Boult.bites Biotech
The end of 2013 saw a flurry of activity in the SPC world as the CJEU handed down its judgements (Georgetown University v Octrooicentrum Nederland) (Actavis Group v SanofiEli Lilly v HGS). These decisions have been eagerly awaited, because > advising
the referrals to the court addressed two key issues: (I) can a Patentee obtain more than one SPC that all first instance cases where the decision per patent and (II) what is a “product protected by a basic patent in force” under Article 3(a) of Regulation No. 469/2009 (the SPC Regulation). Enlarged Board of Appeal’s decisions in G2/12 and G2/13 will be stayed. As reported in our Regarding the first issue, it has been made clear by the decision in C-484/12 that it is possible to obtain several SPCs on the basis of a patent which protects several different products, provided that in particular whether the exclusion of essentially each of those products is ‘protected as such’ by that basic patent. However, in C-443/12, it was biological processes for the production of plants held that Sanofi was not entitled to two SPCs based on their patent covering the active ingredient may affect the allowability of product claims “irbesartan”. More specifically, it was held that the first SPC covering irbesartan and the second SPC, directed to plants or plant material. For more which was based on a later marketing authorisation for irbesartan in combination with a specific diuretic not explicitly identified in the claims of the patent, were connected with the same product. Although the claims of Sanofi’s Patent did cover irbesartan in combination with a general “diuretic”, > In November, the UK Intellectual Property
the court did not consider it necessary to address directly the fundamental issue of what constitutes a “product protected by a basic patent”. However, this second key issue was at the heart of C-493/12, change to SPC practice. In situations where an in which it was confirmed that in principle an SPC could be granted for a product functionally SPC is to be granted on the basis of a European Commission Marketing Authorisation (MA), the date for the purposes of calculating the SPC practice term is the date of notification, rather SPC Regulation back into the hands of the national courts and therefore divergent practices may well continue. But have we learnt anything from these cases? > SPC-type protection is to be introduced into
In all three Judgements, it was emphasised that the purpose of the SPC is to encourage research Canadian law as a result of the Comprehensive and to ensure that investments into research are adequately rewarded. This overarching goal seems Economic and Trade Agreement between to underpin all three decisions. It follows therefore, that in situations such as C-484/12, where a Canada and the European Union. Canada basic patent clearly covers more than one well-defined active ingredient, multiple SPCs should be will implement an up to two-year “patent allowable. However, attempts by Patentees to evergreen SPCs based on subsequent marketing term restoration”, which will be intended to authorisations for combinations of an innovative active ingredient protected by a basic patent with compensate Patentees in the pharmaceutical other active ingredients identified only in general terms may well be unsuccessful. It would also appear that attempts by Patentees to seek reward beyond the intended purpose of the SPC system > In case C-109/12, the CJ-EU confirmed that
will be viewed negatively. That said, how the authorities responsible for the grant of SPCs will a product classified as a “medical device” in reconcile these principles with day-to-day SPC practice remains to be seen.
certain member states of the EU could still be For more information about the referrals and the CJEU Judgements, see our pr regarded as a “medicinal product” in other states. For more information on this decision, r In response to the invitation for observations on the “Broccoli II” referral to the Enlarged and use a patented product in the clinical trials required to obtain marketing authorisation. in “Essentially Biological Products? – “Broccoli However, whether third parties are able to II””), a number of parties have submitted In a landmark ruling in the case of Apotex Pty manufacture and supply the product to generics comments on the patentability of products Ltd (“Apotex”) v. Sanofi-Aventis Australia Pty for the purposes of clinical trials under this produced by essentially biological processes, Ltd (“Sanofi”), the High Court of Australia has confirmed that methods of medical treatment The Düsseldorf Court of Appeal has recently are patentable in Australia. The High Court also AIPPI is an international organisation with referred questions on this matter to the Court decided that the generics manufacturer, Apotex, the objective of improving and promoting of Justice of the European Union (CJEU). The did not infringe Sanofi’s second medical use questions include: whether third party suppliers Patent, on the basis of the “skinny labelling” also benefit from the exclusion; whether this used by Apotex for their generic product. AIPPI Biotechnology Committee and Head of benefit depends on whether the product is Biotechnology at Boult Wade Tennant, oversaw This is one of the first cases to address the issue actually used in exempted clinical trials; and the preparation of the AIPPI submissions; of infringement of second medical use claims, whether the third party supplier must take these set out in detail why the AIPPI consider and in particular, the issue of infringement precautions to ensure that the patented product that the exclusion from patentability of where a generics company sought to carve out essentially biological processes should not limit the patented therapeutic indication from their the patentability of plant products. The full A translation of the referral by the Düsseldorf generic product prescribing information. This issue is yet to be tackled in Europe where a great deal of uncertainty still remains as to the impact of second medical use Patents on the generics industry.
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Supplementary Protection Certificates (SPCs) have been the hot topic in the pharmaceutical patent sector in recent years. On 12 September 2013 the Court of Justice of the European Union (CJEU) heard a number of cases relevant to the issue of whether a product is protected by a basic patent, The three referrals heard (Actavis Group and Actavis; Georgetown University; Eli Lilly and Company) > divergence between the EPO and national
request clarification of the CJEU’s ruling in the Medeva and Georgetown decisions of 2011 that an law as the German federal Court upheld the active ingredient must be “specified in the wording of the claims”. Specifically these referrals seek “Brüstle” stem cell Patent as valid, while the to clarify the level of generality permitted in a claim which is to be used as the basis for an SPC. EPO has revoked the corresponding European Although the questions have arisen primarily in relation to combination products, where a secondary case, for “added matter”. The Patentee has active ingredient is often claimed only in general terms, these decisions are expected to be more appealed the European decision (T1808/13)
widely applicable to any basic patent claiming an active ingredient in a generalised form.
