Canada’s Data Protection Upheld by the Federal Court of Appeal - Apotex Inc. v. Canada (Health)

Canada’s Data Protection regime was upheld by the Federal Court of Appeal on December 9, 2010 (see Apotex Inc. v. Canada (Health), 2010 FCA 334 here). In a unanimous decision penned by Justice Nadon, the Court found the regime was a proper delegation by the Canadian Parliament to the Governor in Council and intra vires pursuant to subsection 30(3) of the Food and Drugs Act. Moreovoer, the Court also found the regime intra vires the Federal government’s jurisdiction under the criminal law head of the Canadian Constitution.

The case involved two challenges filed by the appellants, Apotex Inc. and Canada’s Generic Pharmaceutical Association, seeking a declaration that subsection 30(3) of the Food and Drugs Act[1]  and section C.08.004.1 of the Food and Drug Regulations[2] (the provision in the Food and Drugs Regulations providing for Data Protection), were ultra vires and without legal force and effect. The challenge was dismissed by the Federal Court of Canada at first instance on July 17, 2009[3] .

Since October 2006[4] , Canada’s Data Protection regime provides innovative drug companies with a marketing exclusivity period of 8 years from the date of approval of their “innovative drugs” (with a possibility of 8.5 years, under certain circumstances, if pediatric studies are filed with Health Canada). Within this market exclusivity period, there is a 6 year “no file” period during which generic manufacturers are prohibited from filing a drug submission directly or indirectly comparing their drug with an innovative drug. This new regulatory regime was adopted by Health Canada pursuant to its regulatory authority under subsection 30(3) of the Food and Drugs Act to “make such regulations as the Governor in Council deems necessary” so as to implement Article 1711 of the North America Free Trade Agreement (NAFTA) or Article 39(3) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS).

In finding that the new Data Protection regime was in line with the Canadian Constitution and a proper delegation of the Canadian government’s authority under the Food and Drugs Act, Justice Nadon noted that the test for application of the regime is not reliance on the innovator’s data, either by the Minister of Health or by the generic manufacturer, but rather whether there has been a direct or indirect comparison between the generic manufacturer’s drug and the innovative drug. Although Justice Nadon found in the instant case that reliance was not the test, in his view, in filing an Abbreviated New Drug Submission (“ANDS”), generic manufacturers “at the very least” indirectly rely on the safety and efficacy information filed in the innovators’ NDSs:

While it is true that the Minister does not usually examine the information provided by innovators in granting a NOC to a generic manufacturer following the filing of an ANDS on the basis of bio-equivalence, there cannot be much doubt that the ANDS process involves, at the very least, indirect reliance on the safety and efficacy information derived from innovators’ NDS. In other words, a generic manufacturer relies on the information found in an innovator’s NDS in that: (i) that information provides the actual knowledge about the safety and efficacy of the drug and its conditions of use; (ii) without that knowledge, it would not be possible for a generic manufacturer to produce its new drug without conducting extensive non-clinical and clinical studies […]. It is in that sense that a generic manufacturer relies upon the data provided by an innovator in its NDS[5].

With regard to the constitutional challenge specifically, Justice Nadon rejected the appellants’ argument that the pith and substance of the regime concerned commercial considerations, not public safety, and that the protection of trade secrets and confidential information is a matter of property and civil rights, thereby failing under the provincial jurisdiction of the Constitution. In the view of Justice Nadon, the Data Protection regime is a mechanism deemed necessary to balance the effects of the ANDS regulatory scheme which may provide a disincentive for innovative manufacturers to develop new and innovative drugs. By granting innovators a period of market protection for eight years, the Canadian government sought to put in place a regime which provides incentives for innovators to continue their search for “innovative drugs”. Ultimately, according to Justice Nadon, Data Protection “exists to encourage the development of new drugs which constitutes a valid public health and safety purpose”, a matter clearly falling within the federal government’s legislative criminal law power.

This decision will provide comfort to innovative manufacturers which expend heavy investment in pre-clinical development and clinical trials on new drugs. Given the importance of this matter to the generic industry, however, it may well be anticipated that an application for leave to appeal the Federal Court of Appeal’s decision to the Supreme Court of Canada will be forthcoming.

By Catherine Lemay

[1]  R.S., 1985, c. F-27.

[2]  C.R.C., c. 870.

[3]  2009 FC 725.

[4]  See Regulations Amending the Food and Drug Regulations (Data Protection), SOR/2006-241.

[5]  Para. 91.

Avon Products, Inc. v. Farleyco Marketing Inc. – Successful Trademark Opposition

Congratulations to Susan Chao of MBM on a successful Trademark Opposition on behalf of Avon Products, Inc.

The Trademarks Opposition Board recently released its decision in Avon Products, Inc. v. Farleyco Marketing Inc. 2010 TMOB 186. This matter concerned Avon’s opposition to the registration of the trademark "MesmorEyes" in association with various types of eye beauty products by Farleyco Marketing Inc.

Avon, represented by MBM Intellectual Property Law, was primarily relying on its prior registration and/or use of the trademarks MESMERIZE (Reg. No. TMA442,464) with women’s fragrance products, MESMERIZE FOR MEN (Reg. No. TMA635,139) with soap, cologne, hair and body wash, etc. and MESMERIZE FOR HER.

An interesting issue arose when the Opponent’s affiant became unavailable for cross-examination. The Opponent filed the affidavit of Ms. Lebel of Avon Canada, Inc. in support of the opposition. After an order for her cross-examination had been issued, the Opponent informed the Registrar that Ms. Lebel was unavailable for her cross-examination. Rather than filing a new affidavit by another witness to replace the evidence of Ms. Lebel, the Opponent presented a new affiant, Colleen Leithman, also of Avon Canada Inc., who "adopted" the affidavit of Ms. Lebel as her own and was cross-examined on her behalf.

In light of this somewhat unusual scenario, the parties were invited to make supplemental written arguments on the issue of whether the affidavit of Ms. Lebel and the transcript of the cross-examination of Ms. Leithman could be accepted as part of the record.

MBM drew the Board’s attention to the Federal Court decision Nedship Bank N.V. v. "Zoodotis" (The) (2000), 2000 CarswellNat 1238 which concerned a similar situation relating to ship sale priorities determination. In light of this decision, as well as a Practice Notice stating that "If the parties are in agreement that a particular form of evidence should be accepted, the Registrar will generally accept it", the Board decided to accept both forms of evidence.

The Opposition Board found in favour of the Opponent on the issue of confusion between MesmorEyes and MESMERIZE, highlighting the similarities in the marks in appearance, sound, and in the ideas suggested by them, as well as the overlap in the nature of the wares (women’s beauty products) and channels of trade.

With respect to the channels of trade, the Board noted that Avon’s registration was not limited to any particular channels of trade. Thus, although evidence showed that the parties’ respective goods were sold through different channels (drugs stores vs. through catalogues to sales representatives or online), it is the "normal" channels of trade for such products that are considered.

The Board also found in favour of the Opponent on the issue of distinctiveness.

By Jennifer Dove

Improved Tools for IP Practitioners and Inventors

One of the more daunting tasks for any patent practitioner is to conduct a thorough search of the prior art. There are databases available that can help; some are available at no charge, while others are fee based. One of the more useful data services is that provided by the World Intellectual Property Organization (WIPO) located in Geneva, Switzerland. WIPO is a specialized agency of the United Nations and is charged with administering many of the international IP treaties, including the Paris Convention, the Patent Cooperation Treaty, the Hague Treaty on Designs, the Madrid Protocol on trademarks, the Berne Convention on copyrights, the Budapest Treaty on deposits of microorganisms, etc. Visiting the WIPO website one will find an expanding array of information that is very helpful.

The recently inaugurated WIPO Gold service provides a one-stop site where interested parties can link to information on patents, trademarks, domain names, designs, WIPO statistics relating to patents, trademarks, utility models, designs, plant varieties and microorganisms. Additionally, there are links to the individual IP laws in most countries of the world. WIPO Gold should be the first stop for anyone searching IP issues around the world.

One link is particularly useful for patent practitioners and inventors, PATENTSCOPE®. PATENTSCOPE® has been in existence for some time and has traditionally been the search engine for the PCT publication database. Through PATENTSCOPE® someone searching for information on published PCT applications had the ability to quickly find the publications of interest through the logical search engine. Additionally, searchers had the ability to browse through the PCT publications on a weekly basis just to see "what's new." As useful as PATENTSCOPE® was, until recently it was limited to searching PCT publications. Over the past months, WIPO has completely revamped the PATENTSCOPE® site and added some very useful new features.

The older PATENTSCOPE® search page is still available, although it is being phased out. Searchers looking for the traditional PCT database search can still go to www.wipo.int/pctdb/ and find the familiar site. However, by "clicking" the link at the top of the traditional page or by going through WIPO Gold or directly to www.wipo.int/patentscope/search/en/search.jsf, the new (and soon to be only) PATENTSCOPE® search page will open. The first thing a visitor will note is that the search service now goes way beyond published PCT applications. A growing list of national patent collections can now be searched via PATENTSCOPE®, including ARIPO, Cuba, Argentina, Republic of Korea, Mexico, Singapore, Vietnam, South Africa, Israel, Morocco, Spain and Brazil. The searcher can select one or all of these countries and have the search engine look at all these relevant databases.

The new search facility can search these collections for a wide range of bibliographic information as well as a full text search for key words of interest. If you have used or are familiar with the old version of PATENTSCOPE®, please be aware that the field identifiers for the new version are different from the old identifiers. Be sure to review the "HELP" tab for instruction on how to use the new system and formulate your search.

The newest feature of PATENTSCOPE® is multi-language searching. If one goes to the SEARCH tab and clicks on "Cross Lingual Expansion" in the drop-down menu, the system gives the searcher the option of entering the search query in one language (currently only available for queries in English, French, German, Spanish and Japanese) and having the system do a machine translation of the query and search the available national databases in the appropriate language. The cross-lingual feature is new and continues to be tested and expanded. The announcement of this feature and helpful links can be found in the PCT Newsletters for May, 2010.Further announcements on expansion of WIPO's search services can be found on the WIPO website as well as in future issues of the PCT Newsletter.

The information and searching needs of the IP community continue to grow and WIPO is responding to those needs with new services such as WIPO Gold and expanded and enhanced services such as PATENTSCOPE®. Any inventor or IP practitioner not familiar with the information available on the WIPO website, including those discussed above, would do themselves a favor by exploring the website and learning of all the valuable information available and all free of charge.

By David Reed

Highlights from the Amazon 1-click Decision in Canada

On October 14, 2010, Justice Phelan of the Federal Court of Canada, released his decision ("the decision") in the case of Amazon.com v. The Attorney General of Canada and the Commissioner of Patents. This decision addresses Amazon.com's appeal of the Commissioner's previous decision that Amazon's "1-click" patent application pertained to a business method and was therefore unpatentable. Justice Phelan reversed the Commissioner's decision, stating that "a business method can be patented in appropriate circumstances."

The current decision is highly significant to the prosecution of a variety of types of patents at the Canadian Intellectual Property Office (CIPO), including but not limited to so-called "business method" patents. Some highlights are listed below:

Form and Substance Examination: This refers to the Commissioner's proposed test that a claimed invention should be deemed unpatentable subject-matter if what makes it new and unobvious comprises non-statutory subject matter. However, Justice Phelan found that the Commissioner stepped outside of her jurisdiction in adopting this test. The test was held to be "confusing and unnecessary," and a departure from both recent jurisprudence and the Canadian Patent Act. Instead, Justice Phelan stated that the claims are to be interpreted in a purposive manner, as previously established, for example, in Free World Trust v. Electro Sante Inc., [2000], 2 S.C.R. 1024, a landmark Supreme Court of Canada decision on the issue of claim construction.

From the Federal Court Decision:

"A return to 'form and substance' language… is confusing and unnecessary. Further, it represents a departure from the clear direction of the Supreme Court to apply purposive construction universally."

"It is problematic to suggest that "what has been discovered" stands apart from the claims as a whole." and "It is contrary to settled law to purport to look at 'what has been invented' and 'substance' by failing to look at the invention as a whole."

