The recent US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 raises possible challenges for companies attempting to obtain patent protection for diagnostic methods in the US.

The patent claim at issue in Prometheus recited a first step of administering a drug to a patient, a second step of measuring the concentration of a particular metabolite of the drug in the patient’s blood, and a third step of recognizing that a metabolite concentration above a specified threshold indicates a need to decrease the amount of drug subsequently administered, whereas a metabolite concentration below a specified threshold indicates a need to increase the amount of drug subsequently administered. Administering the drug and determining its metabolite concentrations in blood were well known in the prior art. Unknown was the proper metabolite concentration range. What the inventors had discovered was an optimal metabolite concentration range that a doctor could target by adjusting the dosage of the drug.

Although the US Patent Act extends patent protection to “any new and useful process”, established jurisprudence has long held that this provision precludes the patenting of laws of nature, natural phenomena, and abstract ideas. The Court in Prometheus characterized the relation between the metabolite concentration in the blood and the likelihood of the drug dosage being too low or too high as a natural law because this relation exists apart from any human action.

The Court then determined the discrete issue to be whether the patent claims “add enough to their statements of the correlations to allow the processes they describe to be patent-eligible processes that apply natural laws”. The Court held that they did not. The Court found that the steps of administering the drug and measuring the metabolite concentration were “well understood, routine, conventional activity…not sufficient to transform unpatentable natural correlations into patentable applications of those regularities”.

There are concerns that the Court has inappropriately expanded the scope of patent ineligible “natural laws”. The optimal concentration range of a specific metabolite for therapeutic efficacy of a specific drug is arguably distinguishable from the examples of natural laws given by the Court such as e=mc2 and the law of gravity. Since most if not all diagnostic inventions are essentially a discovery of a natural correlation between a biomarker and a medical condition, if these natural correlations cannot form the basis for a patent claim then it is unclear how any diagnostic method claim could still be patent-eligible. There are also concerns that the Court appears to have conflated the threshold issue of patent eligibility with subsequent patentability issues of novelty and non-obviousness by requiring under the patent eligibility analysis an application of the natural law that is beyond “well understood, routine, conventional activity”.

Those seeking US patent protection for diagnostic methods should carefully consider the implications of Prometheus in their claiming strategy. For example claims reciting the discovered correlation could additionally recite specific assay steps, specific reagents and/or specific devices, or improvements thereto, tailored to exploit that correlation and go beyond well understood, routine, conventional activity.

NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as legal advice. You should not rely on, or take or fail to take any action, based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Oyen Wiggs Green & Mutala LLP professionals will be pleased to discuss resolutions to specific legal concerns you may have.

Nortel sold its patent portfolio for $4.5 billion. Microsoft paid $1 billion for the majority of AOL’s patents. It is undeniable that intellectual property is often a company’s most valuable asset.

If you are considering exploiting your IP, then you should be prepared for an IP audit by potential buyers, investors or licensees. The purpose of an audit is to probe for potential weaknesses or vulnerabilities in your IP which can affect its value. Potential buyers, investors or licensees may want to ensure that you own and have the right to exploit all of the IP that they are interested in. In addition to reviewing patents and other documents that grant IP rights, an audit can include a review of assignments, licenses and other contracts, and documents related to ownership and validity of your IP assets.

To prepare for an IP audit, you should have well-organized records showing that proper steps were taken to acquire, protect and maintain your IP rights. Conducting your own mini-audit in advance can help by providing advance warning of issues that may arise. Here are a few things you can do to help ensure a smooth IP audit:

Maintain a list of your IP assets
These assets can include trademarks, patents, copyrightable works, designs, domain names and trade secrets. The IP rights may be generally worldwide (e.g. copyrightable works) but are more typically limited to the specific countries in which the rights are granted. The list of IP assets should be reviewed and updated periodically. Your IP lawyer or agent should be able to provide status reports upon request for the applications and registrations that they are handling for you.

Identify all persons who took part in creating your IP assets
Absent suitable agreements, employees, contractors, inventors, authors, joint venture partners and others who develop IP assets through their work for or with you may have claims to rights in those assets. You can avoid potential headaches by having clear written agreements in advance, such as original assignments and appropriate waivers signed by all such persons.

Non-disclosure agreements
Trade secrets are only protected if they remain secret. You may lose rights to a patent if your inventions are disclosed before your application is filed. Non-disclosure agreements can protect against an inadvertent loss of IP rights.

Document disclosures of inventions
In general, to obtain valid patent protection, an application must be filed before any non-confidential disclosure of the invention. In a few countries (including Canada and the US), valid patent protection for an invention may still be obtained if the application is filed within one year after the earliest non-confidential disclosure of the invention. It is important to record dates of non-confidential disclosures and offers for sales as these dates can determine when an application must be filed.

