Source: http://ipkitten.blogspot.fi/2017/03/
Timestamp: 2018-04-20 23:35:52
Document Index: 427918138

Matched Legal Cases: ['CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ', 'CJEU ']

Posted by Annsley Merelle Ward at 20:05:00 0 comments
Posted by Annsley Merelle Ward at 19:47:00 29 comments
Labels: AmeriKat, Article 50, Brexit, Ratification UPC, UK IPO, UK ratification, Unified Patent Court, unitary patent
The AmeriKat facing the wind of
combo SPC validity
A cool wind seems to be blowing from the Patents Court, especially if you are an SPC owner for a combination product. In the past three months, Mr Justice Arnold has decided three SPC cases - Teva v Gilead [2017] EWHC 13, Abraxis v Comptroller General of Patents [2017] EWHC 14 and, last week, Teva v MSD [2017] EWHC 539. The first two cases were subject to references to the CJEU (see previous IPKat post here), with the latest decision keeping to the UK's shores...at least for now. The headline point seems to be that SPC owners will have a tough time trying to maintain their combination product SPCs. So how does the decision in Teva v MSD fit into this? The AmeriKat summarizes the decision below.
What was the SPC?
MSD's SPC/GB08/022 ("the SPC") - a combo SPC covering the anti-retroviral medication used in the treatment of HIV sold as Atripla by BMS and Gilead. Atripla is a fixed-dose combination of three active ingredients which are inhibitors of a viral enzyme known to reverse transcriptase - efavirenz ("EFV"), tenofovir in the form of disoproxil fumarate ("TDF") and emtricitabine ("FTC").
FTC is a NRTI (nucleoside reverse transcriptase inhibitor). EFV is a NNRTI (a non-nucleoside reverse transcriptase inhibitor). Tenofovir, a NtRTI (i.e. a nucleotide RT inhibitor), is a nucleotide analogue.
The rationale of Atripla is that it simplifies HIV-treatment regimens by improving patient compliance (one pill being easier to take than three separate ones).
The SPC described the product as
"A combination of efavirenz, emtricitabine or a pharmaceutically acceptable salt or ester thereof, and tenofovir or a pharmaceutically acceptable prodrug, salt or ester thereof, particularly tenofovir disoproxil, especially tenofovir disoproxil fumarate"
The marketing authorization ("MA") for Atripla was granted on 13 December 2007. An MA for EFV was granted in 20 November 1998. This MA was used as the basis to obtain an earlier SPC - SPC/GB00/35 - for EFV, alone ("the EFV mono SPC") which expired on 19 November 2013. The MAs for TDF and FTC were granted on 5 February 2002 and 24 October 2003, respectively.
Article 3(c) as MSD already obtained an SPC for EFV based on the basic patent. Because it was agreed that the basic patent disclosed and claimed EFV specifically and as part of a class of compounds, Teva argued that the Atripla product had already been subject to an SPC (the EFV mono SPC) which compensated MSD for the delay in exploiting the invention.
Article 3(c) precludes the grant of SPCs for a combination of active ingredients where one of those active ingredients embodies the "core inventive advance" (at [30] of Actavis v Sanofi) or "sole subject-matter of the invention" (at [39] of Actavis v Boehringer) of the basic patent and that active ingredient has already been the subject of an SPC based on that patent. This is irrespective of whether the patent contains one of more claims which protect the combination itself.
But an SPC can be granted if the combination is a distinct invention - it will not matter whether its protected by the same patent or by a different patent. In those circumstances, one of those active ingredients could not be said to be the "sole subject-matter of the invention".
The judge first decided under the Article 3(a) objection. With the aid of expert evidence, Mr Justice Arnold held that the construction of Claim 16 would include tenofovir (MSD successfully argued that it could be described as a nucleoside analog). However, he held that the "a" in front of " a nucleoside analog" meant that Claim 16 was limited to a duel combination product, but not a combination of all three of EFV, TDF and FTC. For that reason, since the "minimum requirement" is that all three must fall within a claim of a basic patent, the SPC was held to be invalid under Article 3(a). It was on the basis of this construction which meant that the SPC did not meet this "minimum requirement" that the question of a reference to the CJEU did not arise, as it had in Teva v Gilead.
The judge then turned to Article 3(c). In answering the question posed above, he considered that Claim 16 was not independently valid over the claims which protect efavirenz and
"does not represent a distinct invention. There is nothing in the Patent to suggest that claim 16 represents a distinct invention. Given the need for a simple and transparent system for the grant of SPCs, it seems to me that that should ordinarily be the end of the matter and that it should not be necessary to adduce expert evidence on this question."
He went on to acknowledge that if (note the word "if") it was appropriate to have regard to expert evidence:
"I consider that the evidence establishes that, given efavirenz, it would have been obvious to combine it with a NRTI in vitro because that would have been an obvious thing to try and the skilled person would have had a fair expectation of success. This is for the following combination of reasons."
