For the half-year to 30 June 2015, the IPKat's regular team is supplemented by contributions from guest bloggers Suleman Ali, Tom Ohta and Valentina Torelli.

Regular round-ups of the previous week's blogposts are kindly compiled by Alberto Bellan.

Monday, 26 January 2015

Never too late: if you missed the IPKat last week ...

The IPKat weblog was exceptionally busy last week.  Our page counter recorded no fewer than 39,271 site visits, making it our second best week on record.  Even so, it's possible that, amid the flurry of breaking news and patent revelations, even dedicated readers may have missed some significant content.  Accordingly the IPKat and Merpel thank Katfriend Alberto Bellan for preparing the 30th consecutive weekly "Never Too Late" post for those readers who are in catch-up mode. Not counting regular medley posts, this is what you missed: 
Eleonora breaks the news of a revolutionary report that Pirate Party MEP Julia Reda has carefully drafted in order to turn EU copyright upside-down. Will Julia succeed in her attempt?

Valentina reports on two trade mark decisions (T-69/14 and T-70/14) that the General Court has just delivered as regards the chance to obtain a perpetual monopoly on the shape of a bottle of water -- two bottles, actually.

Jeremy informs readers that on Tuesday 24 February the IPKat weblog will be teaming up with BLACA to host an exciting meeting on sensory copyright. Topics will include the scent of perfume, the taste of cheese and other non-traditional works of authorship’s protection with copyright. And yes, Eleonora will be in.

Earlier this month, Jeremy posted an announcement concerning the publication of The Research Handbook on Cross-Border Enforcement of Intellectual Property. In this post, London-based barrister Ashley Roughton provides a more detailed review of that book.

The IPKat has already covered the UK litigation of Generics (t/a Mylan) v Yeda/Teva, in which a patent that covered glatiramer acetate was held valid even though the claims specified a particular molecular weight range without specifying what method was used to measure that weight (here, here, and here). As Darren explains, the Supreme Court of the USA has just weighed in on the same matter in the case of Teva v Sandoz.

Jeremy gives the floor to Míchel Olmedo Cuevas, who seizes the moment when a brand-new Hollywood colossal is being launched to explain the brand-new enforcement measures that the recent Spanish reform provides to battle online copyright infringement.

This post is about the General Court of the European Union delivering its judgment in in Case T‑11/14Grundig Multimedia AG v Office for Harmonisation in the Internal Market, concerning registrability of the ‘PIANISSIMO”trade mark for vacuum cleaners and similar machines.

Some days ago, Merpel posted a copy of Sir Robin Jacob's letter to the Administrative Council of the European Patent Office. She has now learned that the EPO has responded in the form of an email sent by Mr Guillaume Minnoye, Vice-President of Directorate General 1, which Merpel leaks here in all its majestic unbelievability.

Second medical use claims, skinny labels, and public policy issues around healthcare are the topics addressed in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat) (21 January 2015), a decision that Mr Justice Arnold has just delivered and on which Darren timely comments in this post.

The CJEU has just issued its much-awaited decision in Case C-419/13  Art & Allposters, addressing the adaptation right in the InfoSoc Directive and copyright exhaustion. This piece comes from Eleonora, of course.

When an unregistered right has been allegedly infringed online, what court is competent to hear and decide the resulting case? It is a matter of access, the CJEU lays down in Hejduk -- again explained by Eleonora.

After Birss J’s ruling, the Court of Appeal for England and Wales takes Rihanna under its umbrella, Eleonora reports.

EPO Vice President Guillaume Minnoye invites EPO examiners to perform non-examining functions in additional to a normal examining workload. Is that a good thing, wonders Merpel?

We are accustomed to view a brand in positive terms, as a valuable asset of its owner. Things may go differently in the Galapagos Island, where the Charles Darwin Foundation has been prevented from selling souvenirs not bearing its trade mark to not incur in unfair competition against other souvenir shops. Is that fair, wonders Neil?

