June 2013 JIPLP: the contents

The June 2013 issue of the Journal of Intellectual Property Law & Practice (JIPLP) is now available in full online.  Subscribers may access the entire content; non-subscribers can purchase limited-duration access via the JIPLP website.  The full contents of this issue are as follows:

Guest Editorial

Current Intelligence

Articles

Practice Point

From GRUR Int.

IP in Review

Dexilant not an ‘innovative drug’ under Canada's Food and Drug Regulations

Authors: Emir Crowne (Faculty of Law, Associate Professor, University of Windsor) and Lida Moazzam (Faculty of Law, Law student, University of Windsor)

Takeda Canada Inc v Canada (Health), 2013 FCA 13, 18 January 2013

Journal of Intellectual Property Law & Practice (2013) doi: 10.1093/jiplp/jpt067, first published online: May 24, 2013

A majority of the Federal Court of Appeal refused to list Takeda's acid reflux drug, Dexilant, as an ‘innovative drug’ under Canada's Food and Drug Regulations.

Legal context

Canada's data protection regime provides a degree of market exclusivity for ‘innovative drugs’ against generic competition. As stated by Justice Near in the Federal Court decision below:
Once deemed eligible for listing on the Register, an ‘innovative drug’ receives data protection consisting of two formal restrictions. Firstly, a generic drug manufacturer cannot file a submission based on a comparison to an ‘innovative drug’ within the first six years of the eight-year period after the drug has received a NOC (subsection C.08.004.01(3)(a)). Secondly, the Minister may not issue a NOC to the generic drug manufacturer before the end of the eight-year period (subsection C.08.004.01 (3)(b)). (2011 FC 1444 at para 12.)
Under s C.08.004.1(1) of Canada's Food and Drug Regulations, CRC c 870, an ‘innovative drug’ must ‘[contain] a medicinal ingredient not previously approved in a drug by the Minister’; and not ‘[be] a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.’

Facts

The medical ingredient in Dexilant is dexlansoprazole. The Minister, who had not previously approved dexlansoprazole in a drug product, refused to list Dexilant as an ‘innovative drug’ because the second limb of s C.08.004.1(1) of the Regulations had not been satisfied. As Justice Stratas noted in dissent at the Federal Court of Appeal: [
According to the Minister] DEXILANT was not an ‘innovative drug’ because its medicinal ingredient, dexlansoprazole is an enantiomer of lansoprazole. In her view, drugs containing any of the listed variations of a previously approved medicinal ingredient (here an enantiomer) can never be an ‘innovative drug’, regardless of the innovator's effort in developing the drug. Any drug containing a medicinal ingredient that is an enantiomer of a previously approved medicinal ingredient is automatically a ‘variation’. (ibid, para 17)
The Minister's refusal was upheld by Justice Near in the Federal Court (2011 FC 1444: application for judicial review dismissed).

