More on mythical creatures – FRAND and hold up revisited

Those of you who are interested in FRAND and standardisation issues will, I hope, have read with interest the twin blogs that Sophie and I put up a couple of months ago reporting on a couple of conferences about standard setting, one in Liege and one in London. The organisers of the Liege conference, the Liege Competition and Innovation Institute, have now produced a more detailed summary of the proceedings at their conference. We thought we’d draw it to your attention, and you can find it here.

Keeping a weather eye on competition and innovation

Last week we updated our CLIP of the month to an article on the theme of innovation, as considered through the lens of competition law.  Pablo Ibanez Colomo’s article focuses on the identification of harm to innovation in competition cases (across the behavioural / merger spectrum).  He distinguishes between cases where such analysis has been just one factor among many (referred to as cases where innovation considerations have had an “indirect” role), and cases where "direct" harm to innovation is central.  

This academic contribution is timely, as innovation is now a topic at the forefront of debate in competition circles.  Last month, Commissioner Vestager gave a speech addressing this topic head-on, in particular in relation to digital markets - the trend of favouring disruptive innovation over repeat innovation by an ‘incumbent’ remains evident.  

DG Comp also focuses on innovation in its recently published Competition Merger Brief.  The brief notes how innovation concerns have been key in mergers relating to industries as diverse as gas turbines (GE/Alstom) and biosimilar medicines (Pfizer/Hospira).  The discussion of the Pfizer/Hospira merger decision (see p.12 of the Merger Brief) is likely to be of particular interest to readers of this blog, as it is the first case in which the Commission has engaged in detail with the markets for biological and biosimilar drugs, concluding that they belong in the same market, but observing considerable differences compared to the dynamic between originator and generic versions of small molecule medicines.  (And for those with a deeper interest in this area, Bristows’ own 2015 Biotech Review  carried an article (by two of the regular writers on this blog) looking at how innovation, in the form of competition between pipeline products, played a significant role in a couple of earlier mergers - see p.17.)

The current concern with innovation does not extend only to product innovation, but also encompasses changing business models - another subject which is a particularly hot topic at present - with the CMA’s Alex Chisholm having recently noted the fragility of such innovation, and the challenge of ensuring “an economic and regulatory environment in which new business models and consumer-friendly innovations can emerge and thrive”.  It was this concern that late last year led the CMA to reject proposals from Transport for London that would have curtailed the advances made by Uber on London’s taxi scene. 

We at the CLIP Board will continue to keep a weather eye on discussions of innovation and competition law - just click on the “innovation” tag on our home page to see more.

Recent pay-TV developments: the dawning of a new era?

As part of the European Commission’s ongoing pay-TV investigation, it was announced last week that Paramount Pictures have offered commitments in order to address competition concerns. As we have previously discussed, the Commission’s July 2015 Statement of Objections considered that six Hollywood studios (of which Paramount is one) and Sky UK had bilaterally agreed contractual restrictions that prevent Sky from allowing EU consumers located elsewhere to access, via satellite or online, pay-TV services available in the UK and Ireland.

The Commission’s preliminary view was that these clauses restrict Sky’s ability to accept unsolicited requests for its pay-TV services from consumers located in other Member States ("passive sales") where the company is not actively promoting or advertising its services. As a result, these clauses grant BSkyB ‘absolute territorial exclusivity’, eliminating cross-border competition between pay-TV broadcasters and partitioning the internal market along national borders.

Margrethe Vestager said: "European consumers want to watch the pay-TV channels of their choice regardless of where they live or travel in the EU"

Paramount’s proposed commitments, to apply throughout the EEA, include the following:

  • When licensing its films for pay-TV to an EEA broadcaster in the EEA, Paramount would not prevent or limit a pay-TV broadcaster from responding to unsolicited requests from consumers within the EEA but outside of the pay-TV broadcaster’s licensed territory (No "Broadcaster Obligation").
  • When licensing its films for pay-TV to an EEA broadcaster, Paramount would not prohibit or limit pay-TV broadcasters located outside the licensed territory from responding to unsolicited requests from consumers within the licensed territory (No "Paramount Obligation").
  • Paramount would not bring an action for the violation of a Broadcaster Obligation in an existing agreement licensing its films for pay-TV.
  • Paramount would not act upon or enforce a Paramount Obligation in an existing agreement licensing its films for pay-TV.
If accepted by the Commission, these commitments will apply for five years and cover both online and satellite broadcast services. Paramount is the first studio to have offered commitments in an attempt to settle the Commission’s investigation; the other parties are still disputing the allegations.

