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Global Media and Communications Watch

The International Legal Blog for the Tech, Media and Telecoms Industry

Posted in Artificial Intelligence, Data Protection & Privacy Mark BrennanBret CohenFilippo Raso

NIST Seeking Input on AI Technical Standards by May 31, 2019

On May 1, 2019, the National institute of Standards and Technology (NIST) announced a Request for Information (RFI) in the Federal Register regarding ongoing efforts to develop technical standards for artificial intelligence (AI) technologies and the identification of priority areas for federal involvement in AI standards-related activities. Responses to the RFI are due by May 31, 2019.

The RFI comes in response to President Trump’s Executive Order to Maintain American Leadership in Artificial Intelligence, which among other actions directs NIST to develop a plan to guide the federal government’s engagement with initiatives to develop technical standards for AI technology. This RFI, along with others released by this Administration, reflect a desire to promote AI technologies that enhance America’s interests and strengthen the public’s trust and confidence in AI.

According to the RFI, NIST is seeking input from a variety of stakeholders, including industry, academia, and civil society, with the hopes of understanding more fully the following topics:

  • The current status and plans regarding the availability, use, and development of AI technical standards and tools in support of reliable, robust, and trustworthy systems that use AI technologies;
  • Needs and challenges regarding the existence, availability, use, and development of AI standards and tools; and
  • The current and potential future role of Federal agencies regarding the existence, availability, use, and development of AI technical standards and tools to meet the nation’s needs.

To achieve a better understanding of the points above, NIST identifies 18 specific topics that it considers to be the “major areas” about which it needs more information. NIST categories these topics into three groupings:

  • AI Technical Standards and Related Tools Development: Status and Plan
  • Defining and Achieving U.S. AI Technical Standards Leadership
  • Prioritizing Federal Government Engagement in AI Standardization

NIST will also be gathering information from the public through additional means, including public workshops, and it plans to release the draft Plan for public comment. It has also published a page dedicated to the AI Standards effort.

Visit the Hogan Lovells Artificial Intelligence Topic Center for notable developments and thought leadership on the promises and perils of artificial intelligence.

 

Posted in International/EU privacy

South Africa Data Protection Regulations Expected to Take Effect in 2019

Although South Africa’s first comprehensive piece of data protection legislation, the Protection of Personal Information Act (POPIA), was originally signed into law in November 2013, the substantive provisions of the law have not yet taken legal effect. That is likely to change since South Africa’s data protection authority, the Information Regulator, published the final draft of its POPIA regulations in December 2018.

Although the Information Regulator has not indicated exactly when those regulations will become final, it has indicated that the full implementation of POPIA should follow shortly thereafter. Section 114 of POPIA provides that once the law is fully implemented, its substantive provisions will become enforceable after a one-year transitional period. So, to the extent that the POPIA Regulations are finalized at some point in 2019, its substantive provisions will become enforceable one year later in 2020.

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Posted in Policy & Regulation

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed rule for FY 2020

On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020 (Proposed Rule), to be published in the Federal Register on 3 May 2019.

In addition to the annual updates made to the IPPS and the LTCH each year as part of this Proposed Rule, CMS also proposes or asks for information about a number of changes to the new technology add-on payments (NTAPs) under the IPPS, including:

  • Changes to increase the calculated add-on payment for devices with NTAP designation.
  • A new NTAP pathway for devices that are part of the U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program.
  • A request for comment on CMS’ approach to reviewing the substantial clinical improvement criterion for NTAP or transitional pass-through payment applications under the IPPS and outpatient prospective payment system (OPPS), respectively.

Read More: CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed rule for FY 2020

Posted in Internet, Policy & Regulation David Taylor

The European Union adopts a new .EU Regulation

On 19 March 2019, the European Union adopted Regulation (eu) 2019/517 of the European Parliament and of the Council of 19 March 2019 on the implementation and functioning of the .eu top-level domain name and amending and repealing Regulation (EC) No 733/2002 and repealing Commission Regulation (EC) No 874/2004, otherwise known as the .eu Regulation.

