Tag Archives: Janssen

Biosimilar Remedies Not Limited Without Full Patent Dance

The judge presiding over the pending biosimilar litigation between Janssen and Celltrion/Hospira has issued guidance regarding the ramifications of a potential standing defect. Judge Wolf opined that Janssen’s biosimilar remedies would not be limited to a reasonable royalty under 35 USC § 271(e)(6) if it turns out that Janssen lacks standing for failure to join … Continue reading this entry

Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors” including “intellectual property considerations.” The pending biosimilar patent litigation got one step closer to resolution last week when Judge Wolf of the U.S. District Court for the District of Massachusetts … Continue reading this entry

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016, and also could impact the production of the Celltrion/Hospira products sold abroad. This complaint is separate from the pending biosimilar litigation and based on … Continue reading this entry

Remicade Biosimilar Closer To Approval, But Patent Dance Goes On

Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3 in favor of approval. While the FDA is not bound by the Advisory Committee’s decision, it is expected to follow the recommendation and approve the product. However, other requirements of the Biologics Price … Continue reading this entry

Amicus Briefs On Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. (I wrote about the court’s decision in this article.) The appeal is on an expedited briefing schedule at the Federal Circuit, and three amicus briefs have been filed. All of the amicus … Continue reading this entry

The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of Amgen’s Neupogen® (filgrastim) product), another biosimilar patent dispute is brewing between Janssen Biotech, Inc. and Celltrion Healthcare Co., Ltd. over Remicade® (infliximab). On … Continue reading this entry

Solving Utility Problems

The Federal Circuit decisions in Cancer Research Technolgoy Ltd. v. Barr Labs., Inc. (Nov. 2010) and In Re '318 Patent Infringement Litigation ("Janssen") (Sep. 2009) present an interesting contrast in utility issues. In Cancer Research, the USPTO raised utility rejections that the Applicant eventually overcame and the patent was found to be enforceable, while in Janssen, the USPTO never raised the issue but both the district court and the Federal Circuit found the patent invalid for lack of utility. The Federal Circuit may address the issue again this week, when it hears oral arguments in Eli Lilly & Co. v. Actavis on Thursday.bv … Continue reading this entry