Category Archives: Intellectual Property

My brain hurts. Just tell me what this case means…

Doing his usual Saturday morning trawl through recent cases on BAILII, IP Draughts today stumbled across the case of Accord Healthcare Ltd v Research Corporation Technologies, Inc [2017] EWHC 2711 (Ch) (07 November 2017).

In the middle of the case report (starting at paragraph 53), Birss J goes into some detail on the subject of rights of priority and assignments of inventions.  Oh no, not this subject again! Why? Because, in the words of the judge:

Accord took a wide range of points prior to the trial but by the opening its case came down to a single point.  Accord contends that the assignment of 4th February 1997 only took effect as an assignment of the bare legal title to the invention and priority claim.  What it did not do was assign the equitable or beneficial title to that property to RCT.  That equitable or beneficial title was with the University of Houston (“Houston”).  It may (or may not) have ended up with RCT later but that does not matter.  Accord submits that as a matter of law, what is required for the priority claim to be accepted in this court at this trial is that the substantive right to priority, also known as the equitable or beneficial title to that right, was with the correct party on the correct day.  The correct party was RCT and the correct day was 17th March 1997 when the international application was filed.  Accord contends that this did not happen and so the claim to priority should fail.

In very simple terms the issue that sometimes comes up is this:

  1. You file a patent application (PA), claiming the priority date of an earlier application (EA).
  2. But at the time you make PA, you were not the owner of EA. So how can you claim the priority date?
  3. If you are later party to a back-dated assignment of the EA (known in the US by the Latin name of nunc pro tunc assignments), is this good enough, if you weren’t the owner at the time that PA was made?

The isssue in the Accord case seems to be a variation on this theme, but the same underlying question arises. On the law, Birss J quoted the decision of Kitchen J in the landmark, 2009 case of Edwards v Cook Biotech, where he said:

In my judgment the effect of Article 4 of the Paris Convention and section 5 of the Act is clear. A person who files a patent application for an invention is afforded the privilege of claiming priority only if he himself filed the earlier application from which priority is claimed or if he is the successor in title to the person who filed that earlier application. If he is neither the person who filed the earlier application nor his successor in title then he is denied the privilege. Moreover, his position is not improved if he subsequently acquires title to the invention. It remains the case that he was not entitled to the privilege when he filed the later application and made his claim. Any other interpretation would introduce uncertainty and the risk of unfairness to third parties.

Nunc pro tunc! Squawk!

The Edwards case caused much fluttering in the dovecots of US patent firms, where backdated assignments seem to have been the norm.

Later UK cases qualified the Edwards case, by focusing on the English law distinction between legal ownership and beneficial ownership (a distinction that seems not to exist in the laws of many countries). In Accord, at paragraph 69, Birss J quotes himself in an earlier case (HTC v Gemalto) where he said:

Mr Mellor submitted that this [Arnold J’s reasoning in KCI] showed that as long as an applicant had, at the relevant date, what English law would characterise as a beneficial title to the invention, even if the bare legal title had not been acquired, then the applicant was a successor in title in the relevant sense. I did not understand Mr Tappin to dispute that and I think he was right not to. In my judgment if the relevant person has acquired the entire beneficial interest in the invention at the relevant time then that should be enough to satisfy the law.

Birss J cites various English patent cases to show that this is the current position under English law. This line of thinking is a bit of a fudge, as it may be possible to show beneficial ownership in the absence of a formal assignment document. It only works in countries where the law recognises a distinction between legal and beneficial ownership (a common law concept) such as England and the USA.

In Accord, Birss J heard evidence on US law from a galaxy of stars, including several retired US patent judges and Mr Chisum of Chisum on Patents fame, about beneficial ownership and what was required under US law to transfer it. On the facts, he held that RCP was the beneficial owner of the priority right at the time it made the later patent application. So, Accord failed in their challenge to the assignment.

On the priority right issue, IP Draughts thinks Accord simply affirms the position in Edwards v Cook, as softened by the later cases that allow beneficial ownership of priority right, and gives guidance on what this means in the context of US patent rights.

But this subject seems unnecessarily complex and convoluted. The simple solution is to make sure you obtain an assignment of the priority application (formally, in writing, etc) before you file a later application. IP Draughts would be interested to know whether US patent attorney firms have changed their practice since the Edwards case, so as to get their clients to execute assignments at an early stage, or are still relying on executing them after the event.

 

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Technology transfer (the other type)

Nowadays, when the term technology transfer (TT) is used, most people probably think of TT from universities and other research institutions to industry. Or at least, they probably think this way in the UK and other developed countries. Since the 1980s, national policies such as the Bayh-Dole Act in the USA, and the decision to allow UK universities to commercialise their own IP, have led to the proliferation of TT offices across the universities of North America and Europe.

