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.

May JIPLP online in time for INTA

The May 2013 issue of the Journal of Intellectual Property Law & Practice (JIPLP) is available in full to online subscribers.  Non-subscribers can purchase limited time access to any number of individual items -- articles, current intelligence notes and book reviews -- from the JIPLP website here.  The full contents of the most recent issue can be reviewed online each month here.

In the May issue -- which contains content from Canada, the EU, Germany, Hungary, India, Scotland, Thailand, the United Kingdom and the United States--  you'll find the following:

Guest Editorial

Current Intelligence

Articles

From GRUR Int.

IP in Review

European trade mark law, Quo Vadis?

While the issue which it leads has not yet been published, Willem Leppink's guest editorial, "European trade mark law, Quo Vadis?", is now available online. Willem, a leading member of European trade mark organisation MARQUES and a partner in the firm of Ploum Lodder Princen, Rotterdam, is a man whose opinions, based on years of experience and dedication in the field of European trade mark law, has this to say:
"On 23 January 2013 the UK Prime Minister David Cameron delivered a speech about the future of Europe and Britain's place in that future. Cameron mentioned that the first purpose of the European Union – to secure peace on the European continent – has been achieved, but that the main, overriding purpose of the EU is not to win peace but to secure prosperity.

In addition to his concerns about the Euro, Cameron said that there is a crisis in European competitiveness and a gap between the EU and its citizens that is only growing. He advocated that the single market in the EU is crucial, but that we cannot harmonize everything. In Cameron's view the EU has gone too far and some powers should flow back to the individual member states. Cameron used the example that there is no need for the working hours of British doctors to be set in Brussels. Cameron called for a flexible, adaptable and open European Union and his speech has sparked a fierce debate in the various countries of the EU. Former Belgian Prime Minister, Guy Verhofstadt, has for example warned against trying to “hold the EU to ransom”.

The debate is interesting because there is probably no right or wrong. Having grown up on the German-Dutch border and having seen the Customs checkpoints and in their slipstream the actual borders disappear, I am perhaps prejudiced about the advantages of the EU. In that border area many national differences have really vanished, of course also helped by the globalization of our society. Clear differences in food, electronics, fashion and even hairstyle on both sides of the national boundaries are simply gone.

A single market without borders requires honest competition and thus a level playing field. It will be unacceptable for a company in one EU country who has to adhere to strict environmental standards, if it has to accept the import of products that have been produced by a competitor in another EU country that is not so strict in applying its environmental standards. However, the question remains, to what extent and in how much detail should the EU harmonize the legislation of the EU member states?

Except for maybe competition and customs law, intellectual property law, and in particular trade mark law, is one of the most Europeanized areas of law. Especially after the coming into force of the European Trade Mark Harmonization Directive, the Anti-Piracy Regulation, allowing pan-European Customs border detention orders, and the Community Trade Mark Regulation (CTMR), creating the single European trade mark, most practitioners can now advise on most trade mark issues everywhere in Europe. Thus a single market for trade mark practitioners has been created.

The Europeanization of trade mark law has not led to much concern amongst European citizens about giving up national sovereignty, except maybe for the discussion around the official languages of OHIM. Most trade mark owners would even prefer further harmonization. Different opposition periods in the EU are not symbols of national culture and it is not to be expected that further harmonization there would lead to much resistance.

In my view there are two areas in trade marks where the EU and its institutions should be concerned about what Cameron calls “a lack of democratic accountability and consent”: (1) The growing role of the Court of Justice of the EU (CJEU) in the creation of trade mark law; and (2) the inability of the EU to distinguish in its legislation between counterfeits and other infringements.

Of all the EU institutions, the CJEU is the one with the most influence in European trade mark law. The CJEU goes beyond the point of giving interpretations of the legislation passed by the European legislator. The CJEU is not the only institution to be held responsible for that, as the European legislator often fails – probably as a result of too many compromises – to deliver clear and understandable legislation. The CJEU is then forced to take the decision that the legislator has failed to take, which is not an easy task for a court that mainly consists of well-respected experts on European and competition law and not with a traditional background in trade mark law.

