Insight

Not a Dry Eye in the House Federal Circuit Thwarts Drug Company’s Attempt to Avoid Inter Partes Review

August 30, 2018

We’re all familiar with the phrase, “there was not a dry eye in the house,” which conveys that all of the attendees at a particular event felt emotional about what they had seen or heard, and many were crying. Less well known is the eye condition appropriately known as “dry eye,” in which the natural tearing of the eye does not function properly.
 

Insight

3rd Cir. Refines Numerosity: 22 is NOT the New 40

November 1, 2016

Twenty-two class members was not enough “strength in numbers” to pass the Third Circuit’s newly-created “particularly rigorous” review of classes of only 15 to 40 members who fail to show judicial economy and practicality when seeking class certification.

Insight

U.S. v. Bayer Is Proof ─ Daubert Is Not Hard To Digest

August 13, 2015

No matter what you’re ailing from, there’s a pill for it.  But how much proof does a manufacturer need to advertise a product’s medicinal benefits?  This question was the topic of discussion in the recent U.S. v. Bayer case over Bayer’s claims that one of its medications offers probiotic benefits.  In analyzing competing motions to exclude expert opinions, the court proved one thing for sure: Daubert is simply not that hard to digest.

Insight

Inter Partes Review Decision on Pharma Patents May Open Floodgates

August 4, 2014

The America Invents Act introduced a procedure called inter partes review (IPR) that provides accused patent infringers with a mechanism to use prior art consisting of patents and printed publications to challenge the validity of patent claims before the Patent Trial and Appeal Board.

Case Study

Food and Drug Administration (FDA) Statistical Analysis Expert

A food and drug administration (FDA) statistical analysis expert was needed for a patent dispute that arose in connection with a request for FDA approval for the commercial manufacture, use, and sale of a generic drug.

Case Study

Pharmaceutical Licensing Agreement Expert

A pharmaceutical licensing agreement expert was needed for a breach of contract case involving a dispute over biotechnology licensing, development and intellectual property agreements.

Case Study

FDA Marketing Compliance Expert

An FDA marketing compliance expert was needed for a case involving allegations of pharmaceutical product mislabeling and failure to meet FDA regulations and requirements.

Case Study

Geriatric Neurology Expert in Cerebral Ischemia

A geriatric neurology expert in cerebral ischemia was needed for a patent infringement case.

Case Study

Pharmacokinetics Expert in Drug Formulation

A pharmacokinetics expert in drug formulation was requested for pre-litigation consultation in a patent infringement case.