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PATENT PROTECTION FOR PHARMACEUTICAL PRODUCTS IN CANADA – CHRONOLOGY Of Great Occasions
Law and Government Division
30 March 2000
PATENT PROTECTION FOR PHARMACEUTICAL PRODUCTS IN CANADA – CHRONOLOGY Of Great Occasions
1923 — The Patent Act was amended to maintain compulsory licensing for manufacturing purposes for drug and food patents. With regards to patented medicines, the amendment permitted a compulsory licence to become granted if your medicine’s ingredients were produced in Canada. (A compulsory licence is really a statutory licence that provides the licensee the authority to manufacture, use, or sell a patented invention prior to the patent expires. Licences might be granted with no consent from the patent holder and also the licensee was needed to pay for a royalty.)
1969 — The Patent Act was amended allowing compulsory licences to import medicines into Canada. This permitted generic drug producers to import a medicine’s ingredients and process them into final form for purchase. The Commissioner of Patents was approved to issue compulsory licences to import and also to fix a royalty on their behalf. Royalty rates were set at 4% from the internet selling cost of the drug in the final dosage form.
1983 — The government Minister of Consumer and company Matters known as for any rebalancing from the 1969 policy on compulsory licensing to be able to generate development in the pharmaceutical industry.
1984 — The us government established the Commission of Inquiry around the Pharmaceutical Industry (Eastman Commission), a part of whose mandate ended up being to make tips about patent protection for that pharmaceutical industry.
1985 — The Commission of Inquiry around the Pharmaceutical Industry suggested that the who owns a patent for any medicine be granted a brief period of exclusivity (4 years) in the date whenever a new drug received a Notice of Compliance (NOC)(1) authorizing marketing. The Commission also suggested that royalties compensated under compulsory licences ought to be put in a unique royalty fund. The royalty rate could be determined in compliance having a formula that required into consideration the need for a licensee’s sales of compulsorily licensed products in Canada, the pharmaceutical industry’s world-wide ratio of development and research to sales, plus 4%. Distributions in the fund to firms whose patents were under compulsory licence may be in line with the relative research concentration of the patent-holding firms.
1987 — Bill C-22, which amended the Patent Act, made significant changes towards the compulsory licensing system for patented medicines. The amendments guaranteed patent proprietors a time period of defense against compulsory licences. A brandname-name drug manufacturer receiving an NOC for any drug after 27 June 1986 was guaranteed ten years of protection against compulsory licences to import and 7 years’ protection against compulsory licences to fabricate. Patented medicines that NOCs have been issued on or before 27 June 1986, as well as for which generic drug producers had acquired either an NOC or perhaps a compulsory licence to import, although not both, were titled to seven years’ protection against compulsory licences to import. Similarly, medicines that an NOC have been issued on or before 27 June 1986, however for which neither a compulsory licence nor a normal NOC have been issued, had eight many years of protection against compulsory licences to import.
Additional protection was granted to drugs invented and coded in Canada compulsory licenses to import weren’t available, but compulsory licences to fabricate might be issued if, inside the seven years following the NOC for that drug have been issued, the inventor unsuccessful to help make the drug in Canada with regards to completely or substantially offering the Canadian market.
Bill C-22 also altered the overall patent law to supply the term of the patent could be twenty years in the date which a patent application was filed, instead of 17 years in the date the patent was issued. This transformation grew to become good at 1989.
1991 — The then Director-General from the General Agreement on Tariffs and Trade, Arthur Dunkel, compiled a Draft Final Act for that conclusion from the Uruguay Round from the GATT multilateral trade negotiations, that also contained a text from the draft Agreement on Trade-Related Facets of Ip Legal rights (Journeys). Article 31 from the Journeys agreement contained provisions on "Use With no Authorization from the Right Holder." It had been generally recognized the Canadian compulsory licensing regime for pharmaceutical products around at the moment was incompatible with Article 31. (The written text from the Journeys Agreement as within the so-known as Dunkel text was informally decided to by both sides towards the GATT negotiations and grew to become area of the Agreement finally adopted in 1994.)
1992 — The us government endorsed the Dunkel text. The written text from the United States Free Trade Agreement (NAFTA) was finalized, with Chapter 17 largely according to, and in most cases just like, the provisions from the then draft Journeys Agreement. Article 31 from the Journeys Agreement was reproduced almost identically in Article 1709(10) of NAFTA.
1992 — The us government gone to live in further customize the Patent Act and also to implement the Journeys and NAFTA provisions on ip by presenting Bill C-91, the Patent Act Amendment Act, 1992, in the home of Commons. The balance eliminated compulsory licences for pharmaceutical products though compulsory licences around before 20 December 1991 ongoing essentially, susceptible to the seven and ten-year limitations established in Bill C-22. Compulsory licences granted after 20 December 1991 before your day the Act arrived to pressure were ended once the Act grew to become effective.
