Gibbons Law Alert
On December 3, 2013, the Fifth Circuit Court of Appeals reversed the decision of the National Labor Relations Board (the “Board” or “NLRB”) in D.R. Horton, Inc. and held that D.R. Horton’s arbitration agreement prohibiting class or collective action claims did not violate the National Labor Relations Act (“NLRA”). In so holding, the court found that the Board did not give proper weight to the Federal Arbitration Act (“FAA”).
Ranbaxy Laboratories, Ltd. (“Ranbaxy”) and Vertex Pharmaceutical, Inc. (“Vertex”) recently settled an inter partes review (“IPR”) proceeding regarding Vertex’s U.S. Patent No. 6,436,989 (“the ‘989 Patent”). Vertex had listed the ‘989 Patent in the FDA’s published Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the Orange Book, as covering its HIV drug, Lexiva®. The significance of this event is the rarity of the use of IPR on patents typically challenged under the Hatch-Waxman framework. Recent statistics show that the majority of IPR have involved electrical/computer patents. Less than 6% of IPRs have been directed to biotechnology/pharmaceutical patents. The likely reason for the limited use of IPR on pharmaceutical patents, particularly those listed in the Orange Book, is the estoppel provisions of the IPR proceedings. See 35 U.S.C. §§ 315(e).
On Monday, a group of some 60 law school professors from across the country formally joined the debate on the perceived abuses by Patent Assertion Entities (“PAEs”), or so-called patent trolls. The Professors signed a letter to Congress that decries “abusive patent enforcement” by trolls. The result of these litigations, according to the Professors, is the diversion of billions of dollars from employee hiring and retention and product development to “wasteful litigation.”
According to the Tufts Center for the Study of Drug Development, the pharmaceutical industry, particularly Big Pharma, has decidedly changed course, shifting its R&D focus away from small molecule drugs towards biotech products. Such biotech products are muscling out small molecules’ prior domination of the top 10 drug product sales. For example, in 2012, biotech products accounted for 71% of the revenues generated by the world’s top selling biopharmaceutical products. This remarkable growth mirrors the successful evolution of biotech research over the last three decades. Drilling down further, the Tufts Report notes that monoclonal antibody (mAb) biotech products saw the largest increase in growth over the last decade and now account for almost 60% of the biotech products being clinically developed by the largest pharmaceutical companies.
Just ten months after issuing its Decision to Initiate Trial in the very first Inter Partes Review (“IPR”) proceeding (IPR2012-00001, Garmin International, Inc. et al. v. Cuozzo Speed Technologies LLC ), the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) has issued a Final Written Decision in favor of the Petitioner, Garmin. In its Decision, the PTAB found the claims at issue to be unpatentable as obvious in view of the cited prior art, and further denied Patent Owner Cuozzo’s Motion to Amend the claims.
We previously reported on the recent efforts by Congress to reform patent litigation procedures by way of the House’s “Innovation Act” H.R. 3309. The Senate is considering its version of the bill, entitled the Patent Litigation Integrity Act, S. 1612.
In a decision of first impression, Judge Maxine M. Chesney of the Northern District of California dismissed Sandoz’s declaratory judgment action against Amgen for lack of jurisdiction. Sandoz had brought its suit on June 24, 2013 seeking a ruling that its biosimilar version of Amgen’s patented arthritis drug Enbrel (etanercept) would not infringe and that the patents are invalid. Amgen moved to dismiss the case for lack of subject-matter jurisdiction or, alternatively, to decline to exercise Declaratory Judgment jurisdiction.
In a precedential opinion, the Third Circuit in Vodenichar v. Halcón Energy Properties, Inc., clarified the “home state” and “local controversy” exceptions to federal subject matter jurisdiction under the Class Action Fairness Act (“CAFA”). The decision provides guidance on two undefined terms within CAFA, adopting broader interpretations for what makes a defendant a “primary defendant” for purposes of the home state exception and what constitutes an “other class action” for purposes of the local controversy exception.
Keeping track of all of the state and federal family and medical leave laws, paid family leave laws, and workers’ compensation and disability laws is difficult for any business owner or HR professional. Properly determining leave eligibility and ensuring that leave is not abused is even harder and generates the most mistakes and lawsuits.
Last week, Senate Judiciary Chairman Orrin Hatch (D. UT) introduced the Patent Litigation Integrity Act, S. 1612. The Senate bill follows the introduction of a bill proposed by House Judiciary Committee Chairman Bob Goodlatte (R. VA), H.R. 3309, entitled “Innovation Act,” which also proposes a number of significant changes to patent litigation procedures.