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Patent Act Pharmaceutical Industry

Fish & Richardson

Should the Experimental Use Exception Be Broadened?

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On June 28, 2024, the United States Patent and Trademark Office (“USPTO”) requested the public’s views on the current state of the common law experimental use exception to patent infringement and whether legislative action...more

Haug Partners LLP

Written Description for Genus Claims Following Juno Therapeutics v. Kite Pharmaceuticals

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Section 112 of the Patent Act contains multiple requirements that relate to the adequacy of an inventor’s disclosure within a patent application.  The Supreme Court has offered some clarity to inventors seeking to patent...more

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

Federal Court finds PMPRB reasonably concluded Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN

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On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...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

Goodwin

Who Gets the Patent When AI Is the Inventor?

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Artificial intelligence is transforming drug design — but it could also disrupt intellectual property law. To realize AI’s full promise, the US may have to reconsider its approach to issuing patents....more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - September 2023

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This marks the first issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more

Buckingham, Doolittle & Burroughs, LLC

Amgen Ratifies CAFC’s Requirement to Enable a Claim’s Full Scope

The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more

Smart & Biggar

Federal Court of Appeal dismisses appeal challenging amended basket of comparator countries in PMPRB Regulations

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On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more

BakerHostetler

Supreme Court to Address What it Means to Have an Enabling Disclosure

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The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address...more

Smart & Biggar

PMPRB finds ultra-rare drug PROCYSBI is excessively priced

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On September 1, 2022, a Panel of the Patented Medicine Prices Review Board (PMPRB) issued a decision that the price of Horizon Pharma’s PROCYSBI (cysteamine delayed release capsules) was and is excessive under sections 83 and...more

Goodwin

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

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The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order...more

Haug Partners LLP

FTC’s Pharmaceutical Antitrust Suit Over Opioid License Agreement Between Endo and Impax Dismissed Because Patent Act Permits...

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On Wednesday, March 30, 2022, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia, released a redacted opinion dismissing the Federal Trade Commission’s follow-on antitrust suit regarding Endo...more

Proskauer - Life Sciences

Update on Artificial Intelligence: USPTO Urges Federal Circuit to Affirm Decision That AI Cannot Qualify as an “Inventor”

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s...more

Smart & Biggar

Regulatory amendments provide permanent measures to address therapeutic product shortages

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On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more

Smart & Biggar

FCA remits pricing decision on ALEXION’S SOLIRIS to PMPRB

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Update: On September 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858). In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...more

Smart & Biggar

Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

Smart & Biggar

PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs

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Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more

Smart & Biggar

Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

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In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more

Smart & Biggar

Innovators challenge final PMPRB Guidelines in new Federal Court application

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On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board...more

Bradley Arant Boult Cummings LLP

Drug Patent Invalid Due to Poor Quality Translation

In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more

Smart & Biggar

Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations

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UPDATE: On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed. As...more

Smart & Biggar

Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

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UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more

Smart & Biggar

COVID-19 Update: CIPO, Federal Courts, Health Canada

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This article was last updated on June 26, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more

McDonnell Boehnen Hulbert & Berghoff LLP

Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (Fed. Cir. 2019)

Section 112 of the Patent Act as codified, entitled "Specification" in the statute, specifies the amount of disclosure required to support a patent claim (among other requirements).  Section 112(a) contains three...more

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