enforcement action by the FTC comes thanks to a June 2013 ruling from the United States Supreme Court in FTC v. Actavis, Inc.  In a nutshell, writing for the majority, Justice Breyer explained that there is no valid reason for the FTC to be denied the opportunity to pursue reverse payments as an antitrust violation.  Breyer (joined by Justices Kennedy, Ginsberg, Kagan, and Sotomayor) determined that reviewing courts should apply the rule of reason when determining whether reverse payments violate antitrust law. See Supremes Say Reverse Payments May be an Antitrust Violation. Prior to the ruling in FTC v. Actavis, it was widely believed that the FTC did not have authority to challenge reverse payments as settlements of patent disputes. See Pharma Reverse Payments Are Not an Antitrust Violation.

(more…)

SCOTUS Ending Term with Patent Decisions

Over the past several days, the United States Supreme Court has issued several important decisions that will impact the patent system.

First, on June 13, 2013, the Supreme Court issued a decision in Association of Molecular Pathology v. Myriad Genetics, which has sometimes been referred to as “ACLU v. Myriad” in recognition of the fact that it was the American Civil Liberties Union that was responsible for bringing the challenge in the district court and pursuing the matter through the judicial system.

In Myriad, Justice Thomas wrote for a nearly unanimous Court.  Only Justice Scalia wrote a brief separate opinion in which he concurred in part and concurred in the judgment.

The majority decision in Myriad is not long, and the first 10 pages are background. Despite not giving much detailed attention to the significant legal issues presented, the Supreme Court did manage to do real and serious harm to much of the biotechnology industry.

Justice Thomas summarized the Court’s decision by saying:

“[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”

The decision has widely been reported as the Court recognizing that cDNA is patent eligible, but the ruling is far more nuanced. In fact, Justice Thomas specifically recognized that some cDNA is not patent eligible. He wrote:

“cDNA is not a ‘product of nature’ and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”

I have spoken with a number of people who are in the biotech industry and they all seem to think this decision means that cDNA is patent eligible and I shouldn’t make too much out of Thomas specifically saying that at least some cDNA is not patent eligible. Personally, I think this is misplaced hope; we all know how the district courts will respond, and it won’t be to an expansive reading of patent eligibility. While the USPTO seems poised to say that cDNA is patent eligible, the fact that some has been determined not patent eligible will be used by challengers and likely successfully so. Further, it seems clear that Thomas is saying that if something is man-made but identical to what appears in nature, it is not patent eligible. This fundamentally undercuts the most important aspects of Chakrabarty and would effectively kill research into such important areas as artificially grown organs, which by their very nature must be identical to what is produced in nature to be transplanted into the human body, for example.

(more…)

Buying Patents by the Pound: Today’s Patent-Acquisition Boom and Tomorrow’s Antitrust Consequences

The market for patents is hotter than it has ever been, particularly in technology fields for smartphones and Internet searching. On June 26, 2012, PLI is hosting a one hour briefing discussing the recent multi-billion dollar patent portfolio transactions and how the size of these transactions requires them to be presented to and cleared by regulators in the U.S. and abroad to make sure competition won’t be harmed.

In addition, many of the affected patents have been asserted in litigation already, and others are bound to be soon.  That will bring further antitrust scrutiny, in all likelihood including counterclaims that the new owners’ assertion of the patents violates the antitrust laws.

The one hour briefing is entitled, “Buying Patents by the Pound: Today’s Patent-Acquisition Boom and Tomorrow’s Antitrust Consequences,” and features Charles S. Crompton, of Latham & Watkins LLP, and Ronald S. Laurie, Managing Director & Principal, Inflexion Point Strategy, LLC.

The panelists will discuss the forces driving the current strategic patent acquisition market, market developments that can be expected, how a potential market participant can prepare for antitrust scrutiny, and the possible approaches taken by the courts and regulators.

Register for “Buying Patents by the Pound: Today’s Patent-Acquisition Boom and Tomorrow’s Antitrust Consequences,” today!