USPTO Extends Cancer Immunotherapy Pilot Program

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO has examined qualifying applications out of turn thereby expediting examination. The Program was implemented to support the National Cancer Moonshot and was scheduled to expire on June 28th, 2017. While only in effect for just less than one year, over 80 petitions for Program participation have been filed and 9 patents have been granted to date. On June 23rd, 2017, the USPTO announced that the Program is now extended until December 31, 2018.

To qualify for the fee-free program, the patent application must contain one or more claims to a method of treating cancer using immunotherapy. The Program is open to:

  • Any application that has not yet received a first Office Action;
  • Any application where the petition is filed with a Request for Continued Examination; or
  • Any application that is not under final rejection if the claimed therapy is the subject of an active Investigational New Drug (IND) application that has entered Phase II or Phase III (FDA) clinical trials.

Additional information and the appropriate forms can be found at this USPTO web address.

The USPTO also announced on June 23rd that it may further extend the Program (with or without modifications) or terminate it depending on feedback received, continued interest, and program effectiveness.

NIH Begins Beta Test of Million Patient Cohort

The National Institutes of Health announced the enrollment of the first participants as beta testers of the “All of Us research program. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us” will be the largest health and medical research program on precision medicine.

The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment and care for all of us.

The program follows and is built upon recommendations from a Precision Medicine Working Group organized by the NIH to develop a framework for the program for collecting, protecting, and analyzing medical data collected from volunteers. The program will start small and gradually expanded to more than 100 sites nationally during the beta phase.

Presently, enrollment in the program is by invitation only with enrollment to be expanded at partner sites at different times. Citizens that receive care at a participating a health care provider organization may be contacted to participate as a beta tester. Interested individuals can subscribe for email updates on the program at https:://www.joinallofus.org/.

Federal Circuit’s Primer on Equivalence Infringement of Chemical Process Patents

In an appeal characterized as “unusual,” the Federal Circuit affirmed the grant of a preliminary injunction, holding it likely that plaintiff patent holder would succeed on the merits its claim of infringement of a patent claiming a purified chemical compound, but reversed a finding of infringement under the doctrine of equivalents of related chemical process patents. Mylan Institutional LLC v Aurobindo Pharma Ltd., 2017-1645 (May 19, 2017 Fed. Cir.). The decision is an interesting read because, as the court admitted, “of the sparse and confusing case law concerning equivalents, particularly the paucity of chemical equivalents case law, and the difficulty of applying the legal concepts to the facts.” Slip Op at 12. Continue reading this entry

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align with current theories of disease and treatment. Continue reading this entry

Proving Utility, Demonstrating Value: How to Align the Moving Parts in Personalized Medicine Reimbursement

Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that it should result in cost savings as treatment that is unlikely to work for that patient is avoided.

Continue reading this entry