The outcome of, for example, the Opel/Autec case, allowing a third party to put the OPEL logo on its miniature cars may seem to be reasonable, but there is hardly any trade mark lawyer who can explain the reasoning of this decision to a layperson. The judgment in ONEL, in which the CJEU had to answer the question whether use in one EU member state was sufficient to constitute genuine use of a Community Trade Mark (CTM), has created more confusion in the market than this test case sought to answer. According to the CJEU, the territorial borders of the Member States should be disregarded in the assessment of whether a trade mark has been put to genuine use in the EU. In my view this is a correct answer. From an EU point of view it is also a politically correct answer as the CTM was meant as a trade mark for a Europe without borders. However, in its considerations, the CJEU has said that it is reasonable to expect that a CTM should be used in a larger area than a national mark. In other words: the existence of national borders has not lost its relevance and it could perhaps make a difference whether a trade mark is used in two Dutch provinces, or in one Dutch and one Belgian province. This must confuse the average trade mark owner who is reasonably well-informed and reasonably observant and circumspect. The implementation of the Trade Mark Study by the Max Planck Institute into the European Trade Mark Harmonization Directive and the CTMR is a good start to move the emphasis again on the legislator rather than on the court.

The EU should also put more effort into distinguishing between counterfeits and other types of infringement. Many legislative initiatives, such as the Anti-Piracy Regulation and the Enforcement Directive have all originated from the war against counterfeits. The statistics on the trade in counterfeits justified creating rights for IP owners to request invasive and far-reaching legal measures against counterfeits. This made sense as the trade mark owner in the war on counterfeits had to take over the role of crime fighter as many governments and law enforcement agencies did not have the resources to fulfil this role properly.

However, during the legislative process and also later on, the far-reaching measures also became applicable to other forms of infringement, such as products with trade marks that just crossed the line in being confusingly similar. The Anti-Piracy Regulation was extended to any type of patent infringement and became a tool in high-tech wars between competitors trying to force each other into concluding licence agreements and thus absorbing many of the resources of the European Customs authorities. Now the Anti-Piracy Regulation will be expanded to parallel trade. Many IP owners have been satisfied about this extension to other forms of infringement beyond counterfeits.

I honestly doubt whether IP owners should be satisfied with this development. Most of the general public will understand that the fight against counterfeits requires far-reaching measures against criminals to prevent low quality and often life-threatening products from reaching consumers. There will, however, not be much support in society or the courts, including the CJEU, for far-reaching measures that can be invoked against bona fide companies and citizens, in cases that are in essence comparable to any normal civil case in which another party can be held accountable for having done something wrong.

The lack of support for far-reaching measures in non-counterfeit cases may shift to a call to limit or abolish such far-reaching measures, regardless of whether this relates to counterfeits or other infringements. Therefore the war on counterfeits can be seriously jeopardized.

If there had been a clear distinction between counterfeits and other infringements, the CJEU's judgments in Montex, Nokia and Philips, which have limited the rights of the trade mark owner to act, would not have been so disastrous for trade mark owners in their fight against counterfeits. The judgments all make sense insofar as they relate to normal infringements, but not in relation to counterfeits.

In that sense I agree with Cameron's call for a flexible and adaptable European Union …".

More books for review

JIPLP has a number of books awaiting review.  They are listed below.  If you would like to be considered as a reviewer, please email Sarah Harris at sarah.harris@oup.com and let her know before close of play on Monday 29 April.  If you have not yet written or reviewed a book for JIPLP, it would help if you could say a little bit about yourself so that we can appreciate why you wish to review it.


Thesaurus of Claim Construction (2nd Ed)
Author: Stuart B Soffer and Robert C Kahrl
Publisher: Oxford University Press
"Claim construction is a major phase of a patent litigation where the meaning and scope of the claims themselves - the invention - is determined by the court. The outcome of this definition phase is crucial to the respective infringement and invalidity positions of the parties. The Thesaurus of Claim Construction directs practitioners to cases-and in contrast to searches on more general electronic databases, only those cases-in which claim terms have previously been construed, and further to the sources of the evidence used by past courts to construe the terms in dispute. This two-volume Second Edition is updated to include over 3,500 additional entries, some of which focus on Biotechnology, Pharmacology, and Cleantech. Ordinary Skill is now included as a topic".
This title has been previously offered for review

For further details concerning this title click here

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Intellectual Liberty: Natural Rights and Intellectual Property 
Author: Hugh Breakey
Publisher: Ashgate

"Considering the steady increase in intellectual property rights in the last century, does it make sense to speak of ‘user’s rights’ and can limitations on intellectual liberty be justified from a rights-based perspective? This book philosophically defends the importance of the public domain and user’s rights through the use of natural-rights thought. Utilizing primarily the work of John Locke, it contends that considerations of natural justice and human freedom impose powerful constraints on the proper reach and substance of intellectual property rights, especially copyright. It investigates both the internal and external natural-rights constraints on intellectual property, and argues in particular for the importance to human freedom of the right to intellectual liberty - the right to inform one’s actions by learning about the world. It concludes that respect for fundamental freedom-based interests require a balanced approach to the scope, strength and duration of intellectual property rights".

