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BIO SPECIAL EDITION
Spring 2016 BREXIT DECISION IMMINENT BUT A
‘LEAVE' VOTE MEANS IP UNCERTAINTY MAY
‘REMAIN' FOR SOME TIME
The UK referendum to leave or
remain part of the European Union
(EU) will be held on 23 June 2016. A
vote to leave the EU will not become
effective for a further two years and,
in that time, much will have to be
decided. In the world of patents, one
of the key decisions will be what will
happen to the impending Unitary
Patent system, which is presently only
open to members of the EU, (also true
for the current Community Trade Mark
and Registered Community Design
systems), and the Unitary Patent Court
for life science inventions, which is
replacing the UK as the third mandatory This may lead to the slightly odd currently being set up in London.
situation that the Unitary Patent Court As one of the three countries, along Even if the UK does vote to leave the in London would not have jurisdiction with Germany and France, which must EU, it will still be a part of the European over UK patent rights and litigation of a ratify the Unitary Patent for it to come Patent Convention such that patents will life sciences patent would have to begin into existence, it is uncertain what the be prosecuted through the European at the UK Courts in London for the UK effects may be if the UK leaves the EU. Patent Office as normal. After the Unitary patent and at the Unitary Patent Court in However, it is perhaps likely that the Patent system has come into effect, a London for the Unitary Patent effective for system will continue with the Netherlands patent proprietor may obtain a Unitary other European territories. Patent to protect the invention in most of In conclusion, leaving the EU may IN THIS ISSUE
Europe and the patent will automatically lead to a number of uncertain years for be validated in the UK (provided the patents as the fine details are worked out. Brexit decision imminent but a ‘leave' patent is in English) and it will then be up However, it is perhaps more likely that vote means IP uncertainty may ‘remain' for some time 1
to the proprietor to decide if protection this will all just be a storm in a very British How much is enough to fall outside the in the UK is desired and pay the UK tea cup and nothing at all will change. scope of a second medical use patent? 2
Patentability of Parthenotes in Europe 4
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Todays crystal ball gazing may be tomorrow's lack of sufficiency 5
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BIO SPECIAL EDITION
HOW MUCH IS ENOUGH TO
FALL OUTSIDE THE SCOPE OF A
SECOND MEDICAL USE PATENT?
The UK Courts have spent a
WHEN IS A DRUG PRESCRIBED
considerable amount of time
over the last few years wrangling
"FOR" PAIN?
over the question of what a generics
manufacturer is required to do in
- Further developments in the Pregabalin wars order to prevent those they supply
Warner-Lambert v Actavis and Mylan and with a drug from using it in an
Warner-Lambert v Sandoz and Lloyds Pharmacy infringing way. To put it another
way, after the sale of a product or
As a brief reminder of the background Both Activis and a generic drug composition indicated for use in
of the various recent cases relating manufacturer named Mylan filed for a non-infringing way, how much
to pregabalin, Warner-Lambert had a revocation of the Warner-Lambert responsibility is on the manufacturer
patent for the drug pregabalin (supplied second medical use patent. These two to defend the patent rights of a
under the trademark Lyrica) which has revocation actions were tried together competitor? This is at the heart of
now expired. However, they also have a along with the infringement case. This the following cases and, as detailed
second medical use patent for pregabalin was a complex case and several issues below, the UK Courts are not averse
for the treatment of pain which is in force were referred to the Court of Appeal. to requiring that generic drug
until 15 July 2017. Warner-Lambert However, in September 2015, the High manufacturers prove they have taken
alleged infringement by Actavis, a Court issued its full trial decision which every possible step to ensure that
generic manufacturer intending to supply found the patent to be partially invalid, their products are not used to infringe the same drug (under the trademark
and in particular the claims relevant to the the patents of larger pharmaceutical
Lecaent), for off-patent indications issue of infringement (i.e. claims 1 and 3 including generalised anxiety disorder directed to the use for treating pain and and epilepsy. The issues of the case neuropathic pain respectively) were found surround the extent to which the generic to be invalid for lack of sufficiency.
