Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions

Chelsea NimmoChristopher A. GuerreiroJudith RobinsonBy Chelsea Nimmo, Christopher A. Guerreiro and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences

The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the common hearing of issues reduces the likelihood that Taro will benefit from any “first to market” advantage.

Background

Taro and Apotex are both seeking to market a generic version of Biogen’s FAMPYRA (fampidrine) product in Canada.  Both generics served Notices of Allegations (NOAs) alleging that each of their products will not infringe Canadian Patent 2,562,277 (the 277 Patent) and that the 277 Patent is invalid. In response, Biogen commenced section 6 actions against both generics; first, the Taro action on June 15, 2018 (T-1163-18), and subsequently, the Apotex action on July 24, 2018 (T-1416-18).

The Court first set the Taro action down for trial to begin on March 2, 2020. When scheduling the Apotex action, Biogen and Apotex advised that they could also be ready for a trial on March 2, 2020. With Biogen’s consent, Apotex intended to amend its pleadings to include Taro’s invalidity allegations and the two parties therefore proposed that the issues of validity raised in both actions be heard concurrently. Despite Biogen’s offer to permit matching amendments to its pleadings, Taro opposed the idea of a concurrent hearing.

Concurrent trial does not deprive the “first” generic of any commercial advantage

Taro argued that a concurrent trial would result in simultaneous judgments, depriving Taro of any commercial advantage of being first to market with a generic fampidrine product. The Case Management Judge disagreed, explaining that a concurrent trial may or may not result in Apotex having its judgment at the same time as Taro. In any event, the Court noted that “[b]eing the first to send out a [NOA] in respect of a particular medicine does not entitle a generic to be the first to obtain a judgment in an action pursuant to the Regulations, or guarantee it that result.”

Efficient use of judicial resources dictates a concurrent trial

The Court held that a concurrent trial on common validity issues is the most efficient use of the Court and the parties’ time and resources. This was based on a number of common elements across both actions: same judge; similar invalidity issues; same counsel for Biogen in both actions; and the same inventors.

In conclusion, the Court stated that a concurrent trial would “achieve the just, most efficient and least expensive determination of the issues in both actions, and would not likely result in prejudice to Taro’s substantive or procedural rights, including any rights it may have pursuant to the Regulations.” The Court ordered accordingly, holding that the Apotex trial would be adjourned following the conclusion of the case on invalidity in order to permit argument on infringement in the Taro case. The Apotex case would then resume on issues of infringement at a later date.

ONCA Permits Pleading Amendments Asserting Validity of Previously Invalidated Patent following Nexium Decision

Kassandra ShorttDavid YiAllyson Whyte NowakBy Kassandra Shortt, David Yi and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences

This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug.

Apotex’s claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 Patent had previously been invalidated  based on the application of the “promise doctrine”. In June 2017, the Supreme Court of Canada (SCC) held that the invocation of the “promise doctrine” was an error in law and abolished the doctrine once and for all in AstraZeneca Canada Inc. v. Apotex Inc. (Nexium). This decision of the ONCA reverses a lower court decision denying Sanofi’s pleadings amendments, which asserted that the underlying decision invalidating the 206 Patent was based on wrong legal principles, and relied on the Nexium decision.

This is a significant development in this case which also highlights a growing tension between decisions of the Federal Court and the Ontario Superior Court in a novel legal proceeding.

Background

In this action Apotex claims damages pursuant to three statutes: An Act concerning Monopolies, and Dispensation with penal laws, etc., R.S.O. 1897, c. 323 (Ontario Statute of Monopolies); An Act concerning Monopolies and Dispensations with Penal Laws, and the Forfeitures thereof, 1624, 21 Jac. I, c. 3 (UK Statute of Monopolies, and collectively with the Ontario Statute of Monopolies, the Monopolies Acts); and the Trade-marks Act, R.S.C., 1985, c. T-13.  While the Patented Medicines (Notice of Compliance) Regulations (the Regulations) provide a specific remedy for delayed generic market entry pursuant to section 8, and despite Apotex having already received $215 million in section 8 compensation, Apotex commenced this novel action in the Ontario Superior Court claiming additional sums under the Monopolies Act and Trade-Marks Act.