Document your IP use
Your right to use your IP is subject to certain laws and regulations. Depending on the jurisdiction and type of IP, you may need to exercise care and control over others’ use of your IP, mark your goods and services to bring notice of your IP rights, or use your IP in trade to prevent a loss of rights. For example, failure to mark patented products in the US can limit your ability to collect damages for patent infringement. For trademarks, failure to exercise care and control over licensees’ use of the trademark (by way of a properly drafted license agreement, for example) can result in non-distinctiveness of the trademark, which negates its registrability. You should ensure that you are properly using and marking your IP, and compile records related to or showing use of the IP by you and/or your licensees.

Keep an organized collection of all IP-related agreements
Such agreements may include licensing (in or out), non-disclosure, employment, consulting, joint venture, product development, funding and security agreements and any other agreements referred to above. These agreements may contain terms and conditions that affect ownership and/or validity of your IP assets. The agreements should be compiled and organized so that it is easy to locate and review the agreements of interest.

This is not an exhaustive list, but mentions just a few things you can do to facilitate an IP audit. For further information, please contact one of our lawyers at Oyen Wiggs Green & Mutala LLP.

NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as legal advice. You should not rely on, or take or fail to take any action, based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Oyen Wiggs Green & Mutala LLP professionals will be pleased to discuss resolutions to specific legal concerns you may have.

Canada has a deferred examination system, wherein patent applications are examined only upon request. Once examination has been requested, patent applications enter a queue. The Canadian Intellectual Property Office (CIPO) currently has a 2-3 year backlog of applications awaiting examination.

In appropriate cases, there are a few ways for an applicant to accelerate the examination of an application. Expedited examination can reduce the wait time for a first office action to as little as 2 to 3 months.

Accelerated Examination under Rule 28(1)(a)

If failure to advance the application is likely to prejudice the applicant’s rights, an applicant can ask CIPO to expedite examination of the application under paragraph 28(1)(a) of the Patent Rules. The applicant has to pay a CA$500 government fee and make a statement that failure to advance the application is likely to prejudice the applicant’s rights. The application must be published before it can receive expedited treatment. Canadian patent applications are automatically published by CIPO 18 months after the priority date. If publication has not occurred when expedited examination is requested, immediate publication can be requested.

Accelerated Examination under the Green Tech Initiative

An additional mechanism to expedite the examination of applications relating to so called “green technology” is provided under paragraph 28(1)(b) of the Patent Rules which came into force on March 3, 2011 .

Under this programme, an applicant can request expedited examination of an application by submitting a statement that “the application relates to technology the commercialization of which would help to resolve or mitigate environmental impacts or conserve the natural environment and resources”. The request does not currently require any supporting affidavit or further explanation. No extra government fee is required. In order to receive expedited treatment under the Green Tech Initiative, the application must be published.

Patent Prosecution Highway (PPH)

The Patent Prosecution Highway (PPH) is an initiative currently being used by a number of intellectual property offices around the world. The PPH provides a means of accelerating examination of patent applications where examination of a corresponding application has already been conducted by another intellectual property office and has resulted in one or more allowed claims.

CIPO currently has PPH pilot projects with the patent offices of: the United States, Japan, United Kingdom, Spain, Finland, Denmark, Germany and South Korea.

A patent application examined in the United States, Japan, United Kingdom, Spain or Finland can potentially serve as the basis for requesting expedited prosecution of a Canadian application under the PPH if:
the Canadian application claims priority to the corresponding application or vice versa,

the Canadian application and the corresponding application share a common priority document,
the Canadian application and the corresponding application are national phase applications derived from a common PCT application having no priority claim, or
the Canadian application is a divisional of another Canadian application that meets any of the above criteria.
Slightly different requirements apply for Canadian applications corresponding to Danish, German, or South Korean patent applications.

There is currently no government fee for requesting expedited prosecution under these PPH pilot projects. The request requires filling out a specific PPH request form and often requires amending the Canadian claims to conform to those allowed by a foreign patent office.

Strategic Considerations

According to CIPO’s announced service standard, the target turnaround time is the same for the three types of expedited examination, whether under Rule 28(1)(a), Rule 28(1)(b) (i.e. GreenTech), or PPH, i.e., first action within 3 months after CIPO accepts that the application qualifies for expedited examination.

A request under Rule 28(1)(a) is more generally applicable, although it requires a CA$500 government fee. Currently, requests under Rule 28(1)(b) or the PPH do not require any extra government fees.