manufacturer can supply the generic drug Applying the infringement test set out without care or regard to whether doctors by the Court of Appeal, the High Court and pharmacists prescribe it for the judge Mr Justice Arnold also found that, patented second use.
even if claims 1 and 3 had been found When a generics company seeks a to be valid, Actavis has not infringed marketing authorisation for an off-patent these claims. The test is based on drug and there is a patent still in force the interpretation of "for" in the Swiss for a second (or subsequent) medical claim as "suitable and intended for" use, it is normal to identify the off- and consequently requires that the patent indications in the accompanying manufacturer (generic manufacturer summary of product characteristics Actavis) knew or could reasonably and the patient information leaflet. The foresee that some of his products would patented indication is said to have been intentionally be used for the patented "carved out". This is known as a "skinny indication. This was found not to be the label". Activis planned to apply such a case and Arnold J granted a declaration label to its Lecaent product. Warner- that the manufacturer of Lecaent Lambert argued that this was insufficient (Actavis), the wholesalers of Lecaent, to prevent prescription of Lecaent for the the doctors prescribing Lecaent, the patent protected indication of pain relief.
pharmacists dispensing Lecaent and the

BIO SPECIAL EDITION
patients taking Lecaent did not infringe High Court in order to obtain an interim been challenged by Mylan and Actavis. injunction against both Sandoz and Accordingly, there was no need for Following the decision of the High Lloyds Pharmacy. Sandoz to bring its own action for Court, Warner-Lambert applied for Mr Justice Arnold held that Sandoz had revocation. The marketing by Sandoz an amendment of the claims. The not attempted to "clear the way" and of the Sandoz Full Label Product defendants argued that this late stated in paragraphs 100 and 101 of the raises a distinct issue on infringement amendment was an abuse of process as which did not arise in the Mylan and Warner Lambert had waited until after the "It is well established that, where a Actavis proceedings, however. It would decision had been issued to make the generic supplier intends to market a have been open to Sandoz to seek a application. In a decision of 25 November product covered by a patent which the declaration of non-infringement in respect 2015, Mr Justice Arnold agreed and the generic supplier contends is invalid, of the Sandoz Full Label Product prior to application for amendment was stuck out. then the proper course for the generic launch, but it did not do so. To that extent, However, the parties were given leave to supplier is to commence revocation Sandoz failed to clear the path for its appeal both the above decisions for both proceedings to "clear the path" for the launch of that product." validity and infringement and it seems launch of its product sufficiently far in The outcome of the decision was the likely that they will do so.
advance of launch to enable the validity issuance of an interim injunction against In a further development, it became of the patent to be determined prior both Sandoz and Lloyds.
known to Warner-Lambert that another to the launch date: see SmithKline The story of patent rights relating to generics manufacturer Sandoz Limited Beecham v Apotex at [38]-[40] (Aldous pregabilin is far from over and we expect had created a "full label", i.e. no skinny LJ). This principle has also been applied to hear more about the appeal in the label, pregabalin drug (supplied as in cases where the generic supplier has Warner-Lambert v Actavis and Mylan Pragabilin Sandoz) and that Sandoz had a non-infringement argument available case later in the year. All of the latest shipped over 100,000 packs of this drug on these cases can be found at www.
to Lloyds Pharmacy Limited. Warner- In the present case, of course, the Lambert made an application to the validity of the Patent had already WOULD YOU LIKE A JELLY BABY WITH YOUR
PEMETREXED DIACID?
Actavis v Eli Lilly & Company
Pemetrexed disodium is a derivative thereof and optionally a folic
chemotherapeutic treatment for
protein binding agent. This second
lung cancer which has been marketed
Patent will expire on 15 June 2021.
by Eli Lilly. Alimta is sold as a
Actavis sought a declaration of non- lyophilised powder with instructions
infringement (DNI) from the UK Courts in to reconstitute it in a saline solution.
respect of the French, German, Italian, Eli Lilly had a European patent for
Spanish, and UK designations of the pemetrexed and its pharmaceutically
Patent for their forthcoming Pemetrexed acceptable salts. This patent expired
disodium product. Subsequently, as part on 10 December 2010. However,
of the same proceedings, DNI's were protection was extended by a
also sought for pemetrexed diacid and Supplementary Protection Certificate
pemetrexed ditromethamine. In the Court which expired on 10 December 2015.
