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Drugs and Health Products

Patent Register - Frequently Asked Questions

  1. When can a generic version of a drug come on the market?
  2. Who administers the Patent Register?
  3. How do I apply for a patent and where can I find further information on patents?
  4. When can I submit a patent list for inclusion on the Patent Register?
  5. When will a drug be added to the Patent Register?
  6. How can I print the results of my search?
  7. Why do PDF files sometimes not display?
  8. Why are fields in a record sometimes empty?
  9. How up-to-date is the information retrieved?
  10. Is an actual hard copy of the Patent Register available for viewing?
  11. Are removed patents searchable?

1. When can a generic version of a drug come on the market?

The expiry date of patents listed on the Patent Register is not always a good indication of when a generic version of a drug may receive its Notice of Compliance (NOC) and, thereby, come on the market. Generic drug manufacturers who file a submission for a drug must address all patents listed on the Patent Register for the medicinal ingredient or Canadian Reference Product (CRP). The generic drug manufacturer may elect to await expiry of one, some or all of the patents listed on the Patent Register in respect of the CRP or may address the patents in a Notice of Allegation (NOA) and serve that NOA on the first person (brand name drug manufacturer of the CRP). If the generic drug manufacturer addresses the patent(s) in an NOA, then the first person has 45 days to file an application for an order of prohibition with the Federal Court regarding all or some of the patents addressed in the NOA. The court will decide if the generic drug manufacturer's allegations are justified or not. If the decision is in favour of the first person, the NOC cannot issue until the expiry of the patent(s), depending on the court's order. If more than one patent is the subject of the application, the court can render a different decision for each patent. The court's decision will determine whether or not the generic drug manufacturer must await the expiry of any of the patents and will affect the date on which the generic drug's NOC can issue.

2. Who administers the Patent Register?

The Patent Register is administered by Health Canada and lists only patents that meet the eligibility requirements as set out in the Patented Medicines (Notice of Compliance Regulations). The submission of a 'patent list' is not obligatory. Therefore, even if a drug has received marketing authorization in Canada, patents may not be listed on the Patent Register for that drug.

3. How do I apply for a patent and where can I find further information on patents?

Next link will take you to another Web site The Canadian Intellectual Property Office (CIPO) is the agency responsible for the administration of the intellectual property system in Canada. CIPO's mandate includes the examination and granting of patents in Canada. The CIPO website also has a Next link will take you to another Web site searchable database of Canadian patents.

4. When can I submit a patent list for inclusion on the Patent Register?

Subsections 3(5) and 3(6) of the Patented Medicines (Notice of Compliance) Regulations specify when a patent list may be submitted for addition to the Patent Register.

"A first person who submits a patent list must do so at the time the person files a new drug submission or a supplement to a new drug submission to which the patent list relates."

"A first person may also submit a patent list after the date of filing of a new drug submission or a supplement to a new drug submission, and within 30 days after the issuance of a patent that is issued on the basis of an application that has a filing date in Canada that precedes the date of filing of the submission or supplement. The patent list would include the information referred to in subsection 4(4) of the Patented Medicines (Notice of Compliance) Regulations, in relation to the submission or supplement."

5. When will a drug be added to the Patent Register?

The Patent Register lists patents in respect of drugs that have received marketing authorization from the Minister of Health. Subsection 3(7) of the Patented Medicines (Notice of Compliance) Regulations states:

"No patent on a patent list or other information submitted under section 2 shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or the supplement to a new drug submission, as the case may be, to which the patent or information relates."

6. How can I print the results of my search?

There are three methods of printing the results of your search. The first requires using the print function built into your browser to print the page you are viewing. The second requires using the print icon on the top right corner of the page you are viewing. The third requires printing the actual Portable Document Format (PDF) of the Form IV for the record you are interested in by using the print function within the Adobe Acrobat file viewer.

7. Why do PDF files sometimes not display?

The scanning of Form IVs for conversion into the Portable Document Format (PDF) is an ongoing process. If you select the PDF version icon and receive an error message informing you that the page cannot be found, the Form IV for that record may not have been scanned. Please report any omissions to opml_bmbl@hc-sc.gc.ca.

8. Why are fields in a record sometimes empty?

The Form IV itself has changed over the years such that the information required on the older forms is not the same as that required on the current Form IV. Consequently, in the case of older Form IVs, it is common to have data missing in the web page display. To ensure that there has not been any error in retrieving the data from the database, please view the Form IV directly.

9. How up-to-date is the information retrieved?

The database from which the Patent Register search pages retrieve data is updated on a daily basis. The date of the last update is shown on the bottom of each page.

10. Is an actual hard copy of the Patent Register available for viewing?

The official paper version of the Patent Register is maintained at the offices of the Therapeutic Products Directorate at 101 Tunney's Pasture Driveway in Ottawa, Ontario. It is available for viewing from Monday to Friday during regular business hours.

11. Are removed patents searchable?

Yes, removed patents are searchable as of January 1, 2010. Inquiries relating to patents that were removed prior to this date can be sent to opml_bmbl@hc-sc.gc.ca. The patents which were removed and were available for viewing previously on the Patent Register are listed below.

1319682, 2319201, 2521958, 2521980, 1328262, 2355493, 2262268, 2324324, 2314571, 2290766, 2285733, 2277017, 2286753, 2254061, 2176974, 2277722, 1303996, 1324962, 1304080, 1309024, 1341206, 2199778, 2089748, 2176144, 2304657, 1305137, 1305139, 1305140, 1305141, 2224792, 2387361, 2387356, 2386527, 2471102, 1337549, 2165446, 2269053, 2041113, 2333024, 2230303, 2023217, 1321393, 2277914, 2142320, 2168364, 2135062, 2201264, 2325541, 1331860, 2018438, 2115170, 2180530, 2104793, 2125665, 2277890, 2019324, 2193384, 1338507, 2257431, 2310926, 2310950, 1340492, 2204180, 2133503, 1312548, 2222133, 2265712, 1323836, 2292629, 1335999, 2024789, 2165830, 2094726, 2099586, 2303685, 2094727, 2007764, 2011428, 2024181, 2024188, 2290974, 2469019, 2307101, 2223404, 1338895, 1338937, 2283671, 2061566, 2151890, 2212548, 2061703, 1318253, 1340649, 2224125, 1340588, 2037884, 2093203, 2063671, 2074215, 2072573, 1339198, 2249336, 2143208, 2210038, 2023089, 2158166, 2382549, 2382387, 2224284, 1333616, 2326198, 2245661, 2126305, 2199778, 1334166, 1339666, 2098196, 2166794, 1338377, 2170647, 2180535, 2186037, 2133762, 2166483, 1329130, 1335111, 2238978, 2224738, 2055670, 2178632, 2337846, 2285119, 2271196, 2135890, 2224438, 2334568, 1339047

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