Bill C-91 also produced two exceptions for an action for patent violation (the rule that anybody who, with no consent from the patent owner, makes, uses or sells an item in which a patent is within pressure is likely for patent violation). Both exceptions permit persons to utilize a patented product for several purposes prior to the patent expires. The very first exception, referred to as "early working" exception, enables someone to make use of a patented invention as the relevant patents have been in pressure just for acquiring regulatory approval to market a similar product following the patents have expired (section 55.2(1)). Under this provision, a normal drug manufacturer could create a generic form of medicines and take whatever steps were essential to satisfy the regulatory needs relating to the purchase prior to the expiry from the relevant patents. The 2nd exception ("stockpiling" exception) enables someone to make use of a patented invention for time prior to the patent expires to be able to manufacture and store an item meant for purchase following the expiry from the patent (section 55.2(2)).
Bill C-91 also deliver to product patents for pharmaceutical inventions. Before the bill such inventions were only patentable as process patents (approximately-known as "product-by-process patents").
Feb 1993 — The Patent Act Amendment Act, 1992 grew to become law.
March 1993 — The Patented Medicines (Notice of Compliance) Rules (Linkage Rules) detail the way the granting of the NOC for any generic drug is going to be from the expiry of patents for that brand-name equivalent drug. Basically, these rules provide that, unless of course a patentee consents to the building of the generic drug, the appropriate patents are invalid, or there’s no violation associated with a patent legal rights, the Minister of Health cannot issue an NOC to some generic manufacturer before the relevant patents expire.
The Manufacturing and Storage of Patented Medicines Rules provide that the generic manufacturer can stockpile a normal form of a medication six several weeks prior to the relevant patents result from expire.
April 1997 — Home of Commons Standing Committee on Industry issued a study around the Patent Act Amendment Act, 1992 recommending the government re-go to the regulatory regime connected with Bill C-91.
December 1997 — The Eu (EU) requested that Canada hold consultations underneath the WTO dispute settlement procedures with regards to the security of pharmaceutical inventions underneath the Canadian Patent Act and Canada’s obligations underneath the Journeys Agreement.
March 1998 — Amendments towards the Patented Medicines (Notice of Compliance) Rules arrived to effect. Even though the amendments made numerous changes to the whole process of the Linkage Rules, they didn’t alter the overall regime governing patent violation, early working or stockpiling.
Feb 1999 — The Dispute Settlement Body underneath the WTO established a Panel to listen to the ecu Union’s challenge underneath the Journeys Agreement according from the early working exception (section 55.2(1)) and also the stockpiling exception (section 55.2(2)) from the Patent Act.
The EU contended that Patent Act and also the rules that offer for that manufacturing and stockpiling of pharmaceutical products with no consent from the patent holder for six several weeks before the expiration from the 20-year patent term (section 55.2(2)) violate Canada’s obligations underneath the Journeys Agreement (Article 28.1 and Article 33).
Furthermore, the EU maintained that by treating patent holders in the area of pharmaceutical inventions less favourably than patent holders of inventions in most other fields of technology, Canada had violated its obligations under Article 27.one of the Journeys agreement. This involves patents to be shown and patent legal rights to become enjoyable without discrimination regarding the field of technology.
The EU further contended the provisions of Article 28.one of the Journeys Agreement are violated through the provisions from the Patent Act (section 55.2(1)), whereby a 3rd party may, with no consent from the patent holder, make use of a patented invention as the patent remains in pressure to be able to obtain regulatory approval for that purchase of the equivalent product following the patent has expired.
Canada, however, contended that that section 55.2(1) and 55.2(2) from the Patent Act did conform with Canada’s obligations underneath the Journeys Agreement, because:
all these provisions is really a "limited exception" towards the exclusive legal rights conferred with a patent inside the concept of Article 30 from the Journeys Agreement and
these provisions neither discriminate regarding the field of technology by which any relevant invention occurs nor lessen the minimum term of patent protection.
March 2000 — The WTO Panel agreed with Canada around the early working exception in section 55.2(1) from the Patent Act, holding that it hadn’t been sporadic with Canada’s obligations underneath the Journeys agreement however, the Panel sided using the EU with regards to the stockpiling exception in section 55.2(2) and figured that it was sporadic with Canada’s Journeys obligations.
April 2000 — Canada announced it would implement the WTO Panel’s discovering that Canada’s stockpiling exception isn’t in line with Canada’s Journeys obligations.
May 2000 — Ruling towards the U . s . States, a WTO Panel figured that Canada’s term of patent protection for patent applications filed before 1 October 1989 (17 years in the granting from the patent) didn’t satisfy the minimum term of patent protection established under Journeys. The Panel discovered that Journeys needs a minimum term of twenty years in the date a patent application is filed.
Bill C-22 produced two patent term provisions: 17 years in the granting from the patent for applications filed before 1 October 1989 ("old regime") and twenty years in the filing from the application for applications filed on or after 1 October 1989 ("new regime").
The U . s . States claimed that Journeys needed the absolute minimum 20-year term in the date of declaring all patents. The dispute concerned patents granted underneath the old regime within 3 years in the date the applications on their behalf have been filed.
Canada announced it would appeal the WTO Panel decision.
(1) A Notice of Compliance may be the name provided to the document from the government Department of Health that formally authorizes the purchase of drug after it’s met the requisite safety and effectiveness standards.