News & Analysis as of

Abuse of Process Pharmaceutical Patents

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Smart & Biggar

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

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UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

Smart & Biggar

Amgen not precluded by invalidity decision under pre-amended PMNOC Regulations from litigating same patent under amended...

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On October 4, 2019, the Federal Court of Appeal dismissed Pfizer’s appeal of its failed motion to dismiss Amgen’s action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for a...more

Smart & Biggar

Infringement based on making/selling under existing NOC for one strength struck from action under the PMNOC Regulations triggered...

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The Federal Court has granted in part Pharmascience’s motion to strike out portions of Teva’s statement of claim under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating...more

Fish & Richardson

Bass’ Altruistic IPR Petitions

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At the beginning of 2015, Kyle Bass, founder of Dallas-based hedge fund Hayman Capital Management, announced plans to challenge 15 drug companies’ patents via Inter Partes Review. As of November 30th, 2015 Bass and his...more

McDonnell Boehnen Hulbert & Berghoff LLP

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

Foley & Lardner LLP

PTAB Refuses To Sanction Kyle Bass

Foley & Lardner LLP on

Many pharmaceutical companies have complained about the IPR petitions filed by Kyle Bass and the Coalition for Affordable Drugs against Orange Book-listed patents covering approved pharmaceutical products, but Celgene Corp....more

Foley & Lardner LLP

PTAB Requests Additional Briefing on Hedge Fund IPR Questions: A Decision May Be Near

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On Sept. 1, 2015, the PTAB issued an order in Coalition for Affordable Drugs (CFAD) v. NPS Pharmaceuticals for the parties to brief the following questions in 7 business days...more

Foley & Lardner LLP

Kyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents

Foley & Lardner LLP on

On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more

Foley & Lardner LLP

PTAB Denies Institution of Kyle Bass's Ampyra Patent Challenge

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The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more

Morrison & Foerster LLP

Celgene’s Pending Sanctions Motions against Kyle Bass’s Hedge Fund

The Patent Trial and Appeals Board (PTAB) previously authorized Celgene Corporation (“Celgene”) to move for sanctions against the Coalition for Affordable Drugs (“Coalition”), an entity affiliated with a Kyle Bass hedge fund...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Denies Inter Partes Review Petitions Against Two Acorda Patents

One of the statistics gleaned from Director Michelle Lee's recent blog on the post-issuance review provisions of the America Invents Act is that only 42% of inter partes review petitions have been granted over the past three...more

Foley & Lardner LLP

Will New PTAB Rules Impact IPRs Filed By Kyle Bass Hedge Fund?

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On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more

Fish & Richardson

Bass Opposes Sanctions and Defends His Actions at the PTAB

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On July 28, 2015, Celgene filed a motion for sanctions in IPR Nos. 2015-01092 and 2015-01103, proceedings challenging the validity of Celgene patents covering Thalomid®, Revlimid® and Pomalyst®. Celgene specifically...more

Morrison & Foerster LLP

PTAB to Consider Motion for “Abuse of Process” Sanctions Against Kyle Bass Hedge Fund IPR Petition

In a recent order, the Patent Trial and Appeals Board (PTAB) indicated that it will consider a motion for sanctions based on a claim of “abuse of process” in Inter Partes Review (IPR) proceedings filed by the Coalition for...more

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