Inspired by "Biotech patent case law: why is it different, idiosyncratic and always changing?", which Suleman posted last week, Jeremy reflects over the one-law-fits-all-sectors approach and IP. Also, he presents C5's 7th Forum, "Pharma & Biotech Patent Litigation", which IPKat readers may attend with a Kat-reduction on the ticket.

This is the fourth post in series of Suleman’s Katguide on biotech inventions [the earlier posts can be found here (introductory), here (ethics) and here (case law)], which are substantially useful (and, most of all, fully understandable) to both patent-lovers and any kind of curious person.

Our beloved former guest Kat Marie-Andrée Weiss pens a great piece on Omega v Costco, a US Court of Appeals for the Ninth Circuit ruling on first sale doctrine (aka exhaustion) applied to copyright. 
******************************
PREVIOUSLY, ON NEVER TOO LATE

Never too late 29 [week ending Sunday 11 January] -- Martin Luther King’s movie ‘Selma’ and copyright problems | CJEU’s copyright decisions awaited in 2015 | The Modern Law of Patents reviewed | China becoming a ‘protector’ of patent rights | ‘Je suis charlie’ trade mark in France and OHIM| UK IPO logo’s licensing system | High Court for England and Wales in Enterprise Holdings Inc v Europcar Group UK and Another [2015] EWHC 17 (Ch) | Spain without Google News | CJEU on database protection in Case C-30/14 Ryanair | Can UPC and national law of infringement diverge? | GC on ‘Monaco’ trade mark in Case T-197/13 Monaco v OHIM | Corriere della Sera major infringement in Charlie Hebdo case | GoPro and Apple patent | Biotech patent case law.

Never too late 28 [week ending Sunday 11 January] -- German Minister for Agriculture against GIs | Europe’s 2015 resolutions re innovation | All the must-read IP blogs | UK and EU Parliaments v the EPO | The bizzarre EPO BoA’s Business Distribution Scheme | UPC location in London | New spare-part reference to the CJEU | Sir Robin Jacob and other Europe Judges for judicial independence (at EPO) |Reform of EPO Boards of Appeal | Data brokers and IP | The Research Handbook on Cross-Border Enforcement Of Intellectual Property, a review | China’s patent targets for 2020 | Reproduction of Charie Hebdo cartoons without permission | Bioderma trade mark litigation | Biotech ethics.

Never too late 27 [week ending Sunday 4 January] -- The Irish PTO on well-known TMs’ extended protection in Stone Electrical Ltd v British Sky Broadcasting Group plc | The Irish PTO on revocation for non-use in HBI Branded Apparel Enterprises LLC v Dunnes Stores Ireland Company | Criminal penalty for infringement in Sweden | Congratulations to Trevor Graham Baylis | Australia copyright reforms and copyright enforcement on-line | The new guest Kats | New USPTO guidance on Patent Matter Eligibility | Confusion between TM with little distinctiveness | 9th U.S. Circuit Court of Appeals in Pom Wonderful LLC v Hubbard et al | Biotech inventions: controversies, case law, uncertainties and financing.



Never too late 26 [week ending Sunday 28 December] -- Arnold J on Ice cream van design in Whitby Specialist Vehicles v Yorkshire Specialist Vehicles | Adios to positive right of TM in Spain | Costs of Vestergaard Fransen v Bestnet Europe | Irish PTO on slogan TMs | Merpel summarises what’s going on with EPO | CoA for England and Wales on patent infringement by numbers in Jarden Consumer Solutions (Europe) Ltd v SEB SA& Another | Database rights and much more in Medical Innovations Ltd v Eakins and others | What if China turns inwards on technology? | European Copyright Society on full harmonisation of copyright | Book review of Biotechnology and Intellectual Property Rights.

