Canada Gazette

The proposed amendments are intended to restore the balanced policy underlying the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") by reaffirming the rules for listing patents on the register and clarifying when listed patents must be addressed.

The Government's drug patent policy seeks to balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower priced generic competitors. The current manner in which that balance is realized was established in 1993, with the enactment of Bill C-91, the Patent Act Amendment Act, 1992, S.C. 1993, c. 2.

On the one end of the balance lies subsection 55.2(1) of the Patent Act, better known as the "early-working" exception. In the pharmaceutical industry, early-working allows second-entrant drug manufacturers (typically generic drug companies) to use a patented, innovative drug for the purpose of seeking approval to market a competing version of that drug. Normally, conduct of this kind would constitute patent infringement but an exception has been made so that generic drug companies can complete Health Canada's regulatory approval process while the equivalent innovative drug is still under patent, in order to be in a position to enter the market as soon as possible after patent expiry. The generic pharmaceutical industry estimates that early-working can accelerate the market entry of its products in Canada by some three to five years.

The PM(NOC) Regulations represent the other half of the balance. As explained in the original Regulatory Impact Analysis Statement (RIAS) which accompanied their passage in 1993, in creating the early-working exception, Bill C-91 removed an exclusive right otherwise available to patentees and the PM(NOC) Regulations are therefore required "to ensure that this new exception to patent infringement is not abused by generic drug applicants seeking to sell their products during the term of the competitor's patent . . . ." The PM(NOC) Regulations do this by linking Health Canada's ability to approve a generic drug to the patent status of the equivalent innovative product which the generic seeks to copy. Under the current scheme, a generic drug company which compares its product directly or indirectly with a patented, innovative drug in order to establish the former's safety and efficacy and secure marketing approval from Health Canada (which comes in the form of a "notice of compliance" or "NOC") must make one of two choices. The generic company can either agree to await patent expiry before obtaining its NOC or make an allegation justifying immediate market entry that is either accepted by the patentee or upheld by the court.

Thus, while early-working is intended to promote the timely market entry of generic drugs by allowing them to undergo the regulatory approval process in advance of patent expiry, the PM(NOC) Regulations are intended to provide effective patent enforcement by ensuring that the former does not result in the actual issuance of a generic NOC until patent expiry or such earlier time as the court or patentee considers justified having regard to the generic company's allegation. Despite their seemingly competing policy objectives, it is important that neither instrument be considered in isolation, as the intended policy can only be achieved when the two operate in a balanced fashion.

Considering the societal imperative of encouraging new and better medical therapies and the difficulties associated with protecting pharmaceutical patent rights by way of conventional infringement litigation, the PM(NOC) Regulations are intended to operate as a very potent patent enforcement mechanism. The 24-month stay under the Regulations serves that purpose by providing pharmaceutical patentees with the means to pre-empt the market entry of suspected generic infringers. At the same time, it is this very potency which calls for moderation in the application of the PM(NOC) Regulations, lest their effect dominate that of early-working and defeat the overall purpose of the policy. As has been observed by the courts on countless occasions, the PM(NOC) Regulations are a special enforcement remedy which exists in addition to, not in lieu of, the right to pursue an action for patent infringement.

Consistent with this understanding of the PM(NOC) Regulations is the fact that not every patent pertaining to an approved drug qualifies for enforcement under the scheme. Only those patents which meet the current timing, eligibility and relevance requirements set out in section 4 of the Regulations are entitled to be added to the register and to the concurrent protection of the 24-month stay. Embodied in each of these requirements are certain fundamental principles which must be respected if the PM(NOC) Regulations are to operate in balance with early-working. While the operation of some of these requirements is described in more detail below, a brief discussion of the principles they represent is warranted.

By stipulating that the application filing date of the patent precede the date of the corresponding drug submission, the timing requirement promotes a temporal connection between the invention sought to be protected and the product sought to be approved. This ensures that patents for inventions discovered after the existence of a product do not pre-empt generic competition on that product. Similarly, the relevance requirement limits the protection of the PM(NOC) Regulations to that in which the innovator has invested time and money to test and have approved for sale. This prevents hypothetical innovation from impeding generic market entry and encourages innovators to bring their latest inventions to market. Finally, in only allowing patents to be listed which contain claims for the medicine or its use, the eligibility requirement makes it clear that subject matter without direct therapeutic application, such as processes or intermediates, does not merit the special enforcement protection of the PM(NOC) Regulations.

