John Cox, PhD
John Cox is a Partner with Barnes & Thornburg LLP. Through his ability to communicate effectively and succinctly, John advises on, develops, and carries out global IP strategies for the benefit of innovative companies, his clients, who are focused on developing core assets that save and improve the lives of patients. John enjoys leveraging his unique ability to put together targeted and enduring teams for each matter – paying close attention to each person’s strengths and skillsets and how they fit with one another, alongside his highly specialized experience and thoughtful and responsive nature.
John is intimately familiar with the pharmaceutical industry, having dealt with patent and IP subject matter ranging from brain chemistry, the gastrointestinal system, drug delivery systems and treatments of rare diseases and cancer to medical diagnostic methods, the generation of biofuel using bacteria, and processes for manufacturing chemicals and pharmaceutical products. He also has almost two decades of experience in Abbreviated New Drug Application (ANDA) cases, including pre-litigation investigations.
John offers guidance from the first step of a matter through to resolution, including all aspects of litigation. He has extensive experience related to discovery and motion practice, as well as in developing offensive and defensive strategies. He is well versed in dealing with complex subject matter and technical witnesses, such as inventors and experts.
John adeptly helps clients navigate the crossroads of foreign business practices and the complexities of U.S. patent practice, having worked with foreign pharmaceutical, chemical, and biotechnology companies throughout his career.
John is intimately familiar with the pharmaceutical industry, having dealt with patent and IP subject matter ranging from brain chemistry, the gastrointestinal system, drug delivery systems and treatments of rare diseases and cancer to medical diagnostic methods, the generation of biofuel using bacteria, and processes for manufacturing chemicals and pharmaceutical products. He also has almost two decades of experience in Abbreviated New Drug Application (ANDA) cases, including pre-litigation investigations.
John offers guidance from the first step of a matter through to resolution, including all aspects of litigation. He has extensive experience related to discovery and motion practice, as well as in developing offensive and defensive strategies. He is well versed in dealing with complex subject matter and technical witnesses, such as inventors and experts.
John adeptly helps clients navigate the crossroads of foreign business practices and the complexities of U.S. patent practice, having worked with foreign pharmaceutical, chemical, and biotechnology companies throughout his career.
Recent Articles by
Beyond Curiosity: Practical Guidance on the Research Exemption and Hatch-Waxman Safe Harbor
In several previous articles (1, 2a, 2b), we reviewed key cases on the common law experimental use exemption and the statutory safe harbor under the Hatch Waxman Act. In this last installment, we will provide practical advice on what it takes to successfully invoke the exemptions during litigation or (where possible) avoid litigation entirely. We thus conclude our series of with some practical tips for both patentees and defendants dealing with (A) the common law research exemption and (B) activities “reasonably related” to the development and submission of information under the Hatch-Waxman Act, including an update from the Federal Circuit’s § 271(e)(1) safe harbor jurisprudence.
Hatch-Waxman Safe Harbor: Lessons from Recent Court Precedent
We recently wrote an introductory overview of navigating the Common Law Research Exemption and the Hatch-Waxman Safe Harbor and an exploration of the application of the Common Law Research Exemption. Here, we take a closer look at the Hatch-Waxman safe harbor under 35 U.S.C. § 271(e)(1), particularly through treatment by the courts over the past decade.
Treading Carefully: How to Navigate the Common Law Research Exemption and the Hatch-Waxman Safe Harbor
When exploring exemptions to patent infringement, there are several key U.S. Court of Appeals for the Federal Circuit cases to be aware of. First, we will examine a number of cases that have shaped the contours of the common law experimental use exemption, which applies to all industries, and secondly, we will look at recent decisions evaluating activities under the safe harbor of 35 U.S.C. § 271(e)(1) for products requiring U.S. Food and Drug Administration (“FDA”) approval.
The coupling of § 101 and § 112, and what it means for patent practitioners
A recent opinion by the Federal Circuit suggests that there will be considerable uncertainty about the respective boundaries of §§ 101 and 112 in the years ahead. In Trading Technologies Intl. Inc. v. CQG, Inc., Judge Newman wrote on behalf of a unanimous panel, following up on her concurrence in Bascom… Of particular interest is her continued endorsement of a flexible approach to § 101 and the traditional measures of patentability, such as § 112. Judge Newman wrote that the “threshold level of eligibility is often usefully explored by way of the substantive statutory criteria of patentability,” and that this approach is in harmony with the Supreme Court’s reasoning in in Alice.
Sections 101 and 112: Eligibility, Patentability, or Somewhere in Between?
Sections 101 and 112 provide their own separate limitations to the scope of patent protection in ways that are sometimes complimentary and sometimes contradictory… Inventors are motivated to maximize the breadth of their claims. But they may seek to do so by employing imprecise claim language. Both §§ 101 and 112 corral this behavior, although in slightly different ways. Section 101 safeguards against claims that are too abstract or overbroad to be patentable, being concerned with claims that would “wholly pre-empt” any other use of an inventive concept, thereby foreclosing independent innovations or application. Bilski, 561 U.S. at 610 (quotation omitted). Section 112 protects against claims that are not completely and functionally disclosed within the patent specification ensuring that patentees cannot claim more than what they have invented – and shared with the public.