of Appeal decision of 25 June 2015, it Eli Lilly is also the proprietor of
was held that Actavis did not directly another European patent for the use of infringe the Eli Lilly patent. However, if
pemetrexed disodium in combination
they provided instructions for the product with vitamin B12 or a pharmaceutical
to be reconstituted and diluted in saline Patent issues

BIO SPECIAL EDITION
How much is enough to fall outside the scope.Continued solution, which was the case at the including cutting off from further sales any time, then it was considered that they end user found to be diluting the product would be indirectly infringing the patent in saline, implementing a systematic (contributory infringement). checking of all related worksheets, and In this latest case, Actavis applied to making it a contractually binding point in the Courts for a declaration of non- any agreement relating to the product. infringement for a pemetrexed diacid Indeed, Eli Lilly were not able to suggest liquid concentrate product which is any further measures that could be taken supplied with explicit instructions that it by Actavis to ensure that the product is must only be diluted in dextrose (glucose) only diluted in dextrose solution.
solution. The decision of Mr Justice In addition, Actavis stated to the Court Arnold on this case was issued on 12 that they would not disclose any stability February 2016.
data for the product in saline and that As was written in the decision, Eli Lilly it had made it part of any contractual resisted a DNI in respect of the supply arrangement that no hospital or medical of Actavis' products with instructions centre would be allowed to carry out its for reconstitution and/or dilution with own stability study. dextrose solution on the basis that it was Regarding the concern that pharmacists foreseeable that some pharmacists would may dilute the Actavis product in saline not follow the instructions contained in due to concerns relating to diabetic the Summary of Product Characteristics patients, this was dismissed as unlikely. (SmPC) to use dextrose solution, but As one expert witness pointed out to instead would reconstitute and/or dilute the Court, the amount of dextrose is the products in saline.
equivalent to a single jelly baby or 100ml Eli Lilly argued that when stability data of skimmed milk. Also, it was noted became available for the Actavis product, that it was not uncommon to monitor then it was foreseeable that the Acatavis blood sugar levels after administering product would be diluted in saline pemetrexed due to the use of other co- "because of concerns as to the effect of administered sugar compounds.
dextrose on patients with diabetes".
Mr Justice Arnold held that "it is not Acatavis argued that they had taken foreseeable that the Actavis Product every step possible to prevent dilution will be diluted in saline. Accordingly, for with saline, including specifically stating the foreseeable future, the supply by this in the SmPC, sending a letter to Actavis of the Actavis product will not the relevant competent authorities and infringe the Patent" Therefore, DNI were medical centres stating this, implementing granted in respect of the UK, French, a policy that Actavis representatives Italian and Spanish designations of the contacting hospitals must explain that the Patent (a separate decision was issued product must only be diluted in dextrose by the German Courts for the German solution, regulating the supply chain

BIO SPECIAL EDITION
PATENTABILITY OF PARTHENOTES
IN EUROPE
In response to a referral from
and cannot differentiate into the full range 98/44/EC must be understood in a wide the UK High Court in the case of
of cells required to create a foetus.
sense. Both fertilised human ova and International Stem Cell Corporation
The referral by the High Court sought non-fertilised human ova whose division (ISCC) v Comptroller General of
to clarify the meaning of the phrase and further development have been Patents (the UK Intellectual Property
‘capable of commencing the process stimulated by parthenogenesis were Office), the Court of Justice of the
deemed to qualify as "human embryos" European Union (CJEU) issued
of development of a human', as the and therefore excluded from patentability.
an opinion on the patentability of
parthenote is incapable of actually parthenotes in Europe.
