Category: Canada

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3

Lisa L. Mueller July 22, 2020

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3

This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada. Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here. Part 2 examined the patentability of diagnostic inventions in Europe and can be found here. Part 3 will examine the patentability of diagnostic inventions in Canada.

Canada

In Canada, the patentability of medical diagnostic methods is currently in a state of flux. The issues began with the decision in Amazon.com v. Attorney General (Amazon.com) 97 C.P.R. (4^th) 171 (F.C.A). In Amazon.com, the Federal Court of Appeal identified three important elements for patentability subject matter: (i) it must not be a disembodied idea but have a method of practical application; (ii) it must be a new and inventive method of applying skill and knowledge; and (iii) it must have a commercially useful result. Additionally, the Court also ruled that “purposive construction” of patent claims must be performed prior to making a determination of subject matter eligibility, which involves identifying and assessing the essential and non-essential elements of the claims.

Moreover, in 2015, the Canadian Intellectual Property Office (CIPO) released patentability Examination Guidelines specific to diagnostic methods (Guidelines). These Guidelines have now been incorporated into the CIPO Manual of Patent Office Practice (MOPOP) and contain the following instructions for Examiners when approaching a claim directed to diagnostic methods:

(a) Identify the problem the inventors set out to solve and the solution provided by the invention, guided by the description and the Examiner’s understanding of the common general knowledge in the relevant art.

(b) Consider that for diagnostic methods, an inventor is generally looking to solve a data acquisition problem and/or a data analysis problem.

(c) Factors that may indicate a data acquisition problem include novel analytes or biomarkers and novel means of identifying or quantifying an analyte (regardless of whether the analyte is new).

(d) Factors that may indicate a data analysis problem include a new correlation between a condition and an analyte that is common general knowledge.

(e) Determine whether elements in the claims are essential (provide a solution to the identified problem) or non-essential (do not provide a solution to the identified problem).

(f) If the essential elements are required solely to solve a “data analysis problem” as opposed to a “data acquisition problem”, the claim will be refused as directed to non-statutory subject matter.

Practically, the Guidelines direct Examiners to reject patent claims where the subject matter of the claim is based only on the identification of new and non-obvious correlation, for example, between a disease state and a known biomarker. While some claims directed to diagnostic inventions have issued since the Guidelines were established, there has been a fair amount inconsistency at CIPO with respect to the application of the Guidelines. Canadian patent practitioners still determining types of claims which are currently allowable in Canada under CIPO policy, drawing on claim wording strategies similar to those used in the U.S.

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions. You can register for the webinar at the following link: Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

Filing a Divisional Application in Canada – Part 6

Lisa L. Mueller May 1, 2020

This is the sixth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order). Our first five posts examining divisional practice in Brazil, Mexico, China, India and Argentina and can be found here: Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, and Divisional Practice – Argentina.

Time Periods for filing a Divisional Application

In Canada, a divisional application must be filed during pendency of the original application (parent application). Typically, a divisional will be filed during prosecution of the original application, or at the latest, when paying the issue fee. The ultimate deadline to file a divisional is the day before issuance. Additionally, if an original application is refused, a divisional application can be filed before 6 months from the mailing of the refusal or, if there is an appeal, 2 months from when the appeal process ends. Divisional applications can be filed for any reason (often referred to as “voluntary” divisional applications) or in response to a lack of unity rejection. Cascading divisionals (meaning a divisional application filed from another divisional application) are permitted.

Requirements for Filing a Divisional Application

When filing a divisional application, a copy of the specification, abstract and drawings from the parent application must be filed. A set of claims (either the original claims from the parent application or a new claim set) must also be included. Often an applicant refiles the original claims for continuity of subject matter. The cost of filing a divisional is comparable to the cost of a new application. The content of the divisional filing papers are similar to that of the parent application. The disbursement for a divisional is often significant because of the requirement to pay all the annuity fees accrued since the filing date of the parent application. The term of patent for a divisional application is twenty years from the filing date of the very first parent application.