Organisations such as PraxisAuril in the UK, ASTP-Proton in Europe, and AUTM in the USA, have helped to train a generation of specialist TT practitioners. The first generation is now reaching retirement and we have a second generation that hasn’t experienced the pioneering days of TT.

When IP Draughts qualified as a lawyer, just before the start of the developments mentioned above, the dominant meaning of TT was rather different. Most people probably thought of TT in relation to the policies of developing countries that sought to obtain technology from industrialised countries, with a view to improving the economic development of the former.

Back in the 1980s, there seemed to be a constant stream of articles in technology law journals about the TT policies of particular countries. For instance, it seemed that Brazil came out with a new government policy every few years, and most of these policies seemed deeply unattractive to technology owners in industrialised countries. If you licensed software to a Brazilian company, the terms of the licence had to be approved by a Brazilian government agency, you had to deposit the source code with them, and the source code would be made freely available after 5 years. IP Draughts recalls such a transaction where both parties ignored the local laws.

An illustration of this understood meaning was that the publishers of IP Draughts’ first book, now in its third edition (fourth out soon) and called Technology Transfer, thought this name was potentially unclear and misleading to readers in the mid-1990s. Instead, IP Draughts had to settle for the clumsy name Technology: The Law of Exploitation and Transfer.

IP Draughts wonders what has happened to this other meaning of TT. The general trend of international IP policy seems to have been towards a more pro-IP approach, supported by international treaties such as TRIPS. In specific sectors, there have been initiatives to support developing countries, such as EU Regulation 816/2006 on ‘compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems’.

We seem to hear less about the national TT policies of developing countries. IP Draughts speculates that these policies have been shown to be a failure, like some other economic theories that focus on state control of the market. But here he is sounding dangerously like a right-winger, which doesn’t sit easily with his status as a member of the liberal, metropolitan elite.

 

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IP Draughts’ table of tables 2018

It’s that time of the year again, when the nights are drawing in, and IP Draughts prepares his traditional table of UK IP transactional lawyers. As in previous years, this table simply identifies UK lawyers who appear on both the IAM Patent 1000 list of UK patent licensing lawyers and the Chambers Directory list of UK transactional life science lawyers (which was published earlier today).

This year, the following individuals make it on to the list:

Highly recommended in IAM Patent 1000, recommended in Chambers UK Life Sciences
Laura Anderson – Bristows LLP
Mark Anderson – Anderson Law LLP
Malcolm Bates – Taylor Wessing LLP
Patrick Duxbury – Gowling WLG
Daniel Pavin – Covington & Burling LLP
Chris Shelley – Penningtons Manches LLP
Sally Shorthose – Bird & Bird LLP
John Wilkinson – Cooley LLP

Recommended in IAM Patent 1000 and recommended in Chambers UK Life Sciences
Richard Binns – Simmons & Simmons LLP
Allistair Booth – Pinsent Masons
Alison Dennis – Fieldfisher LLP
Jim Ford – Allen & Overy LLP
Michael Gavey – Simmons & Simmons LLP
Mark A Lubbock – Ashurst
Nicola Maguire – Cooley LLP
Lucinda Osborne – Covington & Burling LLP

There are two new names compared with last year: Richard Binns and Allistair Booth (both of whom are leading practitioners and IP Draughts thinks they should be in this table). Stephen Reese of Clifford Chance has dropped off the IAM list so does not make it into the above table. Some other worthy licensing lawyers fail to make the table as they are not recognised life science specialists, including Matthew Warren of Bristows. And some, such as IP Draughts’ partner Lisa Allebone, have made the IAM list and are recommended as “up and coming” in the IP section of Chambers, but have not yet made the UK Life Science list.

Congratulations to all of you!

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Using personal data in research: all change….?

Pondering, as one does, the likely impact of the General Data Protection Regulation on one’s working life, this Blogger has been trying to figure out how simple it will be to use personal data for research purposes (especially research in healthcare) after 25th May 2018 – the day on which the GDPR comes into force.  Before you ask, whatever happens with Brexit, the timing is such that the GDPR will come into force in the UK.

The GDPR is similar and yet different to the present Data Protection Act.  Similar in that the use of personal data is still governed by a series of principles and that processing of personal data must have a lawful basis.  Different in the detail of the duties placed on data controllers and processors, the rights granted to individuals and the justifications available to show that data is being processed lawfully.  For now, this Blogger is focussing on the research use context.

20171014 Latitude

Oxford is 51.7520° N

The GDPR allows some latitude for research uses.  ‘Latitude’ is not the same as ‘get out of jail free’.  If research users apply appropriate safeguards and data minimisation (limiting any processing to the extent necessary for the particular purpose) then some of the individual’s rights may be excluded.  But the core principles of the GDPR still apply.