"The Commissioner has simply adopted a novel legal test by which to assess patentable subject-matter. It is not supported by recent Canadian jurisprudence or the Patent Act. This is an error of law and far outside the Commissioner’s jurisdiction."

Change of Character or Condition: The decision further attempts to clarify the definition of a patentable "art," stating that, although a claim must have practical application, this requirement should be widely interpreted in light of today's "electronic age" technology. The Commissioner's heretofore interpretation of the practical application requirement was thus held to be too restrictive, since it failed to "take into account a wider definition of physical, "change in character or condition," or the concrete embodiment of an idea."

From the Federal Court Decision:

"It is important to remain focused on the requirement for practical application rather than merely the physicality of the invention."

"It is not necessary for the material objects in question to physically change into another thing."

The Commissioner’s "application of the test suggests that [a physical object] must be changed in some way. Further, her interpretation of practical application does not take into account a wider definition of physical, "change in character or condition" or the concrete embodiment of an idea."

"The Patent Act is not static; it must be applied in ways that recognize changes in technology such as a move from the industrial age to the electronic one of today."

Business Method Exclusion: Since December 2009, the CIPO's policy has been to automatically exclude business methods from patentability on the basis that business is not a field of technology. However, the current decision states that this position is without basis and again outside of the Commissioner's jurisdiction. Rather, Justice Phelan stated that it "makes an eminent amount of sense" to instead adopt the approach in the USA and Australia. That is, business methods should not be unpatentable per se, although they must still be meet the definition of "invention" in the Patent Act, typically as an art, process or machine.

From the Federal Court Decision:

"The Court concludes that a "business method" can be patented in appropriate circumstances."

"Contrary to what the Commissioner suggests, to implement a business method exception would be a "radical departure" from the current regime requiring parliamentary intervention."

"There is no basis for the Commissioner's assumption that there is a "tradition" of excluding business methods from patentability in Canada."

"There is not, nor had there ever been, a statutory exclusion for business methods in Canada as there is in the UK."

J. Phelan also hinted at what would constitute statutory subject-matter, stating:

"A mere business scheme will have no practical embodiment and, like any other abstract idea or theorem, will of course not be patentable. This is not the case with the business method claimed in the present case."

In this regard, The Federal Court appears to at least partly agree with the CIPO’s position. Chapter 12.04.02 of the Manual of Patent Office Practice (MOPOP) states that "Fields of human endeavour such as economics, commerce, accounting, record-keeping, marketing, and law are not themselves fields of technology… advances in the concepts of their practice are beyond the scope of section 2 of the Patent Act." MOPOP 12.06.02 defines a business method as "a scheme or plan for conducting commercial interactions." However, the Federal Court found that Amazon’s patent had practical application, and was therefore patentable.

Technological Requirement: The Commissioner's and the CIPO's position that a claimed invention must be "scientific or technological" in order to be a patentable art was also addressed. For example, since December 2009, the CIPO has required that the practical form of a statutory invention must be a technological solution to a practical problem (Manual of Patent Office Practice 12.04). However, once again the current decision holds that there is no reference to such a test in the Canadian jurisprudence, nor was it within the Commissioner's jurisdiction to introduce one. Furthermore, such a test, if it were introduced, was deemed to be overly restrictive, inflexible and confusing, as well as highly subjective and unpredictable.

From the Federal Court Decision:

"Technology is in such a state of flux that to attempt to define it would serve to defeat the flexibility which is so crucial to the Act."

"There is no reference to such a test in the Canadian jurisprudence… It was not within the Commissioner's jurisdiction to introduce one."

In summary, it appears that "business method" patents are once again generally considered patentable in Canada. However, a claim must still meet novelty and nonobviousness requirements, as well as being directed, in some sense, to a practical application or form. Mere business schemes, having no practical embodiment, remain unpatentable like any other abstract idea or theorem. More generally, the current decision appears to have wider implications to patent applications in other fields, such as biotechnology. For example, the "Form and Substance" test outlined in Section 13.05 of MOPOP may no longer hold as much sway during examination. Likewise, the requirement that "inventions must relate to fields of technology" as outlined in Section 12.04 of MOPOP may be clarified, relaxed, or even discarded entirely. Indeed, we expect that MOPOP Chapters 12 and 13 may eventually be rewritten in light of the current decision.