Following the SCC’s rejection of the promise doctrine in Nexium, Schering and Sanofi-Aventis et al. (Defendants) sought to amend their pleadings, which Apotex opposed on the basis of issue estoppel. The motions judge denied the Defendants’ amendments, as we previously reported.

The amendments assert the validity of the 206 Patent, which was previously held to lack utility in both PM(NOC) proceedings and in a subsequent infringement action. Both cases predated the abolition of the promise doctrine by the SCC in the Nexium decision, reported here. The ONCA found that the SCC’s rejection of the promise doctrine in Nexium constituted “special circumstances” that exempted the application of the doctrine of issue estoppel and distinguished a decision by the Federal Court of Appeal (FCA) on a similar point in Eli Lilly Canada Inc. v. Teva Canada Ltd., 2018 FCA 53 (FCA Olanzapine), previously reported.

Decision on Appeal

The ONCA allowed the Defendants to amend their pleadings, finding that the preconditions for issue estoppel had been met, but exercised its discretion not to apply the doctrine. It found that the SCC’s decision in Nexium constituted a change in the law and that denying the amendments would work an injustice in the circumstances of the case. Apotex’s own claims for relief put the validity of the 206 Patent in issue — it is an essential element of Apotex’s claims. Additionally, the quantum of damages claimed is approximately $1 billion to $3 billion. The ONCA accepted that allowing the amendments would lead to re-litigating the 206 Patent’s validity, but noted that the costs of any re-litigation of patent validity paled in comparison with the quantum of damages claimed by Apotex. Accordingly, it would be fundamentally unfair to deprive the Defendants of the opportunity to defend the validity of the 206 Patent in these circumstances.

Distinguishing FCA Olanzapine

In its analysis, the ONCA also distinguished the FCA Olanzapine decision. In FCA Olanzapine, the impact of Nexium on the validity of a patent was raised on appeal in a section 8 action. The FCA found that the validity of the patent had been previously determined and that Nexium did not warrant the application of the “special circumstances” exception to issue estoppel in the circumstances of that case.

The ONCA observed that the exercise of discretion in the application of issue estoppel permits different courts to exercise their discretion differently. Nevertheless, it distinguished FCA Olanzapine on the bases that it:

  • Concerned a section 8 damages award, not claims for damages pursuant to the Monopolies Acts and the Trade-marks Act; and
  • Was an appeal of a trial decision rather than a decision on a motion for leave to amend pleadings.

The ONCA also expressly disagreed with the FCA on certain issues. First, the ONCA rejected the distinction drawn by the FCA between litigation involving commercial interests and other types of litigation and the FCA’s suggestion that issue estoppel is more applicable in commercial litigation. Second, the ONCA disagreed that permitting a change in the law to constitute a “special circumstance” weakened the objective of finality and held instead that the change in the law presented by Nexium was “precisely the type of special circumstance” that warranted the principle of finality yielding to the circumstances of the case.

Link: Apotex Inc. v. Schering Corporation, 2018 ONCA 890; rev’g 2018 ONSC 903

Ontario Superior Court rejects Apotex attempts to revive the Promise Doctrine by dismissing motion for leave to amend, awards substantial indemnity costs

Morgan WestgateDavid YiKristin WallBy Morgan Westgate, David Yi and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences

The Ontario Superior Court of Justice (ONSC) recently denied Apotex’s attempt to repackage the now defunct “promise of the patent” doctrine (the Promise Doctrine).  Apotex sought to amend its pleadings to reintroduce the Promise Doctrine under the guise of invalidity allegations of over-breadth, insufficiency, and willful misrepresentation pursuant to sections 27 and 53 of the Patent Act.

The motion was heard in the broader context of the quantum phase of an action for damages by Apotex pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Abbott and Takeda counterclaimed for infringement of two patents relating to lansoprazole (Lansoprazole Patents), which Apotex alleged were invalid. In dismissing Apotex’s motion, the ONSC awarded substantial indemnity costs against Apotex for its unfounded allegations of fraud.