Monday miscellany

With just six days to go, the IPKat's sidebar poll on IP and the International Women's Leadership Forum has attracted a wide array of opinions and little apparent consensus. Do please feel welcome to participate in this poll (which email subscribers will find on top of the left-hand sidebar on the IPKat's home page), which may have repercussions not just for women but for ethnic, religious and other special interest groups.



Around the weblogs 1. "Nespresso sues Espresso Club for using Clooney look-alike in advertisement" is the title of a blogpost from the IP Factor. The litigation, brought in Israel, has so far got no further than a failed attempt to secure a preliminary injunction: in the absence of either specific copyright or trade mark infringement, and with the legend "The actor is not George Clooney" cunningly placed in the top left hand corner of viewers' TV screens, the defendant looks as though it may have successfully stirred more than coffee. Over in The Netherlands, Sander Vermeulen's IP & ICT blog, in "Someone's child on your mug", relates the tale of  designer Yuri Veerman and reporter Dimitri Tokmetzis, whose Koppie Koppie website features mugs with random pictures of children from Flickr are for sale. This, he explains, is a joke with a serious message: Koppie Koppie was created to warn people that they should be more careful with the things they put on the internet.



Around the weblogs 2.  SOLO IP carries the fourth episode in the mini-series of posts on trade mark attorney Sally Cooper's office move, this time dealing with her mail and communications issues. The 1709 Blog hosts a short guest piece from Thomas Dubuisson on The Pirate Bay's curious habit of returning to haunt IP owners, while Ben Challis notches up a fresh CopyKat post.  Afro Leo posts on the Afro-IP blog on IP and legacy issues in South Africa.  Over on Class 46, former Kat Mark Schweizer tells us how domain name renewal snatching can constitute unfair competition, while another of our old colleagues, Laetitia Lagarde, regales readers with a feline fracas when Spanish word mark CLEAN CAT was able to ward off the threat of a Community trade mark application for a figurative mark containing the words CAT & CLEAN.



Patent Cooperation Treaty: new guide for applicants. The IPKat's very good friend Rosina from the World Intellectual Property Organization (WIPO) has just reminded him that many readers of this weblog have expressed an interest in knowing when the special edition of the PCT Applicant’s Guide, prepared for students sitting the European Qualifying Examinations (EQE exams), is available.  We are all now excited to hear from Rosina that WIPO has just published the latest version in English and French. It contains the entire contents of the Guide as of 31 December 2014 and it may be downloaded in English here and in French ici.



Uniforms for EPO examiners?
Want to be a Patent Examiner at the European Patent Office? Of the fifty-plus comments which readers have added to Merpel's oh-so-innocent post last week, ""New career system" for EPO Examiners: take on extra work", here, at least one is too good to leave in the relative obscurity of the Comments column.  Plainly inspired by Monty Python's Lumberjack Song (YouTube here, lyrics here), the anonymous author must also have enjoyed reading blogger Eleonora's Katposts on the Deckmyn ruling and the defence of parody to an action for copyright infringement in the European Union, with which the following seems to comply:
I’m Examiner and I’m okay
I work all night and I work all day
(He’s Examiner and he’s okay
He works all night and he works all day!)

By day my thing’s examining
Idees for novelty
By night I earn my bonus
With new activities!

(By day his thing’s examining
Ideas for novelty
By night he earns his bonus
With new activities!
He’s Examiner and he’s okay
He works all night and he works all day!)

I will not shirk some packaged work
If it earns extra bunce
And those who just ignore this
Are clearly simply dunce!

(He will not shirk some packaged work
If it earns extra bunce
And those who just ignore this
Are clearly simply dunce!
He’s Examiner and he’s okay
He works all night and he works all day!)

I earn big fees, by doing these
New things outside my core
It pleases Billy Minnoye
And leaves me wanting more!

(He earns big fees, by doing these
New things outside his core
It pleases Billy Minnoye
And leaves him wanting more!
He’s Examiner and he’s okay
He works all night and he works all day!)

When do I sleep? Well, that can keep
To earn I’ll buckle down
And at the end I’ll give me
The best fun’ral in town!

