Publications

"Tips for Safeguarding Your Products from Fakes"

Derek Mason was interviewed by Michael Keating for a blog post entitled "Tips for Safeguarding Your Products from Fakes," featured in Industrial Equipment News (IEN).

Industrial Equipment News

An Approach to Pharma Life Cycle Management

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.

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

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.

USPTO Publishes its Second PTAB Trial Practice Guide Update

On July 16, 2019, the Patent Office published its 2019 Trial Practice Guide Update, a copy of which can be found here. This follows on the heels of last August's Trial Practice Guide Update (here) which, perhaps most importantly, provided patent owners with a sur-reply to petitioner's reply brief as a matter of right.

ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY

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:

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

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) (http://www.lifesciencesipblog.com/?t=39&format=xml&A=18655&p=15972).

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

In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101.

The U.S. Supreme Court is Not Above Delivering a Good Pun

A good pun is always welcome when reading a legal opinion. Recently, in Return Mail v. U.S. Postal Service, neither snow nor rain nor heat nor gloom of night stopped U.S. Supreme Court Justice Sotomayor from dropping a well-placed pun in her majority opinion. Deep in the opinion at Section II(B), Sotomayor outlined the U.S. Postal Service's three arguments in three sentences. Of these arguments, her pithy conclusion is that "None delivers." Brilliant.

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

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.

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

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.