For further details concerning this title click here

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International Copyright Law and Access to Education in Developing Countries
Author: Susan Isiko Strba
Publisher: Brill
"Susan Isiko Štrba offers an understanding of the legal relationship between copyright regulation and access to education in developing countries, and explores both institutional and normative ways to facilitate access to printed educational and research materials".
For further details concerning this title click here

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African Contributions in Shaping the Worldwide Intellectual Property System
Author: Tshimanga Kongolo
Publisher: Ashgate
"Africa is playing an increasingly more significant role in the domain of international intellectual property law, and this book underlines the contributions made by African countries as a group to the development of the current international IP system. 
It examines in detail their breakthrough proposals and initiatives at the WTO, WIPO and WHO with regard to IP and public health; IP and traditional knowledge, traditional cultural expressions and genetic resources; IP and biodiversity; and exceptions and limitations to copyright. Using Botswana, Burundi, Egypt, Ghana, Kenya, Mauritius, Morocco, South Africa and Tunisia as examples, it examines the systems under which these IP subject matters are protected. From a regional perspective, the book also analyses some initiatives taken by ARIPO, OAPI and the African Union to protect traditional knowledge and traditional cultural expressions, especially in relation to protection of the rights of local farming communities and breeders, regulation of access to biological resources, genetically modified organisms and the proposed establishment of the new Pan-African Intellectual Property Organization (PAIPO)".
For further details concerning this title click here

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Patenting Medical and Genetic Diagnostic Resources
Author: Eddy D Ventose
Publisher: Edward Elgar
"This well-researched book explores in detail the issue of patenting medical and genetic diagnostic methods in the United States. It examines decisions of the Patent Office Boards of Appeal and the early courts on the question of whether medical treatments were eligible for patent protection under section 101 of the Patents Act. It then traces the legislative history of the Medical Procedures and Affordability Act that provided immunity for physicians from patent infringement suits. After considering the Supreme Court’s jurisprudence on patent eligibility, the book then comprehensively sets out how the Federal Circuit and the Supreme Court have dealt with the issue, paying close attention to the Supreme Court’s recent decision in Bilski and Prometheus".
For further details concerning this title click here 

GRUR Int. in JIPLP: how to find it

Good news is always worth trumpeting about!
The question has been asked: given the much-trumpeted cooperation between the Journal of Intellectual Property Law & Practice and our German friends at GRUR Int., is there any convenient way of identifying at a glance the materials which GRUR Int. has supplied for publication in English in JIPLP?

The answer is "yes". All you have to is to click this link, and a list of GRUR Int.-supplied material will appear. Since the arrangement has only been running since the beginning of the calendar year, the list is still agreeably manageable -- though both JIPLP and GRUR Int. look forward to it growing in due course.

The jiplp weblog looks forward to bringing you a link to the JIPLP articles and Current Intelligence notes that have been published in GRUR Int. in due course.

Enantiomers are obvious even though they have unpredictable properties

Author: Suleman Ali (Holly IP, London)

Novartis AG v Generics (UK) Limited (t/a Mylan) [2012] EWCA Civ 1623, Court of Appeal for England and Wales, 12 December 2012

Journal of Intellectual Property Law & Practice (2013), doi: 10.1093/jiplp/jpt049, first published online: April 14, 2013

The Court of Appeal has upheld the finding of the High Court that an enantiomer and its use in therapy were obvious from disclosure of the racemate mixture, given that at the priority date it was standard practice in the art to resolve racemate mixtures and there was no difficulty in doing so.

Legal context

This case concerns inventive step of an enantiomer which has been resolved from a racemate mixture. Previously in H Lundbeck A/S v Generics (UK) Ltd [2008] EWCA Civ 311 and Generics (UK) Ltd v Daiichi Pharmaceutical [2009] EWCA Civ 646 the courts decided that enantiomers which had been resolved from racemate mixtures were inventive, essentially based on the difficulty of obtaining the relevant enantiomer. However, in the present case there was no difficulty in resolving the enantiomer at the priority date, and so the previous cases on enantiomers were not considered relevant. Instead the court assessed inventive step based on the criteria developed in case law for assessing inventive step of a new therapeutic molecule.