Separately, it was reported recently that Sky has signed its first pan-European movie deal with Sony Pictures. While the immediate driver for the deal appears to be Sky’s acquisition of Sky Deutschland and Sky Italia from 20th Century Fox and the resulting increase in its European subscriber base, it is also likely to allow Sony to address the seemingly imminent shift in the way the EU views content licensing agreements. 
 
The background to the Commission’s investigation into the Hollywood studios is that in 2011 the CJEU held, in a case concerning the exclusive licensing of broadcasting rights for Premier League football matches on a territorial basis, that any agreement designed to stop cross-border provision of broadcasting services is deemed to be anti-competitive and prohibited by EU competition law.

What is the likely consequence for licensors?

The Commission’s investigation seems certain to have far-reaching consequences for the business model of content licensors across the EU, as splitting rights into multiple national territories as opposed to selling a single, pan-European license is a key part of many business models.

The CMA still has pharma and medical devices in its sights

The CMA has been slowly but surely opening a raft of new investigations in the pharma and medical devices industries.  

It announced last week that it is investigating suspected anti-competitive conduct in the medical equipment sector under Chapter II CA 98 and Article 102 TFEU.  An initial 6-month timetable is set down, with the CMA hoping to be in a position to decide whether to take the investigation into the Statement of Objections phase by around October.

Last week also saw the CMA announce that it is investigating anti-competitive arrangements in the pharmaceutical sector under Chapter I CA and Article 102. This will follow the same timetable. 

Just a few weeks earlier, the CMA announced another separate investigation into suspected abuses of a dominant position in the pharma sector.

The CMA recently closed a possible market investigation into possible anti-competitive causes of medicines shortages and it is possible that at least some of these investigations will be shelved before more public information is made available.  However, at least two other longer-standing pharma-industry-focused investigations remain on foot, including:

  • The investigation into possible excessive prices charged by Pfizer for phenytoin sodium, which we have been following here on The CLIP Board: a formal Statement of Objections has been sent in this case, and an oral hearing held; last week Pfizer was fined £10,000 for a procedural infringement in connection with a failure to provide information, a salutary reminder for those involved in CMA investigations in any industry, as the CMA itself points out (“The imposition of an administrative penalty [on Pfizer] […] is critical to achieve deterrence, ie to impress both on the party under investigation, and more widely, the seriousness of a failure to comply with a statutory deadline, without a reasonable excuse.”…).  A decision is due in around August 2016.
  • An investigation into possible abusive discounts which is coming towards the end of its initial phase, and should be the subject of a decision to close or proceed next month.
One case which was not shelved was the Paroxetine patent settlements case (see our earlier post here).  Following the CMA’s imposition in February of £45 million of fines, it has been confirmed that GSK and all of the generics have appealed to the CAT.  The full text of the infringement decision has still not been published by the CMA, but the notices of appeal against the CMA’s decision have appeared on the website of the Competition Appeal Tribunal.  

GSK’s appeal encompasses eight separate grounds, six of which are on issues of substantive law (with two subsidiary grounds on the fining decision).  It is evident from GSK’s appeal that the CMA has followed the Commission in proceeding on the basis of both object and effect analyses in their Article 101/Chapter I infringement decisions, as well as in claiming an abuse of dominance arising from the set of facts.  GSK is unsurprisingly appealing the finding of dominance, which arose from the identification of a relevant market limited to a single molecule.
The CMA is clearly keeping a close eye on the pharmaceutical and medical industries – and we will continue to keep a close eye on the CMA’s activities in this area.

UPDATE: International spring cleaning time to review those IPR Guidelines

For those of you who read my blog post from earlier this month on the recent flurry of international IPR guidelines announcements (see here), we thought some of you might be interested in a more in depth look at the Canadian IPR Enforcement Guidelines written by Canadian law firm McCarthy Tétrault (for a link to their interesting article see here).  

The article summarises the most notable new guidance in the Canadian guidelines – namely in relation to pharma patent litigation settlements, product switching, standard setting and SEPs and patent assertion entities.  It also contains links to previous articles discussing the evolution of the guidelines.  There are many parallels to ongoing IPR policy developments in Europe but a few differences also stand out (e.g. express discussion of the potential for criminal liability for pharma patent litigation settlements (not something that has reared its head in Europe… (yet?)) and a helpful distinction between so called ‘hard’ and ‘soft’ product switching).