On November 15, 2010, the Department of Justice appealed the Federal Court decision to the Canadian Federal Court of Appeal. However, we believe that the current Federal Court decision should be interpreted as the "law of the land" until the Federal Court of Appeal renders its own decision on this matter. For patent applications currently undergoing prosecution at the CIPO, we therefore believe it may be prudent to review any objections raised by Patent Examiners to determine whether parts of these objections are based on practices which the Federal Court has rejected. In such cases a response to the Examiner may include an assertion that the Examiner’s position is wrong in law, citing appropriate passages in the Federal Court decision.

Although the Federal Court decision appears to favour a wider definition of the practical application requirement than was proposed by the Commissioner, we believe that it may still be prudent, when drafting a patent application for prosecution in Canada, to explicitly specify physical characteristics of the claimed invention, such as its physical nature or the physical changes in character or condition of a physical object effected by the claimed invention.

By Michael Maskery

Double Patenting in Canada

Canadian jurisprudence clearly sets forth a prohibition against double patenting. Double patenting, in Canada, is simply not limited to “same invention double patenting” which applies in situations where the claims are identical or conterminous. There is a second branch of double patenting which is referred to as "obviousness double patenting". This is a more flexible and less literal test that prohibits the issuance of a second patent with claims that are not "patentably distinct" from those of the earlier patent.

Terminal disclaimers as they exist in the U.S. are not available in Canada, and as such, during prosecution, a double patenting objection can not simply be overcome by filing a terminal disclaimer. Accordingly, when filing voluntary divisional applications, care should be taken to ensure that there is subject matter claimed in the divisional application that is patentably distinct from the claims of the parent application. For example, a double patenting objection may be issued where a specific embodiment is pursued in the parent application and a generic embodiment which encompasses the specific embodiment is pursued in a divisional application. In a recent case, the Federal Court of Appeal (2010 FCA 275) found that the Commissioner of Patents was correct to refuse a patent (divisional) for a compound because a patent (the parent of divisional application) issued for the same compound made by a specific process on the grounds of obviousness type double patenting. Likewise, a double patenting objection may also be issued where a genus is pursued in the parent application and a species is pursued in a divisional application, unless there is a specific advantage in the selection of the species over the genus which has been disclosed in the application.

One option to address any uncertainty regarding whether the claims to be filed on a voluntary divisional application are patentably distinct, is to consider adding the “divisional claims” to the parent application and filing the divisional application in response to a Restriction Requirement from an Examiner. Moreover, Applicants need to be aware of this risk of double patenting when adopting the strategy of withdrawing subject matter in a parent application and filing divisional applications in order to simply expedite allowance of an application. If the subject matter is of particular importance, Applicants should consider continuing prosecution of the subject matter in the parent application.

By Dr. Kay Palmer

Canadian Federal Court Decision: Business Methods are Patentable

On October 14, 2010, Justice Phelan of the Federal Court of Canada, released the anxiously awaited decision ("the decision") in the case of Amazon.com v. The Attorney Ageneral of Canada and the Commissioner of Patents.  This decision addresses Amazon.com's appeal of the Commissioner's previous decision that Amazon's "1-click" patent application pertained to a business method and was therefore unpatentable.  Justice Phelan reversed the Commissioner's decision, stating that "a business method can be patented in appropriate circumstances."

The current decision is highly significant to the prosecution of "business method" patents at the Canadian Intellectual Property Office (CIPO).  Some highlights are listed below:

Form and Substance Examination: This refers to the Commissioner's proposed test that a claimed invention should be deemed unpatentable subject-matter if what makes it new and unobvious comprises non-statutory subject matter.  However, Justice Phelan found that the Commissioner stepped outside of her jurisdiction in adopting this test.  The test was held to be "confusing and unnecessary," and a departure from both recent jurisprudence and the Canadian Patent Act.  Instead, Justice Phelan stated that the claims are to be interpreted in a purposive manner, as previously established, for example, in Free World Trust v. Electro Sante Inc., [2000], 2 S.C.R. 1024, a landmark Supreme Court of Canada decision on the issue of claim construction.