Request for Examination

A divisional application gets the same filing date as its parent application. The deadline for filing request for examination a divisional application will vary depending on the filing date of the parent application from which the divisional application originates. There is variance because Canada is in a transition period following new Patent Rules that came into effect October 30, 2019 (“transition date”). Specifically, if a divisional application has a parent filing date before the transition date, then examination must be requested and the examination fee paid within the later of five years from the original filing date and six months from the presentation date of the divisional application. However, if a divisional application has a parent (i.e. original) filing date on or after the transition date, examination must be requested and the examination fee paid within the later of four years from the original filing date and three months from the presentation date of the divisional application.

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent or PCT application. However, the claims of a divisional application filed with the same claims of a parent or PCT application will need to be amended at some point during prosecution to a non-elected group, if there was a unity objection in the parent. Otherwise, they will need to be amended in a manner to ensure that the divisional application claims are patentably distinct (meaning novel and non-obvious) from the parent claims.

Double Patenting

In Canada, much like the United States (U.S.), there is a prohibition against double patenting. Divisional applications following a unity objection are treated differently than voluntary divisionals.

Divisional Following Unity Objection

If the claims being pursued in a divisional application were previously cancelled in response to a lack of unity rejection in a parent application, then the claims of the divisional application are immune from a double patenting attack based on the parent application.

When prosecuting a divisional application after a unity objection, care should be taken to avoid amendments that might cause the claims to depart significantly from what the Examiner originally considered to be a separate invention group. Therefore, to ensure validity of both parent and the divisional patents, it is advisable to refer back to the original unity requirement to divide a set of claims so that new issues of double patenting are not created inadvertently.

Voluntary Divisional

Voluntary divisionals are where double patenting concerns arise. Specifically, in Whirlpool Corp v. Camco In., 2000 SCC 67, the Supreme Court of Canada confirmed that an inventor is only entitled to one patent of each invention. A patentee who claims successive patents for a single invention by way of obvious variations unlawfully extends the scope of the patent term, such that the second patent is invalid on the basis of double patenting. Note that a double patenting objection during prosecution of a divisional is not fatal if the applicant can amend claims and/or argue to traverse.

In Canada, the double patenting prohibition comprises 2 branches:

A “same invention” or “coterminousness” branch; and
An “obviousness” branch.

The “same invention” or “coterminousness” branch is similar to statutory double patenting in the U.S., where claims of a pending application and an issued patent cannot have the same exact (identical) scope. An applicant needs to amend pending divisional claims to overcome this objection.

The “obviousness” branch is similar to “obviousness-type” double patenting in the U.S., and the applicant will have to amend pending claims or argue with the Patent Office. Under this branch, the claims of a pending application (such as a divisional application) must be patentably distinct (meaning novel and nonobvious) over the claims of an issued patent or co-pending application. In the U.S., in most instances, an obviousness-type double patenting rejection can be obviated by the filing of a terminal disclaimer. However, Canadian law does not provide for a terminal disclaimer.

Therefore, an Applicant filing a voluntary divisional in Canada must be very careful to make sure that the claims of its divisional application: (1) do not claim the same invention as the parent application; and (2) are patentably distinct over the claims of the parent application.

Similar to the U.S., an issued patent can be invalidated for double patenting in Canada. Once a patent has issued, it may still be possible in Canada to cure a deficiency by disclaimer or reissuance, if the double patenting arose due to mistake.

As a matter of practice, the best option in Canada is to file all claims of interest in the parent application, and allow the Examiner to make an assessment of whether there is more than one invention so that a formal unity objection (i.e., requirement for division) is on record before a divisional application is filed. In effect, voluntarily filed divisional applications should be avoided in Canada where possible.

This post was written by Lisa Mueller and Noel Courage of Bereskin & Parr, LLP.

Are you ready for the significant changes coming to Canadian patent practice?