Analysis

A majority of the Federal Court of Appeal agreed with the Minister's refusal. The term ‘variation’, as used in s C.08.004.1(1)(b), is sufficiently precise as to allow its ‘ordinary meaning’ to govern its interpretation. At para 122, Justice Dawson, writing for the majority, stated:
To aid in the interpretation of what constitutes a ‘variation’ five examples are cited in the definition of ‘innovative drug’. Salts, esters, enantiomers, solvates and polymorphs are listed as examples of molecular structures that are variations of a previously approved medicinal ingredient. The Governor in Council would have created an incoherent scheme if the enumerated examples of variations are, in some unarticulated circumstances, not variations. The interpretation that all of the listed examples are variations avoids such incoherence.
In his dissent, however, Justice Stratas argued that the wording of s C.08.004.1(1)(b) was ambiguous. The use of the phrase ‘such as’, according to him, was quite open-ended (ibid paras 49–52). According to Justice Stratas:
The more open meaning imported by the words ‘such as’ can be shown by an example. Suppose a particular regulation is aimed at reducing emissions that pollute. The regulation applies to ‘vehicles such as cars, trucks and buses’. Are all cars caught by the regulation? It may be that electric cars or hybrid cars are not covered by the regulation. Although they are literally ‘cars’, they may not be ‘vehicles’ for the purposes of the emissions regulation because they do not emit pollution or emit much less pollution than other cars. (ibid para 52)
The majority took a different approach. Substituting vehicle emissions with dog shedding, the majority noted that:
The New Shorter Oxford English Dictionary (1993 edition) defines the phrase ‘such as’ to mean ‘for example’. This is consistent with the common usage of the phrase. To illustrate, ‘I like dogs that do not shed, such as Kerry Blue and Soft Coated Wheaten terriers.’ Kerry Blue and Soft Coated Wheaten terriers are examples of non-shedding dogs. (ibid para 120).
The by-products of vehicles and canines aside, the majority then rely on the Regulatory Impact Analysis Statement (RIAS) (which accompanied the Regulations) to bolster their analysis. The RIAS states that:
The definition of ‘innovative drug’ specifically prohibits innovators from obtaining additional terms of data protection for variations of medicinal ingredients. The list of variations is not exhaustive, but rather meant to give examples of the types of variations not considered for protection. The exclusion of variations of a previously approved medicinal ingredient from the scope of protection was introduced to avoid the granting of an additional eight years of protection where an innovator seeks approval for a minor change to a drug. For other arguable variations not included in the list, such as metabolites, an assessment will be made as to whether or not approval is being sought primarily on the basis of previously submitted clinical data (i.e. without the support of new and significant clinical data) or not. This position is consistent with both NAFTA and TRIPS which only require the granting of protection for undisclosed data, the origination of which involved a considerable effort. (emphases added by the court) (ibid para 124)
According to the majority, the five enumerated substances in s C.08.004.1(1)(b) of the Regulations must therefore be considered variations of a previously approved medical ingredient (ibid para 125).

In his dissent, however, Justice Stratas would have adopted a more open-ended approach. Where the ‘controlling idea’ in s C.08.004.1(1)(b) is not whether the medicinal ingredient falls within the five categories of substance, but whether a medicinal ingredient is a ‘variation’ or not (ibid paras 57–59). What is a ‘variation’ would then depend on the circumstances surrounding the data submitted when seeking regulatory approval. Justice Stratas gives the example of an enantiomer that requires ‘little testing’ versus ‘much testing’. At para 68 he writes:
If the safety and efficacy of an enantiomer is established after only a little testing, there is a sense in which it is not all that different from the previously approved medicinal ingredient. If, on the other hand, much testing has to be done, there is a sense in which it is quite different or new when compared with the previously approved medicinal ingredient. These concepts—considerable effort in testing and difference/newness—ie at the heart of the concept of what is and is not a minor variation under subsection C.08.004.1(1).
Practical significance

The current data protection regime was enacted to implement Canada's obligations under the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). NAFTA signatories are obligated to protect pharmaceuticals which utilize ‘new chemical entities’. The majority argue that these obligations required the Governor in Council to determine what constitutes ‘new chemical entities’ when crafting the Regulations. Any under inclusiveness of the regime must be remedied by the Governor in Council, and not the courts. At para 131 the majority states that
It was open to the Governor in Council to decide, as a matter of policy, that salts, esters, enantiomers, solvates and polymorphs were not sufficiently different to be ‘new chemical entities’. If, as the appellant argues, the data protection regulations are under inclusive, this is a matter for the Governor in Council to remedy. This Court ought not to thwart the decision of the Governor in Council as expressed in the definition of ‘innovative drug’ and in its rejection of the request by the innovative drug industry that data protection be extended to salts, esters, enantiomers, solvates and polymorphs.
In his dissent, Justice Stratas argues that the Minister's interpretation of s C.08.004.1(1)(b) as to make the five categories of substance mandatory and absolute examples of ‘variations’ will run counter to Canada's NAFTA and TRIPS obligations (ibid para 96). Instead, he refers to two particular aspects of TRIPS and NAFTA, which ensure that innovators get data protection only where the public will benefit: namely, ‘considerable effort’ and ‘new chemical entity’. He writes that:
Neither TRIPS nor NAFTA define these terms. However, the concept behind them can be seen from the foregoing analysis. Trivial efforts, such as perfunctory and simple testing, do not warrant protection. Similarly, engaging in considerable efforts to test enantiomers which differ little from a racemic mixture or each other in safety or efficacy—in every relevant sense, old chemical entities—does not warrant protection. In both cases, an innovator would receive the large reward of protection in circumstances where it incurred little risk. That is not what the TRIPS and NAFTA provisions are aimed at. Instead, they are aimed at altering the risk-reward equation for innovators, giving them an incentive to undertake considerable effort in circumstances where the safety and efficacy of a candidate drug are uncertain.
‘Considerable effort’ within the drug approval process, consistent with the purposes of the relevant provisions of TRIPS and NAFTA, must mean new and significant evidence bearing upon the safety and efficacy of the drug. ‘New chemical entity’ must mean that the medicinal ingredient in the drug is ‘new’ in the sense that it has qualities of safety and efficacy materially different from a previously approved medicinal ingredient. Both these meanings implement the purposes of the relevant provisions of TRIPS and NAFTA: they alter the risk-reward equation for innovators, create appropriate incentives, and ensure that data protection is afforded only where the risk undertaken merits it. (ibid paras 83 and 84).

