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In January, the United States Food and Drug Administration (FDA) released a draft guidance entitled, “Considerations in Demonstrating Interchangeability” aimed at helping to implement the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This guidance serves to directly address the issue of demonstrating interchangeability of biological products and the standards required to do so. Interestingly, no product has yet been shown to be interchangeable, including the four biosimiliars that have already been approved by the FDA.

Magnetic nanoparticles, also known as superparamagnetic nanoparticles are small inorganic crystals about 5-20 nm in diameter. Two main classes of MNPs currently used for clinical imaging are ferromagnetic iron oxide nanoparticles and ultrasmall superparameganetic iron oxide nanoparticles (USPION). MNPs are usually multilayer materials, which give them their various properties and functionalities for diagnosis and disease treatment. The structure of iron oxide nanoparticles has three main components: an iron oxide core as a Magnetic Resonance Imaging (MRI) contrast agent, a biocompatible coating outside the core, and an outer therapeutic coating with specific ligands for biomarker targeting. See (US 8,945,628 by Dr. Ralph Weissleder at Massachusetts General Hospital and US 7,462,446 by Dr. Miqin Zhang at the University of Washington). This unique structure enables MNP accumulation in the sites of interest via biomarker targeting. It further allows the diagnosis of diseases, the evaluation of treatment efficacy, and the localized delivery of drugs and disease therapies. The integration of both diagnostic and therapeutic modalities into one single agent is called a theranostic agent. We will discuss the diagnostic and therapeutic properties of MNPs in cancer.

Dilworth IP’s Dr. Jing Zhou has been approved to practice before the United States Patent & Trademark Office, and is now a registered Patent Agent. Dr. Zhou has earned her doctorate from the University of California, Berkeley in Mechanical Engineering with a focus on biomaterials. She later pursued postdoctoral research at the National Institute of Standards and Technology (NIST) in a variety of areas including biomaterials, nanocomposites, energy storage devices and live cell-nanomaterial interface. She has held a position as Associate Research Scientist/Lecturer at the Yale School of Medicine, and currently also serves as Review Editor for Frontiers in Bioengineering and Biotechnology. “Jing has been a great addition to the firm with an incredible knowledge in several advanced technologies, and a dedicated work ethic,” commented Dilworth IP Founder, Michael Dilworth, “with her recent certification as a patent agent, I look forward to seeing her role here grow.”

Dr. Jonathan L. Schuchardt of Dilworth IP will present a FREE webinar on Wednesday, March 22nd at 1:00 p.m. EST. This installment in the Dilworth IP Webinar Series is entitled “Not so Obvious: How the Federal Circuit is Interpreting Section 103.” Since the US Supreme Court decided KSR v. Teleflex, Section 103 law has continued to evolve as courts struggle to understand the proper role of “common sense,” predictability, “teaching away,” and motivation to combine reference teachings. Practitioners know all too well about Section 103 rejections that are conclusory and devoid of a rationale for why a combination of references renders a claim obvious. In recent developments, the CAFC has reversed or remanded cases in which a district court or the USPTO Patent Trial and Appeal Board (PTAB) failed to adequately explain why a skilled person was motivated to combine references. Is this a mere ripple in the court’s jurisprudence or a welcome wave of change?

Dilworth IP’s Microbiome series, “The Emergent Microbiome: A Revolution for the Life Sciences,” was recently featured in an article recognizing David Puleo, Dilworth IP contributor and Yale doctoral candidate, by the Yale Graduate School of Arts and Sciences (GSAS). Dilworth IP Partner, Dr. Anthony Sabatelli, was also mentioned as a co-author of the Microbiome piece which enjoyed broad circulation online, including PatentDocs, a major biotechnology and pharmaceutical patent blog. Click here to read the article published about Mr. Puleo on the Yale GSAS news site.

Dilworth IP is a sponsor of the 2017 Yale Healthcare Case Competition which is being presented by the Jackson Laboratories this Saturday, February 25th in Evans Hall at the Yale School of Business. The competition will present teams of students with a live case in the area of new delivery methods in immunotherapy, which they will have to review, and present recommendations on to a panel of judges. Dilworth IP’s Dr. Anthony Sabatelli will serve on the panel as a judge. More information regarding the event can be found here.

Last week, the United States Patent and Trademark Office’s (USPTO) Patent and Trademark Appeal Board (PTAB) handed down its decision in the contentious CRISPR patent battle between UC Berkeley and the Broad Institute. Somewhat unsurprisingly, the PTAB ruled that there existed no interference-in-fact between the patents and patent applications held by the Broad Institute and those held by UC Berkeley. In short, the PTAB was looking to whether the Broad Institute claims and the UC Berkeley claims were overlapping and if so, would have determined which party had first made the invention. The PTAB clearly stated there exists no overlap, or interference-in-fact, meaning that each institution will be allowed to license and assert its patents as it wishes, granting a victory to the Broad Institute in what has evolved into an extended, and at times, a bitter CRISPR patent battle.

Dr. Anthony Sabatelli, Partner at Dilworth IP, will be co-hosting the CURE Legislative Briefing entitled “Biotech Drug Discovery: Innovation, Process and Talent” on Thursday, February 23rd from 10:00 AM to 11:00 AM at the Connecticut State Capitol in Hartford. The event will gather members of the Connecticut bioscience community and of Connecticut’s General Assembly for a discussion on the research and innovation involved in drug discovery; Connecticut Governor Dannel Malloy will be presenting the opening remarks.

On December 2016, another CAR-T patent fight temporarily came to the end by the issuing of the final written decision from the Patent Trial and Appeal Board (PTAB) (IPR2015-01719). This Inter Partes Review (IPR) was initiated by Kite Pharma Inc. (“Kite”) to challenge a patent held by Memorial Sloan Kettering Cancer Center (MSKCC), relating to chimeric antigen receptors (CAR) T-cells for cancer immunotherapy (US 7,446,190). The IPR petition was filed on August 2015 and granted by the US PTAB on February 2016. After review, the PTAB determined that Kite did not show by a preponderance of the evidence that all the claims in the ‘190 patent are unpatentable.

The USPTO has expanded its practice of testing the veracity of post-registration Declarations of Use under a program intended to improve accuracy and integrity of the trademark register, under a new rule which goes into effect Feb. 17, 2017. The rule formalizes a small-scale trial program in effect since 2012.

Under the new rule, the USPTO may respond to the filing of a Declaration of Use by requiring additional proof of use of the mark in connection with the goods/services identified in the registration. The additional proof may be provided in the form of information, exhibits, affidavits or declarations, and specimens of use. A registrant who cannot produce the additional proof of use for particular goods/services, or an acceptable claim of excusable nonuse, will be advised to cancel those goods/services from the registration as well as any others no longer being offered under the mark.