Change of Character or Condition: The decision further attempts to clarify the definition of a patentable "art," stating that, although a claim must have practical application, this requirement should be widely interpreted in light of today's "electronic age" technology.  The Commissioner's heretofore interpretation of the practical application requirement was thus held to be too restrictive, since it failed to "take into account a wider definition of physical, "change in character or condition," or the concrete embodiment of an idea."

Business Method Exclusion: Since December 2009, the CIPO's policy has been to automatically exclude business methods from patentability on the basis that business is not a field of technology.  However, the current decision states that this position is without basis and again outside of the Commissioner's jurisdiction.  Rather, Justice Phelan stated that it "makes an eminent amount of sense" to instead adopt the approach in the USA and Australia.  That is, business methods should not be unpatentable per se, although they must still be meet the definition of "invention" in the Patent Act, typically as an art, process or machine.

Technological Requirement: The Commissioner's and the CIPO's position that a claimed invention must be "scientific or technological" in order to be a patentable art was also addressed.  For example, since December 2009, the CIPO has required that the practical form of a statutory invention must be a technological solution to a practical problem (Manual of Patent Office Practice 12.04).  However, once again the current decision holds that there is no reference to such a test in the Canadian jurisprudence, nor was it within the Commissioner's jurisdiction to introduce one.  Furthermore, such a test, if it were introduced, was deemed to be overly restrictive, inflexible and confusing, as well as highly subjective and unpredictable.

In summary, it appears that "business method" patents are once again generally considered patentable in Canada.  However, a claim must still meet novelty and obviousness requirements, as well as being directed, in some sense, to a practical application or form.  Mere business schemes, having no practical embodiment, remain unpatentable like any other abstract idea or theorem.  More generally, the current decision appears to have wider implications to patent applications in other fields, such as biotechnology.  For example, the "Form and Substance" test outlined in Section 13.05 of the Manual of Patent Office Practice (MOPOP) may no longer hold as much sway during examination.  Likewise, the requirement that "inventions must relate to fields of technology" as outlined in Section 12.04 of MOPOP may be clarified, relaxed, or even discarded entirely.  Indeed, we expect that MOPOP Chapters 12 and 13 may eventually be rewritten in light of the current decision.

We will await to see whether or not the Commissioner of Patents will appeal this decision to the Federal Court of Appeal. It may be recalled that the Commissioner had applied for leave to appeal to the Supreme Court of Canada a few years ago when its  decision regarding the Harvard Mouse application was overturned by the Federal Court of Appeal.  Given the Commissioner's aggressive stance on the matter, both in the current case and its recent revisions to the Manual of Patent Office Practice, it is likely that an appeal will be filed.

By Michael Maskery

CIPO Releases a Revised Chapter 16 of the MOPOP Relating to Computer-implemented Inventions

The Canadian Intellectual Property Office (CIPO) released a revised Chapter 16 of the Manual of Patent Office Practice (MOPOP) relating to computer-implemented inventions on October 1, 2010. This chapter outlines the examination practices of the CIPO with respect to computer-implemented inventions and attempts to clarify the teachings of other chapters of MOPOP, in particular Chapters 12 (relating to Utility and Subject Matter) and 13 (relating to Examination of Applications), with respect to computer-implemented inventions specifically. It is important to remember, however, that MOPOP is based on the CIPO's interpretation of the Patent Act, Patent Rules and jurisprudence available prior to the release date of the chapter. The revised chapter is available here.