developing into a human being. In In their judgement, the CJEU were of the Parthenogenesis is a process that the prior case of 34/10 (Oliver Brüstle opinion that Article 6(2)(c) of Directive creates a parthenote which has many of v Greenpeace), the CJEU ruled that 98/44/EC must be interpreted as meaning the characteristics of an embryo in the inventions necessarily involving that an unfertilised human ovum whose early stages of division but, because it destruction of an embryo were not division and further development have was created from an unfertilised ovum, patentable, but left several question been stimulated by parthenogenesis does cannot develop further to become a marks as to what constitutes "an not constitute a ‘human embryo' human being. The cells that form the embryo". The CJEU ruled that inventions This judgement provides welcome news early state of a human embryo are that necessarily involve the destruction to those in the field of stem cell research known as ‘totipotent' and can go on to of human embryos were excluded from and provides much needed clarity to what differentiate into any cell type, e.g. liver patentability and stated that the concept constitutes unpatentable subject matter cells, heart cells, etc, whereas, the cells of ‘human embryo' within the meaning of in Europe after the 34/10 Brüstle case that form the parthenote are ‘pluripotent' Article 6(2)(c) of Biotechnology Directive Unipotent cells
Inner Mass Cells
(circulatory system, nervous system
and immune system)
Unipotent cells
Inner Mass Cells
(circulatory system, nervous system
and immune system)
Patent issues
BIO SPECIAL EDITION
TODAYS CRYSTAL BALL GAZING
MAY BE TOMORROW'S LACK OF
SUFFICIENCY -
Regeneron Pharmaceuticals v Kymab Limited
and Novo Nordisk A/S Regeneron were the proprietor to could not be performed without undue
two European patents relating
burden in 2001/2, and that the likelihood to transgenic mice that could be
was that neither of the insertions and used as platforms for therapeutic
deletions referred to in [the specification] antibody discoveries. The mice in
would have worked." question had a replacement of the
mouse variable gene with human
It was also noted in the decision: variable genes to produce hydrid
"the ‘100 kb out, 200-300 kb in' / ‘150 kb out, 75 kb in' replacements by Regeneron alleged that the defendants homologous recombination are not infringed these patents. The defendants technically feasible even today, and that filed for revocation of the patents. they would certainly not have been seen Mr Justice Carr stated in the decision: as feasible at the priority date" "claim 1 includes the case where the relevant murine sequence is deleted, Therefore, both patents were found to be and also the case where it is moved invalid and revoked.
to a different location and inactivated. This case demonstrates the pitfalls Deletion of the relevant mouse gene of using unrealistic ranges in order to segments is undoubtedly within the prevent infringement not only at the time scope of the claim, and repeatedly of filing but at any point during the life referred to in the specification." of the patent. Clearly, the rapid growth Upon construing claim 1 it was held: of this technology and the prospect that "claim 1 covers introduction of up to larger sequences would be readily usable about 300 kb of human sequence. with the technology in the future made However, there is no upper limit imposed by the claim on the amount of inserting the claimed sequence lengths mouse sequence that is to be replaced." highly attractive. However, it is always Regarding infringement, the mice worth bearing in mind, as frustrating as strains produced by Kymab were found it may be for the prescient inventor who to fall within the scope of the claims. rightly knows where the technology will However, after lengthy expert witness be in years to come, a patent application testimony, Mr Justice Carr stated: must be sufficiently disclosed at the time "insertions and deletions of this size BIO SPECIAL EDITION
VIRTUAL PATENT MARKING
Recent changes to UK patent
to date and the Crown Prosecution relevant model numbers and variants law allow "virtual marking" or
Service would not relish such a case, that exist. Each time this is updated, a "webmarking" of products using
the greater risk would be from a private record should be kept (preferably by the a web address, pointing potential
prosecution brought by an aggrieved patent or legal department) of the change infringers to a webpage listing
competitor.) Webmarking is an efficient and the date it is posted. As a guide, we details of patents and/or pending
and cost-effective way of ensuring all provide a sample web page template that applications associated with the
patent markings are kept up to date is generally suitable for marking patented products. This practice has been
without the need to mark patent details products in the UK and US: widely adopted in the US since a
directly on the product. It also provides a similar provision of the America
convenient point for the public to access Invents Act came into force in March
current patent information in relation to a 2013 and is gaining popularity here in
product and thereby negate the defence of "innocence" in any award of damages. It is important that patent markings are clear and kept up to date, to ensure The product or its packaging (or both) that sufficient notice is given to potential should be marked with a web address infringers of the existence of all relevant pointing to the relevant webpage on the patents and pending applications, company's website. while avoiding the potentially severe The webpage should clearly associate consequences of falsely marking a each product with the relevant granted product as patented. (It is a criminal patent and/or published application offence in the UK punishable by fine and numbers. The products should be clearly whereas we know of no prosecutions identified, for example by including any Patent issues
Patent
issues BIO SPECIAL EDITION
Patent
Reuben E Jacob
Reuben has an honours degree in microbiology and genetics and is a European patent attorney and a UK patent attorney. He has 25 years of Partner, Life Sciences
experience in advising clients operating in the fields of biotechnology, medtech, Chartered Patent Attorney medical device patents and chemistry, including representing industrial European Patent Attorney clients, universities and research organisations; helping SMEs through the E: [email protected] creation of strategies for the acquisition, organisation and exploitation of their IP rights. Reuben has a particular interest in fungal genetics/technologies, medical device patents, medtech and laboratory instrumentation such as thermalcyclers and lab-on-a-chip devices.
