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On March 21, 2017, the PTAB refused to cancel claims of a Biogen MA Inc. (Biogen) patent covering multiple sclerosis drug Tecfidera® during IPR2015-01993, which was instituted in response to a petition filed by the Coalition for Affordable Drugs V LLC (CFAD), a group started by hedge fund manager Kyle Bass.

Biogen’s U.S. Pat. No. 8,399,514 claims methods of treating patients for multiple sclerosis (MS). Each claim requires the administration of a dose of about 480 milligrams (mg) per day of dimethyl fumarate (DMF), monomethyl fumarate (MMF), or their combination. CFAD argued that a combination of several prior art references renders obvious all claims of Biogen’s patent. Generally, this combination of prior art describes results from administering 120, 360 and 720 mg/day of DMF to MS patients, but do not disclose the claimed dose. The 720 mg/day dose was reported to reduce brain lesions in a dose-dependent manner, while the 120 and 360 mg/day dose did not show statistically significant results versus placebo. CFAD nevertheless argued that a person of ordinary skill in the art would have been motivated to conduct routine experiments to optimize the effective dose and ultimately arrive at the dose recited in the claims.Continue Reading Coalition for Affordable Drugs Fails to Knock Out Biogen’s Tecfidera® Patent

Introduction of Panelists and summary of Session

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Early March 2017 kicked off the PTAB Bar Association’s Inaugural Conference in Washington, D.C.  I had the privilege of attending several sessions, one of which was “View from the Tech Industry,” which included panelists from the Tech Industry who commonly practice before the PTAB in either petitioner or patent owner roles. Representatives of Google and Microsoft presented petitioner views.  Representatives from Personalized Media Communications, LLC, and Trading Technologies International, Inc., presented patent owner views.

The Tech Industry panelists debated the current state of AIA proceedings, expressing their views on AIA jurisprudence, mechanics of AIA proceedings, and strategies vis-à-vis co-pending district court litigation. 
Continue Reading Tech Industry Debates AIA Proceedings at Inaugural PTAB Conference

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

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Update: The Federal Circuit’s decision in this case was vacated as moot, on the basis that the challenged claims had been canceled in a separate IPR proceeding. PNC Bank Nat’l Assoc. v. Secure Axcess, LLC, 138 S. Ct. 1982 (2018).

A patent that is merely incidental to a financial activity is not sufficient to render that patent eligible for CBM review.  Secure Access, LLC v. PNC Bank National Association et. al, Case No. 2016-1353 (Fed. Cir. Feb. 21, 2017).  In Secure Access, the Federal Circuit reversed and vacated the PTAB’s decision that U.S. Patent No. 7,631,191 (“the ’191 patent) is a CBM patent.  The Board had concluded that the method and apparatus claimed by the ’191 patent “perform operations used in the practice, administration, or management of a financial product or services and are incidental to a financial activity.”  (Op. at 18).  The Court concluded that the Board had improperly broadened the scope of the statute that defines a CBM patent, and that under proper scope, the ’191 patent is not a CBM patent.
Continue Reading CBM Eligibility: Patent Must Have a Claim that Contains, However Phrased, a Financial Activity Element

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In the spirit of “if at first you don’t succeed, try, try again,” the Coalition for Affordable Drugs (CFAD) challenged a fourth Orange Book-listed patent relating to VIVOMO®, Horizon Pharma’s naproxen/ esomeprazole product.  While denying CFAD’s previous three petitions, the PTAB instituted inter partes review for U.S. Patent No. 8,945,621.  Despite CFAD’s success at the institute phase, the PTAB ultimately determined in its Final Written Decision that the Petitioner did not meet its burden in proving the unpatentability of the challenged claims.
Continue Reading Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard

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In Slot Speaker Techs., Inc. v. Apple Inc., Nos. 2015-2038, 2015-2039 (Fed. Cir. February 17, 2017) (non-prec.), the Federal Circuit affirmed a portion of the PTAB’s decision in an IPR that concluded claims 1 and 2 of U.S. Patent No. 7,433,483 would have been obvious over a combination of two prior art references, but reversed the portion that concluded that the same combination does not render dependent claim 3 obvious. The decision is interesting because the Board and the Federal Circuit concluded that the reduced effectiveness of the combined references as compared to a single reference  alone would not deter a person of skill in the art from having a reasonable expectation of success in making the invention.
Continue Reading Federal Circuit Finds Portion of Board’s Obviousness Decision Supported

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In Unwired Planet, LLC v. Google Inc., the Federal Circuit affirmed the PTAB’s IPR decision that the challenged claims are invalid as obvious and dismissed the PTAB’s CBM review as moot.

Petitioner Google filed IPR and CBM petitions challenging claims 1-6 of U.S. Patent No. 7,024,205 (“the  ’205 patent”) owned by Unwired Planet, LLC.  The ’205 patent describes a system and method for providing wireless network subscribers with prioritized search results based on the location of the mobile device.  Claim 1 is the sole independent claim of the ’205 patent and recites “farther-over-nearer ordering” in the context of wireless location-based services.  We previously discussed a related CBM review between the same parties.
Continue Reading Federal Circuit Affirms Cancellation of Claims Based on Analogous Art

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In MPHJ Technology Investments, LLC v. Ricoh Americas Corp., Appeal 2016-1243 (Fed. Cir. Feb. 13, 2017), the Federal Circuit affirmed the PTAB’s final written decision canceling all eight claims in U.S. Patent No. 8,488,173. The patent issued from an application that was the tenth continuation-in-part of a 20-year-old application that relies for priority on seven provisional applications. The decision may be noteworthy if only because it highlights how seemingly-minor changes to these applications over time influenced the PTAB’s interpretation of certain claim terms—an interpretation that finally led the PTAB and court to conclude the claims were not patentable, just as the patent is about to expire.
Continue Reading Claims Construed and Canceled as Patent Nears its Expiration Date

Work in progressOnce a trial has been instituted at the PTAB, a party seeking consideration of supplemental evidence may file a motion in accordance with the following requirements: (1) the request for the authorization to file a motion to submit supplemental information must be made within one month of the date the trial was instituted; and (2) the supplemental information must be relevant to a claim for which the trial was instituted.  37 C.F.R. § 42.123(a). Mere satisfaction of these requirements for filing a motion may not, however, be sufficient to convince the PTAB to grant the motion. Instead, in deciding the motion, the PTAB will use its broad discretion to determine if the proffered supplemental evidence will assist the PTAB in “ensur[ing] efficient administration of the Office and the ability of the Office to complete [trial] proceedings in a timely manner.” See Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 445 (Fed. Cir. 2015), and our discussions here and here.
Continue Reading Your Supplemental Evidence is Timely, but is it Relevant to a Claim at Issue? PTAB Will Decide.

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In Phigenix, Inc. v. ImmunoGen, Inc., No. 2016-1544 (Fed. Cir. Jan. 9, 2017), the Federal Circuit dismissed, for lack of standing under Article III of the Constitution, a petitioner-appellant’s (Phigenix) appeal of a PTAB final written decision that refused to cancel claims challenged in an IPR. The court’s decision demonstrates that statutory right of appeal from a PTAB final written decision in an inter partes review does not necessarily establish Article III standing for the appeal.
Continue Reading Federal Circuit Dismisses Appeal where IPR Petitioner Lacked Standing to Appeal

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.