Background

As its name indicates, the Regulation repeals its predecessors which were considered no longer adapted to the market, the political and legislative context and the online environment.  With this Regulation the European Union has sought to future-proof the regulatory framework, in light of the fast-changing environment, and to promote the digital single market.

The Regulation also seeks to strengthen collaboration between the Registry, the European Union Intellectual Property Office and other EU agencies in order to combat speculative and abusive domain name registrations and to provide simple administrative procedures for small and medium enterprises.

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Posted in International/EU privacy Patrice NavarroElisabethann Wright

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. One of the most disconcerting areas of divergence between EU Member States is the different national positions on whether patient consent is a valid legal ground for processing personal data in clinical trials.

Because clinical trials involve the use of “data concerning health,” controllers must cumulatively respect both the provisions of Article 6 GDPR governing the basis on which data may lawfully be processed and the conditions provided in Article 9 GDPR governing the processing of special categories of personal data, including data concerning health. A basic legal requirement that pharmaceutical and medical device companies conducting clinical trials must always respect when conducting a clinical trial is the obligation to obtain patients’ consent to their participation for clinical trials.

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Posted in Consumer Privacy Mark BrennanJulian Flamant

CCPA Amendments Advance through California Assembly

A number of legislative proposals seeking to amend the California Consumer Privacy Act (CCPA) are moving forward following an April 23 hearing before the California Assembly’s Committee on Privacy and Consumer Protection in which the bills were approved. The bills will now advance to the Assembly’s Appropriations Committee before being voted on by the full Assembly and potentially advancing to the California Senate for consideration.

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Posted in Advertising Anthonia GhalamkarizadehEugene Low

Webinar recording: From homes to stadiums – Brand presence in esports

Last month, our IP Outlook webinar series looked at the emerging opportunities and risks for brand owners exploring opportunities in the esports market: from innovative advertising and marketing activities during tournaments and within games, sponsorship of tournaments or teams, to merchandise and fan items.The recording of the webinar is now available to watch here.

What are esports?

Esports refers to competitive video gaming at a professional level, with competitors playing matches in arenas with huge live and online audiences, accompanied by match commentators. The buzz and spectacle accompanying those matches, as well as their audience reach, easily reach Olympic spheres, and outshine most traditional sports events.

The numbers speak for themselves: esports have generated over US$900 million in revenues in 2018, with revenues expected to grow to US$1.4 billion by 2020. Today, it is lined up to be the next billion dollar industry, reaching broad global audiences and attracting heavy investment and endorsement from major brands across all sectors. Meanwhile, many questions around right ownership and regulatory implications in this dynamic multi-stakeholder industry are still uncharted territory.


In January, we launched our third Global Intellectual Property Outlook, covering esports and many more legal, political and technological trends transforming the field of intellectual property.

You can read the Outlook here.

Posted in Copyright Penny ThorntonAlastair Shaw

DSM Watch: new rules for online transmissions of TV and radio programmes

On 15 April the Agriculture and Fisheries Council formally adopted the Directive on online transmissions of broadcasting organisations and retransmissions of TV and radio programmes (the “Directive”), following the European Parliament’s first-reading adoption on 28 March (which also amended the proposed Regulation to a Directive). Broadly, the Directive aims to facilitate the cross-border transmission, within the EU, of certain radio and TV programmes. Once it has been published in the Official Journal of the EU, Member States will have 24 months to implement. As with the new Copyright Directive, it is not certain whether the UK will be obliged to implement, which will depend how and when the UK leaves the EU.

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Posted in Policy & Regulation, Technology Mark BrennanBret Cohen

Consumer Horizons 2019

The Consumer industry is evolving at lightning speed, and the way consumer companies operate is shifting. From issues in supply chain to the digitalization of the consumer experience, companies are rapidly changing to keep up with consumer demands. Last year businesses in the consumer industry saw a wave of unprecedented disruption and transformation, and 2019 promises challenges of similar or greater magnitude.

