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Federal Court rejects non-infringing alternative defence; Apotex ordered to pay over $100 million to Eli Lilly in cefaclor damages reference
On January 23, 2015, the Federal Court released its decision on the quantum of damages in the cefaclor (Eli Lilly's CECLOR) litigation: Eli Lilly and Company et al v Apotex Inc, 2014 FC 1254. This is only the second Federal Court decision which quantifies a damages remedy in a pharmaceutical patent infringement proceeding, the first being the lovastatin proceeding in Merck & Co Inc v Apotex Inc, 2013 FC 751, as we previously reported, the appeal of which was heard on January 15, 2015.
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Federal Court revisits the issue of method of medical treatment claims
As we reported previously, the Federal Court allowed Abbvie's appeal from a refusal of the Commissioner of Patents to grant Canadian Patent No. 2,385,745. The refusal was on the basis that the claims at issue cover a method of medical treatment (Decision #1362). The Court held that the claims — for use of a known drug, HUMIRA (anti-TNF alpha antibodies) at a specified fixed amount (40 mg) and fixed interval (bi-weekly) — were patentable.
Federal Court Decision (amended) — 2014 FC 1251
STELARA litigation settled
As we reported previously, Abbvie sought leave to appeal the decision of the Federal Court of Appeal that ordered a new trial in the STELARA patent infringement litigation and, in a separate decision, also set aside an injunction that had issued against Janssen at trial. On January 19, 2015, as a result of the parties having advised the Federal Court that they had settled the action, the Court dismissed with prejudice, among other things, the claim and counterclaim and all claims that arose or could be advanced in connection with the action. On January 20, 2015, Abbvie, on consent, discontinued its application for leave to appeal to the Supreme Court of Canada.
Federal Court decisions — 2014 FC 55; 2014 FC 489
Federal Court of Appeal decisions — 2014 FCA 242; 2014 FCA 241
Abbvie Corporation, et al v Janssen Inc, SCC Case No. 36232
PMPRB issues a Notice of Hearing for allegations of excessive pricing of SOLIRIS
On January 22, 2015, the Board announced that it will hold a public hearing (with further details to be provided at a later date) with respect to the price of Alexion Pharmaceutical Inc.'s SOLIRIS (eculizumab). The purpose of the hearing is to determine whether Alexion has sold or is selling SOLIRIS in Canada "at a price that, in the Board's opinion, is or was excessive; and if so, what order, if any, should be made to remedy the excessive pricing."
News Release; Notice of hearing; Statement of Allegations of Board Staff.
Health Canada requests a quarantine of products from another Indian manufacturer
Health Canada announced on January 6, 2015, that at its request, importers and distributors have agreed to quarantine products using active pharmaceutical ingredients from Sri Krishna Pharmaceuticals Ltd. This action was taken "in light of recent information from trusted regulatory partners that raised concerns about the reliability of the laboratory data generated at this site." The action follows a number of similar actions taken in the fall of 2014, relating to the following Indian manufacturers:
- Dr. Reddy's Laboratories in Srikakulam and IPCA Laboratories in Pithampur (as reported here)
- three Micro Labs facilities in India (Bangalore, Goa and Hosur) (as reported here)
- Apotex Pharmachem India Pvt Ltd, Apotex Research Private Limited (ARPL) and IPCA Laboratories (as reported here)
On October 17, 2014, Health Canada provided an update "on measures it is taking so that Canadians can have access to affected medically necessary products."
Information update
Recent Court decisions
Patented Medicines (Notice of Compliance) Regulations
Eli Lilly obtains Order prohibiting NOC to Mylan for tadalafil (Eli Lilly's CIALIS). On January 7, the Federal Court issued an Order prohibiting the Minister of Health from granting an NOC to Mylan Pharmaceuticals ULC regarding its generic version tadalafil (Eli Lilly's CIALIS). The patent at issue relates to the use of tadalafil for the treatment of erectile dysfunction (ED). Mylan had asserted invalidity on the basis of lack of sound prediction of utility and "obviousness-type" double patenting.
The Court agreed with Lilly that patent promises treatment of ED by the use of tadalafil or 3-methyl tadalafil. Relying on the testing disclosed in the patent and the common general knowledge, the Court found the utility promised was soundly predicted: the ability of tadalafil to treat ED was not a "lucky guess" and the patent claims were not based on mere speculation. The Court disagreed with Mylan's argument that the promise requires efficacy upon oral administration, but held that it too was soundly predicted, in part in light of a study published between the priority and Canadian filing dates. The Court also disagreed with Mylan's argument that the patent promised lack of undue side effects. The Court reasoned that absent an explicit statement promising reduced side-effects, a mere reference to treatment was not sufficient to amount to a promise of lack of toxicity or undue side-effects. In the patent at issue, there is no reference to toxicity in the patent, none of the claims mentions reduced side effects, nor is there any data relating to toxicity.
