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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”!

Just a few weeks back the Federal Circuit decided an interesting patent infringement case in which the U.S. government waived its sovereign immunity from suit. In this case, the plaintiff, Iris Corporation, had originally brought suit against Japan Airlines Corporation for infringement of its patent on an electronic passport system. What is even more interesting about this case is that it involves 28 USC §1498(a). This is a little-known statute governing patent infringement activities by the United States government and the requirement to adjudicate such suits in the specially-created Court of Federal Claims. See Iris Corp. v. Japan Airlines Corp., 769 F.3d 1359, (Fed. Cir. October 21, 2014). […]

Connecticut Innovations (CI), the leading source of financing for Connecticut’s innovative, growing companies, has partnered with Dilworth IP on a new four part series entitled “Patents: Beyond the Basics”. The series consists of several answers to FAQs from CI’s venture companies and entrepreneurs on intellectual property strategy and is authored by six Dilworth IP attorneys, Michael Dilworth, Dr. Anthony Sabatelli, Dr. Jonathan Schuchardt, Gerard Wissing, William Reid, and Fred Spaeth. The Firm is very excited to have been selected for this distinction. Part I of this series is now available on CI’s website. Subsequent editions to the series will be launched over the next several weeks. Please stay tuned for further updates.

The Supreme Court is currently scheduled to take on only one patent case this upcoming term. On October 15th, the Court will hear oral arguments in Teva Pharm. USA, Inc. v. Sandoz, Inc., No. 13-854. This is an appeal dealing with important issues of patent claim construction. The central question before the Court is whether a district court’s factual findings on claim construction may be reviewed de novo by the Federal Circuit.

On March 4th the US Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of the Supreme Court’s decisions in Myriad, Prometheus, and related cases. See, “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.” The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.

Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple.1 For those of you not yet familiar with this latest trend, allow me to explain.

Most drug products are small, synthetically produced substances. The common pain reliever ibuprofen, for example, contains only 33 atoms and has a molecular weight of 206. In contrast, there is a whole new class of complex drug products that are isolated or produced from biological sources such as living cells. These biologically produced drugs, more commonly called “biologics”, are orders of magnitude larger than their small molecule cousins and present special challenges in their preparation, isolation, and administration. Insulin is a common example of a biologic. It is a protein having a molecular weight of approximately 5800. Another example is the hormone erythropoietin (or “EPO”), which is used to treat anemia. EPO is a far larger biological drug with a molecular weight of nearly 35,000.

Dilworth IP is very excited to announce our newly formed partnership with the Yale Entrepreneurial Institute (YEI). YEI’s mission is to foster innovation at Yale by providing resources and education in the form of incubator space, seed funding, and mentoring, as well as educational programs on the legal and business considerations of entrepreneurship. This mission meshes well with Dilworth IP’s commitment to education and innovation. Seeing the great value in encouraging and mentoring students in their pursuit of entrepreneurial success, the firm has partnered with YEI to provide legal resources to its start-ups in the form of educational training, resource materials, and counseling.