Canada: Canadian Court Of Appeal Has Something To Say On Obviousness: Critical Of Rigid Tests And Using A Solution-Based Identification Of The Inventive Concept That Excludes Serendipitous Discoveries Means Atazanavir Salt Obvious

The Federal Court of Appeal ("FCA") recently affirmed a Federal Court ("FC") finding that an antiviral salt was obvious, although based on different reasoning1. The FCA provided a detailed analysis of the "inventive concept" ("IC"), although it is arguably still unclear as to when/why it is appropriate to use an elevated IC as opposed to a minimal IC. It appears the IC in this case arose out of the patent disclosure (and the "solution taught") and expert evidence as to common knowledge, although the FCA spends very little time reviewing the former. The decision certainly underscores the importance of the IC – with an elevated IC generally being more difficult to render obvious. At the same time, the FCA expresses its dissatisfaction with the varying judicial interpretations of the IC. The court advocates that there really is no new definition of obviousness with this term. Although not required on the facts before it, the FCA also conducted an intensive critical review of the apparent "over-use" of the "obvious to try" test – stressing that the Supreme Court of Canada ("SCC")2 was clear that such a test "be approached cautiously" as only one factor to consider.

Analysis

The appellate decision is interesting for several reasons.

Firstly, the FCA spends a great deal of time going through the intricacies of the FC's analysis of the "inventive concept" and application of the "obvious to try" test. Clearly, both topics were of interest to the appellate court.

Secondly, the FCA found an extricable error of law regarding the FC's alleged improper focus on the "properties" of the atazanavir salt in setting the IC, as opposed to the "solution" of the patent. The FCA then found that the IC was actually one of the three "properties" initially identified by the FC (better bioavailability), and concluded such a solution obvious.

Thirdly, the FCA found that improved bioavailability was already understood from simply the prior art reference to pharmaceutically-acceptable atazanavir salts – there was "no difference" between the prior art point and the IC point. In any event, any difference was obvious based on mere common general knowledge, without even using the SCC's "obvious to try" test. The FCA went on to find the salt was also obvious to try in any event, despite repeatedly stressing that "obvious to try" was not necessary to apply in this case. In fact, the FCA emphasized that "obvious to try" should not be used in many instances. Arguably, this latter finding may be a "plus" for brand names – although it did not assist Bristol Myers Squibb ("BMS") in this case. Traditionally, the "obvious to try" test has been considered a potential tool for impeachers to use to assist with invalidating a patent for obviousness.

In its articulation of the IC, the FCA quickly found that the FC used the wrong definition of the IC, and instead of looking at properties of the salt, should have focused on "the solution taught by the patent" [75]. A comparison of the FC and FCA inventive concept is useful:

As an aside, it is actually unclear how or why the FCA included the very low standard of "equal bioavailability" in its IC – neither BMS' patent, nor the FC reasons refer to "equal" bioavailability. On a practical level, it would not be expected that equal bioavailability would have been part of the patentee's solution to the problems of the free base. Instead, their efforts in making a salt would be directed at improving bioavailability (which is, strangely enough, what the FCA actually focuses on in its analysis – ignoring "equal" bioavailability after including it in the IC).

The FCA appears to equate the IC and claims construction, in its useful description of the obviousness analysis, as evaluating the distance between two key "points":

"[T]he obviousness analysis asks whether the distance between two points in the development of the art can be bridged by the Skilled Person using only the common general knowledge available to such a person. If so, it is obvious. The first of those points is the state of the prior art at the relevant date. References in the jurisprudence to "the inventive concept", "the solution taught by the patent", "what is claimed" or simply "the invention" are attempts to define the second point." [emphasis added]

At the same time, the claims were only briefly discussed early on by the FCA reasons as "background," at which point the FCA acknowledges (and ultimately refuses) Teva's arguments that the IC is merely the claimed compound. This refusal may be difficult to reconcile with the FCA's later analysis that the IC is actually the same as "what is claimed." Really, this may illustrate the continuing complexity of identifying the IC. In this case, it appears that the IC is what is claimed, having regard to a purposive review of the solutions/problems discussed in the disclosure.

Regarding the obviousness analysis (including use of the obvious-to-try approach), BMS wanted a hard and fast rule – "if you can't predict each IC property before making it, the invention will not be obvious to try." The FCA denied such a rigid rule. The FCA stated that any such categorical approach to obviousness was the "antithesis" of the SCC's obviousness approach.

Certainly, there were several "bad facts" for BMS in this case: it was routine to do a salt screen; there was an expectation that salts would increase solubility which would tend to/generally (though not necessarily) increase bioavailability; and BMS made the salt on its very first day of drug development, and then used routine techniques to characterize the salt. The FCA also found that BMS' inventors were not "working at a higher level" than the skilled person.

Practice Points

Inventive Concept

Whether one calls it a property or a solution, it is arguably still unclear exactly how to define the IC, or if this is even necessary. The FCA notes that the UK courts (who coined the term) caution that if there is disagreement regarding the IC, one should simply forget the IC and work on "the features of the claim," otherwise there may be an "unnecessary satellite debate." Canadian jurisprudence suggests such debates are the norm. The FCA was also concerned by the "varying interpretations" of the IC by Canadian courts, in coming to its ultimate conclusion that there really has been no change in the definition of obviousness by the introduction of the term IC. Instead, we are to just focus on "Point 2" like we did at the Beloit4 1986 stage (i.e., before the IC and "obvious to try" entered Canadian jurisprudence). Yet, despite being critical of the usefulness of the IC, the FCA went ahead and identified the IC in this case, which was determinative of the obviousness of BMS' salt.