This adds to the body of law that has resisted attempts to revive the Promise Doctrine following the Supreme Court of Canada’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (AstraZeneca).

Background

This dispute, which has been ongoing for the past eight years, has a complex procedural history that includes the hearing of two summary judgment motions, in addition to raising various other interlocutory matters. In 2013, Abbott and Takeda were successful in seeking an order for partial summary judgment against Apotex denying it the right to a disgorgement of profits for the period after the parties agreed to settle the litigation with respect to liability. The motion was brought on the basis that the parties had initially agreed on a settlement of future damages, even though that agreement had since dissolved.

Four years later, Abbott and Takeda brought another summary judgment motion seeking dismissal of the damages action in its entirety on the basis that Apotex’s generic lansoprazole product would not have been approved at the relevant time because it did not comply with applicable health regulatory laws. This motion was dismissed; the Court granted summary judgment to Apotex for damages under section 8 of the Regulations, and ordered that the action be set down for trial. We have previously reported on the results of this most recent summary judgment decision here and here.

In 2018, following the release of AstraZeneca, Apotex brought a motion seeking leave to amend its pleadings prior to the damages trial. If granted, the proposed amendments would have allowed Apotex to include in its defence new allegations of over-breadth, insufficiency, and willful misrepresentation pursuant to sections 27 and 53 of the Patent Act in respect of the Lansoprazole Patents.

Another Attempt to Revive the Promise Doctrine

Since the Supreme Court put an end to the Promise Doctrine last year, a number of proceedings have made their way through the Federal Court on the issue of whether promise-based claims can still support an allegation of patent invalidity. We have previously reported on some of this post-AstraZeneca case law, which can be found here.

The ONSC noted that there had been five judgments in the post-AstraZeneca jurisprudence where, in every case, the Federal Court specifically rejected the efforts of generic drug manufacturers (including Apotex) to advance these types of “Promise Doctrine allegations” cloaked as grounds of insufficiency, overbreadth, and willful misrepresentation. The ONSC also emphasized Apotex’s admission that that there had been no changes to the facts underlying its allegations.

The Supreme Court did not Intend Promised-based Claims of Patent Invalidity to Survive AstraZeneca

The ONSC found that it is “counterintuitive” that the Supreme Court would intend for promise-based arguments to survive the banishing of the doctrine by being imported into claims of overbreadth, insufficiency, or misrepresentation. The ONSC concluded that “a party cannot change what was really a promise based pleading into one that could result in invalidity under s. 27 or 53, even though the Supreme Court recognized that there are “mischiefs” that could fall under those heads.”

On the issue of Apotex’s allegations of willful misrepresentation, the Court held that Apotex had failed to meet the requirements of section 53 of the Patent Act. In light of the seriousness of the assertion, allegations of fraud must “set out precisely” each alleged wrongful act, including the “when, what, by whom and to whom” of the relevant circumstances, and be plead with “full particularity”.

Apotex failed to meet this standard. It had expressly admitted that it had “merely recycled” its Promise Doctrine allegations, and specifically acknowledged that its section 53 fraud allegations were not informed by anything other than AstraZeneca.

In light of the severe prejudice that the defendants would have faced if these unfounded allegations were permitted to be advanced, the Court awarded heightened costs against Apotex.

Link to decision:

Apotex Inc. v. Abbott Laboratories, Limited et al, 2018 ONSC 5199

File-wrapper admissibility and other changes to the Patent Act are coming: what’s new for pharmaceutical patentees in Bill C-86

Christopher A. GuerreiroJordana SanftBy Christopher A. Guerreiro and Jordana Sanft on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The federal government’s recent omnibus budget bill, Bill C-86 tabled October 29th, 2018, proposes significant changes to Canada’s IP laws. Division 7 of the Bill is intended to implement many aspects of the government’s IP strategy, announced in April 2018. The Bill targets the Patent Act, the Trade-marks Act, and Copyright Act; provides for a new College of Patent Agents and Trade-mark Agents Act; and effects changes to diverse legislative schemes impacting the IP regime, including privacy and bankruptcy.

