Gibbons Law Alert

Gibbons Law Alert

Tagged: Patent Litigation

A Rare Inter Partes Review for an Orange Book Listed Patent

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Posted in Patent

On December 3, 2013

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).

Law School Professors Weigh in on Troll Debate

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Posted in Patent

On November 27, 2013

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.”

Lawmakers Urge Caution on Innovation Act

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Posted in Patent

On November 18, 2013

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.

First Biosimilars Ruling is Out … Industry, Take Heed!

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Posted in Biotech

On November 15, 2013

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.

Senate Proposes Its Bill on Patent Litigation Changes

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Posted in Patent

On November 6, 2013

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.

Patent Law Bill to Rein in Litigation Abuses . . . (No really)!

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Posted in Patent

On October 31, 2013

Last week, House Judiciary Committee Chairman Bob Goodlatte (R-VA) introduced H.R. 3309, entitled “Innovation Act,” a 51-page bill proposing a number of significant amendments to the Patent Act (Title 35 U.S.C.). We reported last month on an earlier proposed draft of this bill. As we noted last month, among the more noteworthy provisions of the bill is a proposed new 35 U.S.C. § 281A, which heightens the pleading requirements for patent cases. Specifically, the proposed new section mandates providing detailed information about the patents alleged to be infringed, identifying each accused product/process, and providing information with “detailed specificity” regarding how the product infringes. This provision also sets forth that, for any required information not disclosed, the plaintiff must establish why such undisclosed information was not readily accessible, and the efforts made by such party to access it.

Supreme Court Will Not Review Bar for Proving Inequitable Conduct

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Posted in Patent

On October 24, 2013

We have previously reported on the Federal Circuit’s en banc decision in Therasense, Inc. v. Becton Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) issued on May 25, 2011. In that decision, the Federal Circuit heightened the standard required to show that a patent holder committed inequitable conduct during the prosecution of the patent at issue. Prior to Therasense, an accused infringer asserting inequitable conduct as a defense had to show that the withheld information or false statements were material and the patent applicant intended to deceive the USPTO. Materiality and intent were analyzed on a sliding scale, where intent could be inferred if the withheld information was considered highly material.

Proposed Amendments to Patent Laws to Rein in Litigation Abuses

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Posted in Patent

On October 9, 2013

Recently, House Judiciary Committee Chairman Bob Goodlatte (R-VA) announced a 47-page draft of a bill that proposes various amendments to the Patent Act, Title 35 of the United States Code and the Leahy-Smith America Invents Act. Importantly for IP practitioners, the draft bill would heighten pleading requirements for patent cases under a new 35 U.S.C. § 281A, by requiring detailed information in a complaint, including all the patents alleged to be infringed, an identification of each accused product and information with “detailed specificity” regarding how the product infringes. The proposed revisions would eliminate the current “Form 18,” which is the baseline model for alleging patent infringement.

Hoping to Understand the Troll: the FTC Seeks Public Comment on its Proposed Information Requests

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Posted in Patent

On October 7, 2013

On September 27, the Federal Trade Commission (“FTC”), announced that it had unanimously voted to seek public comments on its proposed requests for information from selected Patent Assertion Entities (“PAEs”), typically referred to as “patent trolls.” The FTC’s proposed 6(b) order seeks information from approximately 25 yet-to-be-named PAEs in the wireless communications sector regarding among other things, their “patent acquisition, litigation, and licensing practices.”

ANDA Product Controls Infringement Analysis In Hatch-Waxman Framework

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Posted in Patent

On October 3, 2013

Last week, the Federal Circuit, in Sunovion Pharm. v. Teva Pharm. USA, et al., addressed the appropriate infringement analysis in the context of Hatch-Waxman (aka “ANDA”) litigation. It held: Although no traditional patent infringement [occurs] until a patented product is made, used, or sold, under the Hatch-Waxman framework, the filing of an ANDA itself constitutes a technical infringement for jurisdictional purposes. But the ultimate infringement question is determined by traditional patent law principles and, if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue.

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