Unfortunately, the FCA does not provide much guidance on articulating the IC/"Point 2," presumably because it does not want to create any more of the very "rigid tests" that it criticizes in its decision.5 The bioavailability "solution", as found by the FCA, was not specifically claimed but reflected in claim 2 of BMS'   patent, directed at a pharmaceutical form. Although not discussed by the FCA, under the Field of Invention section, the BMS' patent states:

The present invention provides the novel crystalline bisulfate salt ... which exhibits unexpectedly superior aqueous solubility/dissolution behavior compared to other salts, and significantly improved oral bioavailability in animals compared to the free base. The bisulfate salt is thus useful for pharmaceutical dosage forms of the above-indicated protease inhibitor, particularly oral dosage forms. [emphasis added]6

Ostensibly, other insignificant properties were not part of the main solution to which the patent was directed, and as such, excluded from the IC. Although the FCA was loath to give any more rigid rules, particularly on the nebulous concept of obviousness, arguably the use of tests (even if not definitive/applicable every time), provide some clarity/structure to guide both parties and courts alike.

Ironically (and bad for BMS), it appears that the common understanding of the day7 was also identified as the IC, necessitating an obviousness finding. A few questions may arise from this:

  • If a patentee discovers other properties in their research, when can these properties transcend to the status of the IC/the solution taught by the patent? Presumably, careful language in the patent would assist.
  • When/why is the IC not readily discernable from the claims, in a non-selection patent? (i.e., If an element/feature/property is included in a claim, as opposed to excluded in a claim, why should the IC be treated the same, with the result that the IC/claims are basically imputed to include disclosed properties/solutions taught by the patent disclosure?)
  • What could BMS have done differently/how could this type of invention be saved next time? If there is a general discussion of salts in the prior art (which is often included in the basic compound patent), it may be very difficult to argue that a particular salt is inventive. One must query whether BMS' salt patent could have been saved if they had drafted/argued it as a salt selection, to bring the case closer to the Sanofi SCC decision regarding the enantiomer clopidogrel. The FCA spends a lot of time reviewing this decision, and agrees with the FC that Sanofi SCC was distinguishable because it was in a completely different context: there was no motivation to do further work with the racemate, and there was a selection from 250,000 genus compounds.

Obvious to Try

It is not immediately clear as to why the FCA decided to comment on the apparent over-use of the "obvious to try" test. The FCA may be expressing an underlying (and certainly unstated) concern that this test is being used too often to invalidate patents. Ironically, in this case, BMS appeared to want to use the test in order to support its argument that its case was on all fours with Sanofi SCC (where the SCC found the compound not obvious using the obvious to try test).

Significantly, one would have thought that salt selection would clearly be within the ambit of the "obvious to try" realm, given the practical realties of the salt selection process. The SCC says the test "might" (as emphasized repeatedly by the FCA) be acceptable in the "pharmaceutical industry where advances are often won by experimentation". Again, the underlying/unstated view of the FCA may be that any new rigid rules are inappropriate, because really the test for obviousness has not changed.

The FCA characterizes the "obvious to try" test endorsed by the SCC as "the innovative feature" of the Sanofi SCC decision. The FCA then reviews the history of the obviousness test (including the standard Beloit 1986 definition), and the SCC's concern with rigid application of the Beloit definition to all types of claims, as rigid non-statutory rules are inappropriate. The FCA repeats the SCC's warning that the obvious to try test should be approached cautiously, as only one factor, and is not mandatory in Canada; there is no single approach. The FCA instructs (as it has in earlier non-pharmaceutical cases) that there be a "flexible, expansive, and fact driven inquiry." The FCA notes that the old Beloit 1986 test remains possible, but just don't apply it out of context. This may be one of the first pronouncements by the FCA to go back full circle to using Beloit for the obviousness analysis.8

Footnotes

1 Bristol Myers Squibb v Teva 2017 FCA 76, affirming 2016 FC 580 (Mactavish) [NOC proceeding]. As Teva has now received its Notice of Compliance, there will be no appeal to the SCC.

2 Apotex v Sanofi 2008 SCC 61 (referred to as "Plavix I" by the FCA) ("Sanofi SCC")

3 Interestingly, the FCA at paragraph 1, in generally summarizing BMS' salt patent, uses the same type of description as it later applies for the IC: "[1] ...[BMS]... filed a patent application for Type-I atazanavir bisulfate, a salt of atazanavir whose superior bioavailability makes it useful in the formulation of an oral dosage of atazanavir." [emphasis added]

4 Beloit Canada Ltd. v. Valmet OY, (1986), 8 CPR (3d) 289 (FCA).

5 As noted by both the FC and FCA, the Sanofi SCC case looked to the disclosure to determine the IC of the selected enantiomer compound as claimed, and included properties that were not discussed in the claims. Of course, the fact that the SCC was considering a selection patent (which by definition permits a selected compound to be claimed where there is a special/unexpected property or advantage that was not present in the genus), may make such comparisons difficult. Notably, before the FC, Teva provided examples where Canadian courts had not gone to the disclosure to identify the IC, with the result that the FC found that there were no hard and fast rules (an aversion to strict rules that was echoed by the FCA).

6 Cited in the FC Reasons at para. 424.

7 It was accepted that the skilled person would make salts of poorly soluble compounds to increase solubility and bioavailability.

8 The FCA has certainly continued to refer to Beloit 1986 in their obviousness analysis, but has generally then acknowledged refinement by the framework provided in Sanofi SCC (for example: Bridgeview Manufacturing v 931409 Alberta 2010 FCA 188).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Kitt Sinden
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions