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Remicade™ Biosimilars US: Pfizer sues J&J for anticompetitive conduct

by | Sep 21, 2017

Biosimilar development is not for the faint hearted.  The time and costs involved in R&D, clinical, and regulatory are exorbitant, and the patent barriers to launch are unprecedented.  From a legal perspective, not only must biosimilar developers address significant patent barriers to launch, they must also anticipate parallel (or post-patent litigation) disputes regarding untested regulatory standards, and new forms of anticompetitive conduct.

Yesterday, Pfizer commenced suit against J&J and Jannsen in the US District Court for the Eastern District of Pennsylvania, alleging J&J engaged in anti-competitive behaviour relating to Remicade™, preventing the uptake of Pfizer’s biosimilar infliximab, Inflectra™, launched in 2016.

Pfizer alleges J&J “deployed improper exclusionary tactics to maintain the dominance of its flagship product”, and categorises J&J’s behaviour as “exclusive contracts with insurance company players” and “exclusionary rebates and bundling arrangements with insurance company payers“.

Pfizer’s complaint states (emphasis in complaint):

even though Inflectra™ is covered by Medicare and other government programs, providers have been unwilling to stock Inflectra even for potential use with such government-insured patients. …. As of September 1, 2017, about 90 percent of healthcare provider accounts using infliximab had purchased no Inflectra at all.

In the fledgling global biosimilars industries, it will be cases like Pfizer v J&J that help determine the difference between clever marketing strategies for originators, and illegal conduct.

Once the patent barriers to biosimilar launch have been addressed, the world focuses in on each market as biosimilars are rolled out region-by-region.  But the legal team for sophisticated biosimilars companies are still in their bunker, preparing for the next round of challenges relating to regulatory standards and anticompetitive conduct.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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