Below, we have outlined some of the most significant changes likely to affect the patent-intensive life sciences industries. To read more about other IP changes in Bill C-86, be sure to visit our Brand Protection Blog and watch for our forthcoming IP Monitor post.

Background

The patent-law changes in Bill C-86 are not specifically directed at pharmaceutical patentees, but have the potential to significantly affect this area of litigation. In general, each of the changes below applies in parallel to certificates of supplementary protection (CSPs), which are either directly referenced in the new provisions or addressed by coordinated amendments in other parts of the Act. For simplicity, we have referred only to patents below.

Prosecution history (file-wrapper) admissible for claims construction

The government intends to make a patent’s file wrapper admissible on the issue of claims construction in litigation, overturning a long-standing Canadian Supreme Court precedent. Here are the details:

  • The proposed new provision, section 53.1, is limited to written communications (or parts thereof) and can only be used to rebut a patentee’s representations in the action regarding claims construction.
  • The prosecution history of a divisional application is deemed to include that of the original application before that divisional is filed.
  • The prosecution history of a reissued patent is deemed to include both that of the application for the patent that was surrendered and from which the reissued patent results, as well as the application for reissuance.

The proposed transitional provisions indicate that litigants will be able to rely on this provision in any action or other proceeding that has not been finally disposed of on the date that it comes into force.

Revised and re-stated exceptions to infringement

The proposed amendments include two changes to the statutory exceptions to infringement provided by the Patent Act:

  • Experimental use. The government proposes to add a new provision stating that an act committed for the purpose of experimentation relating to the subject-matter of a patent is not an act of infringement.
    • The exception is contained in new section 55.3, and would stand alongside the existing exception to infringement for activities reasonably related to seeking government regulatory approval, which remains in subsection 55.2(1) of the Act. Although many of the details regarding implementation have been left to regulations, it appears that these amendments are intended to codify and replace an existing common law exception.
    • The proposed transitional provisions indicate that the new exception will apply to any action or other proceeding that has not been finally disposed of on the date that it comes into force.
  • Continued acts first undertaken prior to the claim date. The proposed amendments would replace the existing prior-use exception in section 56 with a new provision.
    • Notably, the revised section 56 requires that the prior act was undertaken in good faith. It does not apply if the person claiming under the provision obtained knowledge of the subject-matter of the claim directly or indirectly from the applicant and knew that the applicant was the source of the knowledge.
    • Revised section 56 also extends protection to situations where “serious and effective preparations” to commit such an act were committed prior to the claims date, and includes flow-through protection for third-party purchasers/users.
    • The proposed transitional provisions indicate that the current version of section 56 will continue to apply in respect of any action of other proceeding concerning a patent filed after October 1, 1989 (i.e., “New Act” patents), provided the proceeding was commenced before October 29, 2018.

Demand letters

Bill C-86 provides for regulations stipulating requirements of a written demand concerning a patent, apparently addressing a concern regarding the use of IP demand letters as a means to extort funds. Bill C-86 also provides a right of action for persons who receive a written demand that does not comply with the regulations, or who are aggrieved by another person’s receipt of the same. This provision extends to letters in respect of any invention patented in Canada or elsewhere, provided the letter is received by a person in Canada and meets other prescribed requirements. Under special circumstances, a corporation’s directors, officers, agents, or mandataries may be held liable for a non-compliant written demand sent by the corporation.

Standard-essential patents

New sections 52.1 and 52.2 introduce the concept of standard-essential patents (SEPs) to the Act on terms to be defined by regulation. The only substantive requirement with respect to SEPs is contained in section 52.1, which provides that an SEP patentee’s licensing commitments bind any subsequent patentee. The inclusion of CSPs as a potential form of SEP is interesting and noteworthy. Section 55.2 confers the power to make regulations concerning what constitutes (or does not constitute) an SEP or licensing commitment.

The authors wish to thank Amy Grenon and Anna Wilkinson for their help in preparing this legal update.