In the end, the decision is unsatisfactory. The majority have embraced the Minister's literalist approach, at the expense of Justice Strata's more responsive and reflexive open-ended interpretation. Dexilant may settle one's stomach, but it has done quite the opposite to the jurisprudence.

Amazon's use of term ‘appstore’ is not deceptive

Author: Eleonora Rosati (University of Cambridge)

Apple Inc v Amazon.com Inc, US District Court for the Northern District of California, No C 11-1327 PJH (N D Cal, 2 January 2013)

Journal of Intellectual Property Law & Practice (2013) doi: 10.1093/jiplp/jpt075, first published online: May 24, 2013

Abstract

With its order on 2 January 2013, a US District Court rejected Apple's claim that Amazon's use of term ‘appstore’ in relation to its sale of applications (‘apps’) for Android devices and the Kindle Fire (Amazon's tablet computer) was false advertising.

Legal context

Following Amazon's initiative to set up its own mobile software download service called ‘Amazon Appstore’, in 2011 Apple filed a lawsuit claiming, among other things, that Amazon's use of the term ‘appstore’ amounted to trade mark infringement, false designation of origin, false description and false advertising under s 43(a) of the Lanham Act, as well as dilution under s 43(c) of the same Act. The order rendered at the beginning of 2013 concerned Amazon's request for partial summary judgment in relation to the cause of action for false advertising.

Facts

Apple had since 2008 used its App Store to market apps for its mobile devices. In the same year, Apple applied to register the App Store mark with the US Patent and Trademark Office (USPTO). Microsoft opposed the registration, asserting that this mark could not be registered because of its generic character. At the end of 2011, the USPTO's Trademark Trial and Appeal Board suspended the opposition proceedings pending the outcome of the lawsuit initiated by Apple against Amazon earlier that year, following three unsuccessful requests that Amazon cease to use the App Store mark in relation to its mobile software download service.

At the end of October 2012, Amazon filed a motion for partial summary judgment, asking the court to decide whether it had made a false statement of fact in a commercial advertisement about its own or another's product. Apple had argued that, by using the word ‘appstore’, Amazon implied that its store was affiliated with or sponsored by Apple. By doing so, not only would have the goodwill associated with Apple been lessened, but also a substantial segment of consumers were or could have been deceived into believing that Amazon Appstore was similar to Apple App Store. As a result of this deception, consumers could have altered their own purchasing decisions, with revenues being unduly diverted from Apple to Amazon.

Analysis

As mentioned by the court, an action for false advertising under s 43(a) of the Lanham Act has five elements: (1) a false statement of fact by the defendant in a commercial advertisement about its own or another's product; (2) the statement actually deceived or has the tendency to deceive a substantial segment of its audience; (3) the deception is material, in that it is likely to influence the purchasing decision; (4) the defendant caused the false statement to enter interstate commerce; and (5) the plaintiff has been or is likely to be injured as a result of the false statement, either by direct diversion of sales from itself to defendant or by a lessening of the goodwill associated with its products.

What was disputed in this case was solely the first element of the action, that is, whether Amazon had made a false statement of fact in a commercial advertisement about its own or another's product.