Lisa L. Mueller August 2, 2019

As many readers are aware, on December 1, 2018, the Canadian government published for public consultation an updated version of its proposed amendments to the Canadian Patent Rules (Rules). The consultation period ran from December 1, 2018 to December 31, 2018 and followed a consultation process performed with respect to an earlier draft of the Rules which was published in August 2017. The updated version of the Rules is based on those published in 2017, and together with complementary amendments to the Canadian Patent Act, represent some important changes to Canadian patent practice. These changes are being implemented in part to meet Canada’s obligations under the Patent Law Treaty (PLT) and are intended to harmonize Canada’s patent system with those of its international trading partners. The changes will be coming into effect beginning October 30, 2019.

Tightening of Timelines – Including Elimination of Entitlement of 42 Month National Phase Entry

Under current practice, a response to an Office Action is generally due six months from the mailing date of an Office Action, examination must be requested on an application within five years of its filing date, and the Final Fee must be paid for an application within six months of the mailing date of a notice of allowance.

Under the new Act and Rules, a response to an Office Action is generally due four months from the mailing date of the Office Action, examination must be requested within four yours of its filing date, and the Final Fee must be paid within four months of the Notice of Allowance. The four month deadline for responding to an Office Action may be extended at the discretion of the Canadian Patent Office (CPO) with the payment of a CA $200 fee, whereas the time periods for requesting examination and paying the Final Fee are not extendible.

Additionally, under current practice, a patent applicant may enter the National Phase in Canada between 30 and 42 months of an international application’s earliest priority date as of right by paying a late entry fee of CA $200. The new Act and Rules eliminate this right. While entry between 30 and 42 months remains possible, an applicant must satisfy the CPO that failure to enter by the 30th month deadline was unintentional, in addition to paying a reinstatement fee of CA $200.

These changes are summarized in the table provided below.

	Current Practice (Up to October 29, 2019)	New Act and Rules (Coming into Effect October 30, 2019)
Response to Office Action	6 months from mailing date of Office Action (not extendable).	4 months from mailing date of Office Action (a maximum of 2 months extension available at the discretion of the CPO).
Examination Request	Within 5 years from filing date (not extendible).	Within 4 years from filing date (not extendible).
Final Fee	6 months of the mailing date of the Notice of Allowance (not extendible).	4 months of the mailing date of the Notice of Allowance (not extendible).
Entering National Phase in Canada	30 months; however, entry up to 42 months available with payment of CA $200 late fee.	30 months; however, entry up to 42 months is available only if the delay to enter was unintentional and applicant pays a late fee of CA $200.

Abandonment and Reinstatement

Under current practice, a patent application that goes abandoned for failure to perform an action (e.g., respond to an Office Action, pay a fee), goes abandoned immediately following that deadline, and may be reinstated as of right within one year from that deadline by performing the action that was due at the deadline and by paying a reinstatement fee.

Under the new Act and Rules, abandonment does not necessarily occur immediately following a missed deadline, nor is reinstatement as of right necessarily available. Instead, the timing and nature of the abandonment and reinstatement depends on the nature of the missed deadline as shown in the below table:

Timing and Nature of Abandonment	Reinstatement possible as a matter of right?
Failure to respond to an Office Action	Yes. Reinstatement remains available as of right within 12 months of the deadline.
Failure to pay a Final Fee	Yes. Reinstatement remains available as of right within 12 months of the deadline.
Failure to request examination	Yes. Abandonment will result if the fee is not paid within two months after the date of a notice that will issue from the CPO following the missed examination deadline. An applicant may reinstate the application and request examination as of right within six months of the examination request deadline. If the reinstatement fee and request are not filed within six months of the original examination request deadline, the applicant will only be able to reinstate by establishing that the abandonment occurred despite due care, and no later than one year from abandonment.
Failure to pay a maintenance fee for a pending application/issued patent	No. Abandonment results six months from the missed deadline or two months from the date of notice from the CPO requiring payment, whichever occurs later. Once abandoned, the application may be reinstated as late as 18 months from the date the maintenance fee was due only by establishing that abandonment occurred despite the applicant having taken due care*.

*The new Act and Rules do not provide any guidance as to what would qualify as due care, although informally, the Office has stated that the threshold will be high.