New protections for biologics and other pharmaceuticals under the United States-Mexico-Canada Agreement (USMCA)

Christopher A. GuerreiroKristin WallJudith RobinsonBy Christopher A. Guerreiro, Kristin Wall and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences

As we reported, Canada has joined a new trilateral trade deal called the United States-Mexico-Canada Agreement (USMCA). The USMCA contains important new protections for biologic and other pharmaceutical innovation. Chief among them, Canada will introduce an extended ten-year period of data protection for biologics and patent-term restoration (PTR) for delays in the patent office.

The USMCA, which replaces the North American Free Trade Agreement (NAFTA), will come into force after it has been signed and ratified by the member states. It is anticipated that the USMCA will be signed before the end of 2018, but dates for its ratification and the NAFTA’s expiry have yet to be determined.

Extended data protection for biologics

Ten years of protection…  Article 20.F.14 of the USMCA requires parties to provide new biologics with a minimum of ten years’ data protection from the date of first marketing authorisation. This period is greater than the eight years currently provided by Canada for biologics (together with all other pharmaceuticals), but less than the twelve years already provided for biologics by the U.S. under the Biologics Price Competition and Innovation Act.

…for new biologics.  The USMCA obligations regarding extended data protection apply to new pharmaceutical products that are or contain biologics. The scope of this obligation is defined by the following:

  • New pharmaceutical products are defined to be those that do not contain a chemical entity that has been previously approved in that party.
  • The USMCA does not include a definition of “biologic” per se, but provides that each Party shall apply this Article to, at a minimum, a product that is produced using biotechnology processes and that is, or, alternatively, contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, for use in human beings for the prevention, treatment, or cure of a disease or condition.
  • Parties are not required to apply this provision to biosimilars.

Coming into force.  Pursuant to the transitional provision, Canada is not required to fully implement Article 20.F.14 until five years after the date that the USMCA comes into force.

Patent-term restoration

PTR for all.  Article 20.F.9 of the USMCA requires Canada to adopt a PTR system for time lost due to “unreasonable delays” in the issuance of a patent, at the request of the applicant. This new PTR system is not specific to pharmaceuticals, applying to all patents generally. PTR granted under this system will be additional to any certificate of supplementary protection (CSP) that may be available for pharmaceutical patents under existing Canadian law.

What is an “unreasonable delay”?  The definition of “unreasonable delay” in the USMCA is non-exhaustive, but includes at least patent issuance after the later of: (1) more than five years from the filing date in the party country; or (2) more than three years after a request for examination. In determining the duration of a delay, periods of time may be excluded, e.g., if they are attributable to the patent applicant.

Coming into force.  Pursuant to the transitional provision, Canada is not required to fully implement Article 20.F.9 until 4.5 years after the date that the USMCA comes into force. PTR applies to all patent applications filed after the date of entry into force of the USMCA, or the date two years after the signing of the USMCA, whichever is later for that party.

Other provisions

Other IP provisions. Chapter 20 of the USMCA contains other provisions relating to the protection of intellectual property, similar to pre-existing obligations under the NATFA and/or the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and/or that are already reflected in Canadian law.

Other provisions regarding pharmaceuticals and medical devices.  In addition, Annex 12F and Chapter 29, Section B, contain articles related to the administration of the drug-regulatory system, including issues of transparency and procedural fairness.

Investor-state dispute-resolution system (ISDS).  Notably, Canada has withdrawn from the ISDS under the USMCA. You can read our summary of the changes to the ISDS and transitional provisions here.

Links:

Abbreviated New Drug Submissions will be posted on the Submissions Under Review List and other pre-market transparency initiatives

Jillian HyslopKristin WallSara ZborovskiBy Jillian Hyslop, Kristin Wall and Sara Zborovski on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada recently published a notice outlining its phase III pre-market transparency initiatives for prescription drugs. Beginning October 1, 2018, Health Canada will publish a new list of abbreviated new drug submissions (ANDSs) on the Submissions Under Review (SUR) List, as well as publish Regulatory Decision Summaries (RDSs) for ANDSs, supplemental abbreviated new drug submissions (SANDSs) and certain supplemental new drug submissions (SNDSs).

