Category: Patent

Is Lear Still King?

In a recent decision, the Second Circuit crowned Lear, Inc. v. Adkins, 395 U.S. 653 (1969), but a petition to the Supreme Court has the possibility of dethroning this ruling and Lear. In Lear, the Court held that a licensee could challenge the validity of patents despite an agreement to the contrary. Contract law, the Court noted, must yield to the public’s interest in ensuring monopolies do not go unchecked. Lear, Inc., 395 U.S. at 670-71. Since that decision, courts have taken varied approaches to Lear. See, e.g., Licensee Patent Validity Challenges Following MedImmune: Implications for Patent Licensing,. 3 HASTINGS SCI. & TECH. L.J. 243-439 (2011).

Did You Submit an IDS During Reexamination? Does It Matter?

Earlier this month, the Federal Circuit in Belkin Int’l, Inc. v. Kappos, 2012-1090, published an important decision potentially limiting the scope of both ex-parte and inter-partes reexaminations. Traditionally during reexamination, practitioners submit information disclosure statements (IDS) to the Patent Office disclosing patents and printed publications with the understanding that the examiner would consider those references in relation to the claims subject to reexam. Very often, if the references were properly submitted, the examiner would record that the references were considered, but would not apply the references against the claims. The benefit to the patent owner is that this could create a heavy burden for subsequent defendants to show that the claims were invalid in view of this prior art. Belkin v. Kappos may change this practice and understanding.

District of New Jersey Stays Pay-For-Delay Cases Pending High Court’s Decision in K-Dur

Defendants in reverse-payment actions pending in the Third Circuit (New Jersey, Pennsylvania, and Delaware) take note: in In re Effexor XR Antitrust Litigation the Honorable Joel A. Pisano, U.S.D.J., of the District of New Jersey has stayed several class-action litigations challenging the legality of certain reverse-payment settlement agreements between Wyeth and generic drug manufacturer Teva Pharmaceuticals, pursuant to which Wyeth allegedly paid Teva to delay its marketing of a generic counterpart to Wyeth’s Effexor XR drug.

USPTO Extends Deadline for Commenting on First Inventor to File Provisions of the AIA to November 5, 2012

On July 26, 2012, the U.S. Patent & Trademark Office (USPTO) published a notice of proposed rulemaking and a notice of proposed examination guidelines to implement the first-inventor-to-file (FITF) provisions of the AIA effective March 16, 2013. The notices set an initial comment deadline date of October 5, 2012. In response to requests for additional time to submit comments, the USPTO recently extended the comment deadline date to November 5, 2012.

Patent Marking Under the America Invents Act – Virtual Marking

As practitioners know, U.S. patent law provides for the recovery of patent infringement damages for a period of time when an infringer has actual or constructive notice of the infringed patent. Actual notice is provided by way of letter or similar mechanism to the infringer after infringement has begun. Constructive notice can be provided by placing the patent number on the patented product. Such constructive notice provides notice to the infringer of the existence of a patent prior to actual notice, thereby extending the time period for recovering damages up to the date the infringement begins.

CAFC Reverses Inequitable Conduct Finding: Outside The Box Innovations v. Travel Caddy

The Federal Circuit recently reversed the Northern District of Georgia’s judgment of unenforceability based on inequitable conduct, in Outside The Box Innovations, LLC v. Travel Caddy, Inc. Other aspects of the decision are outside the scope of this blog. In reversing, and citing last year’s en banc decision in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011), the CAFC reiterated that to establish unenforceability based on inequitable conduct before the United States Patent and Trademark Office (“PTO”), a party must prove by clear and convincing evidence that (1) information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, and that such act was done (2) with the intent to deceive or mislead.

FTC Petitions for Certiorari in Reverse Payments Dispute

As we anticipated, the Federal Trade Commission (“FTC”) filed a petition for certiorari yesterday with the Supreme Court in FTC v. Watson Pharmaceuticals, Inc. In that case, the Eleventh Circuit upheld reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry under the scope-of-the-patent approach, i.e., as long as the anti-competitive effects fall within the scope of the exclusionary potential of the patent, absent sham litigation or fraud), as lawful. The Second and Federal Circuits follow that approach. In contrast, the Third Circuit has held that such payments are presumptively anti-competitive under the “quick look rule of reason analysis” that may be rebutted by showing that the payments was for something other than delay or that the payment has a competitive benefit, and thereby increases competition.

New Derivation Rule — 37 C.F.R. Part 42

The PTO recently announced final rules regarding the new derivation proceedings, 37 C.F.R. Part 42, pursuant to the Smith-Leahy America Invents Act. As practitioners are well aware, the AIA will transform the U.S. from a first-to-invent to a first-to-file patent system on March 16, 2013, aligning the U.S. with the European and Japanese systems. For all applications filed on or after March 16, 2013, under the first-to-file system, interference proceedings, which are used to determine “which [of two] part[ies] first invented [a] commonly claimed invention,” will become obsolete. Derivation proceedings will in part replace current interference practice, but will likely be applicable in a much narrower set of circumstances.

Will the Supreme Court Weigh in on Reverse Payments in ANDA Cases — Revisited

We have written previously on numerous developments concerning reverse payments in Hatch-Waxman litigation settlements (i.e., payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry of proposed generic products). Earlier this month, we reported that Merck & Co. had filed a petition for a Writ of Certiorari seeking to challenge the Third Circuit’s decision in In re K-Dur Antitrust Litig. holding that reverse payments are prima facie evidence of an antitrust violation.

Inter Partes Review Under AIA is Underway …

As we previously discussed, the new inter partes review (IPR) procedures went into effect September 16, 2012, along with several other significant changes. The IPR procedure replaces the previous inter partes reexamination and applies to any patent issued before, during, or after September 16, 2012. This removes one of the hurdles of the previous inter partes reexamination which applied only to applications filed after November 29, 1999. The PTO will only accept a valid IPR petition nine months after a patent issues. As in inter partes reexamination, the IPR permits the petitioner to challenge claims as being anticipated or obvious in view of published prior art references. Also, like the previous inter partes reexamination, IPR carries with it an estoppel effect barring the IPR petitioner from asserting the invalidity of any challenged claim on the same arguments and references in any district court action.