Reuben is a Senior Associate Member of the Royal Society of Medicine.
Tanya Buckley
Tanya has a degree in Microbiology & Genetics (Hons). Her background BSc (Hons), RTMA, MITMA is in the biotech field where she has specific experience in dealing with Senior Associate
pharmaceutical, medical device and biotech clients. She has extensive Trade Mark Attorney experience in working with high-profile blue-chip companies as well as SMEs E: [email protected] in relation to their brand management and portfolio reviews. Tanya has over 15 years' experience and provides a commercial approach to her client's trade mark matters.
Dr. Fiona Kellas
Fiona was awarded a PhD in Biochemistry from the University of Cambridge, having conducted research on the structure of the ATP synthase enzyme. Associate
Fiona entered the patent profession in 2003 and is an Associate with RGC Chartered Patent Attorney Jenkins & Co. Fiona is a European Patent Attorney and has passed the UK European Patent Attorney Patent Attorney qualification exams. Fiona has experience of drafting and E: [email protected] prosecuting patent applications, as well as prior art and freedom to operate searching and assessment. Fiona has worked in a wide range of technologies, including biochemical, immunological, chemical and mechanical areas. In particular, she has experience in the areas of medical devices, in vitro diagnostics, biochemical and antibody technologies.
Dr. Edward Rainsford
Edward has a background in microbiology and virology. Following his PhD at Warwick University in the UK, he moved to the United States where he Associate
worked as a Research Associate at the University of Virginia studying viral Chartered Patent Attorney RNA-protein interactions. During his time as a research scientist he presented E: [email protected] at a number of international conferences and published several research papers. After returning to the UK, he completed an MSc in Management of Intellectual Property at Queen Mary, University of London. Since joining Jenkins, Edward has had experience in all aspects of patent prosecution and has particular experience in the prosecution of diagnostics, medical device, and microbiological patents.
Freiburg
RGC Jenkins & Co RGC Jenkins & Co Jenkins IP Consulting Maucher Börjes Jenkins Maucher Börjes Jenkins Maucher Börjes Jenkins 26 Caxton Street A-1002, Huibin Building Martiusstrasse 5 Aeschenvorstadt 71 Farnham Business Park No. 8 Beichendong Street Tel: +44 (0) 20 7931 7141 Chaoyang District Fax: +44 (0) 20 7222 4660 Farnham, Surrey GU9 8QT Beijing 100101, China Tel: +49 (0)89 340 77 26-0 Tel: +49 (0)761 79 174-0 Tel: +41 61 225 44 90 E-mail: [email protected] Tel: +44 (0)20 7931 7141 Tel: +86 (0)10 8498 9052 Fax: +49 (0)89 340 77 26-11 Fax: +49 (0)761 79 174-30 Fax: +41 61 225 44 89 Fax: +44 (0)20 7222 4660 Fax: +86 (0)10 8498 7962 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] TM Jenkins, the Jenkins logo, R.G.C. Jenkins & Co., and Patent issues are trade marks. R.G.C. Jenkins & Co. 2016 Jenkins is the trading name of R.G.C. Jenkins & Co.

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