The PPH likely has a higher rate of first action allowance since an application under the PPH contains claims similar to claims already found allowable by another patent office. The PPH might also be slightly faster because Canadian examiners know in advance that the claims to be examined have already been allowed by another patent office and so may consider PPH cases easy to move ahead.

For further information on procedures for accelerating examination in Canada, or for advice on selecting the most appropriate option for a particular application, please contact one of our lawyers at Oyen Wiggs Green & Mutala LLP.

NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as legal advice. You should not rely on, or take or fail to take any action, based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Oyen Wiggs Green & Mutala LLP professionals will be pleased to discuss resolutions to specific legal concerns you may have.

The Canadian Intellectual Property Office (“CIPO”) recently completed a consultation on proposed revisions to the Canadian Trade-marks Regulations (the “Regulations”). The stated goals of the proposed changes are to streamline and simplify opposition proceedings, and to respond to evolving business and marketing practices and streamline interactions between applicants and CIPO.

Of considerable interest to trademark applicants, the proposed amendments to the Regulations greatly expand the recognized range of subject matter that can be protected by way of a Canadian trademark application. Many readers will be familiar with the fact that sound marks are now registrable in Canada by reason of a recent Federal Court judgment, granted with the consent of CIPO. However, the proposed amendments to the Regulations provide not only for description of trademarks consisting of a sound, but also trademarks consisting of holograms, motion marks, and trademarks applied in a particular position on a three-dimensional object. The proposed amendments to the Regulations are consistent with a draft practice notice on Non-Traditional Marks circulated by CIPO in October 2010, but never formally adopted.

Hologram marks are taking on greater importance in the commercial marketplace in an effort to combat counterfeiting. Motion marks are becoming more and more important with the rise of e-commerce. Notwithstanding the increasing importance of such trademarks to brand owners, Canada has lagged behind its peers in terms of providing protection for such trademarks due to the restrictive interpretation placed on the definition of “trade-mark” in Canadian legislation.

Previously, CIPO considered that the requirement of the Trade-marks Act (the “Act”) that an application include “a drawing of the trade-mark” meant that marks that could not be depicted in a single drawing could not be registered and did not qualify as a “trade-mark” under the definition of the Act. The actual wording of the Act requires that an applicant provide “a drawing of the trade-mark and such number of accurate representations of the trade-mark as may be prescribed”. It appears that CIPO has broadened its interpretation of this provision and concluded that the present wording of the Act allows for the protection of non-traditional marks as trademarks, provided that the office is given an accurate representation of the trademark.

According to the terms of the proposed Regulations, for hologram marks, applicants will be required to state that the application is for the registration of a hologram mark, provide a drawing or drawings including one or more views capturing the holographic effect in its entirely, and provide a description of the hologram mark.

In the case of motion marks, applicants will be required to state that the application is for the registration of a motion mark, provide a drawing or drawings containing one image or a series of images depicting movement, and provide a description explaining the movement. Applicants may also provide an electronic representation showing the mark in motion.

In the case of sound marks, CIPO is currently accepting applications for such trademarks. In accordance with a Practice Notice dated 28 March 2012, applicants must state that the application is for the registration of a sound mark, provide a drawing that graphically represents the sound (presumably a sonogram), provide a description of the sound, and provide an electronic recording of the sound. The electronic recording of the sound must be in the form of an MP3 or WAVE file less than 5 MB in size and recorded on a CD or DVD.

Similarly in the case of trademarks consisting of a trademark applied in a particular position on a three-dimensional object, CIPO presently accepts applications for such trademarks and a Practice Notice dealing with three-dimensional trademarks issued 6 December 2000 covers such trademarks.

There is also a proposed provision in the draft Regulations to require the filing of a colour drawing of a trademark for which colour is claimed as a distinctive feature of the mark. Presumably, this means CIPO will now publish trademarks for purposes of opposition in colour. Currently, CIPO can receive colour drawings of a trademark with the application, but applications for regular trademarks are published in black and white.

While the proposed amendments to the Regulations are not in force and there is no clear timeline for their implementation, if CIPO has in fact concluded that non-traditional marks are trademarks under the current version of the legislation, such marks could potentially be registrable now, notwithstanding that the Regulations have not yet been implemented. Indeed, this appears to be the case for sound marks, applications for which are now being accepted by CIPO.

NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as legal advice. You should not rely on, or take or fail to take any action, based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Oyen Wiggs Green & Mutala LLP professionals will be pleased to discuss resolutions to specific legal concerns you may have.

Canadian businesses looking to expand (or which have already expanded) south of the border are well advised to consider registering their trademarks in the US.

