Topic in search of an author

Earlier this week, a blogpost by Miri Frankel on the IPKat weblog ("Who owns a family's history? Revlon scraps with the Borgheses", here) reviewed an ongoing dispute over control over the name and indeed the family history of one of Europe's best-known families, the Borgheses.

JIPLP is looking for an author for an article that would look at the concept of "family history" as a protectable item of intellectual property law and that would review the sort of clauses which licensors or licensees might be advised to consider when seeking to monetise or commercially exploit this unusual asset.

If you think you might be a suitable author of an article on this topic, please email JIPLP's Commissioning Editor Sarah Harris here and let her know.

Malaria combination patent invalidated for obviousness

Author: Keo Shaw (McDermott Will & Emery UK LLP)

Glenmark Generics (Europe) Limited & others v The Wellcome Foundation Limited & Glaxo Group Ltd [2013] EWHC 148 (Pat), Patents Court, England and Wales, 7 February 2013

Journal of Intellectual Property Law & Practice (2013) doi: 10.1093/jiplp/jpt101, first published online: June 25, 2013

The Patents Court, England and Wales, has held that a patent for the 5:2 ratio combination of two anti-malarial drugs (atovaquone and proguanil) was obvious, based on prior art that disclosed the two drugs in combination, but not at the claimed ratio.

Legal context

The claimants, Glenmark and Mylan, sought revocation of European Patent (UK) No 0 670 719, protecting the invention of a combination anti-malarial drug, in order to clear the way for the launch of their own generic versions of the drug. The defendants were both part of the GlaxoSmithKline group of companies. The Wellcome Foundation Limited was the registered proprietor of the patent, and Glaxo Group Ltd was the patent's beneficial owner and exclusive licensee.

Facts

The patent related to an anti-malarial medication with a priority date of 26 November 1992, comprising a combination of atovaquone and proguanil in the ratio 5:2. The only ground on which the claimants contended that the patent was invalid was obviousness in relation to two pieces of prior art: a presentation by Dr David Hutchinson, one of inventors named in the patent, and an abstract from a plenary lecture by Dr A T Hudson, who also worked for the defendants.

The defendants sold a pharmaceutical composition consisting of a 5:2 combination of atovaquone and proguanil under the trade mark Malarone. The claimants wanted to launch a generic version of Malarone, resulting in the defendants counterclaiming against both for infringement. There was no dispute that the proposed products would infringe the patent if it was valid. Notably, the defendants made an unconditional application to amend the patent by deleting Claim 1 (a claim to a method of treatment using a combination of atovaquone and proguanil in any ratio), which was granted.

Analysis

There were certain areas of dispute as to what fell within the common general knowledge, the most interesting of which related to combinations. One of the claimants' experts, Professor Molyneux, gave evidence as to the benefit of additive combinations of drugs where there is some resistance to one or both drugs and an absence of any synergy, arguing that it was rational to use an additive combination in the appropriate circumstances. Arnold J agreed with this, commenting that he found a combination that was shown to be significantly synergistic in vitro (experimentation ‘within the glass’, ie in a test tube or petri dish) would encourage the skilled team to go forward to in vivo (experimentation using a whole, living organism) trials.

Arnold J continued by setting out the law on obviousness by reference to consideration of the ‘Windsurfing’ test in Pozzoli v BDMA SA [2007] EWCA Civ 588 and in MedImmune Ltd v Novartis Pharmaceuticals Ltd [2012] EWCA Civ 1234.

Arnold J then applied the test to the patent's claims. He found that there was no technical significance in the 5:2 ratio set out in the claims. The correct question therefore was whether or not it would be obvious to proceed with the development of a medication consisting of atovaquone and proguanil in combination. As the prior art disclosed the combination for the treatment of malaria and set out promising clinical trials results, the defendants needed to show that the skilled team would not proceed with the development of the combination of atovaquone and proguanil in order to be successful. Arnold J rejected the defendants' arguments that critical comments made about the findings would have deterred the team of skilled persons from investigating the combination further. He also rejected arguments claiming that the invention was not obvious because at the time few pharmaceutical companies supported such investigation on account of a perception of limited profit in anti-malarial drugs; he stated that commercial factors are irrelevant in determining obviousness. Arnold J concluded that, against the backdrop of a pressing need for new anti-malarial drugs, the skilled team would have reached the conclusion that the combination merited further investigation and that this would, in turn, have led to a formulation based on suitable proportions of the two drugs. As such, the invention was obvious.

Practical significance

This judgment is another adverse decision for combination patents at the hand of the courts of England and Wales and, once again, highlights the dangers of inventors publicly disclosing the findings of their research before a related patent application has been filed. While this is not a welcome decision for pharmaceutical combination patent owners, especially where their combination product has no other patent protection, the issue of a combination patent where the patent discloses a synergy that was not disclosed in any prior art remains to be tackled by the courts.

The German ‘Google Tax’ law: groovy or greedy?