Judge Hamilton found that Apple had produced no evidence to support the proposition that Amazon had made a false statement about the nature, qualities or characteristics of Amazon Appstore. In particular, the mere use of the term ‘appstore’ by Amazon to designate a site for viewing and downloading or purchasing apps could not be intended as a representation that the nature, characteristics or qualities of Amazon Appstore were the same as that of Apple App Store. In particular, Apple had failed to demonstrate that consumers either understood the term ‘appstore’ as including specific qualities or characteristics or attributes of Apple App Store, or were misled by Amazon's use of this term.

Practical significance

Although the court has yet to decide whether Amazon infringed Apple's trade mark, the order that dismissed the claim for false advertising is likely to have impaired Apple's chances of success in this respect.

Moreover, should the court decide in favour of Amazon, it might become difficult for the USPTO to reject Microsoft's opposition asserting the generic character of the term ‘appstore’. This could have effects also in Europe, and indeed influence the outcome of the cancellation requests that Amazon, Nokia and Microsoft filed independently with the Office of Harmonisation for the Internal Market in 2011, seeking the cancellation for invalidity of Community trade mark No 005 554 779 ‘APPSTORE’, which Apple registered in 2009 in Classes 35 and 42 of the Nice Agreement.

After INTA -- a big "thank-you"

Now that the International Trademark Association's annual Meeting is over, and all the exhibitors have packed their wares in preparation for the great trek from Dallas to their respective homes, I'd just like to express my gratitude to the team from Oxford University Press -- and JIPLP's editorial board members, readers and contributors who were present -- for their support over a very busy four days.

During the course of this week, we have been able to approach fresh authors, listen to readers' comments and generally raise awareness of JIPLP in the professional and commercial IP communities. Editorial Board members who spent time with us at the OUP booth included the indefatigable Marius Schneider, Willem Leppink and Neil Wilkof, and we welcomed many others too.

Several contributors of Current Intelligence notes and editorials acknowledged the efforts of the journal to promote their writings and to take them to a wider audience via JIPLP's @JIPLP Twitter account and this blog.  The Twitter account now has 282 followers and the blog just over 800 email subscribers, all being people who have opted in so that they can be more in touch with JIPLP via the social media.

We are already looking forward to next year's INTA Meeting in Hong Kong. See you there?

The CPVO's Schnitzer Gala

Author: Gert Würtenberger (WürtenbergerKunze, Munich)

Case C-534/10 P, Brookfield New Zealand Ltd and Elaris SNC v Community Plant Variety Office and Schniga GmbH, Court of Justice of the European Union, 19 December 2012

Journal of Intellectual Property Law & Practice (2013) doi: 10.1093/jiplp/jpt053, first published online: May 3, 2013

The CJEU confirms wide discretion of the Community Plant Variety Office (CPVO) in technical examination proceedings.

Legal context

New plant breeding results may be granted Community plant variety rights if the variety is distinct, uniform, stable and new. Whether the first three criteria of ‘distinctness’, ‘uniformity’ and ‘stability’ (the so-called DUS requirements) are satisfied is examined by the Community Plant Variety Office (CPVO) by means of a technical examination according to Article 55 of Council Regulation 2100/94 on Community Plant Variety Rights. Once the Office has reached the conclusion that an application fulfils the formal requirements, it will arrange for a technical examination by an Examination Office appointed by the CPVO. Examination Offices are usually either national authorities which examine whether national applications fulfil the requirements for grant of a national plant variety right or other institutions competent to examine whether a new variety fulfils the DUS requirements.

According to Article 55(4) the CPVO shall determine, through general rules or through requests in individual cases, when, where and in what quantities and qualities the material for the technical examination and reference samples are to be submitted. While so-called ‘technical protocols’ for the distinctness, uniformity and stability tests for certain species set up rules for the technical procedure to be followed (in principle, based on general UPOV documents TG/1/3 and the Guidelines related to those species), the request to the Applicant to submit certain material at a certain time is issued separately for each and every application.