Admittedly, there may be instances where a patent which does not qualify for the protection of the PM(NOC) Regulations is ultimately infringed by the fact of generic market entry. However, the Government's view is that where the patent fails to meet the listing requirements described above, policy considerations tip the balance in favour of immediate approval of the generic drug, and the matter is better left to the alternative judicial recourse of an infringement action. It follows that the continued viability of the drug patent regime greatly depends upon the fair and proper application of these listing requirements.

It has come to the Government's attention that a number of recent court decisions interpreting the PM(NOC) Regulations have given rise to the need to clarify the patent listing requirements. These decisions, which relate to timing and relevance issues, are not a function of judicial error but rather of deficiency in the language of the PM(NOC) Regulations themselves. Of particular concern is the failure of the language to fully account for the range of submission types possible under the Food and Drug Regulations, the differing pharmaceutical patent claims available under the Patent Act and, most importantly, the breadth of scenarios which can arise from the linkage between the two established by the PM(NOC) Regulations.

As mentioned, in order for a listed patent to be added to the register and be protected under the PM(NOC) Regulations, its application must have been filed prior to the date of the corresponding drug submission. Under the Food and Drug Regulations, there are two principal types of drug submission an innovator company may file in order to obtain a NOC in respect of a new drug: a New Drug Submission (NDS) and a Supplement to a New Drug Submission (SNDS). A NDS is filed when approval is first sought for a new drug and contains all of the information necessary to prove that the drug is safe and effective. An SNDS is filed whenever a subsequent change is made to the drug which departs from the information in the NDS in a way that can impact on safety and efficacy.

The PM(NOC) Regulations speak only to the requirement that the patent filing date precede the date of the "submission for a notice of compliance" and do not specify whether this applies to the date of the NDS, the SNDS or both. Until relatively recently, however, the timing requirement was treated as applying to the NDS only. This officially changed in 1999, when the Federal Court ruled that patents which were out of time in relation to the NDS could nevertheless be added to the register, provided they met the timing requirement in relation to a subsequently filed SNDS.

Allowing patents to be listed in this manner is inherently problematic because an SNDS can be filed virtually any time for any number of reasons, ranging from the mundane, such as a change in drug name, to the substantive, such as a change in its indications or formulation. Accordingly, taken to the extreme, this practice has the potential to deprive the timing requirements of any meaningful effect.

In addition to ruling on this timing question, the same Federal Court decision also expressly sanctioned the listing of new formulation patents (i.e. patents claiming the medicinal and non-medicinal ingredients which together make up the dosage form) even where the formulation claimed was not the one the innovator company was approved to sell. The latter finding was predicated on the Court's view that the sole purpose of the PM(NOC) Regulations is the prevention of patent infringement.

Significantly, the ruling in question interpreted the PM(NOC) Regulations as they were prior to their substantial amendment in 1998. That year, the Government introduced a number of changes to the PM(NOC) Regulations designed to improve their operation and reduce and streamline litigation. As further confirmation that the PM(NOC) Regulations were intended to effect a balanced policy objective, the RIAS to the 1998 amendments reiterated the point in the following passage:

The amendments reinforce the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drugs enter the market as soon as possible.

Consistent with maintaining this balance, certain changes will further facilitate the market entry of generic drugs . . .

Among the changes introduced by the 1998 amendments to "facilitate the market entry of generic drugs" were provisions designed to reinforce the patent listing requirements. In particular, the amended PM(NOC) Regulations reaffirm the application of strict time limitations for listing a patent on the register and contain an additional requirement that patents be relevant to the strength, dosage form and route of administration of the approved drug.

Since 1998, the Minister of Health has sought to apply the amendments on timing and relevance in order to place reasonable limits on the ability of innovator drug companies to list new patents on the basis of SNDS filings. The Minister has invoked the timing amendment in opposing attempts by certain innovator companies to add new patents to the register on the basis of an SNDS for a change in drug or company name. Similarly, the Minister has applied the relevance requirement in an effort to prevent innovator companies from adding formulation patents to the register which are not product-specific. The Minister also sought more general guidance on these questions through the filing of a reference with the Federal Court, but the matter was dismissed on procedural grounds following vigorous resistance from parties opposed to its terms.

