Friday fantasies

Forthcoming IP events. Even though it's the summer (in the Northern hemisphere, at any rate) and there's not much going on in terms of conferences and other events, new forthcoming attractions for the rest of the year and indeed beyond continue to be added to the IPKat's Forthcoming Events list. Do check it out when you have the chance!

Grump, Dopey, Sleepy ... surely we aren't
talking about IP Ministers?
Around the weblogs. Mark Anderson's post on IP Draughts, "Snow White and the Seven Dwarfs: What is the point of IP ministers?" needs little explanation and is well worth a read. Over on IP Finance, this blogger's live post, "IP evolution: a chance to talk", has attracted a bit of dialogue on the subject of turning IP into a real asset class by providing better information about it, while Neil asks how one can value the contribution made by a design to a successful product. Via Australian barrister and IP scholar Warwick Rothnie comes a pointer to, which in turn links to what it says is the Commonwealth Government’s Online Copyright Infringement Discussion Paper July 2014. When he received this information, the Discussion Paper didn't seem to be on the Attorney General Department's website -- but it is now [if you're about to go on holiday, don't! Submissions close on 1 September]. Finally, SOLO IP takes a look at the ambitions of IPReg, the UK's regulatory authority for patent and trade mark attorneys.

Medicinal product assessment has
become increasingly sophisticated
since the days of Lewis Carroll
Medicinal product assessment: a new defence to UK patent infringement. The Legislative Reform (Patents) Order 2014 (SI 2014/1997) has now been published and affects the scope of patent infringement in the United Kingdom. This Kat would doubtless have kept tucking it away into the furthest recesses of his "things to do if only I had the time", had it not been for a prompt prompt [the first 'prompt' being an adjective, the second a noun] from Graham Burnett-Hall (Marks & Clerk), who earns a katpat for his pains.  This Order tweaks section 60 of the UK's Patents Act 1977 a bit, by adding add a new subsection 6(D). This provides that anything done in, or for the purposes of, a medicinal product assessment, which would otherwise constitute an infringement of a patent for an invention, should be regarded as having been done for experimental purposes relating to the subject matter of the invention [and therefore as not infringing the patent]. The words "medicinal product assessment" get a crisp new definition under s.60(6)(E) as being any testing, course of testing or other activity undertaken with a view to providing data for any of the specified purposes, which include obtaining marketing authorisations or complying with regulatory rules. If you are planning to retire or to change your career on or before 30 September, you don't need to know about this Order since it only comes into force on 1 October 2014. There are a few other tweaklets to the Patents Act, so do take a good look at the Order.

"Eugh!" But surely we're not
being rude about the CJEU ...
The Unitary Patent and Unified Patent Court are words that are never far from the heart and mind of Rechtsanwalt and IP enthiusiast Ingve Björn Stjerna. Ingve informs us of his latest article, this time on the hearing of the Spanish actions before the Court of Justice of the European Union to challenge the validity and legal basis on those two planks of the new European patent regime. You can read "“Unitary patent“ and court system – The oral hearing on Spain’s actions at the CJEU" here in English and, under its German title „Einheitspatent“ und Gerichtsbarkeit – Die mündliche Verhandlung der Klagen Spaniens beim EuGH" here. Ingve attended the hearing in Luxembourg, his impression being that it was not too conclusive in relation to the Court’s position. If you've not already taken a look, Ingve's archive of interesting bits and pieces concerning patents in the new Europe can be accessed here [Merpel draws the attention of readers to the dictionary entry for EUGH here].
Friday fantasies Friday fantasies Reviewed by Jeremy on Friday, August 01, 2014 Rating: 5


  1. Medicinal products:
    The section is very short, but I assume someone's thought about all the complexities

    - is selling the patented medicinal product to someone who wants to do an assessment included in the exclusion?
    - are devices such as pacemakers included in the term medicinal product?
    - are assessments for 'general' methods of delivering any medicinal product (e.g. a new type of syringe or a new administration schedule) covered by the exclusion? Presumably OK as long as linked to a specific medicinal product
    - is the CJEU SPC case law on whether adjuvants are medicinal products imported into the section?

    I'm assuming the exclusion covers research tools, and selling the means to carry out the research tool, etc.

  2. On Unified Patent Court:

    I haven't read most of information given in the links, nevertheless will dare to suggest that a part of Spain arguments would be circumvented IF the Unified Patent Court had two chambers: administrative one for appeals from the EPO decisions and civil one for infringement cases, etc.

  3. In answer to 1st anon:

    1. No. Selling is for the purpose of making money. The purchase for the purpose of testing would be okay though! Problem? No, make your own. The question was answered in Austria, possibly referred/appealed.

    2. No. A pacemaker is not a medicinal product, whcih is defined as "Any substance or combination of substances presented for treating or preventing disease in human beings." And no, a medical device is not considered a vombination of molecules.

    3. No. "done in or for the purposes of a medicinal product assessment". The assessment you are referring to is for a device, not the medicinal product delivered by the device.

    4. Q: Does the CJEU case law defined an adjuvant as a medicinal product according to the Directive? In any case, what assessments would this apply too? If an adjuvant is patented (are they), then possibly applies, but if it is medicinal product + adjuvant then exemption applies due to testing of drug.

  4. Thank you anonymous of 22:26. I've just found the relevant part of Directive 2001/83/EC. Interesting that the substances can be micro-organisms. I assume therefore they can also be stem cells.

  5. I should add to my answers that Ans 1. is subject to debate, but it has always been my interpretation of such exemptions. Some may desire to read the exemptions as covering the sale in order to level the playing field for those that don't have the resources to manufacture their own drugs.

    However, they could always hire some chemists, or buy material direct from the originator or the pharmacies.

  6. Why is an exclusion from infringement being used to promote clinical trials? Surely compulsory licencing would have been better so that patentees would have received some compensation? Is this driven by an overly-powerful pharma industry? I know that the same exclusion is in place in many other territories, but we don't want to become a place that attracts industries due to holes in our patent system. Presumably this also detracts from our TRIPS obligations to provide patent protection for all industries.

  7. No, it isn't driven by an over-powerful pharmaceutical industry. Your statements are simply contradictory. Pharma ARE the patentees.

    Have a think and come back and I'll answer the compensation point.


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