The NHS opens up to increased competition

From today the NHS is likely to significantly increase the number of contracts it advertises for external competition, as it will now be required to comply with the general EU procurement regime rather than relying on a temporary exemption for healthcare services. 

For the first time, the NHS will be under a statutory obligation to advertise their healthcare services contracts. 

This is a significant change to the UK healthcare landscape, and as many readers of The CLIP Board provide services to the NHS, we thought this a development worth bringing to your attention. 
 
What happens after 18 April 2016?

The NHS’s procurement of healthcare services has, until today, been regulated by the Procurement, Patient Choice and Competition Regulations (No. 2) 2013. 

From 18 April 2016, contracts for healthcare services above €750,000 (£589,148) must be awarded in line with the Public Contracts Regulations 2015 using the “light touch regime” for social services. 

This “light touch regime” requires:
publication of a contract notice in the OJEU; and
an award procedure which complies with the EU principles of non-discrimination and equal treatment.

What does this mean?

From today we anticipate that more NHS contracts will be put out to tender than before and NHS commissioners should reflect carefully on the legal risks of not competitively procuring health services. This change presents increased opportunities for private players and healthcare charities to win business with the NHS and public health services. 

However, this change is likely be accompanied by increasing political controversy, given the contentious debate around the healthcare procurement aspects of the Transatlantic Trade and Investment Partnership.

The government has published a guidance note on the new procurement regime and we are very happy to discuss these changes in greater detail with clients. 

A relatively rare beast: CMA clearance of a pharmaceutical sector merger

The Competition and Markets Authority (CMA) has announced that it has decided not to refer the acquisition by LEO Pharma of certain dermatological products belonging to Astellas Pharma for an in-depth Phase 2 merger inquiry. The CMA concluded that the merger was unlikely to result in a substantial lessening of competition, on the basis that the companies’ products were not sufficiently close substitutes.  

There have been few recent national merger decisions in the UK in relation to the pharmaceutical sector, as many such transactions are caught by the significantly higher EU merger thresholds. Interestingly, in the other recent case, McKesson/UDG Healthcare, the EU referred the UK aspects of the proposed transaction back to the CMA to review.   

Who did the case involve?

LEO Pharma is a Danish pharma company that develops and sells dermatological products. Astellas Pharma is a Japanese pharmaceutical company that develops cancer, immunology, and dermatology products. Both companies are active on the UK market.

Why was the CMA concerned? 

The CMA took the view that a ‘relevant merger’ situation had arisen as the ‘share of supply’ test was satisfied, due to the parties' combined shares of supply of non-steroidal products for inflammatory skin disorders. As is commonly done in merger cases at EU level, it took level 3 of the of the Anatomical Therapeutic Chemical classification as its starting point for this consideration (category D5X).

What did the CMA find? 

The CMA found that, in relation to dermatological products, Leo and Astellas’s products are not the closest alternatives to each other. In relation to the supply of products in the D5X category, the parties' products are not close substitutes as they are used to treat different skin conditions. It also found that the market would remain competitive post-merger, as there will remain several competitors to constrain the merged entity. 

In relation to hydrocortisone products, the CMA found that the increment in the combined share of supply post-merger would be very small (less than 5%). The CMA also found that the parties' products are not close substitutes and that there will again remain several competitors post-merger to constrain the merged entity. 

In relation to topical psoriasis products, again the increment in the combined share of supply post-merger is very small (less than 5%), indicating that the competitive impact of the merger will very limited; and as regards the supply of topical eczema products, the parties' respective products do not compete closely and there will remain several competitors post-merger.

What does this case tell us?

This case demonstrates the importance of contesting Phase I merger reviews as there is often a reasonable prospect of a clearance decision without a referral to Phase II.

International spring cleaning: time to review those IPR guidelines…

A number of national competition agencies have recently been reviewing their IPR guidelines giving rise to some interesting trends and developments…  

On 31 March 2016 the Canadian Competition Bureau released updated IPR Enforcement Guidelines (the “Canadian IPR Guidelines”) (see here for a press release and here for the Enforcement Guidelines themselves). The main revisions to the Canadian IPR Guidelines focus on the Bureau’s position on patent settlements and product switching in the pharma sector as well as the conduct of patent assertion entities and conduct involving SEP owners.
  
