What to expect in 2022: pending patent decisions and upcoming trials/appeals in the federal courts

11 minute read
08 February 2022

Just one month into 2022, the Federal Courts have nearly cleared the docket of pending patent decisions. The Rovi Guides decisions are still pending from the Federal Court, and the Court of Appeal has one patent decision pending.

Instead of writing, the Federal Courts will be busy in 2022 with hearings. There are many interesting cases to watch.

Pending decisions from patent trials & appeals

Rovi Guides, Inc et al v Videotron Ltd / Telus Corporation et al / BCE Inc et al (T-921-17 / T-206-18 / T-113-18)

These decisions were pending when we wrote our article last year,[1] and remain pending today. In fact, the trial against Videotron was the Federal Court's first trial-by-Zoom as a result of the then-new COVID pandemic.

Please see our 2021 article for a summary of these proceedings.

Teva Canada Ltd v Janssen Inc et al (A-131-20)

IVENGA SUSTENNA® (paliperidone palmitate) is the drug at issue in this patent infringement proceeding under the PM(NOC) Regulations. The underlying patent claims a particular dosing regimen (two loading doses followed by a maintenance dose) for long-acting injectable paliperidone palmitate formulations. Teva challenged the patent on the basis of obviousness and non-infringement.

At first instance, Justice Manson found in favour of Janssen and issued a declaration of infringement. With respect to obviousness, Justice Manson compared the essential elements of the claimed dosing regimen to the many different dosing regimens disclosed in the prior art. He then applied the obvious to try factors to find that the claimed regimen was not obvious. In particular, Justice Manson found that while the various elements of the claims could have been pieced together with hindsight, the combination of elements was not obvious.

With respect to infringement, Justice Manson observed that the "heart of the infringement dispute lies in the independent claims" of the patent at issue. Independent claims 1 and 2 are to "prefilled syringes […] for administration […]" while independent claim 33 is to " use of paliperidone as paliperidone palmitate for the preparation of a medicament" (independent claim 34 is similar). Teva argued that it cannot directly infringe these claims because it does not prescribe or administer the medication.

Justice Manson dismissed this argument. He found all of the essential elements in Teva's Product Monograph and product labels. On the issue of administration/use, he accepted Janssen's argument that the "capable, approved and intended use for the Teva Product as specified in the Teva Product Monograph incorporates all dosing and administration elements" of Janssen's patent.

Teva appealed Justice Manson's decision on May 26, 2020. The Court of Appeal hearing took place on September 14, 2021 before Justices Stratas, Gleason and Woods. The decision is likely to come in 2022, and could be an important decision for both obviousness and infringement of patents to dosing regimens.

Upcoming patent trials in early 2022

Merck Sharp & Dohme Corp et al v Pharmascience / Apotex Inc (T-419-20 / T-560-20, T-561-20, T-563-20)

Merck will defend its JANUVIA® (sitagliptin) market against at least Pharmascience in 2022. The trial started on January 10 and closing submissions were heard on January 26. Justice Furlanetto will now take the matter under reserve and likely issue a decision soon. The 24-month stay under the PM(NOC) Regulations expires on March 25, 2022.

By the time the matter reached trial, only a compound patent was left in dispute and only two issues of validity – obviousness and sufficiency. However, there will be substantial evidence for Justice Furlanetto to consider. Based on a decision from a pre-trial reply motion,[2] Merck and Pharmascience filed reports from at least eight experts (five for Merck; three for Pharmascience).

The three Apotex proceedings are also scheduled for trial this year, starting on February 28. The 24-month stay expires on May 20, 2022. However, these proceedings may be veering towards a resolution. The parties submitted a joint confidential letter to the Court on January 7 requesting to adjourn a TMC scheduled for January 11.

NCS Multistage Inc v Kobold Corporation et al / Promac Industries Ltd (T-1420-18 / T-567-20)

NCS's patent infringement trial against Kobold and Promac started on January 12 and is scheduled for 26 days. The parties are in the business of providing equipment to the oil and gas industry for hydraulic fracking. Specifically, they provide down-hole equipment that is inserted into a drilled well and allows the operator to fracture the well for production of oil or gas.

These cases started with NCS's action against Kobold with respect to seven patents relating to fracking tools. Kobold counterclaimed alleging that NCS infringed two of its patents, though only one Kobold patent is being pursued to trial. Nearly two years later, NCS commenced an action against Promac, alleging that Promac infringed the same seven patents. The two proceedings have been joined and are being heard together.