(When does he sleep? Well, that can keep
To earn he’ll buckle down
And at the end he’ll give him
The best fun’ral in town!
He’s Examiner and he’s okay
He works all night and he works all day!
He’s Examiner and he’s okayyyyyyyyyyyyyyyyy
Heworksallnightandheworksallday!)

News from elsewhere.  A katpat goes to Chris Torrero for giving us a link to the Washington Post's piece, "There are now two U.S. trademark applications for ‘Je Suis Charlie,’ because of course there are". This item draws on Robert Ledesma's own hands-on empirical testing of the USPTO's responses to applications to register rallying cries as US trade marks.  There's also some tremendously welcome news from Italy, via the newsletter of Modiano & Partners, that continuing legal education is being introduced for Italian patent and trade mark attorneys.


Nottingham Law School, England, has a suite of postgraduate programmes that may appeal to readers of this weblog. You can explore the links below for details of the following:
Nottingham: home
of the other Robin
There's also a Certificate in IP Basic Litigation Skills. This course runs subject to it attracting a minimum cohort of 20, so if you want to do it you might want to bring a friend.  The remaining teaching date for the new Basic Litigation Skills for Patent Attorneys 2014/15 is 2 to 6 June 2015, and the remaining teaching date for the new Basic Litigation Skills for Intensive ITMA students 2014/15 is 3 to 6 June 2015. Further information about these Certificates can be found below by clicking the relevant links:

Call for submissions. The Indian Journal of Intellectual Property Law is calling for submissions for its 2015 issue. Details can be found in its guidelines for contributors hereSubmissions should be mailed to ijipl.submissions@gmail.com and a copy marked to submissions@ijipl.com. Queries may be directed to the same IDs, but please write “Query” in the subject line. The Editors may also be contacted here. Please do not direct your queries or send your submissions to the IPKat or Merpel ...

Women in IP leadership roles: MIP responds

Last week, in "A woman's place is in ... the lead: thoughts on an upcoming IP Forum", here, the IPKat reviewed a forthcoming International Women's Leadership Forum on Intellectual Property and asked some fairly simple questions about women's leadership and the role of events of this nature. This blogpost has already attracted over 30 comments from readers, reading from the perceptive to the predictably sexist; it has also drawn a fuller response in the form of a blogpost from the event's backers Managing Intellectual Property (MIP) magazine, "Why IP needs events aimed at women", written by MIP's Emma Barraclough. In her piece Emma writes, in relevant part:
"Despite what critics have said, our popular events and network for women working in IP promote inclusive working cultures, networking, career progression and role models. What’s wrong with that? ...
... [H]ere’s why Managing IP decided to launch events aimed at women: we thought it would meet a demand. We looked at the statistics about the number of men and women beginning their careers in law firms and those that made partnership or took on chief IP counsel roles and saw a gap in the figures and in the market.
We don’t know why more women leave the profession than men: perhaps they can’t (or no longer want to) hack it. Perhaps their priorities change. Perhaps they can’t see a way of returning to law after a career break (even as white collar careers might soon stretch to 50 years).

Perhaps they face systemic and unconscious (or conscious) bias that undermines their commitment and ambition. Perhaps they find it hard to find sponsors (not surprising, given the innuendo about "silver spoons" given by "sugar daddies" detailed by one anonymous IPKat commentator). Perhaps they just need to Lean In.

But we do know that many law firms and companies want to limit the number of smart and expensively ­trained staff that choose to leave them and are asking questions about how their culture, practices and policies can help them do that. We thought we could organise events and set up a network that would facilitate the process.

So far our efforts have proved quite popular. Our network has hosted interviews with senior women in the profession and case studies on issues including mentoring and sponsorship. Offering a platform for innovative firms to showcase their own practices and share their experiences helps people at more conservative law firms (of which, we know, there are many) to petition for change.
...
Our events have given a new platform for senior women in the profession to talk about substantive law issues (and with a roster of speakers like this, there is no compromise on quality) as well as talk about strategies for managing career progression. That has proved helpful for senior professionals who want to share ideas about bringing on and retaining junior staff, as well as offering a whole range of role models for younger women.

