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Dr. Anthony Sabatelli, chair of Dilworth IP’s biotech and pharmaceutical patent practice group, has been appointed by CURE (Connecticut United for Research Excellence) to serve on its newly convened government affairs committee. The committee comprises representatives from CURE’s board of directors, the pharmaceutical and bioscience sectors, and the legal community. In this new role, Dr. Sabatelli will spearhead federal outreach initiatives for CURE and will work closely with the government relations firm Rome, Smith & Lutz to assure synergy of action and alignment of state and federal initiatives. “I look forward to working with this committee on issues of importance to the biotech and pharmaceutical industries and to being a voice for our industry here in Connecticut”, says Dr. Sabatelli.

Dr. Anthony Sabatelli, leader of Dilworth IP’s biotech and pharmaceutical patent practice group, has once again been invited by the USPTO to share his thoughts and insights on the Office’s recently issued 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), a supplement to the patent eligibility Guidance issued earlier in 2014. Dr. Sabatelli’s presentation will take place this Wednesday, January 21st, between 1pm and 5pm EST at the public eligibility forum held at the USPTO’s Madison Building. A live internet feed of the forum will be made available by the USPTO. Further information about the Guidance and the forum can be found at the USPTO’s website found here.

If innovation drives progress, then 2014 was the year of progress! During the past year the U.S. Food and Drug Administration approved 41 new drugs. That is 14 more than 2013 and the highest number in 18 years! What spurred this increase? And what challenges do these new drugs face in the 2015 market?

Dr. Jonathan Schuchardt, Partner at Dilworth IP will be presenting as a panelist for the upcoming Strafford webinar Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance. This webinar can be used to obtain CLE credits through Strafford. The webinar is scheduled for Thursday, January 15th from 1:00pm to 2:30pm EST.

The revised Guidance is a step in the right direction by the PTO to simplify the somewhat cumbersome and confusing patent claim analysis set out in the previous guidance and memo documents. The Guidance is an attempt to consolidate the separate frameworks the PTO had previously created for analyzing the patent eligibility of claims relating to laws of nature, natural phenomena, and natural products, versus claims relating to abstract ideas. I agree with the PTO that it is important to have a guidance that “promotes examination efficiency and consistency across all technologies.”

Dr. Cambria Alpha-Cobb has joined Dilworth IP’s Biotech and Pharmaceutical Practice Group as a Technology Specialist. Dr. Alpha-Cobb holds a Ph.D. in Molecular Biophysics and Biochemistry from Yale University where her research focused on bacterial resistance to antibiotics in addition to exploring small molecule signaling through the design of cell permeable drugs. Although her primary focus has been on advancements in the biological field, her research has broadly encompassed genetic engineering, protein and antibody design, and mycological studies. Cambria’s undergraduate work at Rice University included a study of the structural evolution of hemoglobin, while also majoring in Spanish language and culture. She speaks Spanish fluently and is also conversant in German.

Just last week the Federal Circuit affirmed the dismissal of a declaratory judgment in a patent case involving a biosimilar product. I found this case interesting for two reasons: (1) because the Court punted and failed to address the key question of whether a developer of a biosimilar must go through the complex patent infringement adjudication requirements of the Biologics Price Competition and Innovation Act (BPCIA) and (2) perhaps more interestingly, because the facts of the case suggest the FDA may be requiring full-blown Phase III human clinical trials for the approval of a biosimilar product. See Sandoz Inc. v. Amgen Inc., 2014-1693 (Fed. Cir. December 5, 2014).

The United States Patent and Trademark Office published a new, revised Guidance today on patent subject-matter eligibility. This new memorandum is in direct response to criticism received by the PTO from its publication of a previous guidance which had sought to address patent eligibility issues raised by the Myriad and Mayo decisions. The latest revision not only seeks to address the criticisms of the previous Guidance, which dealt primarily with patents in the life sciences, but also includes guidelines on patent eligibility for software and business method patents as set forth in the Supreme Court’s recent Alice Corp. decision. The PTO has also announced that another public forum to discuss this Guidance will be held on January 21, 2015. In concert with that public forum, a 90 day comment period will be open soon after the Guidance is recorded in the Federal Register.

Dilworth IP is very pleased to announce that Dr. Joseph Suhadolnik, formerly of Chemtura Corporation, has joined the firm’s Chemical Patent Practice. Dr. Suhadolnik is a patent agent with a very strong background in polymer chemistry, dyes/pigments, industrial coatings, batteries, UV absorbers and several other technologies. Prior to his work at Chemtura, Joe worked as a patent agent at Ciba Specialty Chemicals and at BASF after its acquisition of Ciba. He holds a Ph.D. in organic chemistry from the University of Minnesota and performed his postdoctoral research at Rensselaer Polytechnic Institute in Troy, NY.

Dr. Suhadolnik is a named inventor on over 65 patents, some of which have set new standards in their respective industries. Having spent most of his career as both a research scientist and as a patent agent, Joe’s strong technical credentials and his in-house experience further strengthens the firm’s already very strong chemical practice and our depth of in-house experience. Dr. Suhadolnik will be working from Dilworth IP’s Connecticut offices.

We are very excited to welcome Joe to the firm and look forward to working with him!

To contact Joe directly, please email him at jsuhadolnik@dilworthip.com.

On October 15, 2014, the U.S. Supreme Court heard oral arguments in Teva Pharmaceuticals v. Sandoz, a case that concerns the amount of deference the Federal Circuit must afford a district court’s construction of patent claims.

Teva, owner of patents on the multiple sclerosis drug Copaxone®, contends that claim construction is intertwined with fact finding, that Federal Rule of Civil Procedure 52(a) should apply to claim construction, and that a district court’s claim construction should only be set aside for clear error. In short, the Federal Circuit’s long-standing practice of de novo review of claim construction—which was validated by the Supreme Court’s 1996 decision in Markman v. Westview Instruments and confirmed by the Federal Circuit (6-4) en banc in February 2014 in Lighting Ballast Control v. Philips Electronics—should be overruled.

Sandoz and other generic drug makers counter that Markman remains good law, that Rule 52(a) applies to fact finding outside the context of claim construction, that claim construction is a purely legal matter best left in the hands of a judge rather than a jury, that the current law promotes uniformity and predictability, and that the Federal Circuit correctly reviews claim construction de novo.

Which side will prevail? Who won the oral argument? Which justices will reverse their position almost two decades post-Markman?

We’ll review important background decisions, analyze the briefs, dissect the justices’ questions, and speculate about how the Supreme Court will rule. Join us—it should be “worth the candle”!