This conclusion pulled support from an earlier finding made by the judge at paragraphs 136-140 where he concluded that it was CGK that combinations of NRTIs and NNRTIs were at least worth considering. This was because emerging research showed that NNRTIs were unlikely to be efficacious alone and given the different mode of action to NRTIs, there were potential advantages in combining the two. The judge held that the skilled person would have considered that there was a reasonable likelihood that a combination of a NRTI and a NNRTI would be either synergistic or additive, in vitro. Further, there was a "reasonable possibility" that the effect would be synergistic, although tests would have to prove this. The SPC was therefore invalid under Article 3(c).
So a combination SPC bites the dust. The AmeriKat is struck by the detail in which the parties went into expert evidence on construction for the purposes of Article 3(a) which was then employed to establish CGK for the purposes of a somewhat fall-back assessment of "distinct invention" under Article 3(c). This assessment was essentially that the combination was obvious over the CGK alone (which in normal patent proceedings is a pretty risky move). On one view, the "distinct invention" test is just an SPC-neutral way of disguising a conventional patent law inventive step test into SPC law. Arnold J's comments about the appropriateness of the use of expert evidence seems to suggest a tacit recognition of this nervousness to adopt conventional patent law tests and practice in the SPC space (or maybe it does no such thing!). Further, given that the correctness and scope of the use of expert evidence in assessing validity under Article 3(c) has not been clarified, will this lead to mini-patent trials inside of SPC proceedings?
If patent law assessments start creeping into SPC assessments of "distinct invention" then this must call into question whether the SPC Regulation (and the CJEU's interpretations of Article 3(c)) is doing justice to the teleological interpretation of the SPC Regulation. Further, how will patent offices be expected to assess the CGK for the purposes of determining Article 3(c) objections - this is not the straightforward, administrative assessment that the SPC regime was meant to embody. But here, we have the CJEU to thank for their Article 3(c) jurisprudence. "Perhaps post-Brexit UK laws will be a bit kinder to combo SPCs" muses Merpel. Well, on that happy note...
Posted by Annsley Merelle Ward at 15:35:00 0 comments
Labels: AmeriKat, article 3(a), article 3(c), Merck, Mr Justice Arnold, mylan, SPC regulation, SPCs, Teva
Posted by Neil Wilkof at 14:03:00 1 comments
Labels: Beit Din, hasagat gevul, Jewish law, pizza, Professor Neil Netanel, Rabbinical Court
Posted by Darren Smyth at 18:19:00 13 comments
Labels: Brexit, CIPA, IPAN, MIP, Unified Patent Court Agreement, unitary patent
In its 2016 decision in GS Media [Katposts here] the Court of Justice of the European Union (CJEU) sought to clarify under what conditions the provision of a link to a work protected by copyright made available on a third-party website (where it is freely accessible) without a licence from the relevant rightholder falls within the scope of the right of communication to the public within Article 3(1) of the InfoSoc Directive.
In its decision the CJEU held that whether linking to unlicensed content falls within or outside the scope of Article 3(1) of the InfoSoc Directive depends – crucially – on whether the link provider has a profit-making intention or knowledge of the unlicensed character of the work linked to.
In this new article that I have written and will be published in Common Market Law Review, I attempt to assess the implications of the GS Media decision: (1) in respect of linking, and - more generally - (2) the construction of the right of communication to the public.
1) GS Media imposes a re-consideration of what amounts to an act of communication to the public
GS Media marks a departure or, at least, signals a re-thinking of the understanding of the right of communication in the context of linking to copyright-protected content, as first provided in Svensson [Katposts here].
Mindful of the importance of links to the overall functioning of the internet, as well as the need to provide an appropriate balance of different interests, the CJEU attempted to mitigate the harsh consequences that a rigorous application of Svensson would have had.
In doing so, the court vested criteria so far only sporadically considered, eg the profit-making intention of the defendant, with a central role. It also introduced an element that in most Member States’ is not present as far as primary liability for copyright infringement is concerned, ie the knowledge by the defendant of the unlicensed character of the content linked to.
As far as the construction of the right of communication to the public in cases other than linking is concerned, similarly to Reha Training [here], GS Media regards the ‘indispensable intervention’ of the defendant as a central element: in doing so, the CJEU appeared to construe the notion of indispensability strictly.
2) Towards a relaxation of the GS Media notion of 'indispensable intervention'?
In their (post-GS Media) Opinions in Filmspeler [here] and Ziggo [here], AG Campos Sánchez-Bordona and AG Szpunar, respectively, proposed a broader construction of the notion of ‘indispensability’.
While the impact of Filmspeler might be somewhat reduced by the highly specific factual context from which this CJEU reference originated (multimedia players with pre-installed hyperlinks to websites that, without the authorization of the copyright holder, offer unrestricted access to copyright-protected works, eg films, series and live programmes), the implications of Ziggo promise to be more far-reaching.