This role model effect, we have found, has proved immensely popular. There are many successful people who put their career achievements down to individual capability and ambition. In doing so they often dismiss the importance of having role models in their own likeness. In my experience, these people’s role models often look and sound very much like themselves".
It seems to this Kat that the issues which Emma highlights are far from being unique to the various branches of intellectual property practice and would appear to be endemic within legal practice as a whole.  Indeed, he would welcome some statistics on how greatly the ability of women to advance in the profession and assume leadership roles varies between different fields of expertise: he has already in his previous blogpost cited the successful assumption by women of leadership roles in trade mark practice. Why should other fields of endeavour be different?

Never mind glass ceilings, even
glass doors are a problem ...
A proper statistical analysis of entry to the legal profession and progress through it might also highlight other trends which this Kat senses to be the case but cannot verify. These include his impression that the proportion of females studying law and entering the profession has continued to rise and now constitutes more than half; that women are much better represented in many public sector and in-house roles than are men, and that they have more or less created a niche role in law firms for the professional support lawyer or "PSL", a role which in many firms is increasingly demanding in terms of knowledge, skill, effort and responsibility.

Sunday, 25 January 2015

First sale doctrine in the US: a closer look at Costco

In  last Thursday's round-up, Annsley the AmeriKat brought news of Omega v Costco, a US Court of Appeals for the Ninth Circuit ruling on that most fascinating of legal beasts, first sale doctrine.  Well, the IPKat has just received an analysis of that decision fresh from our recent guest Kat Marie-Andrée Weiss, which he is delighted to host.  Writes Marie-Andrée:

First Sale Doctrine lets retailer sell in U.S. grey market watches bought abroad 
On 20 January a three-judge panel from the 9th Circuit affirmed a Central District of California decision which had granted summary judgment to the defendant, U.S. discount retailer Costco. The discounter had been sued for copyright infringement by Swiss luxury watch manufacturer Omega. This case is Omega S.A. v Costco Wholesale Corp., No. 11-57137 (9th Circ.).

A grey market of genuine luxury goods

Costco sold Omega “Seamaster” watches in its stores. It had purchased them abroad in 2004 in the “grey market,”after Omega had sold the watches to authorized foreign distributors (instead of buying goods directly from an official supplier, some companies buy genuine goods in the secondary market, after they have been first sold by an authorized distributor).

Choosing where your products will be sold, or “placement”, is an important part of the marketing mix. The watches were sold by Costco for 35% less than Omega’s suggested retail price (p.19) and “price” is also a component of the marketing mix. It is therefore not surprising that many luxury companies are less than happy to see their products sold by discount retailers, for fear of losing the aura of prestige which is one of the reasons customers may buy a luxury product.

Omega did not want its watches to be sold by Costco, and sued the discount retailer for copyright infringement, arguing that it had breached §602 of the Copyright Act, which forbids importing protected works into the United States “without the authority of the owner of copyright.” As watches cannot usually be protected by copyright in the U.S., because they are useful articles, Omega had each of the Seamaster watches engraved on its underside with a tiny copyrighted Omega design, the “Globe Design,” in order to be able to assert a copyright in them. Costco did not have permission to use this design.

Omega watches: pile 'em high, buy 'em cheap?
Costco asserted a first sale doctrine defence. The Central District of California granted summary judgment to Costco, noting that Omega had engraved the Globe Design on its watches at least in part to control importation of the watches, and thus had misused its copyright. But the 9th Circuit reversed the decision in 2008 and remanded, holding that the first sale doctrine does not apply to copies of works produced abroad. The Supreme Court affirmed per curiam in 2010. On remand, the district court granted again summary judgment to Costco. Omega appealed and the 9th Circuit affirmed this time, because the Supreme Court held in 2013 in Kirtsaeng v John Wiley & Sons that the first sale doctrine applies to goods manufactured abroad.