In a separate but related proceeding (T-451-20), Kobold sued NCS for infringement of one of its patents claiming a method for fracking using particular pieces of equipment. NCS sought to dismiss the proceeding on a summary judgment motion by relying on the new section 56 "prior use" defence.

On January 7, 2022, Justice Manson issued a split decision, granting summary judgment in part but requiring certain issues to proceed to trial. Most notably, Justice Manson's decision is the first time any Court has interpreted section 56 of the Patent Act.[3] We recently wrote about the Kobold decision.[4]

Given that the prior use defence was raised in T-451-20, it will be interesting to see if the ongoing trial explores this defence further and if the decision provides further guidance on section 56.

Janssen Inc et al v Sandoz Canada Inc / Apotex Inc / JAMP Pharma Corp (T-549-20 / T-555-20 / T-769-20)

These three PM(NOC) proceedings relating to OPSUMIT® (macitentan) will all go to trial in 2022. The trial against Sandoz started on January 24, with the 24-month stay expiring on May 14, 2022. Apotex starts trial on February 7, with the 24-month stay expiring on May 20, 2022. Jamp rounds out the trio with its trial starting on April 4 and its 24-month stay expiring on July 17, 2022. If Janssen is successful in these cases, it will likely enjoy several more years of exclusivity as the two patents on the Patent Register expire in September 2026 and August 2027.

In the context of the ongoing Sandoz trial, Justice Pallotta issued a unique exclusion Order that excluded Janssen's second expert witness from observing or reading the testimony of the first expert witness.

T-Rex Property AB v Pattison Outdoor Advertising Limited Partnership (T-1066-17)

T-Rex initiated a patent infringement action against four defendants, including Pattison Outdoor Advertising. The allegations are that the Defendants infringed the Plaintiff's patent for digital information systems, specifically relating to outdoor advertising.    

The 15-day liability trial is scheduled to begin on February 14. Our colleagues Peter Choe, Charlotte McDonald and Harvey Lim will be representing T-Rex.

Bernard Charles Sherman et al v Pharmascience Inc (T-1935-13)

In a rare generic-versus-generic dispute, the late Dr. Sherman and Apotex sued Pharmascience for patent infringement in relation to their quinapril products. This case endured a lengthy journey prior to the trial, from 2013 to the doorsteps of trial set to begin on February 14 for 10 days. The patent being asserted is a formulation patent that expired in December 2019.

Tekna Plasma Systems Inc v AP&C Advanced Powders & Coatings Inc (T-126-19)

These two competitors are in a dispute over their respective patent rights for the production of titanium powder for use in industrial applications. Tekna first started an action to impeach AP&C's patent, then started a separate patent infringement against AP&C. In December 2021, the second action was discontinued, but the impeachment action is scheduled for trial on March 28, 2022 for 20 days.

Upcoming patent appeals in early 2022  

Biogen Canada Inc et al v Pharmascience Inc / Taro Pharmaceuticals Inc (A-145-20 / A-146-20)

Biogen's appeals in relation to its product FAMPYRA® will be heard on February 22. The patent relates to the use of fampridine sustained release ("SR") formulations in the treatment of multiple sclerosis. Justice Manson dismissed the underlying action under the PM(NOC) Regulations on the basis of anticipation and obviousness.[5]

With respect to anticipation, the Court found that a document submitted to the United States Securities and Exchange Commission anticipated certain claims of the patent at issue. The Court held that one study protocol, which was contained in the registration statement, would necessarily result in infringement if performed, and therefore was anticipatory. Notably, the study protocol did not contain any results.

With respect to obviousness, the Court held that all of the asserted claims were invalid based on the Court's assessment of the prior art.

Our colleagues John Norman, Alex Gloor, Adam Heckman and Rebecca Johnston are representing Biogen.

Should you have any specific questions about this article or would like to discuss it further, you can contact the authors or a member of our Patent Group.

[2] Merck Sharpe & Dohme Corp v Pharmascience Inc, 2021 FC 1456

[3] Kobold Corporation v NCS Multistage Inc, 2021 FC 1437.

[5] Biogen Canada Inc v Taro Pharmaceuticals Inc, 2020 FC 621.

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