Against the above background, in January 2003, the Federal Court of Appeal rendered a precedent-setting decision based on the amended PM(NOC) Regulations which reaffirmed the right of innovator companies to list formulation patents that do not claim the formulation approved for sale. The Court came to this view on the basis of what it felt to be the plain wording of the relevance provision and notwithstanding the explanatory language on product specificity in the 1998 RIAS. In so doing, the Court appears to have reinvigorated the single-purpose approach to interpreting patent listing requirements, as epitomized by the 1999 decision on SNDS filings discussed above. It has also accentuated a split in the jurisprudence as to the policy underlying the PM(NOC) Regulations.

The Government is concerned that the combined effect of the above-described jurisprudence is a weakening of the listing requirements, potentially to the point of redundancy. Such was the reasoning of the Federal Court of Appeal in a recent case involving a patent list submitted on the basis of an SNDS for a change in drug name. In refusing to allow a patent to be listed in this manner, the Court recognized that the change in name in that case was part of a strategy designed to overcome the time limitation for filing a patent list under section 4, which, if sanctioned, would render the time requirements embodied in that section meaningless.

Although a change in drug or company name now appears to have been definitively ruled out as an opportunity to add new patents to the register, the ambit of remaining changes in respect of which an SNDS can be filed is considerable, and the possible combinations of submission type and patent claims all the more so. Requiring the courts to rule on each of these piecemeal without adequate direction in the language of the PM(NOC) Regulations can only result in confusion, uncertainty and further unintended consequences.

To date, these unintended consequences include the possibility that an innovator company may delay generic market entry by listing new and sometimes irrelevant patents on the basis of minor product revisions. The result is a blurring of the lines between the original product, as approved via the NDS, and the "changed" version, as approved via the SNDS, such that generic companies may be prevented from entering the market with a competing version of the original innovator product even when the original patents have long since expired or been addressed.

Already, the Government has observed instances of SNDS filings being used to list multiple new patents over time in a manner that results in repeat 24-month stays against the same generic competitor. While the possibility of repeat stays due to later-listed patents is expressly contemplated under the PM(NOC) Regulations, their recurrence near and after expiry of the original product patents can only operate to delay generic competition in a manner that is inconsistent with the balanced policy objectives early-working and the PM(NOC) Regulations were intended to serve.

Although, as matters stand, theses instances are exceptional, they do involve drugs of significant commercial value. They also have the potential to serve as a model other innovator companies may be tempted to emulate. In this regard, the Minister of Health has reported a significant increase in new patents being listed on the basis of SNDS filings recently. In many of these cases, the SNDS does not materially change the original drug or is not directly relevant to the patent being submitted for listing.

The purpose of these amendments is to preempt further such behaviour by restoring the original policy intent underlying the PM(NOC) Regulations. This entails reaffirming the requirements which innovators must meet to list patents on the register and clarifying when these patents must be addressed by their generic competitors.

Under the proposed amendments, a patent list must be directly relevant to the content of the submission for an NOC in relation to which it is submitted and only certain clearly defined submission types provide an occasion to submit a new patent list.

The amendments thus stipulate that only patents with application filing dates which precede the date of the NDS and are directly relevant to its content can be listed on the register in relation to the original form of the drug. This will facilitate the market entry of generic versions of the original innovator product as soon as possible after expiry of the original patents. In this context, the amendments do not otherwise change the content requirements for eligibility, as patents submitted in relation to a NDS must continue to contain either a "claim for the medicine itself" or the "use of the medicine." However, greater specificity has been brought to the meaning of the former term to reflect well-settled law that a "claim to the medicine itself" under the PM(NOC) Regulations can be interpreted as constituting either a claim for the medicinal ingredient alone or a claim to a formulation consisting of that medicinal ingredient in combination with non-medicinal ingredients.