First sale doctrine

§109(a) of the Copyright Act authorises the owner of a lawfully made copy of a protected work to sell or dispose of that copy without having to ask permission of the copyright owner. Therefore, once a copy of a protected work has been lawfully sold, the owner of that copy, and the subsequent owners as well, may dispose of it as they wish, because the first sale of the work has "exhausted" the copyright owner's exclusive distribution right under § 106(3).
Another Omega
luxury brand ...
 
In Quality King Distributors, Inc. v L'anza Research Int'l, Inc., the Supreme Court held in 1998 that §602(a)(1), which refers to §106(3)'s exclusive distribution right, incorporates the "first sale" doctrine limitation. That means that §602(a)(1) allows the importation into the United States of a copy of a protected work purchased abroad. In Quality King, however, the copy, while purchased abroad, had been manufactured in the U.S.A., and thus the case could be distinguished from CostcoBut while the Costco suit was under way, the Supreme Court held in 2013, in Kirtsaeng v John Wiley & Sons, that the first sale doctrine also applies to copies of protected works lawfully manufactured abroad. Since the Kirtsaeng judgment retroactively applied in Costco, the Ninth Circuit found that Omega had no copyright infringement cause of action against Costco:

“Omega’s right to control importation and distribution of its copyrighted Omega Globe expired after that authorized first sale, and Costco’s subsequent sale of the watches did not constitute copyright infringement” (p.7).

This decision is a big victory for Costco and similar retailers alike. As noted by Judge Wardlaw in her concurring opinion, Costco sells “a wide range of luxury goods, including Dom Pérignon Champagne, Waterford crystal, Dolce & Gabbana handbags”(p. 9). We may soon see more luxury goods in discounter’s aisles, alongside gallons of laundry detergent and giant cans of tomato soup".

Strategies for patenting biotech inventions: broad claims, changing contributions and data that didn’t make it into the specification

This is the fourth post in series of six on biotech inventions. The earlier posts can be found here (introductory), here (ethics) and here (case law).

The anatomy of a biotech invention

Imagine that new human gene, causing activity X in the body, is discovered and is implicated in disease Y. What claims are possible? Can we claim similar genes with a similar activity? Can we claim the protein the gene expresses and antibodies that bind to the protein? Can we claim a diagnostic test for disease Y based on measuring the level of activity X? Can we claim modulators of activity X for treating disease Y? Does it make a difference here if we already know of substances that could act as such modulators or whether we can only define them by means of screening method which identifies modulators based on their modulation activity? Can we claim animals in which the equivalent gene has been mutated or deleted to produce an animal model of disease Y? Can we claim transgenic cells, animals and plants into which the human gene has been introduced in order to produce large quantities of the protein it expresses?

Anatomical dissection is necessary if you
want to see all the contributions
Essentially, the state of the prior art and amount of data that is in the specification will answer a lot of these questions. My purpose in listing the questions is however to illustrate how an experimental finding in biotech leads to many ‘downstream’ embodiments.

What is the ‘contribution’? Part 1 – and so what is the technical problem?

Imagine that a new correlation is found. Scientists discover that the presence of T cells that detect protein sequence X is correlated with having neurological disease Y (Essentially the role of T cells is to detect certain specific sequences and, when they do, to activate the immune response). What is the contribution? That T cells are involved in neurological diseases? That T cells are involved in disease Y? That T cells that recognise sequence X cause disease(s)? That sequence X is involved in disease Y (which potentially leads to all the questions asked in the above paragraph about a new gene)? That infusing a patient with T cells that detect sequence X could be therapeutic? That antibodies to sequence X might do something useful when administered?