Inventive step in chemical and pharmaceutical cases will often depend on the route used to identify and characterize the relevant substance. It is also dependent on the properties the substance is found to have, though arguably the UK approach places less emphasis on this than the European Patent Office problem–solution approach to inventive step. The courts have recognized the difficulty in deriving a specific test for inventive step where the invention concerns substances that have been identified based on a series of tests in a research program, especially where the results of the tests are unpredictable. When faced with inventions where a specific substance is provided for a given use, the courts have tended to assess whether it was ‘obvious to try’ that specific substance, with ‘expectation of success’ sometimes also contributing to the analysis. The present state of the case law is expressed in the following passage from Generics (IK) Ltd v H Lundbeck A/S [2007] EWHC 1040 (Pat) which is quoted in the present judgment:
The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort in pursuing them and the expectation of success.
Facts

This is an appeal from a High Court decision in which Novartis's SPC certificate SPC/GB98/038 and the basis patent, UK Patent No 2,203,040, were found to be invalid due to lack of inventive step. The claims of the patent cover rivastigmine and its use in the treatment of Alzheimer's disease. Rivastigmine is one of the enantiomers of a compound that occurs in chiral forms, ie the compound has two distinct forms (called ‘enantiomers’) which are mirror images of each other. When such chiral compounds are first synthesized it is usually as a mixture of the two mirror forms and such mixtures are called ‘racemates’. At the priority date the racemate form of the compound was known and its use to treat Alzheimer's had been suggested. Thus the contribution made by the invention could on the face of it be seen simply as resolving the racemate to separate the chiral forms before using one of them, rivastigmine, in therapy. However, Novartis argued that selection of the racemate compound from the prior art was also an important part of the contribution.

At the priority date (4 March 1987) the resolving of racemic mixtures into enantiomers was common practice in the art and in the present case there was no difficulty in doing so. Novartis argued that the disclosure of the racemate in the prior art was in the context of a very early stage in the research, and at that stage the skilled person would not have chosen to resolve the racemate into enantiomers. Instead they would have investigated other compounds with similar structures and so it was not obvious to choose this particular racemate. Novartis further argued that extensive testing of the compound would still need to be done to determine whether it would be suitable for therapy, and there would not have been a fair expectation of the compound surviving such testing. In terms of the enantiomer itself, Novartis argued that the resolution of the racemate could not be deemed to be obvious because the properties of the enantiomers could not be predicted.

Analysis

In the judgment, Justice Kitchin discusses the relevant case law on how to approach inventive step for a therapeutic substance, and in particular discusses whether to apply a simple ‘was it obvious to try?’ approach to the steps of choosing the racemate compound and then choosing to resolve it into enantiomers. He also discusses how to consider the ‘degree of expectation of success’ that is required, but in line with the case law decides to reject using any particular test saying that ‘obvious to try’ and ‘fair expectation of success’ are not the same as the statutory question of whether the invention was obvious. He thus decides that it is more appropriate to judge obviousness based on the facts. However, his subsequent analysis of inventive step essentially amounts to an ‘obvious to try’ approach, at least in as far as selection of the racemate compound is concerned.

When looking at whether the skilled person would focus on the racemate compound, Mr Justice Kitchin's position was that the possibility of investigating other compounds did not preclude further testing of the racemate compound, which was presented as promising candidate in the prior art. When assessing the decision to resolve the racemate into enantiomers, he acknowledged that the properties of rivastigmine were not predictable, but that in itself did not make it inventive since the ‘experimentation is driven by rational technical considerations’. Further, there were good reasons for resolving the racemate into enantiomers since there was the possibility that one of them may have lower toxicity.

Novartis also ran the argument that the High Court had chosen the wrong technical effect when considering the problem–solution approach. In its view it was wrong to see the technical effect as what ‘one would expect from resolution of a chiral compound’. Instead it was use of rivastigmine for treatment of Alzheimer's disease. Mr Justice Kitchin dealt with this very briefly, essentially believing that this point added little to the previous arguments.

Practical significance

Given the facts of the case it is difficult to see how the court could have come to any other conclusion. However, taking the approach of deciding obviousness on the basis of ‘the facts of each case’ will inevitably lead to more uncertainty. In particular it is not clear when ‘fair expectation of success’ should form part of the assessment of inventive step, and for many chemical and pharmaceutical cases that will be the determining factor. Mr Justice Kitchin did not explain in his judgment why he did not consider ‘expectation of success’ when assessing choice of the racemate compound.

Clearly the judgment will have an impact on inventions concerning resolution of enantiomers, making it less likely that mere resolution of a racemate into enantiomers will be considered inventive if there are no difficulties in doing so. In particular it seems that inventive step arguments based on the advantageous properties of the resultant enantiomers will not succeed if the advantages are of the type that enantiomers could be expected to have, even though which advantage a specific enantiomer would have could not be predicted.