Acquisition of DIN(s) from a former patentee (Transcript)
Hello, my name is Kirk Stanley and I am a Senior Regulatory Officer at the Patented Medicines Prices Review Board. Today I will be speaking to you about the acquisition of a or multiple DINS from a former patentee.
Section C.12.8 of the Guidelines states: ‘Where an existing drug product is sold in Canada by persons other than the initial patentee as a result of a merger or acquisition agreement, the PMPRB’s Guidelines will apply to the DINs sold by these persons as if they were the DINs of the initial patentee. For example, if as part of a merger or acquisition, a patentee ceases to sell a patented drug product and the marketing rights to the product are transferred to another patentee, the DIN sold by the new patentee will be considered as a continuation of the original DIN for purposes of the application of the Guidelines and the CPI-Adjustment Methodology.’
If, as part of a merger and acquisition agreement, a patentee ceases to sell a patented drug product and transfers the marketing rights to the product to another patentee, the DIN sold by the new patentee will, for purposes of the application of the Guidelines—including the DIP and CPI-Adjustment Methodology—be considered a continuation of the original DIN
Now I will take a moment to clarify the January 2015 Newsletter. Board Staff will interpret "acquisition" as including individual DIN transfers outside of the specific case of mergers between companies, or acquisitions of entire companies, as long as this interpretation is in compliance with Section 87 of the Patent Act and Section A.9.1 of the Guidelines. That is, the subsequent patentee must provide the PMPRB with proof of authorization as part of the DIN transfer so the PMPRB can disclose privileged information or documents provided by the former patentee.
Proof of Authorization: Board Staff will require an email or letter from an authorized individual of the former patentee certifying that all previously filed data may be carried over to the new patentee.
Following submission of proof of authorization, the new patentee must file an amended Form 1 for each acquired drug product. The Form 1 template available from PMPRB website must be used to file the amended Form 1. The amended Form 1 is to be sent the PMPRB’s Compliance account. The address is email@example.com
The following slide is a checklist for a successful completion of an amended Form 1 by a new patentee. Firstly, check off amendment at the top of the Form. Next, the information on Blocks 1 and 3 to 7 are the same as the former patentee. Block 8 will contain information of the new patentee. Please note that Blocks 1, 4, 6 and 7 may include new information where there are additions or updates.
Next I will walk through the step-by-step instructions of completing an amended Form 1 by the new patentee. Firstly, the new patentee must select "Amendment to Original Filing" and identify the Block(s) being amended.
Block 1 should be the same as the former patentee. This includes the name and uses of the medicine such as Brand name, Generic name, Therapeutic use of the medicine approved by Health Canada and a check box to whether the product is Human prescription, Human Over the counter or Veterinary.
Block 2 is where the new patentee will update the patentee information. This contains the Patentee name, address and the identity if the patentee is the patent holder or a person entitled to the benefits of a patent or to exercise any rights in relation to a patent.
Block 3 and Block 4 should be the same as the former patentee. Block 3 information contains the date of the Notice of Compliance, if the product was offered under the Special Access Program or Clinical Trial Application or Investigational new drug. Block 4 is the DIN, dosage form and strength per unit.
Block 5 (which is the date of first sale) and Block 6 should be the same as the former patentee. It is not necessary to provide a product monograph if one was submitted by former patentee.
Block 7 contains information regarding patents and should be the same as the former patentee. Any additional patents may be added by new patentee.
Finally, Block 8 is where the new patentee provides updated information such as name, title, organization, date, telephone number, fax number and email address.
With respect to questions on Form 1 of a former patentee, a new patentee should consult its Senior Regulatory Officer when in doubt about the information filed in the Form 1 by a former patentee. If a new patentee is unsure of the name of its Senior Regulatory Officer, an email should be sent to the Compliance Account. This address is firstname.lastname@example.org.