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

Four Decisions Designated Informative on 101: Positive Trend for Life Sciences?

July 2, 2019

In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101. Among other things, the guidance emphasized that claims otherwise reciting a judicial exception (i.e., not patentable), would be permitted if they were directed to some type of practical application. See our previous post for more details.... Read more


Category: PTAB 101

"Statutory" Obviousness-Type Double Patenting for Pharma Patents?

June 20, 2019

As all patent practitioners know, obviousness-type double patenting is a judicially created doctrine to prevent the unjust extension of patent term of follow on patents that are simply obvious variants of earlier patents. The doctrine is applied during prosecution with the USPTO and can be used to challenge the validity of issued patents in contested matters. 35 USC 121 also speaks to this issue in certain circumstances.<... Read more

Commercial Success of Claimed Product over Non-Infringing Competitive Products as Evidence of Non-Obviousness

June 17, 2019

During litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case.... Read more

SOVEREIGN IMMUNITY AND IPR'S: AND NOW, THE REST OF THE STORY

June 14, 2019

Radio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…"... Read more

Written Description In Provisional Application: Perdue Pharma L.P. v. Andrei Iancu.

May 28, 2019

Amneal Pharmaceuticals, LLC. ("Amneal") filed two petitions for inter partes review of claims 1–13 and 16–19 of U.S. Patent No. 9,034,376 ("the '376 patent") of Purdue Pharma L.P., P.F. Laboratories, Inc. and Purdue Pharmaceuticals L.P. ("Purdue"). In the petitions, Amneal argued that claims 1–13 and 16–19 were unpatentable for obviousness over the combinations of multiple prior art references including US 2002/0187192 A1 ("Joshi").... Read more

Pending Case, Cannabis Companies May Be Able to Prosecute Patent Infringements in Court

May 22, 2019

In "United Cannabis v. Pure Hemp Collective," United Cannabis claims that Pure Hemp used a cannabis extract that United Cannabis had a patent on. Lawyers say this case is the first of its kind.... Read more