Third Party Rights

Tied to the new due care requirement for reinstating an application abandoned or a patent lapsed for not having paid a maintenance fee or not having timely requested examination, the new Act and Rules introduce the concept of third party rights. These rights limit the liability faced by third parties if they undertake actions that would otherwise lead to infringement during a period when an application or patent is abandoned or lapsed and the applicant or patentee needs to satisfy the due care threshold for reinstatement. The period starts six months from the deadline for paying the maintenance fee or requesting examination, which is when the due care requirement begins. A third party will not be liable for what would otherwise be infringing acts committed in good faith during this period or resulting from “serious and effective preparations” the third party makes during this period. Generally speaking, this period ends upon the patent or application being reinstated, or when a patent grants from the abandoned application, whichever occurs earlier.

Reduced Requirements to Obtain a Filing Date

Under current practice, in order to obtain a filing date for an application other than a PCT national phase application, an applicant needs to pay the filing fee and provide a document in English or French that on its face appears to describe an invention.

Under the new Act and Rules for an application other than a PCT national phase application, it will be possible to submit a translation of a specification into English or French after filing. Additionally, by paying a CA $150 late fee, it will be possible to defer paying the filing fee. If the filing fee is not paid at filing, the CPO will issue a notice requesting payment and the applicant will have up to three months from the date of the notice to pay the filing fee and late fee without loss of its filing date.

However, it will not be possible to defer paying the filing fee or filing a translation of the specification into English or French when requesting national phase entry into Canada. The basic national fee, which is identical to the filing fee for a non-PCT national phase application, must be paid in order to secure national entry into Canada (subject to an exception where an applicant makes a bona fide but unsuccessful attempt to pay the fee at entry).

Adding Matter to an Application

Under current practice, an applicant cannot add new matter to a patent application, regardless of whether that matter is contained in an application’s priority document.

In contrast, the new Act and Rules, permit new matter to be added to a non-PCT national phase application in certain circumstances. Where an application is missing part of the specification or drawing referred to in the specification, the applicant may add that missing part to the specification. An applicant may do this voluntarily, in which case the deadline to do so is two months from the earliest date on which the CPO receives any document or information required for establishing a filing date. Alternatively, the Patent Office may issue a notice requisitioning the missing part from the applicant, in which case the deadline will be two months from the date of the notice. The filing date of the application will be no earlier than the date the applicant submits the missing part, unless the missing part was contained entirely within the priority document in which case the missing part will not prejudice the filing date.

Electronic Filing

Currently, it is not possible to obtain a filing date in Canada on a day the CPO is not open for business, such as the weekend. Under the new practice, using electronic filing, an applicant may file a patent application or any other document with the CPO and secure a filing date that same day, regardless of whether the CPO is open for business. This may be useful to secure a filing date before a public disclosure of an invention is made, or to secure a filing date within one year of an applicant’s own public disclosure so as to be able to rely on the Canadian grace period.

Priority Rights

Under current practice, an applicant is not required to provide a certified copy of a priority document to the CPO unless requisitioned to do so by the Office, which it rarely does. Additionally, Canada does not permit restoration of the right of priority, regardless of whether the Canadian application is a national phase application and priority was restored for the corresponding PCT application during the international phase.

Under the new Act and Rules, applicants will be required to either submit a certified copy of a priority document to the CPO or to make a certified copy available through a recognized digital library for priority claims made to a non-Canadian priority document. This requirement will be waived if the application is a national phase application and the applicant submitted a copy of the priority document during the international phase. Furthermore, restoring the right of priority will be possible in Canada without payment of a fee, so long as the applicant can establish that priority requires restoring because of an unintentional error. An applicant will have two months after the end of the 12 month period from the date of filing the priority application to request restoration of priority for a non-PCT national phase application, and one month after national entry for a PCT national phase application.

Amendments after Allowance

Under current practice, an applicant who wishes to amend an application in a manner that would necessitate a new search after allowance and before payment of the Final Fee must allow the application to go abandoned by not paying the Final Fee and, concurrent with reinstatement, make the amendment. Reinstating has the side effect of re-opening prosecution, thereby allowing the applicant to substantively amend the application.