Overall, Canada and the US have similar substantive and procedural requirements for trademark applications, however, there are some important differences of which Canadians should be aware when applying to register their mark in the US, including the following:

1. Availability of trademarks. Since Canada and the US operate separate trademark registration systems, a mark which is registrable in Canada may not be registrable in the US, and vice versa.

2. Additional filing fees for goods/services in more than one class. Whereas a Canadian application can cover any number of goods or services for the same filing fee, the US classifies goods and services into 45 separate classes. US filing fees are based on the number of “classes” of goods or services listed in the application.

3. Actual use and intention to use. Similarly to a Canadian application, a US application can be based on actual use or intention to use the mark. Where a US application is based on actual use, the application must specify both the earliest use date in the US and the earliest use date anywhere. If an applicant needs time to determine the earliest use dates, it can file an application based on intention to use and later convert the application to an actual use basis. This type of conversion is not permitted in Canada. If a US application is based on intention to use, the applicant must submit a “Statement of Use” in order to obtain a registration. The “Statement of Use” must be filed within six months of the application receiving a “Notice of Allowance”, however the applicant may request and obtain up to five, six-month extensions of this deadline. Note that if an applicant claims an intention to use without actually having a good faith intention to use the mark in the US, the application or resulting registration may be vulnerable to invalidation. Also note that for a federal registration, “use” of a trademark in the US requires use in federally-regulated commerce (e.g. interstate commerce or commerce between the US and another country, such as Canada).

4. Specimens of use. Whereas Canada does not require specimens of use for registration or renewal purposes, the US requires a specimen showing an actual example of how the trademark is being used. One specimen for each class of goods or services must be submitted prior to registration (if the application is based on actual use or intention to use) and again upon renewing the registration. A specimen can show the trademark being used on the goods, or on their packaging or labelling, or in the sale or advertising of services (e.g. signage, brochures, advertisements).

5. Non-traditional marks. While Canada is only now becoming more accepting of applications for non-traditional types of trademarks (see the article Take Advantage of Proposed Changes to Canadian Trade-marks Regulations – Non-Traditional Trade-marks also in this newsletter), the US has generally been more open to registering such trademarks. Sound marks have been registered in the US for more than 60 years. Other types of non-traditional trademarks, such as scents, holograms, motions, and textures have also been registered in the US.

6. Principal and supplemental registers. In Canada, there is a single trademark register. Federally in the US, there is both a “principal register” and a “supplemental register”. The supplemental register can provide limited trademark protection for marks which are ineligible for registration on the principal register. Marks which are “merely descriptive” of the applicant’s goods or services are generally not eligible for the principal register, but they may be eligible for the supplemental register. A registration on the supplemental register entitles the owner to use the ® symbol next to the mark, and can be cited by the USPTO against a pending application. Registration on the supplemental register is also a means of providing notice to the general public that a trademark is already “taken”.

NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as legal advice. You should not rely on, or take or fail to take any action, based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Oyen Wiggs Green & Mutala LLP professionals will be pleased to discuss resolutions to specific legal concerns you may have.

In this case, the Federal Court found that the applicant had been using its trademark PRECISION DOOR & GATE SERVICE LTD. & Design since 1997. The respondent’s applications first came to the applicant’s attention in 2005 when the respondent contacted the applicant seeking  permission to use the marks,  which was refused. At that point it was too late to oppose the applications, which had been allowed. The applicant therefore filed its own trademark application, which was rejected by the Canadian Intellectual Property Office as confusing with the respondent’s earlier filed applications. The respondent’s applications did not reach registration until 2009 and the expungement action was commenced in 2010.

The Court decided that the applicant’s trademark is confusing with the respondent’s three trademarks PRECISION DOOR SERVICE, PRECISION and PRECISION OVERHEAD GARAGE DOOR SERVICE & Design, given the identical nature of the parties’ services (i.e. garage door services) and the close resemblance of the trademarks, among other considerations. As a result, the Court found that the respondent was not the person entitled to secure registration of these trademarks, and its three registrations were declared invalid under sections 16 and 18 of the Trade-marks Act and ordered to be expunged from the register under section 57 of the Trade-marks Act. The Court also ordered payment of costs.

The respondent also argued that the applicant had acquiesced to the registrations given that it learned of the respondent’s applications in 2005. The Court rejected that argument since delay alone is not enough for acquiescence, and by rejecting the respondent’s offer to purchase its rights in the trademark , and filing its own application, the applicant had clearly not acquiesced. Thus it is advisable for a trademark owner who learns that a later user of a confusingly similar mark has applied for registration and reached allowance or registration, to file its own application as well as applying for expungement well within the statutory 5 year period from the date of registration.