Joinder Does Not Prevent Application of IPR Estoppel Provision

Apple Icon ImagesA little more than a month after the Delaware district court narrowly interpreted the IPR estoppel provision to suggest that it may not be necessary to include all known grounds so as to avoid estoppel in district court litigation, the same court issued a decision suggesting that the IPR estoppel provision may not be so narrow after all.  The decision adds to the growing confusion over the scope of the estoppel provision Congress wrote into the AIA.

On December 20, 2013, Parallel Networks Licensing, LLC (“Parallel Networks”) sued International Business Machines Corporation (“IBM”) in the Delaware district court for infringement of U.S. Patent Nos. 5,894,554 (“the ‘554 Patent”) and 6,415,335 (“the ‘335 Patent”).  Parallel Networks Licensing, LLC v. International Bus. Machs. Corp., Case No. 13-2072 (D. Del.).  IBM answered and counterclaimed seeking declaratory judgments of non-infringement and invalidity based on anticipation and obviousness. Continue Reading

CFAD Fails to Knock Out 4 Acorda Patents to Multiple Sclerosis Drug

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A recent set of final written decisions in four IPRs against Acorda Therapeutics puts more marks in the loss column for Kyle Bass and the Coalition for Affordable Drugs.  In IPRs 2015-01850, -01853, -01857 and -01858 (Coalition for Affordable Drugs v. Acorda Therepuatics Inc.), the Coalition for Affordable Drugs (CFAD) requested review of Acorda Therapeutics U.S. patents U.S. 8,440,703, U.S. 8,007,826, U.S. 8,663,865, and U.S. 8,354,437, respectively, directed to sustained release formulations of fampridine (4-AP) and methods for administering the drug to treat neurological disease, such as multiple sclerosis (MS).  Certain aspects of the inventions in the four patents are directed to methods of increasing walking speed of patients with MS by administering 4-AP twice daily for at least two weeks, in a dose of about 10 to 15 mg of 4-AP.  The PTAB instituted review of the issued claims in each of the four patents as potentially obvious in view of a combination of prior art, including an SEC filing by Acorda that included reference to ongoing clinical trials.  Continue Reading

Federal Circuit to PTAB: Prior Art Cannot Anticipate Absent Disclosure of All Claimed Features

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In Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., No. 2016-1900 (Fed. Cir. Mar. 14, 2017), the Federal Circuit issued a precedential opinion explaining that a prior art reference cannot anticipate a patent claim if the reference does not disclose all claimed features. That straightforward explanation of black letter law was prompted by a PTAB decision that effectively concluded otherwise and, accordingly, canceled a claim of a patent owned by Nidec Motor Corporation. The opinion is important because it clarifies the court’s recent holding in Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376 (Fed. Cir. 2015).

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Secondary Considerations of Non-obviousness Retain Some Vigor

IPR 2015-01651 involved a dispute over the obviousness of claims in U.S. Patent No. 8,551,271 owned by Crown Packaging Technology, Inc. and drawn to a grooved crown bottle cap with thinner, harder steel than used in conventional caps.  World Bottling Cap, LLC, petitioned the Board to cancel the ’271 patent claims as being obvious based on two lines of attack.  The Board held the evidence of obviousness to be insufficient, with evidence of secondary considerations of non-obviousness contributing to the Board’s decision that no claims of the ’271 patent were unpatentable. Continue Reading

Coalition for Affordable Drugs Fails to Knock Out Biogen’s Tecfidera® Patent

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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.

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Tech Industry Debates AIA Proceedings at Inaugural PTAB Conference

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

Pending Bill Would Deliver More Judicial Scrutiny to USPTO and FDA Rules

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.

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CBM Eligibility: Patent Must Have a Claim that Contains, However Phrased, a Financial Activity Element

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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

Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard

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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

PTAB Bar Association Conference Kicks Off with Keynote Address

logo-minThe PTAB Bar Association held its first conference in Washington DC March 1-3, 2017 with more than 400 attendees and a wait list of interested individuals. PTAB Chief Judge David Ruschke gave the keynote address.

Chief Judge Ruschke began by acknowledging why we are now at a point where there is an interest in having a PTAB Bar Association. Specifically, he noted that the PTAB has become a vital component of the patent system. We have seen that reflected in an incredible rise in appeals to the Federal Circuit from the PTAB and also that post-grant proceedings are now an important tool for every patent litigator. Continue Reading