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IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy.  Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015.  Mylan, Celltrion, and Pfizer, all with competing biosimilar candidates, have filed IPR petitions challenging patents reportedly covering trastuzumab.  Recently, the PTAB granted a petition filed by Hospira (subsidiary of Pfizer) to institute IPR of U.S. Patent No 7,807,799 (“the ’799 patent”), directed to protein A affinity chromatography.  Hospira, Inc. v. Genentech, Inc., IPR2016-01837, Paper No. 19 (April 7, 2017).
Continue Reading PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent

Business people standing in line under a magnifying glass, as a metaphor for employee performance evaluation, EPS 8 vector illustration, no transparencies The House of Representatives recently sent to the Senate its bill (H.R.5) that combines six previous regulatory reform bills, including, as Title II of the bill, the “Separation of Powers Restoration Act.”  Section 202 of the bill effectively removes the option for courts to apply Chevron deference to agency rulemaking and interpretations.  Thus, rather than deciding whether a regulation is permissible as reasonably related to the purposes of the enabling legislation, by amending 5 U.S.C. § 706, the bill will require a reviewing court to “decide de novo all relevant questions of law, including the interpretation of constitutional and statutory provisions, and rules made by agencies.”  To eliminate any doubt about its intent, the amendment specifically states that the court shall not interpret any gap or ambiguity in a statue or regulatory provision as an implicit delegation of legislative rulemaking authority to an agency, and the court shall not defer to an agency’s interpretation on a question of law.  As a result, rather than simply deciding whether an agency’s construction of silent or ambiguous statutory provisions are permissible as a matter of statutory interpretation, the reviewing court must make its own, independent interpretation.  The change in the statute would mean that prior court approvals of agency rules, applying Chevron deference, will not dictate the outcome of future challenges under the doctrine of stare decisis.
Continue Reading Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules

In Personal Web Technologies, LLC v. Apple, Inc., Case No. 2016-1174 (Fed. Cir. Feb. 14, 2017), the Federal Circuit upheld the PTAB’s construction of disputed claim terms, but did not resolve a dispute over whether the broadest-reasonable-interpretation standard (BRI) or Phillips standard should apply when the challenged patent expires shortly after the PTAB issues its final written decision. Despite the correct claim construction, the court vacated the decision and remanded the case to the PTAB for reconsideration of the merits of its decision on obviousness.

Apple filed an IPR petition challenging claims of Personal Web’s patent directed to methods of locating data and controlling access to the data by giving a data file a substantially unique name that depends on the file’s content. In determining that the challenged claims were unpatentable for obviousness, the PTAB construed the claim term “content-based identifier” and related terms, applying the BRI standard.
Continue Reading What Claim Construction Standard Applies If a Patent Expires During IPR Appeal?

Petitioners are finding themselves caught in a Catch-22.  The PTAB declares claims too indefinite under Section 112 to construe, but then declines to address the patentabilty of the claims.  Section 112 deficiencies are not grounds to challenge a patent in an IPR, but the PTAB has authority to find such deficiencies.

Recently, the PTAB decided that only some claims of Immersion Corporation’s U.S. Patent No. 8,659,571 were challengeable by Apple Inc. in an IPR because the ‘571 patent failed to disclose sufficient structure corresponding to the “drive module limitation” recited in claim 12 to determine the scope and meaning of claim 12.  Apple Inc., v. Immersion Corporation, IPR2016-01372, Paper 7 (January 11, 2017).
Continue Reading PTAB Declines to Institute IPR on Immersion’s Indefinite Means Plus Function Claims

In Apple, Inc. v. Ameranth, Inc. (Fed. Cir. 2016), the Federal Circuit reviewed the final written decisions in CBM reviews of three related patents owned by Ameranth, Inc., directed to computerized systems for generating and displaying menus for use in the restaurant industry.  The court determined that the PTAB properly construed all disputed claim terms, determined that the patents are CBM patents, and determined that most challenged claims were unpatentable under § 101, but that the PTAB erred in concluding that some dependent claims were not unpatentable under § 101.

More specifically, the claims in the disputed Ameranth patents are directed to a “first menu that has categories and items, and software that can generate a second menu from the first menu by allowing categories and items to be selected.” 
Continue Reading PTAB Should Have Canceled All Challenged Claims in CBM Reviews

In IPR2015-01191, American MegaTrends and four other petitioners challenged claims 1-9, 11, 12 and 15 of USPN 6,892,304 owned by Kinglite Holdings, Inc. on grounds of obviousness over three technical documents, supplemented by a fourth document for the challenge to claim 6.  The parties also indicated that they were involved in 11 other IPR petitions and two district court proceedings.

The technology disclosed and claimed in the ‘304 patent involved methods of encrypting instructions to the Basic Input-Output System (BIOS) of a computer operating system using a private-public key pair.
Continue Reading It Isn’t Printed Publication Art Unless It’s Publicly Accessible

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In Schoeller Bleckmann Oilfield v. Churchill Drilling Tools U.S., No. 2016-1494 (Fed. Cir. November 9, 2016) (non-prec.), the court affirmed the Board’s IPR decision of unpatentability of claims directed to oil-drilling equipment.  The court refused to construe the challenged claims as limited to a disclosed embodiment, rejecting the patentee’s argument that the claim term “ball-like” was given an implicit definition in the specification.
Continue Reading Federal Circuit Affirms Board’s Decision Cancelling Claims for Oil Drilling Equipment Based on Broad Claim Construction

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The PTAB’s recent decision on remand in Corning Optical Comm. v. PPC Broadband (IPR2013-00342, Paper No. 57), and the related decision on appeal (815 F.3d 747 (Fed. Cir. 2016)), serve as a reminder that the broadest reasonable interpretation (BRI) standard does not permit an unreasonably broad construction.

In addition, the PTAB’s related order (see Paper 55), denying the parties’ requests for further briefing on remand, indicates that, when the Federal Circuit bases its claim construction on a party’s construction advanced during an earlier proceeding before the PTAB, the PTAB may choose to base its remand decision on the arguments and evidence in the record, without need for further briefing.
Continue Reading PTAB Upholds Claims Under Narrowed BRI Construction on Remand

Woman Upset Hitting Forehead with her HandIn IPR 2015-01127, PAR Pharmaceuticals, challenged claims 1-11 of USPN 8,404,215 owned by Horizon Therapeutics, LLC on grounds of obviousness over various combinations of six references.  Lupin Ltd. and Lupin Pharmaceuticals, Inc. filed another challenge to the claims of the ‘215 patent on the same grounds using the same arguments and evidence as used by PAR.  The Board joined the two proceedings and construed the claims-at-issue in accordance with the plain meaning of the recited terms, crediting the unrebutted testimony of Petitioners’ expert in holding the claims unpatentably obvious under 35 U.S.C. § 103(a) over various combinations of the cited art.
Continue Reading Ignore Occam’s Razor at your Peril

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In a recent non-precedential decision, the Federal Circuit suggested a very expansive interpretation for the oft-used phrase “adapted to.” Relying upon the prosecution history, the Federal Circuit determined that the Board correctly construed claims relating to interactive video programming, and on that basis affirmed the Board’s decision that the claims were anticipated by a prior art reference. Intertainer, Inc. v. Hulu, LLC, No. 2015-2065 (Fed. Cir. Sept. 26, 2016) (non-precedential).Continue Reading Federal Circuit Suggest Expansive Interpretation of “Adapted to” in Affirming CBM Cancellation