Today, consent is the researcher’s go to justification for processing personal data.  Under the DPA and the GDPR, processing is lawful if the individual has given consent.  However, GDPR consent is a different animal to DPA consent.  The GDPR sets higher standards in terms of information (specific uses and specific recipients should be listed) and record keeping.  The GDPR is clear that it must be as easy to withdraw as to give consent – potentially really troublesome for a research project.  The ICO’s draft guidance talks of obtaining granular consent that describes in advance all the proposed uses of the personal data and everybody who will have access to the personal data.  The consent will have to be specific and records comprehensive.  Under the DPA a researcher can be (fairly) comfortable with wording consenting to the use of personal data for a defined project ‘and other related research’.  Under the GDPR, the researcher will have to describe the project (ie the intended use) and list all those that will have access to the personal data and explain which other projects the personal data may be used for.  In effect, ‘if you’re not on the list, you’re not coming in’.  Thankfully, a pragmatic ICO recognises that not all future research uses can be specified in advance and the guidance allows some scope to ‘do the best you can’.

The result of these changes?  From the morning of 25th May2018, existing consents may be rendered inadequate. 20171014 Exclamation

Can you hear the sounds of the research based economy grinding to a halt?  Be afraid, but not petrified.  Other possible means of demonstrating that processing has a lawful basis may be available.

First possibility is legitimate interest: GDPR treats processing as lawful to the extent that it is necessary for the purposes of the legitimate interests of the data controller as balanced against the impact on the individual concerned.  An interest is the broader aim or stake that the controller has in the processing.  It does not need to be described in advance but it will need to fall within the reasonable expectations of the individual.

The problem for healthcare research is that sensitive personal data (classified under GDPR as a ‘special category’), can only be processed where one of a separate list of exemptions applies.  The special categories include data concerning health.  This separate list of exemptions does not include legitimate interest: the legitimate interest justification does NOT justify the use of health data for research purposes.

Second possibility is that processing a special category of data is permitted where it is necessary for scientific research conducted in accordance with appropriate safeguards and where use of the data is proportionate to the research aim.  Useful but the emphasis is on ‘necessary’, ‘appropriate safeguards’ and ‘proportionate’.

A third possibility is to use anonymous data.  Like the DPA, the GDPR only applies to data relating to an identified or identifiable individual.  Currently, individuals do not have to give their consent for their personal data to be anonymised.  So, anonymise the data and all your problems fall away.

20171014 Stig

Anonymous or not…?

Inevitably, it is not that easy.  How anonymous does the data have to be before it no longer relates to a living and identifiable individual?  Today’s test is whether the anonymization process is robust enough to be likely to defeat the efforts of the Motivated Intruder (about whom this Blogger has mused before).  The problem is that big data makes more things are possible.  More pieces of the jigsaw are available to be found and linked together.  The Motivated Intruder doesn’t have to try too hard.

Despite its difficulties, consent may still be a useful possibility.  The GDPR permits processing of special category data where the individual has given explicit consent for a specified purpose.  The granular nature of consent has already been considered: proposed uses must be specified in advance.  In addition, the consent cannot be coerced – an outcome cannot be conditional on consent being given.  This may be a problem for commercial providers (‘you can only use this service if you give me all your personal data’).

20171014 Pencils

A simple answer: the Russians took a pencil…

It is less likely to be a problem in research world.  Does ‘you must consent if you want to participate in this clinical trial’ amount to imposing a condition?  Probably not.  Research is not the provision of goods or a service.  But the problem remains that it must be as easy to withdraw consent as it was to give consent in the first place.  Consent is not a simple answer.

Clearly, researchers (and their admin support!) will have to plan carefully to comply with GDPR.  That is not a Bad Thing: behind every data point there is an individual who deserves protection.  In any case, facing more detailed provisions is not the same as being prevented from performing research.  The GDPR is an intricate piece but, like eating an elephant, it can be dealt with in small chunks.  So, as a starting approach for those wishing to use personal data in their research:

First, establish what data it is that you wish to process.   Do you need to process all of it (data minimisation)?  Could you use anonymous data instead?

Second, establish whether it is a special category of data (eg health data) and if so, whether the intended use is permitted by any of the available exemptions:  including necessary for scientific research, consent (granular) or legitimate interest (but not for health data).

Third, if it is not a special category of data, or, if it is a special category but there is an exemption available, then check that the proposed processing is lawful.  Essentially that means demonstrating that Article 6 of the GDPR is satisfied.  That is worthy of a separate blog post in itself…

Simple.

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