Under the new Act and Rules, an applicant may re-open prosecution as a matter of right by paying CA $400 to the CPO and requesting that the Notice of Allowance be deemed to never have been sent. This allows an applicant to re-open prosecution at any time after the Notice of Allowance is mailed, as opposed to having to wait four months when the Final Fee is due to allow the application to go abandoned. An applicant who wants to amend the application in any manner aside from correcting an obvious error will have to use this process.

Assignment Practice

Under current practice, in order to record a change of name or a change of ownership in the CPO, an applicant needs to submit for recordation the document evidence or effecting that change and pay a CA $100 fee. Any documents that are recorded must comply with Canadian practice. For example, notwithstanding that an assignment need not be witnessed under Canadian law to be effective, an unwitnessed assignment cannot be recorded in the CPO without other evidence to establish it is suitable for recordation, such as an affidavit or Notice of Recordation from the U.S. Patent and Trademark Office.

While recording documents will still be an option under the new Act and Rules, in many instances, the CPO is eliminating the requirement to submit those documents in order to reflect a change at the Office. An applicant/patentee that is also a transferee may record a transfer by filing a request and provide the name and postal address of the transferee. A transferee other than the applicant/patentee will be able to record a transfer without submitting the actual transfer document but will need to provide evidence satisfactory to the CPO, such as an affidavit. An applicant/patentee that wishes to record a name change may similarly do so on request and by paying a fee. The CA $100 fee remains payable for recording transfers under the new regime, regardless of whether a document effecting the transfer is recorded.

Transitional Provisions

The Rules provide a detailed set of transitional provisions. An Office Action or Notice of Allowance mailed before the coming-into-force (CIF) of the Rules will benefit from the longer prosecution timelines (six months for filing an Office Action response and for paying the Final Fee) as opposed to the shorter four month deadline under the new Rules. An application that is abandoned before the CIF, or that is abandoned after the CIF on the basis of a failure to comply with a requisition or notice dated before the CIF, will benefit form the ability to be reinstated as of right under current practice without having to establish that abandonment occurred despite due care. Analogously, third party rights will not apply to any period of abandonment that begins before the CIF or that occurs after the CIF as a result of a failure to comply with a requisition or notice dated before the CIF.

Importantly, the transitional provisions clarify that the international application having an international filing date before the CIF will benefit from the current practice of being able to enter the Canadian national phase within 42 months of its earliest priority date as of right. Similarly, an application that is filed in Canada before the CIF will be entitled to file a request for examination as late as five years from filing as permitted under current practice, as opposed to the shorter four years from filing under the new practice.

This post was written by Lisa Mueller and Trevor Newton and Roch Ripley of Gowlings, WLG.

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Proposed Revisions to the Canadian Patent Office’s Examination Guidelines on Pharmaceutical Solid Forms

Lisa L. Mueller August 10, 2018

The Canadian Patent Office (CPO) is seeking comments on its proposed revisions to Chapter 17 of the Manual of Patent Office Practice (MOPOP) as it relates to pharmaceutical solid forms (namely, polymorphs, salts, hydrates, solvates, desolvates and co-crystals). In this post, we will examine various section of this amended chapter in detail.

Considerations Respecting Anticipation and Obviousness (Chapter 17.08.01)

This section of amended Chapter 17 describes the considerations to be used in assessing anticipation and obviousness of pharmaceutical solid forms. According to this section, where a particular crystalline form (such as a polymorph) of a small chemical molecule has not been disclosed and enabled in the prior art, either explicitly or inherently, a claim to that crystalline form is considered to be novel and satisfy subsection 28.2(1) of the Canadian Patent Act (Patent Act). However, if a polymorph is disclosed and enabled in the prior art, a claim encompassing that polymorph is considered to be anticipated. Thus, a known polymorph will not be novel simply by making it dependent on a new process. Nonetheless, a claim to a process used to prepare a polymorph may be novel if it can be distinguished over the prior art.