These phase III initiatives are being implemented further to five proposals related to prescription drug product transparency that Health Canada consulted on in the fall of 2017. A “What we heard” report was published in April 2018 and Health Canada is now moving forward with implementing the five proposals.

Beginning October 1, 2018, Health Canada will:

  • Prepare and post RDSs for final positive decisions (issued on or after October 1, 2018) and negative decisions (for submissions accepted into review on or after October 1, 2018) for ANDSs and SANDSs that might be of interest to stakeholders, including where Health Canada has significantly deviated from its published guidance, for critical dose drugs and for complex drug substances or drug products;
  • Prepare and post RDSs for SNDSs for positive decisions (issued on or after October 1, 2018) for new routes of administration, dosage forms, and strengths;
  • Publish a new list of ANDSs under review on the SUR List (accepted into review on or after October 1, 2018). The list will include medicinal ingredient(s), therapeutic area, and number of applicable submissions;
  • Publish the sponsor (company) name for new entries on the SUR List for New Drug Submissions (NDSs) and SNDSs (for submissions accepted into review on or after October 1, 2018); and
  • Publish the submission ‘class’ on the SUR List for NDSs and SNDSs (accepted into review on or after October 1, 2018). The submission classes are as follows: (i) extraordinary use submission, (ii) new active substance, (iii) biosimilar, (iv) being reviewed under the priority review policy, (v)  being reviewed under the notice of compliance with conditions guidance, (vi) being reviewed under the submissions relying on third-party data guidance, and (vii)  part of ‘aligned review’ with a health technology assessment (HTA) agency.

 

Links: Notice: Phase III of Pre-Market Transparency Initiatives for Prescription Drugs

CETA Tracker: Update on CSPs

Jillian HyslopKristin WallBy Jillian Hyslop and Kristin Wall on Posted in Pharmaceuticals and life sciences

As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations (CSP).

The protection given under a CSP is intended to “partly compensate for time spent in research and obtaining marketing authorization.” A CSP provides “patent-like rights” that take effect after patent expiry, and is subject to the “same limitations and exceptions” as the patent. Like a patent, a CSP is subject to the jurisdiction of the Patented Medicine Prices Review Board and can be listed on the Patent Register, as well as on the CSP Register.

A year has passed since the Regulations came into force – we provide below an update on recent developments relating to CSPs.

Updated Guidance Document. On September 4, 2018, Health Canada has released an updated Guidance Document on CSPs which provides additional guidance regarding the roles and responsibilities of applicants and the Therapeutic Products Directorate (TPD) with respect to CSPs and applications, the new email address for corresponding with the TPD, and an explanation of how the TPD calculates the CSP term.

“Timely submission requirement” decreases to one year.  To be CSP-eligible, the Canadian NDS for the drug in question must be filed within 24 months of any first international drug submission filing for the same drug in the European Union, United States, Australia, Switzerland or Japan. For CSP applications submitted on or after September 22, 2018 this period decreases from 24 months to 12 months. A new CSP application form that provides for the one year period is available, intended for use on or after September 22, 2018.

To date, a total of 14 CSPs have been issued and three have been refused. On August 31, 2018, the first application challenging the Minister’s decision to refuse a CSP was commenced in Federal Court (Federal Court File number T-1603-18).

Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity

Jonathan ChongBrian R. DaleySara ZborovskiBy Jonathan Chong, Brian R. Daley and Sara Zborovski on Posted in Life sciences and healthcare

The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal Court (FC) properly considered the evidence and that it did not err in finding that the decision to implement the requirement for additional information was not improperly motivated.

Background

This appeal arises from the third in a series of judicial-review applications by Apotex Inc. (Apotex) concerning regulatory intervention by Health Canada against drugs manufactured at facilities owned by Apotex affiliates in India.

The first two applications concerned an import ban on drugs manufactured at these facilities, implemented by the Health Products and Food Branch Inspectorate (Inspectorate) of Health Canada after Apotex informed the Inspectorate of issues concerning the integrity of testing data from these facilities. The FC quashed both the decision to impose the import ban, as well as a subsequent decision to vary the terms and conditions of establishment licences for these facilities, on the basis that they were motivated by an improper purpose.