The amendments also formally confirm the right to list new patents on the basis of SNDS filings and introduce listing requirements governing that right. Under these requirements, patents which precede the date of an SNDS filed for a change in formulation or indication will be eligible for listing on the register, provided they claim the change in question. This will protect and encourage legitimate and substantive incremental innovation of direct therapeutic application. It should be stressed, however, that new patents claiming only the medicinal ingredient (e.g. in a particular polymorphic form) will not be eligible for listing by way of an SNDS, as this is subject matter which, by definition, must be approved at the time of filing the NDS.

Consistent with existing practice, the amendments also contain a provision expressly allowing innovators to carry forward patent lists submitted in relation to a NDS by resubmitting them in relation to a supplement to that NDS.

Also with a view to dispelling any confusion surrounding patent listing issues, the amendments eliminate the unnecessary and somewhat ambiguous distinction in the current section 4 between an "existing" patent list and an "amendment" to such a list. Under the amended PM(NOC) Regulations, each time an innovator submits new patents to the Minister these shall be considered as comprising a unique and stand-alone patent list. This will be the case regardless of which of subsections 4(5) or 4(6) is relied upon in submitting the list and notwithstanding the presence of any preexisting patents on the register for the same form of the drug described in the submission to which the list relates.

As an additional safeguard against the possibility that ineligible patents might impede generic market entry, the amendments also confirm the right of generic companies to justify an allegation on the basis that an innovator has falsely certified a patent's eligibility for inclusion on the register.

To ensure that new patents submitted in relation to an SNDS for a change in formulation or indication do not impede the market entry of generic drugs which do not rely on the change in question, a related amendment is proposed which would dispense with the requirement that a generic company amend its submission to address a newly listed patent if the patent was submitted on the basis of an SNDS which postdates the filing of the generic drug submission. This will significantly reduce the incidence of repeat proceedings attributable to later listed patents.

Similarly, on the matter of use patents added by way of an SNDS for a change in indication, a further amendment is proposed which confirms that a generic company not seeking approval for that new indication may justify an allegation on that ground. This is consistent with a recent Federal Court of Appeal decision on this question which recognized the policy implications if the mere sale by a generic company of a medicine subject to a new use patent were sufficient to attract the special enforcement protection of the PM(NOC) Regulations:

This would result in a real injustice: since a generic company cannot possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holders would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result, would obtain a benefit they were not meant to have.

Again, the Government acknowledges that there may be instances where approval of the generic drug in these circumstances may ultimately result in infringement. However, given that the alternative is a complete bar to generic competition for the lifetime of the new use patent, it is felt that the balance weighs in favour of immediate generic entry and resolution of the issue through an ordinary infringement action.

To ensure that the intent of the above-described changes is not thwarted, the amendments also include an anti-avoidance provision. This provision is targeted at innovators who would seek to forestall generic market entry by withdrawing the original form of the product from the market in order to deprive generic competitors of an immediate Canadian Reference Product. In such an event, the amendment would result in the loss of protection under the PM(NOC) Regulations of any patents on the register relating to the product in question.

Finally, as a separate and unrelated measure, the amendments also propose to repeal subsection 5(1.1) of the PM(NOC) Regulations. This provision was introduced in 1999, when it became apparent that a generic company could avoid compliance with the PM(NOC) Regulations by making an indirect comparison to an innovator's drug with patents on the register. In the Government's view, subsection 5(1.1) was rendered redundant soon after its passage when the Federal Court of Appeal ruled that the pre-existing triggering provision, subsection 5(1), was sufficiently broad to capture avoidance strategies founded on indirect reliance.

Repeal of subsection 5(1.1) will also clarify that the PM(NOC) Regulations are not intended to apply to second-entry drug submissions where the sponsor of the submission is required by the Minister of Health to conduct independent clinical studies to establish the safety and efficacy of its product. Consequential amendments are also being proposed to subsection 5(1) to further confirm that this provision is in fact triggered by a second entrant's indirect comparison to the innovator's drug.

In determining how best to restore the policy intent of the PM(NOC) Regulations to address the recent judicial relaxation of the patent listing requirements, two alternative options were considered.

The first such option was inspired by recent developments in the United States involving the Hatch-Waxman Act, which provides for a linkage regime similar to the PM(NOC) Regulations.