Facts

Having examined Schniga's application in relation to fulfilment of the formal requirements, the CPVO requested that the applicant submit, within a specific period, to the Bundessortenamt—appointed as the Examination Office in this matter—the plant material required for the technical examination. The request was accompanied by the remark that the applicant was responsible for complying with all phytosanitary and customs requirements applicable to the delivery of the material. The Office did not, however, specify the requirements.

With its acknowledgement of receipt of the plant material, the CPVO informed the applicant that the material was not accompanied by a Phytosanitary Certificate and thus asked the applicant to ensure that this essential document was provided ‘as soon as possible’. Obviously, a specific time limit was not stipulated.

In order to comply with this request, the applicant submitted a so-called ‘European Plant Passport’, issued by the Plant Protection Service of Bolzano, to the Examination Office and advised that the Plant Protection Service had informed the applicant that this document serves as a Phytosanitary Certificate. While the Bundessortenamt informed the applicant a few weeks later that the material had arrived in due time and that it was appropriate for the DUS tests, it simultaneously stated that the Plant Passport provided was insufficient for the purpose of conducting the technical examination to determine whether the substantive conditions for the grant of a Community Plant Variety Right had been met. The Examination Office failed, however, to request a copy of the official certificate confirming that the material submitted was virus-free. In the third test period, that is to say three years later, it transpired that the applicant was unable to provide the requested documentary evidence as, in the interim, the material submitted in 1999 for the purpose of the technical examination was not virus-free. As a reaction to this information, the Bundessortenamt informed the CPVO that it intended to uproot the infected material in order to prevent a possible virus spreading to other plants cultivated in the fields of the Bundessortenamt. The question whether the plants were indeed virus-infected, remained open. In June 2001 the Office then informed the applicant that it had, in consultation with the Bundessortenamt, decided to authorize the submission of new virus-free plant material in order to resume the examination of the application. The Office justified its decision by the fact that its instructions regarding the phytosanitary state of the material had not been sufficiently clear.

DUS tests were continued with new material submitted in 2002, leading to grant of a right for the variety in 2006 and causing the parties Elaris and Brookfield, the licensee and the holder of a plant variety right relating to the apple variety BAIGENT, to lodge with the CPVO objections to the grant of a right to Schniga's variety, under Article 59 of Regulation 2100/94. Apart from the argument that Schniga's variety was not sufficiently distinct from the reference variety BAIGENT, they objected to the possibility given to the Applicant to submit new virus-free plant material. According to the intervening parties, the CPVO should have refused the initial application due to failure to submit material appropriate to performing the technical examination. While the Office rejected the objections and granted a Community Plant Variety Right, finding that it was sufficiently distinct from the reference variety BAIGENT and also dismissing the objections against submission of further plant material, the Board of Appeal annulled the Office's decision upon appeal by the opponents, according to Articles 67 to 72 of the Regulation. The Board of Appeal was of the opinion that Article 61(1)(b) of the Regulation did not empower the CPVO to authorize an applicant to submit new material, as in this case it had complied with the requests in an individual case.

The applicant contested this decision by an application for the annulment of the decision with the General Court, which concluded that it was in the scope of the discretion of the Office, conferred on it by Article 55(4) of Regulation 2100/94, to allow the applicant to submit new material. In cases in which the Office has not been sufficiently precise regarding the conditions to be met by an applicant, the Office may consider whether the lack of precision in its instructions to the applicant may be remedied in view of the principle of sound administration and in light of the need to ensure the proper conduct and effectiveness of proceedings. Moreover, the General Court stated that such discretion enables the CPVO to satisfy itself that its request in individual cases is clear, as this would enable other applicants to be unambiguously aware of their rights and obligations.

Analysis

The intervening parties filed an appeal before the Court of Justice of the European Union on two grounds of appeal:
* infringement by the General Court of Article 73(2) of Regulation 2100/94 and

* infringement of Article 55(4) 2100/94, read in conjunction with Article 61 (1)(b) of that Regulation.
In relation to the first ground of appeal, the appellants claimed that, by reappraising the facts, the General Court exceeded its jurisdiction in reviewing the legality of the Board of Appeal's decision. Consequently, the judgment under appeal was based on a new assessment of the significance and scope of certain correspondence of the CPVO. The CJEU did not share this opinion. Referring to established case law, the court emphasized that the General Court has a similar jurisdiction as regards the review of the legality of decisions issued by the CPVO or its Boards of Appeal. Within the limits specified in Article 63 of the Regulation, the General Court may examine whether the pertinent Board of Appeal made a correct legal characterization of the facts of the dispute, or whether its appraisal of the facts placed before it was flawed. This requires that the facts are also considered.