In this year’s edition of Consumer Horizons, the Hogan Lovells global Consumer team identifies trends that will impact food and beverages companies, fashion and luxury goods producers, retailers, consumer electronics manufacturers, and other consumer companies throughout 2019.

Our team breaks down disruptive technology, sustainability and corporate responsibility practices, privacy and consumer data issues, shifting sales models, supply and sourcing matters, M&A and capital markets, and more – all with a look at global perspectives.

Privacy and technology topics include:

  • Technology trends that will reshape e-commerce in 2019
  • Online platforms: New proposal impacting B2B relationships
  • Blockchain: Recent developments and predictions for 2019
  • Virtual social influencers
  • 3D-printing and IP rights
  • New EU rules on geo-blocking impact all online retailers selling within the EU
  • The impact of intellectual property on artificial intelligence
  • Drones in retail
  • Data privacy laws disrupting digital ecosystem
  • Connectivity, smart technologies, and consumer data
  • Are your calls and texts compliant? An update on TCPA
  • The California Consumer Privacy Act of 2018 (CCPA): Privacy law in the U.S. is changing dramatically
  • The FTC sinks its teeth into subscription sales- ROSCA
  • Personalized shopping in Asia

Download Consumer Horizons 2019 by registering here.

For further information, please visit our Consumer Industry page on HoganLovells.com.

 

Posted in patents Dominic Hoar

UK AIPPI rapid response event: Actavis v ICOS (tadalafil) Supreme Court judgment

On 4 April 2019 Hogan Lovells hosted this event, in which Tom Mitcheson QC and Mark Chacksfield QC (who acted against each other) gave their views on the Supreme Court’s decision on inventive step in a case related to the drug tadalafil (Cialis), a PDE5 inhibitor for erectile dysfunction.

Here is a potted history of the case:

Claim 10 of the Lilly/ICOS Patent read: “Use of a unit dose containing 1 to 5mg of a compound having the structure [of tadalafil] for the manufacture of a medicament for administration up to a maximum total dose of 5mg of said compound per day in a method of treating sexual dysfunction in a patient in need thereof”. Such a dose reduced side effects and enables regular daily dosing. That is in contrast to the conventional application of ED drugs (Viagra, sildenafil), which is “on demand”.

Birss J thought the claim inventive, notwithstanding that it was the result of a clinical programme with many routine and obvious steps from a starting point of a 50mg tablet. Some key (to me) factors on the path for the skilled team were that they would:

  • not at the outset know there was a therapeutic plateau at 25 or 10mg
  • not initially know that tadalafil had a longer half-life
  • would have had no reasonable expectation that 5mg would have had a clinically-relevant effect, or one with minimal side effects

Kitchen LJ disagreed. He thought that, on the judge’s findings, the invention lay at the end of a familiar path through pre-clinical and clinical trials. The skilled team “would embark on that process with a reasonable expectation of success and in the course of it they would carry out Phase IIb dose ranging studies with the aim of finding out, among other things, the dose response relationship. It is very likely that in so doing they would test a dose of 5mg tadalafil per day and, if they did so, they would find that it is safe and efficacious. At that point they would have arrived at the claimed invention.”

On appeal to the Supreme Court, Lilly argued that the CA had not applied the test of obviousness correctly under the UK law or the EPO’s approach of finding invention where there was an unexpected technical effect (here, reduced side effects at a dose that worked). Actavis supported the CA’s view: as a matter of policy, routine work cannot be patentable.

Lord Hodge (with whom the other Lords agreed) upheld the CA’s decision.