The different ‘contributions’ lead to different claims: claims to the T cells, their possible use in therapy, a claim to diagnostic test possibly, etc. Again the prior art and the data in the specification will determine how far each of the above ‘contributions’ will reflect patentable subject matter. For the different contributions, different technical problems might be solved, though they all relate to the initial correlation that was found.

What is the ‘contribution’? Part 2 – the ‘balance’ between contribution and claim scope

Walter found it much more difficult to
identify T cells with older microscopes
European Patent Office (EPO) decision T694/92 (Modifying plant cells/MYCOGEN) was about the claim scope reflecting the contribution. Essentially if one claims a specific sequence that has special properties that could not be predicted from the prior art, and the contribution is the finding of a sequence with the special properties, then the ‘unpredictability’ which one has relied on to define one’s contribution (and inventive step) will also limit the scope of claim one is entitled to. One cannot for example cover as-yet-undiscovered sequences which would presumably be equally unpredictable. The situation arises quite often in biotech examination where the prior art forces one to define the contribution as more closely related to the specific ‘special’ properties of the embodiments in the Examples. The contribution over the prior art is therefore usually defined by inventive step, and sometimes also sufficiency, considerations. Crucially for biotech inventions the contribution often changes, sometimes very radically, as more prior art is identified. That will require narrowing of the claim scope to embodiments with more and more ‘special’ properties.

Data in the specification and data that is post-filed

Biotech inventions often arise as part of an ongoing research program. That means that relevant data will usually continue to be generated by the inventors after the patent application is filed. In addition third parties may also be independently working in the area and they may publish relevant data. Such data can be filed during examination proceedings to help overcome objections that have been raised. That raises the issue of how much data does one actually need in the patent specification and how much can be filed during examination. The answer is not clear-cut but as a general rule the post-filing data can only be ‘confirmatory’ of disclosure in the specification.

As an aside, it is worth mentioning Human Genome Sciences v Eli Lilly where the main issue was how much data is required in the specification to support therapeutic use of an antibody to a new protein (see Katpost here).

Why is it important to claim broadly in biotech?

In biotech there are a lot of different ways of taking advantage of the ‘technical effect’, and so there are a lot of different ways of implementing the invention. For example a drug may be administered in its active form. However the active form could also be generated inside the body from a pro-drug form that is administered. A therapeutic protein can be administered to a patient. However a DNA sequence that expresses the protein inside of the body could be administered instead. Depending on the technology there can be more than one way of providing the ‘specific activity’ or ‘binding surface’ or whatever else it is that is the basis of the technical effect. For example if an increase in activity X is required in the invention, it might be achieved by expressing more of the relevant protein or by increasing the amount of protein present in active form. Broad claims are needed to cover all the different scenarios.
The sea of unpredictable surfaces 
is a rich source of inventions

Rules of thumb for protecting biotech inventions
* identify all the technical effects 
* claim broadly – find all the different ways of achieving all the technical effects 
* you won’t know the contribution until you see the prior art cited in the Search Report 
* a biotech invention is like an onion, layers and layers 
* bear in mind that there is usually more data on the way post-filing.

Friday, 23 January 2015

Pharma and biotech patents: a law unto themselves -- and a litigation conference to match?

Cloning: a plus for biotech
This Kat, who loves patent law but is no scientist, has been reading, with interest, enjoyment and increasing understanding, the recent blogposts by guest Kat Suleman Ali on the topic of biotech patents. Suleman started the year with "Biotech inventions: controversies, case law, uncertainties and financing" (here), and this was followed a week later by "The ethics of biotech patenting: a dialogue about monopolies, human dignity and the cost of medicines". Then, to cap it all, last Sunday he posted "Biotech patent case law: why is it different, idiosyncratic and always changing?", in which he wrote:
"Biotech case law has its own concepts. Partly this is because many of its inventions follow from the discovery of properties of molecules or biological systems, and specific case law is needed to guide on the appropriate claim scope based on such contributions. That means biotech practice has its own particular ways of looking at inventive step and sufficiency, and these can be technology-specific. The concept of ‘reasonable expectation of success’ takes into account the inherent unpredictability of biological systems. ‘Sufficiency’ is usually an important determinant of claim scope. ‘Plausibility’ can be used to assess the quality of the data in the specification. The patenting of inventions relating to plants can be surprisingly complicated, and some medical inventions simply won’t fit into the claim formats available in Europe.  ...

