Intellectual Property

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.

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.

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.

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.

On January 22, 2016, the Federal Circuit issued its opinion in Lumen View Technology LLC v. FindTheBest.com (Dkt. No. 15-1275), in which it vacated and remanded the lower court’s award of enhanced attorney fees under 35 U.S.C. § 285.

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).

In the latest development in the patent skirmishes between Apple and Samsung, on Monday, January 18, 2016, U.S. District Court Judge Lucy Koh of the Northern District of California entered a permanent injunction barring Samsung from selling certain smartphone models within the United States due to their infringement of three Apple patents.

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.

In Ethicon Endo-Surgery, Inc. v. Covidien LP, a 2-1 panel split of the Federal Circuit held that neither the American Invents Act (“AIA”) nor the Constitution precludes the same panel of the Patent Trial & Appeal Board (“PTAB” or “Board”) from both deciding whether to institute an inter partes review (“IPR”) of a challenged U.S. Patent and making the final patentability determination in that IPR.

On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal jurisdiction over generic pharmaceutical manufacturers in Hatch-Waxman litigation.

On December 17, 2015, Judge Rodney Gilstrap of the Eastern District of Texas (EDTX) ruled that, in light of Alice Corporation Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014) (“Alice”), a plaintiff’s position on the validity of the patent-in-suit under § 101 was “objectively unreasonable” and that the harm to the defendants was compounded by the plaintiff  litigating in “an unreasonable manner[,]” meriting an award of attorneys’ fees under 35 U.S.C. § 285. eDekka LLC v. 3balls.com, Inc.et al., C.A. Nos. 2:15-cv-541 and 2:15-cv-585 (Dec. 17, 2015).

Join us for the first webinar in our five-part Biologics/Biosimilars series, “Legal and Regulatory Overview” tomorrow, January 7, 2016 at 3:00 PM ET, featuring Terri Shieh-Newton and Joanne Hawana!

2015 was a busy year for post-grant review appeals at the Federal Circuit and produced notable opinions in the areas of claim construction, IPR procedural issues, and the constitutionality of IPRs in general. In 2015, the Federal Circuit reversed the Board’s claim construction in an IPR for the first time, and found that IPRs do not violate Article III and the Seventh Amendment of the Constitution.

On December 17, 2015, the Federal Circuit issued a precedential decision affirming a determination by the Patent Trial and Appeal Board (“PTAB”) that patent claims related to methods of treating elevated homocysteine levels were invalid as obvious.

On Monday, in the latest episode of the smartphone wars, Samsung filed a petition for certiorari with the Supreme Court. Samsung is appealing a Federal Circuit decision that upheld a $399 million judgment against Samsung for infringing three of Apple’s design patents.

George Bailey stands on a bridge begging for another chance at life. Upon being granted a second chance, he joyously runs home to embrace his family. As the community of Bedford Falls rallies around him and raises funds to save the endangered Building and Loan and George Bailey personally from an unjustified failure, someone proclaims a toast to George Bailey, “the richest man in town.”

Mintz Levin is running a series of webinars to educate our clients and friends on developments in the biosimilars space.  A cross-practice team of professionals from the IP, Health and Litigation sections are collaborating to present on Patent Prosecution, Health Regulatory, FDA, Patent Litigation, Transactional and Products Liability issues.