Sections 102/103

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Glass vials for liquid samples. Laboratory equipment for dispensing fluid samples. Shallow depth of field.

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

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In IPR 2016-00039, Costco challenged claims 1, 12 and 14 of USPN 7,228,588 owned by Bosch and drawn to beam (non-yoked) windshield wipers with spoilers to keep the wipers in contact with the windshield in high winds.  Petitioner combined one reference with each of two other references in support of obviousness challenges to the claims. In defense of the claims, Patent Owner relied on evidence in the challenged patent and on expert testimony.  The Board found PO’s evidence contradicted by other evidence of record and found PO’s expert testimony related to challenged patents not at issue in this IPR.  Further, the Board found that evidence of secondary considerations of non-obviousness was insufficiently developed and held the challenged claims unpatentably obvious.
Continue Reading Evidence of Secondary Considerations Fails to Establish Nexus to Challenged Claims

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In Meiresonne v. Google, Inc., No. 2016-1755 (Fed. Cir. Mar. 7, 2017), the Federal Circuit affirmed the PTAB’s final written decision in IPR2014-01188 that the challenged claims in U.S. Patent No. 8,156,096 (the “’096 patent”) are unpatentable as obvious over the 1997 book “World Wide Web Searching for Dummies, 2nd Edition” by Brad Hill (“Hill”) and U.S. Patent No. 6,271,840 (“Finseth”). The sole issue before the Federal Circuit was whether Hill and Finseth teach away from the claimed invention.

The ’096 patent teaches a directory website that contains (1) a plurality of links to supplier websites, (2) “a supplier descriptive portion” located near a corresponding supplier link, (3) “a descriptive title portion” describing the class of goods or services listed on the website, and (4) “a rollover view area” that displays information about at least one of the suppliers corresponding to a link.
Continue Reading Teaching Away for Dummies

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 Joinder Does Not Prevent Application of IPR Estoppel Provision

Illustration and Painting

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

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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).Continue Reading Federal Circuit to PTAB: Prior Art Cannot Anticipate Absent Disclosure of All Claimed Features

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 Secondary Considerations of Non-obviousness Retain Some Vigor

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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

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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

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.