The third application concerned additional limitations that were imposed with respect to approval of drugs manufactured at the Indian facilities. In November 2014, after being informed by the Inspectorate about the data integrity concerns, the Therapeutics Product Branch (TPD) of Health Canada told Apotex that it would not issue a Notice of Compliance (NOC) for drug submissions with data from these facilities, but would request further information as required. Apotex generally complied with the TPD’s requests for additional information relating to data integrity, and NOCs were issued for drug submissions with data from the two Indian facilities. In May 2015, the TPD implemented a general policy requiring additional information to establish the reliability of data from facilities where there were data integrity concerns.

In October 2015, Apotex asked the TPD to remove the requirement for additional information in light of the FC quashing the import ban. The TPD refused to do so on the basis that the Court’s decision did not address the reliability of data from the Indian facilities before Apotex implemented corrective and preventative measures, and because it was required by the general policy applicable to any drug submission for which there were concerns about data integrity.

Apotex applied for an order quashing the TPD’s decision refusing to end the requirement and sought approval of other products obtained from these facilities. As we previously reported, the Federal Court dismissed Apotex’s application, finding that the requirement for additional information to establish data integrity was not improperly motivated by the import ban. The Federal Court also found that maintaining the requirement for additional information was reasonable in light of genuine concerns about data integrity.

Standard of review

The FCA agreed with Apotex that the normal civil standard of review for findings of fact, i.e., palpable and overriding error, applied to the FC’s decision regarding Health Canada’s motivations. The Court rejected the Minister’s submission that the proper standard of review was reasonableness, holding that the standard was appropriate on review of the administrative decision but not for findings of fact or mixed fact and law made in the first instance.

All of the Minister’s evidence was considered

In response to the application, the Minister relied upon evidence from the Director General of the TPD. While the application was under reserve following the initial hearing, the Minister provided a correction to the Director General’s evidence and produced additional documents, leading to further cross-examination and a hearing on the additional evidence. Apotex argued that the FC erred by considering the initial evidence separately from evidence that was later produced, testing conclusions regarding the former with the information in the latter. The FCA rejected this argument, holding that there is no prescriptive methodology for a judge at first instance to follow and finding that all of the evidence was considered.

No error in failing to draw an adverse inference from the Minister’s evidence

The FCA held that the FC did not err by failing to draw an adverse inference against the Minister for not producing contemporaneous documents to establish the basis for the 2014 decision to require additional information and for not leading evidence from a witness with first-hand knowledge. Noting that the decision to draw such an inference is discretionary, the FCA held that Apotex did not ask the FC to do so regarding the evidence of witnesses and held that the scope of documentary production was appropriate.

No error regarding the motivation not to end the data integrity requirement imposed in 2014

The FCA held that the FC did not err in finding that the TPD’s 2014 decision to require additional information to address data integrity was not improperly motivated, unlike the import ban, on the evidence before the Court. As there was no support for the proposition that the 2015 decision to maintain the requirement was tainted independently of the 2014 decision, there was no need for the FCA to consider this issue further.

Links to decisions:

FCA Decision: Apotex Inc v Canada (Health), 2018 FCA 147

FC Decision: Apotex Inc v Canada (Health), 2017 FC 315

Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations

Corey McClaryDavid YiAllyson Whyte NowakBy Corey McClary, David Yi and Allyson Whyte Nowak on Posted in Uncategorized

The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious.

Background

The claims of Canadian Patent No. 2,432,644 (the 644 Patent) relate to pharmaceutical compositions comprising prasugrel and aspirin. Prasugrel is a member of the thienopyridine family of compounds. The asserted claims of the patent claimed the use of prasugrel for simultaneous or sequential, separate administration with aspirin and the compound prasugrel for use in combination with aspirin, in preventing or treating a disease caused by thrombus or embolus.

Obviousness

In its obviousness analysis, the Court accepted the Applicants’ construction of the inventive concept: the combination of prasugrel plus aspirin with an antithrombotic effect that is greater than the sum of the effects of each agent alone. The Court also found that this inventive concept had not previously been disclosed and therefore differed from the state of the art.

