Intellectual Property

The U.S. Patent and Trademark Office (USPTO) explains several patent prosecution trends, goals, and programs to justify proposed spending of its collected fees in its recently-issued Fiscal Year 2017 Congressional Justification report.

Our Biosimilar webinar series continued this month with Tom Wintner’s BPCIA Patent Litigation presentation. Tom discussed the general framework of litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), including the “patent dance” information exchange under 42 U.S.C. §262(l), and three case studies that inform our current understanding of emerging judicial interpretation of BPCIA requirements.

On March 7, 2016, the Court of Appeals for the Federal Circuit recognized “a patent-agent privilege extending to communications with non-attorney patent agents when those agents are acting within the agent’s authorized practice of law before the Patent Office.” 

Following the filing of a petition with the Patent Trial and Appeal Board (PTAB) seeking to initiate either an Inter Partes Review (IPR) or Covered Business Method (CBM) Review, the patent owner may file a preliminary response addressing the arguments in the petition and also potentially raising arguments regarding statutory bars that may prevent the IPR or CBM proceeding from being initiated.

On February 25, 2016, Judge Richard Andrews granted the parties’ cross-motions to exclude both sides’ damages experts in M2M Solutions LLC v. Motorola Solutions, Inc., C.A. No. 12-33-RG.

Kyle 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.

The oft-overlooked design patent has seen somewhat of a revival recently (at least in the media) ever since a jury in California awarded Apple $399 million in damages — i.e., all Samsung profits from the sale of several of its smartphone and tablet devices — for Samsung’s infringement of three Apple design patents in Apple, Inc., v. Samsung Electronics Co., Ltd.

We are excited to announce the arrival of Bill Kezer, PhD, the newest Member in our Intellectual Property Practice. Bill joins our team in San Francisco, where he deepens our bench in the chemical and pharmaceutical spaces.

Patent owners continue to face an uphill battle at the Patent Trial and Appeal Board.  According to U.S. Patent Office statistics as of December 31, 2015, a majority (72%) of the 529 Inter Partes Reviews (IPR) proceeding to trial and receiving Final Written Decisions ended in all examined claims being invalidated. 

The Federal Circuit has affirmed a district court’s awarding of attorneys’ fees to Alps South (Alps) based on inequitable conduct by Ohio Willow Wood (OWW) during reexamination of its patent for gel-coated, cushioned socks that fit over an amputated limb (U.S. Patent No. 5,830,237).

On February 12, 2016, the Federal Circuit Court of Appeals issued a decision confirming two important aspects of the doctrine of patent exhaustion in the anticipated en banc decision in Lexmark Int’l, Inc. v. Impression Prods., Inc., Nos. 14-1617, -1619 (slip op.) (Fed. Cir. Feb. 12, 2016) (“Lexmark”).

Yesterday, the FDA's Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion's proposed biosimilar of Janssen Biotech, Inc.'s Remicade® (infliximab) be approved for all indications -- including, among others, Crohn's disease, ulcerative colitis, rheumatoid arthritis (RA), and ankylosing spondylitis (AS).

The University of Massachusetts' Medical Device Development Center (M2D2) has launched the 5th Annual M2D2 $100K Challenge, an opportunity designed to showcase the innovative ideas and entrepreneurial spirit of seed and early-stage biotech and medical technology companies.

Mintz Levin’s Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation on the Biologics Price Competition and Innovation Act (“BPCIA”) and its implementation.

In Pfizer v. Lee (No. 2015-1265, January 22, 2016), the Federal Circuit upheld the U.S. Patent and Trademark Office’s (USPTO) determination that the toll period for A-type patent term adjustment (PTA) delay stops upon the mailing of a deficient USPTO paper.

It can be tricky to evaluate written description support under 35 U.S.C. § 112 for negative claim limitations since the support may amount to the absence of a feature from an invention that is described positively with respect to what it includes, as opposed to what it does not.

On January 27, 2016, the International Trade Commission (ITC) formally requested a rehearing en banc of a November 10, 2015, Federal Circuit panel decision in ClearCorrect Operating, LLC v. ITC.

The Patent Trial and Appeal Board recently designated as precedential its decision in Westlake Services, LLC v. Credit Acceptance Corp., CBM2014-00176, Paper 28 (PTAB May 14, 2015)  addressing the scope of estoppel under 35 U.S.C. § 325(e).

Last week, the PTAB designated two recent post-grant proceeding decisions as “precedential,” marking only the second and third time it has designated one of its opinions as binding on all PTAB judges.

As 2016 begins and IP strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2015.  According to the many readers of Global IP Matters, hot topics included navigating the waters of U.S. patent prosecution, analyzing Federal Circuit appeals from the International Trade Commission, and handling Japanese patent oppositions.