When assessing obviousness of a new crystalline form, the chapter notes that one factor to be considered is the process by which the new form is produced. Inventiveness may be acknowledged for a form that can only be produced using an inventive process (such a process is considered to go beyond the mere application of common general knowledge and routine experimentation).

Nevertheless, the chapter further states that even if a process used to prepare a new solid form relies on basic crystallization techniques that are standard in the field, the solid form may still be non-obviousness. Specifically, inventiveness may be acknowledged if the originally-filed application discloses that the form provides an unexpected benefit, such as a beneficial physicochemical property that is attributable to the form itself. Specifically, the chapter further notes that:

Only benefits disclosed in the originally-filed application will be taken into account during an obviousness assessment. The disclosure of the benefit may be either explicit (e.g., direct statements) or implicit (e.g. supportive data provided in the application). In a patent application the most persuasive disclosure is one that provides data comparing the form of the invention to the prior art form (or all of the closest prior art forms when more than one exist) and confirms that there is a significant difference or improvement in one or more physicochemical properties compared to the prior art form(s) of the same chemical molecule. Where the specification comprises statements indicating a solid form ‘may’ have a particular benefit or ‘has at least one’ benefit selected from a list of benefits (without clearly stating which it has), this amounts to an inexplicit indication of potential benefit. Unless the benefit would be implicit from data provided in the application, such statements would not be considered during an obviousness assessment. Likewise, a benefit that is recognized subsequent to the filing of the original application would be given no weight in the assessment.

It is important to note that the person skilled in the art would generally expect or predict that a crystalline form will have certain benefits over an amorphous form of the same small chemical molecule, including easier isolating, purifying, drying, and in batch processes, easier handling and formulating. However, such expected are generally not sufficient, when taken alone, to support a finding of non-obviousness.

Considerations Respecting Utility (Chapter 17.08.02)

This portion of amended Chapter 17 states that although the utility of a polymorph does not need to be expressly set out in the application, the subject matter must have utility. Moreover, a person skilled in the art would reasonably expect that polymorphs of a known small chemical molecule that have a previously established utility (either pharmacological or therapeutic) would also possess the same activity. In such cases, because the utility of the polymorph will generally be self-evident to the skilled person, the utility requirement of section 2 of the Patent Act would be satisfied.

A utility defect will be made if the specification is silent regarding the utility of the claimed polymorph and the utility of other known forms of the same small chemical molecule are neither disclosed in the specification or common general knowledge to a skilled person in the art.

In instances where the claimed crystal form has a utility different from other known form(s) of the small chemical molecule, the utility must be established by demonstration or sound prediction. However, if the utility relies on a physicochemical property that was not established and could not have been predicted, then the utility of the subject-matter of the invention cannot be established by sound prediction. Specifically, this portion of the chapter states, “[R]ecall that the specific physicochemical properties of a particular crystalline form are generally considered as unpredictable since the crystal form must be prepared and tested before its properties can be ascertained (see 17.08.01). Given that such properties cannot be predicted and would not be implicit to the skilled person, in order to establish utility the applicant must be in a position to show that the property associated with the utility was demonstrated no later than the filing date of the application.”

Defining a polymorph in the claims (Chapter 17.08.03)

This portion of amended Chapter 17 states that with respect to claiming polymorphs, that the polymorph must be defined in terms of physical characterization data and/or physicochemical properties that are specific to its solid state structure and which serve to distinctly and explicitly distinguish it from all other forms of that molecule or in terms of the process by which it is made.

Polymorphs can be defined in a claim by: (1) the physical parameters relevant to its particular crystal structure; (2) spectral analysis parameters (such as X-ray powder diffraction (XRPD) pattern, Raman spectrum and/or solid-state nuclear magnetic resonance (NMR)); or (3) parameters associated with methods of thermal analysis (such as infrared (IR) absorption, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), melting point or combinations thereof). Polymorphs should not be defined by an internal designation (such as Form I, polymorph B, etc.), molecular formula or chemical name.

