Biotech Patents

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 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.
December 2, 2020
Close-up photograph of a fountain pen writing words in ink on paper.

Written Description Particularly Important if Amending Claims in Response to Competitor

Fed. Cir. 2018-1779: A patent for testing fetal DNA was found to be unpatentable because the claims were not fully supported by the written description.
March 18, 2020
Team of inventors wearing white lab coats in a laboratory.

Federal Court Removes Inventors from Four Patents

2020 FC 338 – The Court concluded that the six individuals were listed as inventors “by inadvertence in the process of the division.”
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.
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.”
January 10, 2017

PAB Finds Proposed Amendments Overcome Defects in Stabilized Alpha Helical Peptides Application

PAB 1393 - The Patent Appeal Board found that Canadian Patent Application No. 2,544,223, entitled “Stabilized Alpha Helical Peptides and Uses Thereof” lacked utility, lacked sufficient disclosure, was obvious, and included indefinite claims.
November 23, 2016

FC Invalidates Selection Patent as Obvious in View of Genus Patent

2015 FC 247 - The Federal Court reminds us that a selection patent will typically require something more than routine testing to justify the reclaiming of a particular compound within a previously known class of compounds.
October 6, 2016

Pharmaceutical Patentees Could Face More than 100% of Actual Damages under PM(NOC) Regulations

2014 FCA 68 - Innovator pharmaceutical companies should be cautious and think twice about how aggressively they defend their patents as they could potentially face paying more than 100% of actual damages as an award under section 8 of the PM(NOC) Regulations.
October 5, 2016

“More or Less Self-evident” Remains the Standard in the Obvious-to-Try Test

2015 FCA 286 - An attack on the Federal Court’s slight rewording of the obvious-to-try test has proven unsuccessful. The FC referring to a 'fair expectation of success'" was not a reviewable error.
October 3, 2016

Careful Patent Drafting Saves Novartis’s EXJADE Patent Despite Two Distinct Promises

2016 FCA 230 - The FCA found that the EXJADE patent was drafted so as to make an important distinction between the utilities of the Formula I and Formula II compounds, and thereby held the Formula II claims to a lesser promise, and dismissed Teva’s allegations of inutility.
April 22, 2016

Gilead Successfully Invalidates Patent Jeopardizing Its Sovaldi Product

2015 FC 1156 - The FC found that Idenix’s patent was invalid for a lack of utility, demonstrated or soundly predicted, and for insufficient disclosure.
April 5, 2016

Strike Two: Second Prohibition Application Regarding Mylan’s Proposed Tadalafil Tablets Denied

2015 FC 125 - The existing patent was invalid on the grounds of lack of utility for having made a promise of utility that could not be demonstrated nor soundly predicted, was anticipated by a previous patent of the applicant that claimed an overlapping dosage range, and was also therefore made obvious by the same previous patent.
February 17, 2016

Data Protection Provisions Block Post-Filing NDS Amendments for Generic Drug

2015 FC 1205 - A quirk in the PM(NOC) rules was resolved that could make the entry of generics into the market even slower if the generic tries to make post-filing amendments to its application.
February 5, 2015

Federal Court Reverses Commissioner’s Opinion that Janssen Altered the Prohibition against Patenting of Methods of Medical Treatment

AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251 - The core of the Commissioner’s argument was that Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123, broadened the prohibition against patents on methods of medical treatment to include generally claims which restrict the “how and when” a physician could administer a particular drug. The Court found that the Commissioner had misread Janssen.
January 23, 2015

Patent for using a Short Needle for Intradermal Delivery for Vaccinations Rejected for Obviousness

Commissioner’s Decision # 1371 - The Commissioner refused to grant GlaxoSmithKline’s patent application for an “influenza vaccine formulation for intradermal delivery” due to obviousness since there was always a motivation to use the ID route, but it had always been impractical until the advent of a short needle device.
November 7, 2014

Federal Court to Hear Challenge to the Patentability of Isolated Nucleic Acids

Children’s Hospital of Eastern Ontario v University of Utah Research Foundation, T-2249-14 - The CHEO will argue that the Long QT Patents that are inhibiting its ability to conduct medical testing claim unpatentable subject matter since the claimed nucleic acids are naturally occurring, encode for naturally occurring human genes, and were discovered by extracting genetic material from human beings. Validity of the method testing claims are also disputed.
October 20, 2014

Australian Federal Court Upholds Patentability of Isolated DNA Sequences, Parts Ways with Supreme Court of the United States

D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 - The Federal Court of Australia Full Court upheld the validity of Australian Patent No. 686004, which claims an isolated sequence of DNA useful for cancer diagnosis, as qualifying as a “manner of manufacture” and thus patentable subject matter pursuant to section 6 of the Statute of Monopolies.
December 23, 2013

PAB Allows Application Despite Examiner’s Rejection Based upon Unpatentable Subject Matter

Re. Patent Application 2,333,184 CD 1345   Background   The patent application at issue is for an automated method of classifying or sorting plant embryos of […]
June 17, 2013

US Supreme Court Holds Isolated Naturally-Occurring DNA Segments Are Products of Nature and Not Patent Eligible

Association for Molecular Pathology v Myriad Genetics Inc, US SC No 12–398 (2013) - The US Supreme Court must determined that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.