  • He considered that the CA had been right to carry out its own evaluation of obviousness since Birss had committed an error of principle in failing to appreciate the logical consequences of his finding, that it was likely the skilled team would continue testing. Lord Hodge then carried out his own analysis of the facts, which supported the conclusion of Kitchen LJ. He noted that the claim was not limited to administration once per day and also covered on-demand use.
  • On obviousness, Lord Hodge considered that both the UK and EPO case law were glosses on the statutory test, and neither the Windsurfing nor PSA approaches should be applied mechanistically. He then set out at paragraphs 64 – 77 ten factors that were relevant in the context of the case: key ones being relied upon by Lilly being ‘surprising result’ (#7) and ‘bonus effect’ (#9), the latter not being referred to (sadly) as ‘the Brucie Bonus’.
  • The EPO and other European courts were not a burden:
    • Although the patent had been litigated elsewhere in Europe (Belgium and Portugal, and Denmark, Poland and the Czech Republic) with mixed results, he did not find the judgments helpful. Where the law was the same, courts may nonetheless come to different conclusions. Even where the evidence is the same, a court’s findings of fact based on that evidence may not be the same.
    • The EPO’s PSA is not the only method used by the EPO and is also a gloss. Nor was Lord Hodge convinced that the PSA would necessarily have given a different answer. (With the ‘necessarily’ being rather compacted – and an acknowledgement that there will sometimes be different answers)
  • On selection patents, Lord Hodge was keen not to rule them out. Efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they meet the statutory tests, even if the enquiries made as to it are otherwise well-established or routine enquiries. Further, inventive step may occur “if the selection is not arbitrary and is justified by a hitherto unknown technical effect”.
  • Yet, Tom noted, the EPO has granted patents in very similar circumstances to these: see G02/98, and T91/98 in which the unexpected and advantageous result was that the compound was effective at such low concentrations.

To me the outcome feels rather tough on the patentee. Consider Kitchen LJ’s “familiar path” through trials. Is a path really “familiar” when it takes unexpected turns (therapeutic plateau, long half-life) and ends in a surprising location (efficacy at 5mg daily with reduced side effects)? One could hardly describe as ‘familiar’ a path through woods if the features it passed were unexpected and the destination a surprise. Unexpected technical effects are often good enough at the EPO but were not good enough here, in this case.

Tom then picked up the following points:

  • Do we have a new ground of appeal: that the judge failed to appreciate the logical consequences of his finding? If so that is likely to make it easier to get an appeal up and running in the future. It is also hard to distinguish the Supreme Court’s reasoning from straightforward interference with a judge’s finding on a multifactorial test, which could have some significant consequences.
  • The English courts appear to be drifting further from the Europe courts and the EPO. In Actavis v Lilly, Lord Neuberger was keen to follow Germany, which was subsequently watered down in Warner Lambert and, now, more so. There are some parallels in current affairs, right there.
  • It hasn’t really changed the law all that much. We now have a list of ’10 factors’ that will be quoted for ever more, but no guidance as to any relative weighting to be applied to them. The Supreme Court has not given us much help in resolving similar issues in the future.
  • The decision was very different in tone to Warner Lambert and Lilly v Actavis. It was more conservative, and less certain in its rightness. There was a hint of Lord Neuberger in it. It will be interesting to see how Kitchen LJ’s voice affects the overall tenor when he joins the Supreme Court.

Mark, I think recently returned from court, chipped in with the following:

  • This is the Supreme Court stressing the statutory test for obviousness, all the rest being gloss and not obligatory. Lord Hodge will no doubt be disappointed when in five years’ time we are all quoting his 10 factors.
  • The most interesting of the factors is the interaction with the surprising and unexpected finding that efficacy could be achieved without big side-effects. Birss J had in mind that efficacy and side-effects would be expected to go hand-in-hand and that the realisation that they did not was capable of producing invention.
  • In paragraph 92 of the decision, Lord Hodge says that Conor v Angiotech “is not authority for the proposition that, in all circumstances, obviousness must be assessed by reference to the precise wording of the claim.” This sentence is likely to cause problems if it is used to dilute the basic proposition in Conor.

In summary, one could define the case (as Tom did) as “MOVE ALONG, NOTHING TO SEE HERE”. We will have to wait to see how it is applied, and whether anything more exciting arrives when the Supreme Court looks into sufficiency for Regeneron.

First published by The IPKat on 17 April 2019.