Eli Lilly, Pfizer among those supporting Sequenom cert petition

Recently, a group of amici led by Eli Lilly filed an amici curiae brief with the United States Supreme Court in the matter of Sequenom, Inc. v. Ariosa Diagnostics, Inc. The Eli Lilly brief was filed in support of the petitioner, Sequenom. Eli Lilly is joined in this brief by Eisai Inc., Upsher-Smith Laboratories, Inc., Pfizer Inc., and Etiometry, Inc.

On March, 21, 2016, Sequenom filed a Petition for Writ of Certiorari in the Supreme Court, challenging the decision of the United States Court of Appeals for the Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc. If the Supreme Court takes this case, they will be asked to reconsider the unfortunate breadth of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. See SCOTUS Blog Founder asks Supreme Court to Reconsider Mayo.

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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.

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Hulk Hogan victory over Gawker shows problems with a bond requirement

A Florida jury recently awarded $115 million to former professional wrestler turned reality TV star Hulk Hogan.  As you might expect, Gawker immediately announced they would appeal. Unfortunately for Gawker, thanks to Florida law, they could be required to post a bond of up to $50 million for the privilege of appealing this decision. Posting a bond that large, Gawker argues, would imperil their ability to defend themselves and mount an appeal. Indeed, this verdict could destroy Gawker altogether.

Without getting into the substance of the Hogan vs. Gawker lawsuit, the issue of posting bonds to appeal is quite relevant in the ongoing debate over patent reform. While the philosophy behind a bond requirement makes some sense, in practice there are serious issues with prohibiting a party from appealing a decision unless they can post a ridiculously expensive bond.

The issue of bonds has been an important matter for innovators. The bond requirement has been promoted by Senator Orrin Hatch (R-UT), for example, as a way to curb abusive patent litigation by forcing those who have lost to reasonably assure the victorious party that the losing party can cover any resulting losses to the appellee before they can appeal.  VCs, universities and others object to the bond requirement and related measures that would enable defendants to get “real parties in interest” to shift fees, arguing that the real motivation is simply to make it financially impossible to ever assert a patent in the first place.

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Coalition for Affordable Drugs IPR against Juxtapid gets “green light”

The Coalition for Affordable Drugs, the entity backed by patent renegades Kyle Bass and Erich Spangenberg, recently won two more victories at the Patent Trial and Appeal Board (PTAB).  This time Bass and Spangenberg obtained favorable inter partes review (IPR) institution decisions on two petitions filed against the University of Pennsylvania, which challenged patents covering Juxtapid. Juxtapid is a drug that slows cholesterol production thereby making it easier for the body to remove remaining cholesterol from the bloodstream. To read these institution decisions see IPR2015-01835 and IPR2015-01836. Because the Board did not find it necessary to construe claim terms at the institution stage, both decisions are mirror images of one another.

The patents in question, U.S. Patent No. 7,932,268 and U.S. Patent No. 8,618,135, relate to “the surprising discovery that one may treat an individual who has hyperlipidemia and/or hypercholesterolemia with an MTP inhibitor in a manner that results in the individual not experiencing side-effects normally associated with the inhibitor, or experiencing side-effects to a lesser degree.”

Ultimately, the Board determined that the petitioner demonstrated that the claims challenged were likely invalid because they were obvious. The case will now proceed through the administrative trial. There were, however, several issues that came up in the institution decision that warrant consideration.

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Become a patent litigator in one easy step

There has never been a busier time to be a patent litigator, and if you have been thinking about what it takes to get started in this exciting practice area, look no further than PLI’s Fundamentals of Patent Litigation 2016, scheduled on April 19 in New York City and May 12 in San Francisco and via Live Webcast. This comprehensive program is perfect for those who want to add patent litigation to their litigation or patent prosecution practices.

Fundamentals of Patent Litigation 2016 will address key topics including:

  • Elements of a patent case and what to expect plaintiff-side and defendant-side
  • Overview of patent prosecution and changes to post-grant review
  • Claim construction and the all-important Markman hearing
  • Valuable practice tips – what can make or break a patent infringement case
  • Critical venue and forum issues, how the ITC fits in, and the timeline of a case

04.4.16 | posts | Mark Dighton

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