USPTO will “Fast Track” Cancer Immunotherapy Applications

July 5th, 2016

fast-trackOn June 29, 2016, Director Lee promulgated rules to implement a one-year pilot program to effectively grant “Fast Track” status to applications with at least one claim to treating cancer using immunotherapy. (A copy of this document can be found at the end of this post.) I am sure that much will be written about this program, but the requirements for achieving this top-of-the-pile on the Examiners’ desk are much like the current “Fast Track” program. But let’s cut to the chase to see just what type of claim qualifies for the “Cancer Immunotherapy Pilot Program:

“The applications must contain at least one claim encompassing a method of ameliorating, treating or preventing a malignancy in a human subject where the steps of the method assist or boost the immune system in eradicating cancerous cells. For example, this can include the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells. The Pilot Program also will consider claims drawn to the co-administration of biological adjuvants (e.g., interleukens, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation or surgery. Claims to administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth are included. The Pilot Program will also consider in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.”

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Exergen Corp. v. Thermomedics, Inc. – How to Flunk s. 101

June 23rd, 2016

On June 22d, the Fed. Cir. issued a summarily affirmed the district courts Order that the method claims in suit did not pass the Alice/Mayo test for patentable subject matter. Claim 51 of U.S. patent no. 7787938 is representative:

“A method of detecting human body temperature comprising: measuring temperature of a region of skin of the forehead; and processing the measured temperature to provide a body [core] temperature approximation based on heat flow from an internal body temperature to ambient temperature.”

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Same-Day Continuing Applications are Co-pending under s. 120

June 21st, 2016

The outcome of this question of statutory construction was not really in doubt, given the fact that an adverse holding could invalidate thousands of patents which needed same-day copendency to avoid intervening prior art. Immersion Corp. v. HTC Corp., Appeal no. 2015-1574 (Fed. Cir., June 21, 2016).

Finding no clear answer in the language of s.120: “if filed before the patenting…on the first application…,” the panel gave great weight to the longstanding practice of the PTO in permitting priority claims when the continuing applications were filed on the same day that the parent application officially issued:

“This is not a case, as we have explained, where the language of the statute actually contradicts the longstanding  judicial and agency interpretation. Nor is it a case in which the longstanding agency position is plainly outside the agency’s granted authority. Here, the position is an essentially procedural one establishing when the agency will consider an input into its process (the legal act of “filing’) and an output of its process (the legal act of “patenting” to occur relative to each other—neither one being a precisely identifiable self-defining physical act, but a legally filing event.”

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“Unclean Hands” Doctrine Erases Merck’s Damage Award

June 16th, 2016

unclean-handsIn my last post on the district court’s ruling in Gilead v. Merck, I implied that Gilead had convinced the Judge that Merck had employed inequitable conduct (“IC”) in conducting its negotiations with Pharmasset, the company Gilead later purchased to obtain the rights to the HCV drug, sofosuvir or Solvaldi®. However, I was reading and writing at an usually high speed and missed the fact that the judge’s finding was based on the pre-IC, unclean hands defense.

I skipped over the section on Therasense, a 2011 Fed. Cir. decision that redefined the IC doctrine, and missed the Judge’s comments distinguishing the two doctrines. In both opinions, it was noted that the unclean hands defense originated with three early S. Ct. decisions in which the “guilty parties” employed egregious misconduct to obtain their patents. The remedy in each case was to bar the wrongdoers ability to sue for infringement of the patents.

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