In July 2002, the Federal Trade Commission (FTC) released a report which confirmed that innovators were wrongfully listing patents in an attempt to unlawfully extend patent protection through repeated 30-month stays. Acting on the recommendations in that report, in August 2003, the Food and Drug Administration (FDA) amended its rules to tighten the requirements for listing patents and to limit innovators to one stay per generic drug application. While the tighter listing requirements bring the U.S. system closer into line with Canada's, the one-stay per drug solution remains unique to the United States.

The Government did consider the adoption of an amendment allowing only one stay per generic drug submission but concluded that it was not feasible in the Canadian context. This conclusion is due primarily to the fact that, in contrast to the United States, where generic companies are limited to one allegation per drug submission, in Canada the courts allow generic companies to serve multiple, successive allegations in respect of the same patents. Thus, if the U.S. proposal were copied in Canada without copying other major aspects of that regime, innovators would have no defence against these successive allegations.

The other alternative considered was to eliminate altogether the ability of innovator companies to list new patents on the basis of SNDS filings. While this approach was thought to have advantages in terms of its simplicity, it was abandoned as inconsistent with the Government's stated policy of encouraging ongoing innovation in existing drugs.

Maintaining the status quo was not considered as an alternative, given the existing imbalance in the PM(NOC) Regulations, as explained above.

By clarifying the rules governing when and how innovators can list patents on the register and when they must be addressed by generic competitors, the proposed amendments are expected to ease Health Canada's administrative burden and reduce stakeholders' compliance costs.

Although the introduction of new language into the scheme typically results in an initial increase in litigation, the amendments should significantly decrease the amount of overall litigation under the PM(NOC) Regulations over the long term.

Reinforcing the listing requirements is also expected to have a marked reduction on the incidence of multiple stays due to patent listing behaviour and should therefore accelerate the market entry of lower-priced generic drugs. This will result in considerable savings to the health care system.

Although these changes should not impact significantly on the market exclusivity of innovators currently abiding by the spirit of the balanced scheme, the Government is also making concurrent amendments to Health Canada's Food and Drug Regulations to bolster Canada's data protection provisions. This will ensure that innovators who might otherwise be discouraged from bringing their drugs to the Canadian market due to a perceived reduction in exclusivity available under the PM(NOC) Regulations as a result of these changes can remain secure in the knowledge that they will enjoy a minimum period of exclusivity in Canada that is internationally competitive.

Lastly, in order to minimize any market disruption and investment uncertainty resulting from the proposed changes, the amendments also include a grandfathering provision which provides that patents on the register as of the date of the amendments' coming into force remain subject to the listing requirements as they were interpreted and applied prior to that date.

In recent years, representatives of the generic sector have been increasingly vocal in their allegations that innovator companies are abusing the PM(NOC) Regulations to unfairly delay generic competition. In investigating these allegations, the Government was mindful of the fact that the 1998 amendments have given rise to a substantially changed regulatory regime and that a meaningful number of cases had to accumulate post 1998 before any accurate or reliable observations could be drawn in respect of litigation trends under that regime. The Government's inquiry thus focussed on litigation in the four-year period following the coming into force of the amendments in March of 1998.

Toward the end of that period, government officials organized a series of meetings with representatives from both sectors of the pharmaceutical industry to better ascertain their views on the specifics of post amendment litigation. In conceiving the proposed amendments, the Government also took into account the testimony of stakeholders during the Standing Committee on Industry, Science and Technology's review of the PM(NOC) Regulations held in June of 2003. In particular, these amendments, and the concurrent amendments to the data protection provisions of the Food and Drug Regulations, are intended to deliver the greater stability, predictability and certainty which both sectors of the industry appeared to agree is needed.

Publication in the Canada Gazette, Part I, will be followed by a 75-day consultation period, during which time stakeholders may provide their views on the proposed amendments to the PM(NOC) Regulations.

The courts and the Minister of Health will continue to exercise jurisdiction over issues related to the administration of the PM(NOC) Regulations.

Susan Bincoletto, Acting Director General, Marketplace Framework Policy Branch, Industry Canada, 10th Floor, East Tower, 235 Queen Street, Ottawa, Ontario K1A 0H5, (613) 952-0736 (telephone), (613) 941-8151 (facsimile), bincoletto.susan@ic.gc.ca (electronic mail).