Cute, but is it patentable
Parts of biotech case law are tied to the capabilities of the relevant technologies. As it becomes easier to characterise and manipulate molecules, ‘enablement’ seems to be becoming stricter, even though in theory this should not change over time. One consequence of this is that functional definitions are becoming less acceptable. In 2001 the Trilateral Study on ‘Reach Through Claims’ led to functional definitions of molecules no longer being acceptable in many claims. The European Patent Office (EPO) is now becoming stricter on how antibodies are defined, requiring more structural definition of the antibody in addition to a functional definition. Similarly more structural data now needs to be provided for mutant sequences defined with reference to particular functions".
Claim formats and the interpretation of claims are matters that lie at the heart of patent litigation and can make or break it. If a claim is too wide or too narrow, the patent may be fatally flawed. If it can't be understood, or if a clear meaning for it can't be projected upon the blank canvas of the mind of the hypothetical person skilled in the art, litigation may resolve nothing.  This sort of thing can happen in every area of technology, but the pharma/bio sector seems to be particularly prone to it.

This Kat appreciates things that help to remind him why a one-law-fits-all-sectors approach is convenient for legislators and for anyone who has to cram the whole of intellectual property law into a single university or college syllabus, but why it's not so convenient in practice.  In the field of copyright, it's quite easy to see why the rules governing authors' works apply differently where the work is a novel, a movie or a piece of software. Likewise in trade mark law sectorally different demands are easy for even a layman to appreciate: after all, the branding of foods and medicines has an entirely different significance to the branding of fashion goods. But how far does the same apply to patents, and why?

Bearing this question in mind, it was with fresh eyes that this Kat took a look at the programme for event organiser C5's 7th Forum, "Pharma & Biotech Patent Litigation". This Forum -- really a fully-fledged two-day conference -- takes place on Thursday 19 and Friday 20 March 2015 at the Hotel Okura, Amsterdam. Good news for readers of this weblog is that C5, in a fit of kindness, are offering readers of this blog a 10% reduction on the registration fee if they quote the VIP Katcode 630IPKAT10.  The feeling that one gets is that the pharma and biotech sector is so different from other areas of innovation, with its regulatory and health issues, genericity, orphan drugs, coaching of expert witnesses, research and experimentation, public policy perspectives, patent term extension possibilities and personal medicine opportunities that a good case could be made for starting afresh and building a sui generis scheme for all pharma and biotech products and processes. But that's another matter, best left for the future ...

Needless to say, there are plenty of Katfriends on the programme. These include, but are definitely not limited to, Galit Gonen (Vice President & General Counsel Europe, TEVA Pharmaceuticals, and winner of Legal 500 Intellectual Property and In-House Counsel of the Year Awards). Galit is speaking in cross-border litigation strategies, including strategies for responding to enforcement proceedings. Then there's Camilla Balleny (Partner, Carpmaels & Ransford LLP) on how to secure supplementary protection certificate protection in the face of constant twists, turns and apparent anomalies resulting from a stream of rulings from the Court of Justice of the European Union [there's no end of them, it seems: you can check them out on The SPC Blog, here] and elsewhere. Merpel, noting that the Kat has so far mentioned only women, reminds him to name at least a token male, so he opts for Simon Cohen (Partner, Taylor Wessing) and Sam Granata (a judge in the Commercial Court, Antwerp).

You can check out the Forum website for further particulars and registration details by clicking here. There's also a pre-conference workshop, which is as good an excuse as any for experiencing an extra dose of Amsterdam's pharma and biotech delights if you click here.

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