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Linyu Mitra, PhD is an Associate based in the firm’s Boston office. Her work involves patent prosecution in the area of biotechnology, including molecular biology, cell biology, biochemistry, microbiology, neurobiology, stem cell technology, cancer therapeutics, and genetic engineering. Linyu has co-authored several papers in peer-reviewed journals, including in the Proceedings of the National Academy of Sciences, the Journal of Biological Chemistry, and Molecular and Cellular Biology.

The Medicines Company (“MedCo”) appealed findings of no infringement made by the United District Court for the District of Delaware. Hospira cross-appealed the district court’s finding that a distribution agreement did not constitute an invalidating “offer for sale” under 35 U.S.C. § 102(b). In a decision rendered by United States Court of Appeals for the Federal Circuit on February 6, 2018, the Court affirmed the district court’s non-infringement findings and remanded the case for the district court to determine if the on-sale bar applies.

MedCo asserted two patents, U.S. Patent Nos. 7,582,727 and 7,598,343, covering its Angiomax drug product against Hospira, a generic drug maker who filed Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration. Although Angiomax has been available for decades, MedCo developed a new method of formulating Angiomax to reduce impurities. This formulation was the subject of the asserted patents, both of which were filed on July 27, 2008. Prior to filing the patents, MedCo entered into a distribution agreement on February 27, 2007 with Integrated Commercialization Solutions, Inc. (“ICS”) to distribute the new Angiomax formulation. The agreement stated that MedCo “desire[d] to sell the Product” to ICS and ICS “desire[d] to purchase and distribute the Product.” Under the agreement, title passed to ICS upon receipt of the Product at the distribution center. The district court concluded that the patents were neither infringed nor invalid. The district court found that the invention was ready for patenting at the time of the agreement, but was not sold or offered for sale before the critical date of July 27, 2008 because the distribution agreement between MedCo and ICS did not constitute an offer to sell. Both parties appealed.

Continue Reading <i>The Medicines Company v. Hospira, Inc.</i>

On October 28, 2016, the United States Patent and Trademark Office (PTO) issued a notice of proposed rulemaking in the Federal Register proposing revisions to the materiality standard for the duty to disclose information in patent applications and reexamination proceedings in light of Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).  The PTO had previously issued a notice of proposed rulemaking regarding the same rules in the Federal Register on July 21, 2011 after the Therasense decision.  However, given the passage of time and the significant changes to patent law as a result of the successful implementation of the Leahy-Smith America Invents Act (AIA), the PTO considered it appropriate to obtain public comment on the proposed changes to the duty of disclosure rules.

In the new notice, the PTO proposes to revise the rules to adopt the but-for standard for materiality required to establish inequitable conduct as set forth in the Federal Circuit’s decision in Therasense as the standard for materiality for the duty to disclose information in patent applications and reexamination proceedings.  The PTO also proposes to revise the rules to explicitly reference “affirmative egregious misconduct” as set forth in the Federal Circuit’s Therasense decision.

Continue Reading Changes to the “But-For” Standard For Materiality at the U.S. Patent and Trademark Office?

USPTO SealSince Kyle Bass founded Coalition for Affordable Drugs X LLC (CFAD) to challenge pharmaceutical patents, CFAD has filed numerous petitions with the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (Office) seeking to institute inter partes review (IPR) proceedings to invalidate a number of pharmaceutical patents, including three patents owned by Anacor Pharmaceuticals, Inc., as previously discussed at Global IP Matters.  On October 21, 2016, the PTAB issued written decisions on the two IPRs filed by CFAD invalidating claims of U.S. Patent No. 7,056,886 (the ‘886 Patent) that covers Shire PLC’s drug Gattex®.

Gattex® is a prescription medicine used in adults with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).  The medicine helps the remaining intestine (bowel) absorb more and reduces the need for parenteral support.

Gattex® received FDA approval in 2012 and had sales of $67.9 million in 2014 and sales of $141.7 million in 2015.

Continue Reading Kyle Bass’ First IPR Win At The PTAB

Supreme-Court-seal II. jpgThe U.S. Supreme Court ruled on June 20, 2016 in Cuozzo Speed Techs., LLC v. Lee that: (1) the statutory authority of the Patent Trial and Appeal Board (“Board”) in instituting an inter partes review (“IPR”) proceeding is final and non-appealable, thereby not being subject to judicial review, and (2) it is appropriate for the Board to construe claims in an issued patent according to their broadest reasonable interpretation, rather than their plain and ordinary meaning as in district court litigation.

Procedural Background

The Patent Office awarded U.S. Patent No. 6,778,074 to Cuozzo Speed Technologies, LLC, (“Cuozzo”) for a speed limit indicator that, upon receiving signals from a GPS, changes color of a display when the speed of a vehicle exceeds the speed limit at the vehicle’s present location. Garmin petitioned for inter partes review of all claims of the Cuozzo patent, asserting that claim 17 in particular would have been obvious based on three prior art patents – Aumayer, Evans and Wendt – in combination.  The Board instituted trial on claim 17 based on this combination, as well as with respect to claims 10 and 14, even though these claims were not challenged by Garmin on this basis.  Construing the claims according to their broadest reasonable interpretation, the Board deemed claims 10, 14 and 17 unpatentable.  Cuozzo appealed to the Federal Circuit, alleging that: (1) the Board improperly instituted inter partes review of claims 10 and 14 on a ground that Garmin did not assert against such claims, and (2) the Board improperly used the “broadest reasonable construction” to interpret the claims instead of the “plain and ordinary meaning” standard used by district courts.  The Federal Circuit denied both these assertions here.

Continue Reading Supreme Court Decides Two Key Aspects of IPR in Cuozzo Speed Techs., LLC v. Lee

USPTO SealKyle Bass continues to make waves throughout the pharmaceutical industry.  Since Bass founded Coalition for Affordable Drugs X LLC (“CFAD”) to challenge pharmaceutical patents, CFAD has filed over three dozen petitions as of this date with the Patent Trial and Appeal Board ( “PTAB”) of the U.S. Patent and Trademark Office ( “Office”) seeking to institute inter partes review (“IPR”) proceedings to invalidate a number of pharmaceutical patents.

On August 20, 2015, CFAD filed three separate petitions against Anacor Pharmaceuticals, Inc.’s Orange Book-listed U.S. Patent Nos. 7,582,621 (the “‘621 Patent”) and 7,767,657 (the “‘657 Patent”), — a continuation-in-part of the ‘621 Patent — covering Anacor’s first approved drug, KERYDIN® (tavaborole), an oxaborole antifungal topical solution approved by the U.S. Food and Drug Administration in July 2014 for the topical treatment of onychomycosis of the toenails.  On February 23, 2016, the PTAB entered decisions to institute all three IPR proceedings, reaching the conclusions that there is a reasonable likelihood that CFAD would prevail in challenging pertinent claims as unpatentable.

Continue Reading Kyle Bass’ Another Three IPRs: Targeting Anacor