Notice is hereby given that the Governor in Council, pursuant to subsection 55.2(4) (see footnote a) of the Patent Act, proposes to make the annexed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Susan Bincoletto, Acting Director General, Marketplace Framework Policy Branch, Industry Canada, 10th Floor, East Tower, 235 Queen Street, Ottawa, Ontario K1A 0H5 (tel.: (613) 952-0736; fax: (613) 948-6393); e-mail: bincoletto.susan@ ic.gc.ca.

REGULATIONS AMENDING THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS

1. The definitions "Minister", "patent list", "register" and "second person" in section 2 of the Patented Medicines (Notice of Compliance) Regulations (see footnote 1) are replaced by the following:

"patent list" means a list submitted under subsection 4(1); (liste de brevets)

"register" means the register of patents maintained by the Minister under section 3; (registre)

"second person" means the person referred to in subsection 5(1) who files, or has filed, a submission referred to in that subsection. (seconde personne)

2. The heading before section 3 and sections 3 to 5 of the Regulations are replaced by the following:

"new drug submission" means a new drug submission as that term is used in Division 8 of Part C of the Food and Drug Regulations, but excludes a new drug submission that is based solely on the change of name of the manufacturer. (présentation de drogue nouvelle)

"supplement to a new drug submission" means a supplement to a new drug submission as that term is used in Division 8 of Part C of the Food and Drug Regulations, but excludes a supplement to a new drug submission that is based solely on any of the matters mentioned in paragraphs C.08.003(2)(b), (d) to (g) and (i) and subparagraphs C.08.003(2)(h)(iv) and (v) of those Regulations. (supplément à une présentation de drogue nouvelle)

(2) The Minister shall maintain a register of patents and other information submitted under section 4. To maintain the register, the Minister may refuse to add or may delete any patent or other information that does not meet the requirements of that section.

(4) No patent on a patent list or other information that is submitted under section 4 shall be added to the register until after the Minister has issued a notice of compliance in respect of the new drug submission or supplement to a new drug submission, as the case may be, to which the patent list or information relates.

(5) For the purpose of deciding whether a patent on a patent list that is submitted under section 4 will be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office.

4. (1) A first person who files or who has filed a new drug submission or a supplement to a new drug submission may submit a patent list in relation to that submission or supplement to the Minister for addition to the register.

(2) A patent on a patent list submitted under subsection (1) in relation to a new drug submission is eligible to be added to the register if the patent contains

(i) if that claim is for a medicinal ingredient, that ingredient has been approved through the issuance of a notice of compliance in respect of that submission, or

(ii) if that claim is for a formulation that consists of medicinal and non-medicinal ingredients, that formulation has been approved through the issuance of a notice of compliance in respect of that submission; or

(b) a claim for the use of the medicine and that use has been approved through the issuance of a notice of compliance in respect of that submission.

(3) A patent on a patent list submitted under subsection (1) in relation to a supplement to a new drug submission is eligible to be added to the register if that supplement is for a change in formulation or use and

(a) in the case of a change in formulation, the patent contains a claim for a formulation that consists of medicinal and non-medicinal ingredients and that formulation has been approved through the issuance of a notice of compliance in respect of that supplement; or

(b) in the case of a change in use, the patent contains a claim for the use of the medicine and that use has been approved through the issuance of a notice of compliance in respect of that supplement.

(a) an identification of the new drug submission or the supplement to a new drug submission to which the list relates;

(b) the brand name, dosage form, strength, route of administration and use set out in the new drug submission or the supplement to a new drug submission to which the list relates;

(c) for each patent on the list, the patent number, the filing date of the patent application in Canada, the date of grant and the date on which the term limited for the duration of the patent will expire under section 44 or 45 of the Patent Act;

(d) for each patent on the list, a statement that the first person who filed the new drug submission or the supplement to a new drug submission to which the list relates is the owner of the patent or has an exclusive licence to the patent, or has obtained the consent of the owner of the patent to its inclusion on the list;

(e) the address in Canada for service, on the first person, of a notice of an allegation referred to in paragraph 5(5)(b) or (c) or the name and address in Canada of another person on whom service may be made with the same effect as if service were made on the first person; and

(f) a certification by the first person that the information submitted under this subsection is accurate and that each patent on the list meets the eligibility requirements of subsection (2) or subsection (3), as the case may be.