If it is decided that a basic patent can only be used as the basis for an SPC application if the specific > for interesting decisions from the EPO Boards
of Appeal concerning the patentability of second
We know that it makes business sense to get to know our customers and to build our services around active ingredient, or combinations thereof, are recited in the claims, we can expect to see more Applicants focussing on narrow claims to specific compounds, rather than relying on generic species medical use claims directed to “novel” patient claims to obtain an SPC. This may cause difficulties in cases where the specific clinical candidate, or subclasses, see T0734/12 and T0108/09.
combination thereof, has not been determined when the patent application is filed.
> A question mark exists over the future of
A full review of the referrals pending before the CJEU was published on our website in January and SPCs in new Zealand after the new Patents a discussion of the outcomes of these referrals will follow as soon as details are released.
Bill was passed on 28 August 2013 without any provision for patent term extension for pharmaceuticals. The Trans-Pacific Partnership their needs. For us, our service is about people, not just IP. That means responding to our clients with may however, ultimately require the Bill to be amended. commercial understanding as well as technical and legal expertise if we are to guide them to the best In June 2013, the US Supreme Court decided In the Uk and Europe, essentially biological Association of Molecular Pathology v. Myriad has recently made a referral to the CJEU Genetics, holding that “a naturally-occurring seeking clarification of the law relating to the about the products of these processes? This dnA segment is a product of nature and not patentability of human embryonic stem cell is now under consideration by the Enlarged patent eligible merely because it has been inventions. The specific question is whether solution for their needs. We want people to choose Boult Wade Tennant and stay with us because or not “parthenotes”, should be classed as so-called “Broccoli II” referral (G2/13).
“human embryos” for patent purposes.
The Court held Myriad had not “created anything” by identifying, locating and “Uses of human embryos for industrial or claim to a plant allowable if the only method commercial purposes” are excluded from available for producing the plant is an essentially identified a product of nature. In contrast, the biological process? does this change if the cdnA of the genes was held to be patentable, Brüstle case), the CJEU provided guidance on as it was distinct from the natural dnA. interpretation of the term “human embryo”. In particular, the term was held to encompass they know we will work with them, not just for them. It remains to be seen how the Myriad decision Observations on this matter may be filed until “unfertilised ova whose division and further will be applied, although it is clear that the 30 november 2013. The complete questions claiming of “isolated” genes in the United parthogenesis”. The evidence before the Uk clarification of this matter from the EBA in Court in the present case makes it clear that parthenotes consist of pluripotent cells only, and can never complete the developmental process leading to a human being. As such, the Court has requested further guidance from the CJEU in relation to this issue.
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Autumn edition
Recently, there have been a series of epic clashes between well known and iconic brands such as: Rihanna v Topshop, Nestle v Cadbury and Lush v Amazon all of which are > Form and function: (have)
examined in this edition of boult.bitesTM. I would like to a break from the norm?
draw your attention to two articles in particular which explore international changes in the law that may directly affect you. > Rihanna v Topshop
The first article reviews the significance of the recent changes via boult.bitesTM
> Welcome changes
Chinese Trade Mark Law, which will come into force
afoot in China
on 1 May 2014, and the second announces the addition of another country to the Madrid Protocol due to take place
> Life’s not so “lushious”
for Amazon
As always, should you need further information please contact > Confusion between
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> Tunisia joins the Madrid
Protocol on 16 October 2013
The Biotechnology and Life Sciences group are soon to be launching a programme of > Touching the parts other
IP rights cannot reach –
Design Rights the unsung
heroes of the IP world
> Form and function:
> Vienna Agreement on
(have) a break from the norm? Figurative Marks entered
into force in the UK on
11 September 2013
seminars. To ensure you are kept up-to-date with the latest dates and seminar topics, > In the inside lane –
UKIPO new fastrack
opposition procedure
> Goodbye Patents County
Court, hello Intellectual Property
Two surveys were also presented by Nestle, Enterprise Court
showing the importance of the case. Allan r ecently issued a first-instance decision in an James, the Hearing Officer for the Registry, is > Case C 252/12 Specsavers
International Healthcare Ltd
email: [email protected], with your name, job title, and the word: biotech.
telephoneon relating to the shape shown above. one of the Registry’s most experienced and v Asda Stores Ltd
respected officers and is widely known for his learned and carefully-reasoned decisions. various kinds of chocolate and confectionery This is no exception, the decision coming in at products along with cakes and pastries, and Emma Pitcher will be
this is only a first-instance decision, the separated into two groups: the first is the sides using expert witnesses, and both sides requesting cross-examination of witnesses. conducted by an independent agency. This research has measured our service against those indicators we aim to work with our clients, not just for them that really matter to our clients and has, for the first time, allowed us to accurately benchmark EdITOr
Joanna Peak, Assistant
Jennifer O’Farrell, Attorney
Edward Ronan, Assistant

ourselves against competitors in our sector. You’re invited to r We aim to work with our clients, not just for them EDITOR


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