As far as the second ground of appeal is concerned, the CJEU confirmed its finding in Case C-38/09 Schräder v CPVO that the CPVO has broad discretion in performing its functions. Thus, the CPVO may, if it considers it necessary, take account of facts and evidence which are submitted or produced beyond the time limits. In this context, by way of analogy the court referred to case C-29/05 P OHIM v Kaul as regards the competence of the OHIM.

The CJEU also emphasized that, since the CPVO is subject to the principle of sound administration, it must examine all the relevant factors of a case with care and impartiality and gather all the factual and legal information necessary to exercise its discretion. In addition, the Office must ensure the proper conduct and efficacy of proceedings which it sets in motion. Article 55(4) lets the Office determine, through general rules or through requests in individual cases, the requirements regarding the quality and quantity of plant material as well the locality to which the plant material required for the technical examination as well as reference samples are to be submitted. The court regarded the request for submission of material as a request in an individual case, allowing the Office to decide whether the applicant may be granted another opportunity to submit fresh testing material. Such a decision must be made by observing the principles mentioned above.

Practical significance

This decision is a further cornerstone in the determination of the CPVO's scope of discretion. Having confirmed a wide scope of discretion in Case C-38/09 P Schäder v CPVO, it now had an opportunity to consider the possibilities for the Office to allow the applicant to submit new plant material in exceptional cases. According to Article 56(4) of the Regulation, technical examination shall begin no later than the date on which a technical examination would have commenced on the basis of an application for a national property right filed, on the date on which the application sent by the Office was received by the Examination Office. The Office maintains an annually updated list of dates for the submission of sample material to be used for the assessment of candidate varieties (Article 55(4)). In principle, non-compliance with these deadlines leads to refusal of the application. The reason for this policy is that the breeder should be forced to apply for plant variety protection only for those varieties which are finalized, excluding the application for unfinished varieties to the disadvantage of competing breeders. By setting strict deadlines, the applicant should be forced to ensure that the variety fulfils—on the date of application—the so-called DUS requirements, including the possibility to establish a priority date for a breeding result which, at the time of filing the application, is not yet particularly stable or uniform.

On the other hand, the applicant must have certainty about the Office's expectations regarding the requirements for quantity and quality of the material submitted for testing purposes. If the applicant submits material which does not meet the requirements necessary to ensure proper technical examination, because the Office has not been sufficiently precise in its request for submission of the requisite testing material, the variety owner must be granted a second chance to submit material, allowing the Office to perform proper examination. In contrast, the variety owner must know as soon as possible whether the variety applied-for does not yet fulfil the DUS requirements, so that it is possible for him to withdraw the application before marketing or otherwise disposing of plant material of the variety destroying novelty. The application as such does not destroy its novelty by the uncontrolled disposing of material of the variety. If this has not yet happened, a fresh application may be filed if, in the meantime, further development of the variety has ensured that all new protection requirements can be fulfilled.

JIPLP at INTA

Oxford University Press, which publishes the Journal of Intellectual Property Law & Practice (JIPLP) together with a host of other IP titles, is establishing a major presence in the Exhibit Hall for next week's International Trademark Association (INTA) Meeting -- the 135th -- in Dallas, Texas. OUP will be occupying booth #815, where you will find Rhodri Jackson, Chris Wogan and JIPLP Content Commissioning Editor Sarah Harris. In addition, editor-in-chief Jeremy Phillips tends to gravitate to that booth when he has a little time between meetings and events. If you're attending the INTA Meeting next week and one of the following applies --

  • you'd like to write an article or current intelligence note for JIPLP and want to discuss it;
  • you have comments or criticisms of JIPLP's content that you'd like to share with us;
  • you have subscription inquiries;
  • you would like to purchase or inspect an OUP intellectual property book

-- do come over and say "hello". We'll be delighted to see you.