On May 13—and more than ten years after Federal Trade Commission v. Actavis, the leading U.S. Supreme Court case on reverse payment settlements—the Second Circuit for the first time weighed in on whether (and how) antitrust...more
Last month I checked in on a discovery dispute regarding the timeliness of disclosing noninfringing alternatives (NIAs) in a case with only two rounds of expert reports. I noted that the problem (defendant waiting until the...more
Can a patentee really just take a pass on alleging that an accused product meets a limitation in an asserted claim, even where the case involves complex technology? That's the upshot of the court's decision in Lindis Biotech,...more
Much like secondary considerations, non-infringing alternatives fit imperfectly within many scheduling orders. The patentee has the burden of proof on damages, but it is the accused infringer who must prove that any...more
The law of patent eligibility was pretty quiet for decades until the Supreme Court breathed new life into Section 101 invalidity challenges in a series of decisions starting in 2010 with Bilski v. Kappos. In its current...more
8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more
3/27/2024
/ Article III ,
AstraZeneca ,
Biotechnology ,
Damages ,
Injury-in-Fact ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Royalties ,
Settlement Agreements
Earlier this month, I previewed a Federal Circuit oral argument in In re: California Expanded Metal Products Co., No. 2023-1140, where the district court vacated a jury award of a 12 percent royalty and denied a motion for an...more
We were so pleased to have the opportunity to address InformaMarkets’ 13th Annual Pharma IPR Conference in Mumbai on legal challenges to polymorph patents. Patents covering one or more crystalline forms of a drug substance at...more
The Federal Circuit will hear oral argument on March 5, 2024, in In re: California Expanded Metal Products, Co., No. 23-1140, a case that presents two intriguing issues regarding patent remedies. The first issue is the...more
On February 26, the Federal Circuit issued its opinion in the battle between Freshub, Inc. and Amazon.com, Inc. regarding the Alexa device. The case came down to a distinction between an “item” and a “word,” which was hotly...more
The Federal Circuit used to get a lot of flak for failing to defer to factual findings of the tribunal it was reviewing. My (highly unscientific) sense is that such criticism has eased somewhat, but I was reminded of it when...more
Judge Bryson's recent decision sitting by designation in Prolitec Inc. v. Scentair Technologies, LLC., No. 20-984-WCB, 2024 WL 341342 (D. Del. Jan. 30, 2024), provides two important reminders on the utility of an accused...more
Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and...more
After seven years of successful litigation, it was understandable that St. Jude Medical wanted to put its dispute with Niazi Licensing Corp. (NLC) to bed. But St. Jude Medical's too-quick response to a mediator's email left...more
Is “milk” an item, or just a word? This question, among others, is set to be answered on January 12, 2024, as Freshub Inc. (Freshub) and Amazon.com, Inc. (Amazon) argue before the Federal Circuit (Nos. 22-1391, 2022-1425). ...more
At least since the Supreme Court’s eBay decision in 2006, a vocal contingent has been decrying the erosion of patent rights. The entry of a preliminary injunction in Natera, Inc. v. NeoGenomics Laboratories, Inc. that would...more
On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services...more
In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...more
The Federal Circuit's decision on claim construction, Barrday, Inc. v. Lincoln Fabrics, Inc., 2023-1903, 2023 WL 7871688 (Fed. Cir. Nov. 16, 2023), takes a dizzy dive into the age-old question of when a claim should be...more
Expert report deadlines are a feature of every patent case's scheduling order, but they nevertheless are the constant source of disputes. For example, battles over whether to have two or three or four rounds of expert reports...more
A great thing about patent litigation is the vast array of legal doctrines, arguments, and defenses that can come up in any given case. One example is the sneaky-powerful (precise legal term!) defense that a purported patent...more
The interplay between contentions and expert reports in a patent case always requires considered judgment. The common sense rule that an expert may “expand on” but not “deviate from” a party's contentions is easy to say but...more
A patent challenger identified a witness as a person with relevant knowledge in Rule 26(a) disclosures and interrogatory responses, and the patentee deposed the witness. Surely the witness can testify at trial, right? The...more
It was a tough day for opposing patent damages experts in Ecolab Inc. v. Dubois Chemicals, Inc., as Judge Andrews of the District of Delaware granted Daubert motions directed to both experts' reasonable royalty opinions.
The...more
The late and great tennis writer and broadcaster Bud Collins loved loud pants (Google it), nicknames (ditto), and “net cords,”* those balls that hit the top of the net and through some combination of physics and fortune fall...more