However, in applying the “obvious-to-try” test, the Court held that the claims were obvious finding that there was a motivation in the art to try the combination of prasugrel with aspirin and that there was a “reasonable expectation” that combining prasugrel, a thienopyridine, simultaneously or sequentially with aspirin would produce a beneficial, complementary mechanism of action.

The Court acknowledged that:

Central to the Court’s analysis was evidence that the prior art had shown that the substitution of one thienopyridine (ticlopidine) for another (clopidogrel) to use in combination with aspirin had been positive.

Despite finding that one of only two thienopyridines approved for sale did not consistently demonstrate synergy with aspirin and that there was no information in the state of the art regarding the mechanism by which clopidogrel and aspirin had developed a synergy, the Court nevertheless concluded that there was a reasonable expectation that the combined use of prasugrel and aspirin could reasonably be expected to achieve a synergy similar to the combination of clopidogrel with aspirin.

This analysis minimizes the well-known unpredictability of structural changes on biological effect. In combination with the “obvious to try” test, this may create a low bar to obviousness that disproportionately impacts pharmaceutical inventions.

Patentable Subject Matter

The Court held that the patent disclosed that the use of prasugrel combined with aspirin results in an effect on platelet aggregation that is new, useful, and more than the mere sum of the effects of the two agents taken alone. The Court accepted as sufficient, data showing that the combination produced a numerically greater inhibition rate than prasugrel or aspirin alone and did not require a more formal statistical analysis.

Insufficiency & overbreadth

The Court rejected Apotex’s argument that the patent failed to disclose how to administer prasugrel and aspirin sequentially. Although time intervals were not specified in the patent, the experts were able to determine an appropriate interval using the patent and common general knowledge. The Court similarly rejected the argument that claim 29 of the 644 Patent was overly broad for failing to include a maximum time interval.

 

Link to Decision:

Eli Lilly Canada Inc., Ube Industries, Ltd. and Daiichi Sankyo Company, Limited v. Apotex Inc., 2018 FC 736

Health Canada Releases Updated Guidance on Amended PM(NOC) Regulations

Morgan WestgateKristin WallBy Morgan Westgate and Kristin Wall on Posted in Life sciences and healthcare

As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations on September 21, 2017. Health Canada has now issued an updated guidance document on the administration of the Regulations in light of these amendments. The update also reflects administrative practices. The guidance document is effective as of May 11, 2018 and is applicable to all drugs that receive a notice of compliance (NOC).

The guidance document elaborates on a number of elements of the new regime, including:

  • The scope and application of section 5 of Regulations, including providing clarification for the types of submissions that will be captured by the provision when a second person applies for an NOC.
  • Information on the TPD’s process for assessing submissions (including supplements) under the new regime. This includes details on the process for submitting Form Vs and addressing additions to the Patent Register, as well as certification letter issuance and service.
  • Situations in which a second person must retract a notice of allegation, including screening rejections, notices of non-compliance-withdrawal, and notices of deficiencies-withdrawal.
  • How parties are to disclose litigation information to the TPD given that the Minister of Health is no longer a party to actions commenced under the amended Regulations. Health Canada has emphasized the importance of complying with this procedure in order to avoid the issuance of an NOC while a proceeding under the Regulations is still ongoing.
  • The TPD’s process for assessing CSPs under the Regulations, and in particular the manner and circumstances in which CSPs will be added to the Patent Register.
  • The process for placing submissions on Intellectual Property Hold.
  • The process for requesting that the TPD verify portions of a submission or supplement under the Regulations
  • The process for a first person to renounce the twenty-four month stay .
  • The TPD’s procedure for maintaining the Patent Register, including the removal of patents and CSPs that are found to be ineligible for listing. Notably, the guidance document states that patents and CSPs declared invalid or void will be deleted after an initial finding and will be added back to the Patent Register if the decision is subsequently reversed. Second persons who file submissions while the patent or CSP is not on the Patent Register will not need to address that patent or CSP.

Link to Guidance Document:

Guidance Document: Patented Medicines (Notice of Compliance) Regulations

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