If the CJEU followed its AGs in both cases (particularly in Ziggo), then the relevance of GS Media could be scaled down, both as far as the understanding of Article 3(1) is concerned and the type of defendants that might be regarded as committing acts of communication to the public.
In this sense, not only users, but also online intermediaries – read: hosting providers – could be regarded as primarily liable for copyright infringement in relation to user-uploaded materials that infringe third-party rights, in line with the construction of Article 13 of the draft DSM Directive as proposed by the European Commission.
3) The next big question for the right of communication to the public is not just what amounts to an act of communication to the public but also determination of who makes it
Ultimately the discussion above suggests that the concept of ‘communication to the public’ has been undergoing an evolution.
The next frontier for Article 3(1) of the InfoSoc Directive appears to be not just a determination of what amounts to an act of communication to the public, but also who makes an act of communication to the public.
The latter in particular is the next question for the CJEU to tackle, and also poses significant – and not entirely worked out – challenges to EU policy- and law-making.
Posted by Eleonora Rosati at 22:05:00 1 comments
Labels: Common Market Law Review, EU copyright, GS Media C-160/15
"In Denmark, the EU Trade Secrets Directive which came into force on 5 July 2016 (as reported on the IPKat here), will be implemented in an entirely new and independent act on trade secrets.
Although we have yet to see the proposal for the new act (which we cannot wait to get our paws on), the implementation of the directive
Like in the US, these are exciting times for trade secrets in Europe. The AmeriKat will be back to report on other Member States efforts in implementing the EU Trade Secrets Directive.
Posted by Annsley Merelle Ward at 20:10:00 3 comments
Labels: AmeriKat, Denmark, EU trade secrets directive, Implementation of EU Directives, Member States, trade secrets
Posted by Mark Schweizer at 13:22:00 1 comments
Labels: Patent statistics, PCT, WIPO
Posted by Hayleigh Bosher at 12:30:00 0 comments
Posted by Neil Wilkof at 13:34:00 0 comments
Labels: Mexico, patents, priority application numbers, WIPO Handbook on Industrial Property Information and Documentation
According to Article 87(1) European Patent Convention, any person who has duly filed, in or for any state party to the Paris Convention or any member of the WTO, an application for a patent or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application (emphasis added). The reference to the "successor in title" in Article 87(1) EPC is generally interpreted as requiring a transfer of the right of priority before the filing of the subsequent application (T 205/14, Reason 3.4).
In T 577/11 of 22 March 2017, Board of Appeal 3.2.05 confirmed this. Transfer of the priority date had undoubtedly taken place in this case, but three days after the filing of the subsequent application. The applicant argued that Article 87(1) EPC did not require that the transfer of the priority right had to occur prior to the filing of the subsequent application. The Board, based on the wording of Article 87(1) EPC and noting that its interpretation was in line with Article 4A(1) Paris Convention and the legislative history of both the relevant provisions of the Paris Convention and the EPC, rejected the appellant’s argument. The transfer had to had taken place by the time the subsequent application was filed.
The Board notes that German case law considers the date the declaration of priority with the particulars relating to the priority application is filed – which can be done up to 16 months from the earliest priority date claimed (Rule 52(2)), and therefore up to four months after the filing of the subsequent application – as the relevant date (German Federal Patent Court, decision of 15 February 2012, 5 Ni 59/10 (EP), Reasons, point I.2, and decision of 28 October 2010, 11 W (pat) 14/09), Reasons, point II.B.2(a)(cc)). In the case at hand, Rule 52(2) was not applicable because the application that led to the patent was a PCT application. Under Rule 4.10(a) PCT, the declaration was to be made on filing the subsequent application, which it was. Nonetheless, the Board indicates that even if the present application had not been a PCT application, it did not consider the German approach convincing, as the filing of the declaration of priority was a “mere formality” that did not change the relevant date, which was the filing date of the application.
The decision does not come as a great surprise. There has long been a consensus that the transfer of a priority right must occur prior to the subsequent filing. However, given the careful reasoning and the amount of space the Board dedicates to the issue, T 577/11 may be considered the leading case on this for the coming years. The take-away for applicants and their representatives is that they better get those assignments signed prior to filing the subsequent application, or else the curtain falls on the priority claim.
Posted by Mark Schweizer at 09:30:00 8 comments
Labels: epc, priority application
A commitment to commission research on how institutions commercialise their IP, looking licensing and spin outs, and how practices vary between different institutions (institution here generally meaning universities)
A commitment to reviewing how the IP system maximises incentives for collaboration and licensing
The call for responses to the consultation on the industrial strategy closes April 17th.
Posted by Nicola Searle at 08:48:00 5 comments
Labels: innovation, Katonomics, Westminster policy