Patent Applicants in Canada should at the same time be aware that there is outstanding litigation in Canada relating to statutory subject matter. Resolution of this litigation should provide further clarity to Applicants in Canada and impact CIPO's current practices with respect to statutory subject matter. Specifically, the Canadian Patent Appeal Board’s (“PAB”) decision regarding Amazon.com 1-Click, is currently under appeal to the Federal Court. The PAB decision was, and continues to be, fairly controversial, having led to, among other things, the CIPO's newly articulated practice of considering the “form and substance” of a claim to determine if the claim is patentable. In particular, if the “substance” of the claim does not relate to a “field of technology”, the claim is not directed to statutory subject matter regardless of the form of the claim. For example, in a claim to an apparatus comprising a general-purpose computer configured to perform a method, a Patent Examiner may argue that all of the parts of the computer are known or obvious and hence that the only new possible contribution is in the method. If the method is non-statutory (e.g. business methods are currently considered non-statutory by the CIPO), the claim as a whole would be rejected. The implementation by the CIPO of this new practice with respect to computer-implemented inventions can be seen in revised Chapter 16 of the MOPOP.

Given the issues pending before the Federal Court, Applicants seeking protection for computer implemented inventions should try to avoid looking solely to current CIPO practice as the deciding factor about whether to file a patent application into Canada. Moreover, Applicants should consider this outstanding litigation when developing a prosecution strategy for currently pending Canadian applications and how the Federal Court may clarify the law as grounded in Canadian jurisprudence. One of the challenges with the PAB decision regarding the Amazon.com 1-Click application, is the manner in which legal practice in the US and Europe was relied upon notwithstanding the differences in law between these jurisdictions and with the law in Canada.

By Dr. Kay Palmer

WIPO’s Service for Electronic Retrieval of Prior Filed Applications

One of the topics covered in a recent Webinar hosted by the PCT E-Services Unit on September 7th and 8th 2010, was the new Priority Document Access Service (DAS). This new service helps to reduce the amount of time required in obtaining and filing priority applications with multiple Patent Offices of second filing (these are the Offices that require a certified copy of a priority application).

The way this service works is it allows an Applicant to authorize one or more Patent Office(s) of second filing to retrieve the priority application electronically from the Patent Office of first filing. For instance, if an International Application is filed claiming priority to a U.S. patent application, this service would allow the Applicant to authorize the International Bureau to retrieve an electronic copy of the priority application directly from the United States Patent and Trademark Office to complete the requirement for a certified copy of the priority application. Please note, however, that prior to authorizing retrieval, the Applicant must first request the Office of first filing to make the priority application available to DAS (if the priority was filed in the US, Japan or Korea, the Applicant will need to file a request form). The Office of first filing will notify the Applicant when the priority document is electronically available in DAS by sending a corresponding access code. The Applicant is able to use the access code and priority application number to authorize an Office of second filing to retrieve the document.

As the service is still in its early stages, electronic availability of priority applications and their retrieval is currently limited to the following Offices: Australia, Spain, Great Britain, Japan, Korea, the United States and the International Bureau. The Chinese and European Patent Offices have been designated as next in line to make priority applications electronically available and perform retrievals, however, no notifications to date have been offered by either Office as to when this will happen. With respect to costs, according to a Representative at the PCT Safe help desk, there is currently no fee associated at the International stage with retrieving an electronic copy of a priority document, however, it is possible that the Patent Office, from which the priority application is being sought, may require a fee.

All in all it appears that plans to provide this service for other jurisdictions is currently being negotiated. Further progress in making Patent Office records electronically available is a good long-term development as it will help to simplify the filing process.

A helpful guide on how to use DAS is the September 7th and 8th 2010 Webinar, which is available here.

By Praneet Singh

Patentable Subject Matter and Claim Substance in Canada and the U.S.

On August 13, 2010, in the case of Ultramercial, LLC v. Hulu, LLC, California Central District Court Judge R. Gary Klausner ruled that U.S. Patent No. 7,346,545 “does not cover patentable subject matter.” The ‘545 patent contains two independent claims to a method for distribution of products over the Internet. Judge Klausner invalidated the patent, in part, because, “At its heart, therefore, the patent does no more than disclose an abstract idea,” and that “the additional limitations beyond the abstract idea at the core of the ‘545 patent do not limit the claimed invention in a meaningful way.”