Author: Eleonora Rosati

Journal of Intellectual Property Law & Practice (2013) 8 (7): 497. doi: 10.1093/jiplp/jpt086

On 22 March 2013, after passing the Bundestag, the German Bundesrat approved a piece of legislation known as Leistungsschutzrecht für Presseverlege (LSR). The act extended press publishers' copyright by providing them with an ancillary right over news contents.

Google Tax: backed
by her coalition
This piece of legislation, which has come to be known in jargon as the ‘Google Tax’ law, was backed by Chancellor Merkel's ruling coalition and is intended to recoup some of the revenues traditional news publishers have lost to the web. According to two studies by the Iowa University and ETH and Boston University respectively, not only are news aggregators unlikely to have complementary effects on the number of visits received by newspapers' homepages, but rather appear to have a substitution effect, which is said to have contributed to declining online traffic in the past few years.

The newly created sections 87f, 87g and 87h of the Urheberrechtsgesetz shall provide for the exclusive right of press publishers to exploit their contents commercially for one year, thus preventing search engines and news aggregators from displaying excerpts from newspaper articles without paying a fee.

Shortly prior to its approval, the text of the bill was amended to the effect that—contrary to the original proposal—no fees will have to be paid for displaying single words or short-text snippets. However, the text approved by the German parliament does not clarify the length required to fall within this exemption. While texts shorter than a headline might be thought to qualify, uncertainty over this point might result in litigation ensuing before the German courts.

Besides considerations pertaining to the possible impact of the LSR on fundamental rights such as freedom of information, it is apparent that this law might also set an important precedent elsewhere in Europe (to say the least).

It is worth recalling that a few months ago France was also considering adopting a bill that would require payment of a fee for displaying links to and snippets of newspaper articles. Eventually, similarly to what happened in Belgium, no such law was adopted, as Google and local newspaper publishers reached an agreement that, while exempting Google from paying fees for displaying content on its News service, provided for the creation of a fund to support transformative digital publishing initiatives in France.

In any case, discussion on whether and how the display of third parties' content over aggregators and search engines should be subject to the payment of a fee is far from settled. At the moment, the possible models for regulating these activities in Europe appear to be the German legislative approach and the conclusion of private agreements between interested parties.

A solution like the German one might have the advantage of providing a general legislative framework. While this might contribute to reducing—among other things—transaction costs, it is not be excluded that this might also have anti-competitive effects, eg raising barriers to entry for smaller players and start-ups, thus contributing to consolidating the market position of established players like Google.

Although the LSR (in compliance with earlier case law) does not expressly prohibit mere linking, from a broader EU perspective the provision of a new ancillary right for press publishers might have worrisome implications, especially considering that the Court of Justice of the European Union has been asked to clarify, inter alia, whether a clickable link might constitute a communication to the public as per Article 3(1) of Directive 2001/29/EC. The forthcoming decision in Case C-466/12 Svensson (a reference from the Svea hovrätt) has the potential to have a profound impact on the way the internet functions. One of the questions referred by the Swedish court is indeed whether it is possible for a Member State to give broader protection to authors' exclusive rights by enabling ‘communication to the public’ to cover a greater range of acts than provided for in Article 3(1). Should the answer to this question be in the affirmative, then the provision of an ancillary right for press publishers would indeed appear a mild solution, if compared to the possibility for Member States to provide press publishers with actual copyright protection against use of their contents by news aggregators and alike. Should this happen, then not only media pluralism would be affected, but innovative services would be prevented from continuing to exist or even emerge. Hence, it appears that the LSR is not only a bad idea for the sake of copyright health, but looks indeed to be aimed at safeguarding certain outdated models to the detriment of breakthrough services and business solutions.

JIPLP welcomes two new Editorial Board members

JIPLP welcomes two new Editorial Board members, both from Germany. One is Karsten Königer (Harmsen Utescher). Karsten (right), who works in the firm's office in Hamburg, also holds a Physics degree and is active within GRUR. Karsten's professional profile may be read here.

The other is Wolrad Prinz zu Waldeck und Pyrmont (Freshfields Bruckhause Deringer), Wolrad (left), an IP/IT principal associate in that firm's Düsseldorf office, has maintained both an academic and a practical side to his interest to intellectual property law, as you can see from his biographical notes here.

JIPLP believes that the addition of Karsten and Wolrad will strengthen the Editorial Board by bringing to readers the benefits of their enthusiasm and energy as well as their legal experience and practical perspectives.

July issue available onlne -- and here are the contents

The July 2013 issue of the Journal of Intellectual Property Law & Practice (JIPLP) is now available in full to subscribers to the online version.  Non-subscribers are welcome to browse the content s (which are also listed below) and can purchase short-term access to any of the items published via JIPLP's website here.  Eleonora Rosati's guest editorial will soon be published in full on this weblog so that it can be read and enjoyed by all.

The contents of the July 2013 issue are as follows:

Guest Editorial

Current Intelligence

Articles

From GRUR Int.

IP in Review