Case: Gilead Sciences, Inc v Apotex
Inc, 2016 FC 857 (Court File No. T-1694-14)
Drug: VIREAD® (tenofovir disoproxil fumarate)
Nature of case: Prohibition application pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations)
Successful party: Gilead Sciences, Inc. and Gilead Canada, Inc.
Date of decision: July 21, 2016 - Confidential Reasons; Public Reasons released August 23, 2016
Gilead Sciences Canada, Inc. markets tenofovir disoproxil
fumarate (TDF) under the name
VIREAD® for the treatment of HIV infection. Apotex
sought approval to market a generic TDF product and was required to
address Gilead's Canadian Patent No. 2,261,619 (619
Patent) under the Regulations. By this
application, Gilead sought an order prohibiting the minister from
approving Apotex's submission until the expiry of the 619
The court allowed Gilead's prohibition application. Gilead established that Apotex's anticipation, obviousness, and inutility allegations were not justified.
The 619 Patent relates to tenofovir disoproxil (TD, also known as bis(POC)PMPA), a prodrug of the nucleotide reverse transcriptase inhibitor tenofovir (also known as PMPA). This prodrug increases the oral bioavailability of the parent drug, tenofovir (PMPA). Gilead asserted only claim 32, which claims TD and its salts, tautomers and solvates.
The blinding of experts is a question of relevance, reliability and weight
The parties adopted different approaches towards the treatment of their expert witnesses. Gilead provided the legal framework regarding anticipation, obviousness, and utility to its experts early; Apotex withheld this information until after the experts had drawn their own conclusions on issues such as the promise of the patent, claim construction, and the prior art, but provided its experts with the prior art and common general knowledge. Justice Brown held that the blinding of experts (or lack thereof) may be a factor when determining relevance, reliability and weight, but it is not a matter that goes to admissibility. He preferred some experts on some issues, and other experts on other issues, taking into account the arguments raised by both parties and assessing the appropriate weight to be given to the expert testimony. In general, Justice Brown preferred the expert testimony of Gilead's experts.
Court is not bound by findings on invalidity allegations in previous NOC proceedings
Justice Brown held that the court was not bound by findings on invalidity allegations with respect to the 619 Patent in a previous NOC proceeding. He was not persuaded that he ought to apply comity except in the limited context of patent construction or another question of law.
Court rejects allegations that Claim 32 is invalid for anticipation, obviousness, or inutility
Anticipation. Justice Brown accepted
Gilead's evidence that claim 32 was not anticipated by a
European genus patent application alleged by Apotex to include TD.
He held that there was no disclosure of a carbonate group moiety in
the prodrugs described. Justice Brown also rejected Apotex's
allegation that claim 32 was an invalid selection from the genus
patent application, holding that even if the genus patent
application included TD, Gilead's prodrug presented special
advantages for efficient oral delivery that were not previously
Obviousness. Justice Brown rejected Apotex's allegation that the discovery of the prodrug TD (bis(POC)PMPA) was obvious or obvious to try. He noted that, as argued by the parties, the inventive concept is "the addition of the bis(POC) moiety to PMPA." He held that reaching this inventive concept was a relatively long and arduous process that required an inventive spark and would not have been obvious to the unimaginative and uninventive skilled person.
Utility. Justice Brown held that the promised utility of the 619 Patent is the efficient oral delivery of the parent drug (tenofovir or PMPA) through its prodrug, which has a specific carbonate moiety (yielding TD or bis(POC)PMPA). He held that contrary to Apotex's allegations, efficacy in HIV treatment was a goal — not a promise. The experimental results disclosed in the 619 Patent were sufficient to demonstrate that bis(POC)PMPA efficiently delivered PMPA. Justice Brown also considered additional studies that showed the low bioavailability of PMPA and demonstrated the improved bioavailability of the prodrug (TD) compared to the parent (PMPA).
For these reasons, the court concluded that Apotex's allegations of invalidity were not justified.
Norton Rose Fulbright Canada acted for Gilead in this matter.
About Norton Rose Fulbright Canada LLP
Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.
Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.
Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.
For more information about Norton Rose Fulbright, see nortonrosefulbright.com/legal-notices.
Law around the world
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.