There are some parallels between this decision and the current Canadian stance on patentable subject matter. One of the new Canadian Patent Office practices, outlined in Chapter 13 of the Manual of Patent Office Practice (MOPOP), and stemming from last year’s Canadian Patent Appeal Board’s decision on Amazon’s 1-click patent, is that the “substance” of a claim may be considered non-statutory, regardless of the claim’s form Re (Patent Application 2,246,933 (Amazon.com) (2009) C.D. 1290, Commisioner of Patents, Canadian Patent Office). For example, in a claim to an apparatus comprising a general-purpose computer configured to perform method X, a Patent Examiner may argue that all of the parts of the computer are known or obvious, and hence the only possible contribution is in method X itself. Furthermore, if method X happens to be a business method, or other non-technological method, or a description of a scientific principle or abstract theorem, the claim can be excluded from patentability.

The Ultramercial decision addressed method claims only, as opposed to apparatus or system claims. Indeed, much of the decision is dedicated to establishing that the ‘545 patent is neither tied to a machine nor transforms an article. In this regard, the Ultramercial decision does not go as far as the Patent Appeal Board did in Canada. The parallels may be a telling indicator, however, of how the comparative practices between the two countries may ultimately converge. In this regard, the 1-click decision is under appeal in Canada and the Ultramercial decision may yet be appealed in the United States. The story, it appears, is still evolving.

By Michael Maskery

Calculating Compensation for Government Expropriation

Under Section 19 of the Patent Act the Federal or any Provincial Government of Canada can apply for a compulsory license to any patent. This section has been in force for over 16 years but never used. Today the Canadian Intellectual Property Office announced a consultation on S. 19 to consider the mechanism by which compulsory licenses would be compensated. Details of the consultation process are available here.

One reason why Section 19 has not been used previously may be the existence of the Patented Medicine Price Review Board. The PMPRB currently oversees patented medicines and the prices that the patent holder can charge to the respective provincial governments. Because of the PMPRB the prices paid by Canadian Provincial Governments are often significantly lower than corresponding prices in the US, thereby reducing the economic incentive to seek a compulsory license.

While no compulsory licenses have been requested in the past, the Federal Government has indicated that it might seek a compulsory license in the event of a national health emergency. The push to produce sufficient H1N1 vaccine last year may be the factor which brought this issue back to CIPO's attention.

Any Patentee or applicant who may be subject to a compulsory license by the Federal or a Provincial Government should consider making a submission on this point before the November 8, 2010 deadline. Should you be interested in this, please contact Ariadni Athanassiadis.

By James Wagner

Recycled Use – Utility Must be Claimed and Supported

Utility

Where there is a new compound, utility can be described in the specification.  For a new use for an old compound, utility must be set out in the claims.

In AstraZeneca Canada Inc. v. Apotex Inc., 2010 FC 714 the invention at issue was a new method of separating the enantiomers of the drug Oesomeprazole.  The claim at issue was for a salt form of the (-) enantiomer at an optical purity of at least 99.8%.

J. Hughes held that the claim was directed to a previously known compound (the enantiomers had been separated previously), but at a high level of purity.  As the compound was previously known, its utility must be claimed.

[90] Even if claim 8 does not expressly claim utility, the claimed invention must possess utility. For example, one cannot simply prepare a compound, then claim it at various levels of purity, say 90%, 92%, 94%, 96%, etc., without stating why such purity level is useful. The invention is not simply a molecule or a molecule of a certain purity, it must, as the Federal Court of Appeal said in Merck & Co. v. Apotex Inc. (1995), 60 C.P.R. (31) 356 at page 373 “inherently” possess utility: (emphasis added)

Insufficiency

Insufficiency was addressed concurrently with utility.  Ultimately the general statement in the specification that an isolated enantiomer would provide “an improved therapeutic profile” was held to be the promise of the patent.

The lack of support for this promise (not even sufficient for a sound prediction), both in the specification and in the inventor’s possession, resulted in a successful challenge on this ground.

Anticipation

Prior art revealed method to separate optically distinct enantiomers, but did not describe specific purity.  Testing indicated that previous method could have been used to achieve same level of purity, but that it was not an inevitable result.  Consequently, J. Hughes held that there was no anticipation.

Obviousness

While the prior art didn’t necessarily result in higher purity levels, it showed one how to achieve them if desired, and there was expert evidence that higher purity is generally desired for pharmaceutical preparations.  Consequently, the claim of obviousness was held to be justified.

By James Wagner