This followed hot on the heels of an announcement by the Korea Trade Commission (“KFTC”) on 30 March 2016 that the Guidelines regarding the Unfair Exercise of Intellectual Property Rights (“the Korean IPR Guidelines”), which have recently been amended, became effective on 23 March 2016 (the revised Guidelines do not yet appear to be publically available in English at least).  The primary purpose of the Korean IPR Guidelines is to provide a framework for the KFTC to regulate abuse of IPRs by holders of SEPs (including in particular NPEs).   The Korean IPR Guidelines were previously amended in December 2014.  The most interesting changes at that time included de facto SEPs being included within the definition of SEPs, and the introduction of examples of abusive or unreasonable acts, including the filing for injunctive relief against willing licensees by an SEP holder that has committed to grant a license on fair reasonable and non-discriminatory (FRAND) terms.  

The most notable changes to the Korean IPR Guidelines this time around are:

  1. carving out de facto SEPs from the IPR Guidelines (stakeholders argued that the previous change to include them led to over-regulation of the exercise of IPRs); 
  2. removing the reference to the choice of governing law and dispute resolution mechanism which is unilaterally unfavourable to one party as a factor in determining whether an exercise of patent rights in unfair; and 
  3. including a standard for determining unfair refusals to license which focuses on the intent of the SEP holder, the surrounding economic circumstances and the effects of the refusal to license.
Similar developments have taken place not that far from South Korea, with China also drafting IPR Guidelines.  China’s top antitrust authority, the Anti-monopoly Commission (“AMC”) of the State Council has instructed four Chinese antitrust enforcement agencies: the National Development and Reform Commission (“NDRC”); the State Administration of Industry and Commerce (“SAIC”); the Ministry of Commerce (“MOFCOM”); and the State Intellectual Property Office (“SIPO”) to draft antitrust guidelines on IPRs.  It has reported that these agencies are finalizing their respective drafts and that they were due to submit them to the AMC by the end of March 2016.  The AMC coordinates antitrust policies in China, so it will be responsible for consolidating the drafts and issuing an integrated policy.  

The purpose of the Chinese Guidelines will be to provide guidance on when the enforcement of IPRs, and in particular patents, would contravene China’s Antimonopoly law.  China’s IPR Policy is still very much under development. However, these latest developments correlate with a growing international view that the Chinese antitrust authorities are increasingly treating IPR as an enforcement priority (although I think it is still agreed that China has some way to go before it becomes a major jurisdiction for the enforcement of IPR).  One recent example from 2014 was the Chinese Authorities’ investigation into Qualcomm for anticompetitive conduct involving its licensing of 4G SEPs (see our previous blog post here).

It is unsurprising that telecoms and pharma both come under the spotlight in all these new IPR Guidelines given the competition law issues afoot globally in both sectors. The EU Commission’s TTBE Guidelines were also updated in 2014 to include new sections relevant to pharma and telecoms (see our previous blog post here).  It is also interesting to see such a detailed approach to IP and antitrust issues being taken in other jurisdictions and that these new Guidelines are in places going further than their EU counterparts, for example in their discussion of PAEs/NPEs, SEPs and injunctions and refusal to license IPRs. 

Competition law no bar to patent licence royalties

Advocate General Wathelet has delivered a significant Opinion on the relationship between Article 101(1) and patent licences. This arose from a disputed arbitration award between Genentech and Sanofi-Aventis, and followed a reference to the Court of Justice of the European Union (CJEU), from the Paris Court of Appeal. 

The AG noted that Article 101(1) is not there to protect the efficacy of commercial arrangements, and will be engaged only where an agreement between undertakings has the object or effect of restricting or preventing competition and affects trade between member states. 

What was the case about? 

The original arbitration concerned a dispute over unpaid royalty payments under a patent licence where one of the underlying patents had been revoked. The arbitrator found that the licensee should continue to pay royalties, notwithstanding the revocation of the patent. This was on basis that the licensee had entered into the licence to enable it to use the relevant technology without the risk of litigation. The licensee contested the award. The French Court of Appeal referred various questions to the CJEU including whether paying royalties for a revoked patent had put the company at a competitive disadvantage to competitors who had not been required to pay for the technology and therefore infringed Article 101(1).

What about Article 101 and Patent royalties?