Mylan submitted that if the promise does not include oral administration, the patent was invalid for obviousness-type double patenting over the patent claiming tadalafil. Construing the claims of the prior patent in light of the patent as a whole, the Court held that the prior patent claimed tadalafil as a PDE V inhibitor, whereas the patent at issue claims tadalafil as a PDE V inhibitor to treat ED, a use not contemplated by the prior patent. The Court held the appropriate date for the obviousness double-patenting analysis was the priority date of the first patent, reasoning that "[o]ne cannot read into the claims of the first patent more than what would have been understood by the person skilled in the art at the claim date when comparing the claims of the second patent to those of the first." The Court however also undertook the analysis as of the priority date of the patent at issue and held that irrespective of which date is most appropriate, the use of tadalafil for treatment of ED would not have been obvious to a skilled person on the basis of the claims of the first patent in light of the common general knowledge. Mylan may appeal as of right.
Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC — 2015 FC 17
Actelion successfully challenges Health Canada practice re: cross-referenced submissions. As we reported last month, the Federal Court held that Health Canada's Guidance Document was incorrect in stating that an administrative or cross-referenced drug submission will not separately trigger the requirement to address patents on the Patent Register (Pfizer Canada Inc v Canada (Attorney General), 2014 FC 1243 regarding exemastane (Pfizer's AROMASIN)). Both Teva and Health Canada have appealed that decision. The Federal Court had also issued a concurrent decision in a judicial review of NOCs issued to two generic manufacturers for bosentan (Actelion's TRACLEER). Consistent with its Pfizer decision, the Federal Court granted Actelion the declaratory relief it sought, namely that Health Canada failed to comply with the PMNOC Regulations in granting the NOCs to the two generic manufacturers. However, as the patent that had been listed on the Patent Register had expired, Actelion's request for an order quashing the NOCs was moot.
Actelion Pharmaceuticals Canada Inc v Canada (Attorney General) — 2014 FC 1249
FCA confirms second person does not bear initial evidentiary burden on non-infringement; failure to produce tablets does not warrant drawing an adverse inference. On January 9, 2015, the Federal Court of Appeal dismissed Bristol-Myers Squibb (BMS), Gilead Sciences and Merck Sharp & Dohme's appeal of Justice Barnes' decision dismissing their application for an Order of prohibition against Teva regarding a combination anti-retroviral medicine containing efavirenz (BMS's ATRIPLA).
The appellants argued Justice Barnes (i) failed to apply the proper evidentiary standard, and (ii) failed to draw an adverse inference against Teva for refusing to produce its tablets for testing.
The Court of Appeal rejected the appellants' first argument that Teva failed to satisfy its initial burden of putting its allegation of non-infringement in play. The Court of Appeal held that such a burden does not exist for an allegation of non-infringement, in contrast to allegations of invalidity where the presumption of validity results in an evidential onus on the second person. As Teva had alleged in its notice of allegation that its product "will not contain Form I nor is Form I used in [its] manufacture," the Court of Appeal found that Teva had put the allegation in play and thus there was no further evidentiary burden on Teva.
With respect to the second ground of appeal, the Court of Appeal rejected the appellants' submission that an adverse inference should have been drawn against Teva for failing to produce its tablets. The Court of Appeal held there were a number of facts before the lower court to support such a finding, including: (i) that the appellants "were "better equipped than most" to make the compound for testing purposes and could have done so;" and (ii) Teva had undertaken "not to assert that the material obtained and tested by the appellants was different in character or composition from [that used by Teva]." The Court of Appeal also noted that the lower court's decision not to draw an adverse inference is "bolstered by the fact that production is not required under s. 6(7) of the PMNOC Regulations."
Bristol-Myers Squibb v Teva Canada Limited, January 9, 2015
Federal Court of Appeal decision — 2015 FCA 3
Federal Court decision — 2014 FC 30
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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varenicline tartrate (CHAMPIX)
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Applicants:
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Pfizer Canada Inc and Pfizer Products Inc
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Respondents:
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Apotex Inc and The Minister of Health
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Date Commenced:
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January 8, 2015
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Court File No.:
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T-14-15
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,316,921, 2,447,405, and 2,467,490. Apotex alleges non-infringement and invalidity.
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Medicine:
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darunavir (PREZISTA)
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Applicants:
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Janssen Inc
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Respondents:
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Teva Canada Limited and the Minister of Health
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Respondent/Patentee:
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Janssen Sciences Ireland UC
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Date Commenced:
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January 9, 2015
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Court File No.:
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T-20-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,485,834. Teva alleges non-infringement and invalidity.
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Medicine:
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ziprasidone hydrochloride monohydrate (ZELDOX)
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Applicant:
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Pfizer Canada Inc and Pfizer Products Inc
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Respondents:
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Mylan Pharmaceuticals ULC and the Minister of Health
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Date Commenced:
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January 16, 2015
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Court File No.:
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T-64-15
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,274,338. Mylan alleges non-infringement and invalidity.
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To check the status of Federal Court cases, please click here.
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