Pharmaceutical Patent

Pharmaceutical inventions have been the subject of special provisions in the past, the likes of which have not been applied to other inventions. Furthermore, pharmaceuticals are the subject of much government regulation outside of the patent system.

August 30, 2023
Photograph of a doctor holding a syringe full of an injectable filler

US Court Rules That Free Samples Don’t Count Towards Commercial Success

Fed. Cir. 2021-2063, 2021-2065: Sales of a product can be used to prove the inventiveness of a patent, but a US court warns that free samples are not relevant to patentability.
June 1, 2023
Photo of a handshake over a desk

Preserving the Patent Bargain: U.S. Supreme Court Limits Amgen’s Monopoly

No. 21-757 (Supreme Court May 18, 2023) The Supreme Court of the United States applied bargain theory in its long-awaited decision regarding the enablement requirement of the Patent Act.
January 20, 2023
Photograph of assorted blister packs containing pharmaceuticals in pill form.

Past Conduct Deemed Relevant to Infringement in ANDA Proceedings

CAFC No. 22-1595: In this precedential decision on induced infringement, the Federal Circuit clarified that “past conduct is relevant to what will happen in the future”.
January 5, 2023
In a hospital room, a woman in a white lab looks at a computer monitor.

USPTO to Launch Cancer Moonshot Expedited Examination Pilot Program

Starting on February 1st, the US Patent and Trademark Office (USPTO) will offer accelerated examination for patent applications aimed at preventing cancer and cancer mortality.
August 18, 2022
A thermometer is shown on a pile of pharmaceutical pills.

Selection Patent for Apixaban Upheld by Federal Court of Appeal

2022 FCA 142: The Court also commented on the relevant date for determining if an invention has been sufficiently described in the patent application.
April 20, 2022
Photograph of a doctor holding out small white pills

Data Protections Once Again Prevent Médunik From Launching Pediatric Drug

The Federal Court disagreed with Health Canada's interpretation of data protection regulations, once again reversing approval of pediatric drug RUZURGI.
January 24, 2022
Photo of a pharmacist holding out a yellow pill in one hand and a white pill in another hand. A patient reaches for the yellow pill.

Teva Blocks Competitor With Patent for 40 mg/mL Dose of Copaxone®

Outside Canada, Teva’s Copaxone® 40mg/mL dosing patents have been invalidated for obviousness, making way for generic competitors.
August 9, 2021
Photograph of an auto-injector needle with a drop of liquid at the tip of the needle.

Federal Court of Appeal Reaffirms Overbreadth as Grounds for Invalidity

2021 FCA 154: The FCA held that overbreadth is not an “improper re-emergence of the promise doctrine”. Overbreadth is supported by bargain theory and s. 27 of the Act.
July 27, 2021
Photograph of centrifuge tubes in a test tube rack on a laboratory bench.

Variations on Previously Approved Drugs Are Ineligible for Data Protection

2021 FCA 137: On July 12, 2021, the Federal Court of Appeal issued a decision dismissing an application for judicial review of a decision of the Minister of Health denying data protection for a drug. Janssen Inc. had sought protection for its drug SPRAVATO but was rejected on the basis that it was not an “innovative drug” eligible for such protection.
January 19, 2021

Quebec Court Finds New Drug Pricing Rules Tip Constitutional Scale

2020 QCCS 4541: Court held that forthcoming amendments to the Patented Medicines Regulations are unconstitutional and infringe on provincial powers.
April 16, 2020
Photograph of white pharmaceutical pills on a blue background.

Prima Facie Obviousness Established From Similar Compounds, Overlapping pH

Fed. Cir. 2018-2097 — The CAFC ruled that Valeant's patent for Relistor(R) is prima facie obvious based on similar compounds with overlapping pH ranges.
March 9, 2020
Photograph of an IV drip delivering a pharmaceutical to a patient in a hospital.

Contested Remicade Patent Will Head Back to Court in June

2020 FCA 30; 2020 FCA 31 – Janssen and Celltrion will return to court in June after the FCA overturned a lower court decision regarding a Remicade patent.
November 25, 2019
Pharmacist in a white lab coat, holding bottles of pharmaceuticals.

Patent Strategy & Potential Changes to Patented Medicine Regulations & Drug Pricing Legislation

The rising cost of patented medicines is an important topic in the United States and Canada. In the United States, the White House is promising to...
October 4, 2019
Stethoscope and a smartphone. Healthcare

Disruptions to the Healthcare Industry: 5 Takeaways From the 2019 Waterloo Innovation Summit

At the 2019 Waterloo Innovation Summit, global thought leaders discussed oncoming disruptions to healthcare and challenges faced by healthtech start-ups.
September 20, 2019
Macro (close-up) photo of a hazel coloured human eye, eyelashes, and eyelid.

Allergan’s Glaucoma Patents Saved by “Wherein” Clauses

CAFC 2018-2207 – The US Court of Appeals for the Federal Circuit ruled that “wherein” clauses in patent claims can be limiting if they are material to patentability.
August 30, 2019
Woman rubs medicinal cream on her skin

Canadian Drug Pricing Regulator Ordered to Reconsider Differin

2019 FCA 196 – In an ongoing dispute between the PMPRB and Galderma, the FCA says the drug pricing regulator erred in its interpretation of the law.
July 2, 2019
Vials containing pharmaceuticals (drugs)

Oxymorphone Patent Is Not Obvious, Federal Circuit Confirms

CAFC confirms that an invention is only obvious and ineligible for a patent where a skilled person would have had a “reasonable expectation of success.”
June 4, 2019
Pharmaceutical researcher in a laboratory

When Can New Uses for Known Drugs Be Patented?

Fed. Cir., 2018-1434 - CAFC clarifies the test for obviousness where the invention claims a use of a known drug.
April 4, 2019
White and blue pharmaceutical pills scattered on a surface

Actions Under Old PM(NOC) Regime Not Automatically Applicable to the New

2018 FC 1078 - Canada's Federal Court confirms that jurisprudence under previous PM(NOC) regime is not automatically applicable to the new.
December 4, 2018

The ONSC Dismisses Apotex’s Attempt to Revive the Promise Doctrine Under the Guise of Fraud

2018 ONSC 5199 – ONSC rejects Apotex’s attempt to recast Promise Doctrine under s. 53 fraud allegations.