Wathelet commended the reasoning in Ottung (1989 CJEU) that an obligation to pay royalties in a licensing agreement after patent expiry “may infringe Article 101(1) TFEU where the licence agreement either does not grant the licensee the right to terminate the agreement by giving reasonable notice, or seeks to restrict the licensee’s freedom of action after termination.” 

Applying that approach, Wathelet considered that there was no infringement of Article 101(1) here, as Genentech was freely able to terminate the agreement with a “very short” notice period of two months, and its “freedom of action was not restricted in any way during the period after termination, and it was not subject to any clause preventing it from challenging the validity or infringement of the patents at issue”. He also observed that the licence contained no restrictions on the licensee’s ability to set prices or conduct research.

The AG therefore held that Article 101(1) was not engaged and that Genentech should pay Hoechst EUR 110 million in back royalties even though a licensed patent had been revoked. In the circumstances:  “the mere use of the technology at issue during the term of the licence agreement was sufficient to trigger the obligation to pay”. 

The position taken by the Advocate-General reflects the views set out in the Technology Transfer Guidelines (paragraph 184) which regards royalty arrangements in technology licences as generally outside the scope of Article 101 and falling into the realm of commercial negotiation.
 
Arbitration disputes and Article 101? 

The AG also confirmed that competition issues arising in the context of arbitrations can always be referred by national courts to the CJEU. 

He gave short shrift to arguments that dealing with Article 101(1) issues through the  preliminary ruling process would infringe French law. It had been argued that French law prevented international arbitration awards being subject to judicial review, save in circumstances where there has been a flagrant infringement of international public policy. 

The AG considered that the CJEU was bound to give a preliminary ruling upon request by a national court, unless the request related to a fictitious dispute, or was on general or hypothetical questions, where the questions to the CJEU bore no relation to the facts.

So where does the case leave patentees?

This case is important for many patent owners and licensees, as it clarifies that Article 101(1) is not a bar to enforcing a licensing agreement and receiving royalties even when a licensed patent has been declared invalid (or, by implication, expired). 

This is in direct contrast to the US Supreme Court’s decision in Kimble v Marvel of June 2015, which confirmed that a patent holder cannot charge royalties for the use of his invention in the US after its patent term has expired. 

It will be interesting to see the CJEU’s final decision, as AG opinions are only persuasive (but in practice usually followed).

Genentech Inc. v Hoechst GmbH, formerly Hoechst AG, Sanofi-Aventis Deutschland GmbH (Case C-567/14).

Digital Single Market – geo-blocking of digital content

The Competition Commissioner, Margrethe Vestager, has today published her initial findings on geo-blocking, as part of the ongoing e-commerce sector inquiry. The inquiry, which was launched in May 2015, forms part of the Commission-wide digital single market initiative (see our previous posts here, here and here).
The Commission has found that geo-blocking is widespread in the EU, particularly for digital content. Geo-blocking is a technical practice which prevents consumers from accessing online content based upon residence.  Technical restrictions which prevent consumers from purchasing goods from other countries are considered alongside content restrictions in this report.  The fact sheet, and accompanying press release, provide significant insight as to how EU competition law may apply to such practices.

First, the Commission recognises that unilateral business decisions not to sell into different territories, when made by a non-dominant company, do not raise competition law issues. However, the Commission fails to comment on whether unilateral geo-blocking by dominant companies could be anticompetitive, leaving the door open for future enforcement… 

Second, the Commission reiterates its concern that geo-blocking linked to agreements between suppliers and distributors may be anticompetitive. The Commission found that 12% of retailers and 59% of digital content providers face contractual restrictions to geo-block.  Vestager indicates that DG Competition will be taking a closer look at these arrangements.  She accepts that there may be legitimate reasons to geo-block but plans to address ‘unjustified barriers’ (without indicating what they might be).  

Looking ahead, it will be interesting to see how Vestager’s findings fit in with the broader digital single market initiative. Particularly in relation to digital content, and in the context of the Commission’s ongoing Hollywood Studios Investigation, little headway can be made without reform of copyright law – there have already been a number of legislative proposals in that area, with further proposals due in May. 

Vestager today promised that the Preliminary Report in the e-commerce sector inquiry is on the horizon, due to be published in mid-2016. In the meantime, we will be assimilating the full report, and picking up on points of interest.  So watch this space…

Francion Brooks