Rx IP Update - April 2017

by Smart & Biggar
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Teva awarded section 8 damages regarding pregabalin and olanzapine

by Shirley Liang Komosa »

On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA) in Teva Canada Limited v Pfizer Canada Inc, 2017 FC 332 (the “pregabalin decision”) and olanzapine (Eli Lilly’s ZYPREXA) in Eli Lilly Canada Inc v Teva Canada Limited, 2017 FC 88 (the “olanzapine decision”). In both decisions, the Court made factual findings that provided direction for a final calculation of Teva’s damages. Notably, an adjustment for “pipefill” was permitted in pregabalin, but not in olanzapine. Generally, pipefill is the difference in a company’s ex-factory sales and IMS retail sales.

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PMNOC proceedings

Medicine:

aripiprazole tablets (ABILIFY)

Applicants:

Bristol-Myers Squibb Canada Co.
Otsuka Pharmaceutical Co., Ltd.

Respondents:

Teva Canada Limited, Actavis Pharma Company and the Minister of Health

   

Date Commenced:

April 12, 2017

Court File No.:

T-530-17

Comment:

Application for Order of prohibition until expiry of Patents Nos. 2,426,921; 2,713,466; 2,689,052; 2,688,934; 2,688,915; 2,689,051;
2,429,496; 2,700,314; 2,526,562; and 2,511,619.
Teva alleges non-infringement and invalidity.

 

Medicine:

atazanavir sulphate capsules (REYATAZ)

Applicants:

Bristol-Myers Squibb Canada Co. and Bristol-Myers Squibb Holdings Ireland

Respondents:

Mylan Pharmaceuticals ULC and the Minister of Health

   

Date Commenced:

April 6, 2017

Court File No.:

T-507-17

Comment:

Application for Order of prohibition until expiry of Patent No. 2,317,736. Mylan alleges invalidity.

Other Proceedings

Medicine:

filgrastim (NEUPOGEN and NEULASTA)

Plaintiff:

Amgen Inc.

Defendant:

BGP Pharma ULC dba Mylan EPD

Date Commenced:

April 5, 2017

Court File No.:

T-501-17

Comment:

Action for a declaration that claims 43-47 of Patent No. 1,341,537 are valid.

 

Medicine:

Unidentified

Applicant:

Unidentified Innovator Company

Respondent:

The Attorney General of Canada and the Minister of Health

Date Commenced:

March 31, 2017

Court File No.:

T-485-17

Comment:

Application for a Declaration that a new drug submission filed by the applicant does not trigger the application of section 5 of the PMNOC Regulations and that the applicant is not a second person. 

To check the status of Federal Court cases, please click here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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