(5) Subject to subsection (6), a first person who submits a patent list must do so at the time the person files the new drug submission or the supplement to a new drug submission to which the patent list relates.

(6) A first person may, after the date of filing of a new drug submission or supplement to a new drug submission, and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date in Canada that precedes the date of filing of that submission or supplement, submit a patent list — including the information referred to in subsection (4) — in relation to that submission or supplement.

(7) A first person who has submitted a patent list must keep the information on that patent list up to date but, in so doing, may not add a patent to that patent list.

(8) The Minister shall insert on the patent list the filing date and submission number of the new drug submission or supplement to a new drug submission in relation to which the list was submitted.

4.1 (1) In this section, "supplement to a new drug submission" means a supplement to a new drug submission as that term is used in Division 8 of Part C of the Food and Drug Regulations.

(2) A first person who submits a patent list in relation to a new drug submission as referred to in subsection 4(2) may, if that list is added to the register, resubmit that same list in relation to a supplement to that new drug submission but may not submit a new patent list in relation to a supplement except in accordance with subsection 4(3).

5. (1) If a second person files, or has filed, a submission for a notice of compliance for a drug and its submission directly or indirectly compares the drug to another drug and if that comparison forms the basis on which the issuance of a notice of compliance is sought, the second person shall, in respect of each patent on the register for that other drug,

(a) state that the second person accepts that the notice of compliance will not issue until the patent expires; or

(i) the certification as to eligibility requirements made by the first person under paragraph 4(4)(f) is false,

(ii) the patent has expired,

(iii) the patent is not valid,

(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by the second person of the drug to which its submission relates, or

(v) in the case of a patent that was added to the register on the basis of eligibility under paragraph 4(3)(b), its submission does not seek approval for the use of the medicine that is claimed in that patent.

(2) Subsection (1) does not apply if the assignment of the drug identification number for that other drug referred to in that subsection has been cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations.

(3) If, before a notice of compliance is issued in respect of a submission filed by a second person, another patent is added to the register for the other drug referred to in subsection (1), the second person shall amend its submission to include, in respect of that patent, the statement or allegation required under subsection (1).

(4) Despite subsection (3), a second person is not required to amend its submission if

(a) the patent referred to in that subsection is added to the register in relation to a supplement to a new drug submission as set out in subsection 4(3); and

(b) the filing date of its submission precedes the filing date of the supplement referred to in paragraph (a).

(5) If a second person makes an allegation under paragraph (1)(b) or subsection (3), it shall

(a) provide a detailed statement of the legal and factual basis for the allegation;

(b) if the allegation is made under any of subparagraphs (1)(b)(i) to (iii), serve a notice of the allegation on the first person;

(c) if the allegation is made under subparagraph (1)(b)(iv) or (v), serve on the first person, on or after the filing by the second person of its submission under subsection (1) and in respect of that submission, a notice of allegation that includes a description of the dosage form, strength and route of administration of the drug in respect of which that submission has been filed; and

6. (1) A first person may, within 45 days after being served with a notice of an allegation pursuant to paragraph 5(5)(b) or (c), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the allegation.

(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register; or

(6) For the purposes of an application referred to in subsection (1), where a second person has made an allegation under subparagraph 5(1)(b)(iv) in respect of a patent and where that patent was granted for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.

(d) subject to subsection (3), the expiration of 45 days after the receipt of proof of service of a notice of any allegation pursuant to paragraph 5(5)(b) or (c) in respect of any patent on the register,

5. (1) In this section, "prior regulations" means the Patented Medicines (Notice of Compliance) Regulations as they read immediately before the coming into force of these Regulations.

(2) Any matter that arises on or after the day on which these Regulations come into force in respect of a patent that is on the register on that day shall be dealt with and disposed of in accordance with the prior regulations, except that

(b) subsection 5(2) of the prior regulations, excluding the reference in that subsection to subsection 5(1.1), applies; and

(c) subsection 5(2) of the Patented Medicines (Notice of Compliance) Regulations, as enacted by section 2 of these Regulations, applies.

6. These Regulations come into force on the day on which they are registered.