Examples (Chapter 17.08.05)

This portion of amended Chapter 17 provides two hypothetical examples involving claiming strategies for polymorphs and the application of the anticipation, obviousness and utility requirements discussed previously. These examples are very useful from a practical perspective in understanding how the CPO will examine these claims.

Considerations relating to particular solid forms (Chapter 17.08.06)

This portion of amended Chapter 17 notes that the patentability of pharmaceutical salts, hydrates, solvates, desolvates and co-crystals involve the same considerations as those described earlier with respect to polymorphs.

Salts (Chapter 17.08.06a)

With respect to assessing whether claims to a novel salt are inventive, this portion of amended Chapter 17 notes that the process used to prepare a salt and any unexpected beneficial properties of the salt may be informative. Where the originally-filed application discloses that a salt can only be produced using an inventive process that goes beyond routine methodologies or that the salt has a beneficial property that is unexpected, the claimed salt is inventive and complies with section 28.3 of the Patent Act. Additionally, a person skilled in the art would reasonably expect that salts of known small chemical molecule having a previously established utility would also possess the same utility despite incorporation of a counterion in its structure.

In terms of defining a salt in the claims, inclusion of the counterion in the structure of the molecule is often sufficient to satisfy the requirements of subsection 27(4) of the Patent Act (such as, for example, by claiming “A besylate salt of compound of Formula (I)…”). In cases where the claim is directed to a specific polymorph of a salt, the physical parameters relevant to the polymorph’s particular crystal structure must also be defined in order to satisfy the requirements of subsection 27(4) of the Patent Act.

Hydrates, solvates and desolvates (Chapter 17.08.06b)

With respect to assessing whether claims to a novel solvate or desolvate are inventive, the amended chapter notes that the process used for the preparation and any unexpected benefits of the particular entity may be informative. As with novel salts, where the originally-filed application discloses that a solvate or desolvate can only be produced using an inventive process that goes beyond routine methodologies or that the solvate or desolvate crystalline form has a beneficial property that is unexpected, the claimed solvate or desolvate is inventive and complies with section 28.3 of the Patent Act. Additionally, a person skilled in the art would reasonably expect that solvates and desolvates of known small chemical molecule having a previously established utility would also possess the same utility despite incorporation of a solvent into the crystal lattice (solvate) or the removal of a solvate form the solvated form (desolvate).

In terms of defining a solvate in the claims, inclusion of the number of solvent molecules per small chemical molecule is often sufficient to satisfy the requirements of subsection 27(4) of the Patent Act (such as, for example, by claiming, “A dihydrate of the compound of formula (I)”). In cases where the claim is directed to a specific polymorph of a solvate, the physical parameters relevant to the polymorph’s particular crystal structure must also be defined in order to satisfy the requirements of subsection 27(4) of the Patent Act.

With respect to defining a desolvate in the claims, inclusion of the physical parameters relevant to its particular crystal structure are often sufficient to satisfy the requirements of subsection 27(4) of the Patent Act.

Co-crystals (Chapter 17.08.06c)

With respect to assessing whether claims to a novel co-crystal are inventive, as with salts, solvates and desolvates, the amended chapter notes that the process used for the preparation and any unexpected benefits of the particular co-crystal may be informative. Specifically, the chapter notes that “[G]iven the state of the art and recognizing the extensive number of potential co-crystal formers that can be used, screening for co-crystals may involve an inventive process and co-crystals produced by such an inventive process would also be inventive”. Additionally, a person skilled in the art would reasonably expect that co-crystals of known small chemical molecule having a previously established utility would also possess the same utility despite incorporation of a co-crystal in its structure.

In terms of defining a co-crystal in the claims, like polymorphs, inclusion of the relevant physical parameters to the particular crystal structure of the co-crystal are often sufficient to satisfy the requirements of subjection 27(4) of the Patent Act.

The deadline for submitting comments to CIPO on the above amended Chapter 17 is August 17, 2018.

This post was written by Lisa Mueller.