Prior Art Introduced During Prosecution Has Important Implications for 101 Challenges

September 19, 2019

Five years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test.... Read more

Prosecution History Estoppel And Amendments Tangential To Patentability

September 17, 2019

The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.... Read more

Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101

September 13, 2019

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more

Specification Must Adequately Disclose the Claimed Invention to Avoid Invalidation for Lack of Written Description

September 9, 2019

Drs. Stephen Quake and Christina Fan ("Quake") appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board ("the Board") finding the four claims of Quake's U.S. Patent 8,008,018 and Claim 25 of their U.S. Application No. 12/393,833 unpatentable for lack of written description.... Read more

Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure

August 16, 2019

Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more

Argument with Emphasis on "Particular" Combination of Salts Invoked Prosecution History Estoppel

August 16, 2019

 「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言(審査経過に基づくエストッペル)が適用された事例<... Read more

An Approach to Pharma Life Cycle Management

August 12, 2019

Every innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the "skinny viii" (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art... Read more

Invalidity of Broad Claims for Lack of Enablement in the Absence of Sufficient Disclosure of the Structure/Function Correlation and Unpredictability in the Art

July 17, 2019

Enzo Life Sciences, Inc. ("Enzo") appealed the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims were invalid for lack of enablement. The Federal Circuit affirmed.... Read more

ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY

July 15, 2019

In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more

Update & Reminder: Patent Term Adjustment Related to IDS Safe Harbor

July 5, 2019

On November 9, 2018, I wrote about the USPTO's release of interim procedures for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (https://www.lifesciencesipblog.com/?t=39&format=xml&A=18655&p=15972).... Read more