Monday, 29 December 2014

Patent litigation and cost shifting in Europe: a new article

"Patent litigation and cost shifting in Europe: critical appraisal and proposal of alternative solutions" by Filipe Fischmann (Research Fellow, Intellectual Property and Competition Law, Max Planck Institute for Innovation and Competition), has today been published online for the benefit of e-subscribers to the Journal of Intellectual Property Law & Practice (JIPLP). You don't have to be a regular subscriber to read it, though, since non-subscribers can purchase limited-time access to it from the JIPLP website here. According to the abstract:
"This article analyses different costs rules and practices regarding patent litigation in Europe, explains the functions played by cost-shifting provisions and proposes the introduction of a modulated two-way fee-shifting system, in order to enhance patent litigation".
The author concludes:
Cost shifting is one of the fundamental elements of litigation, as it represents an important element in the decision to go to court. In Europe, the Enforcement Directive tried to harmonize national costs rules, but they, and the respective practices, are still particularly divergent among EU Member States, as the analysis showed. The different systems adopted by Germany and England and Wales show that each scheme has its advantages, but also some shortcomings. Although one Member State can learn from the practice of the others, its own tradition may represent a barrier to the implementation of alternative solutions.

However, the creation of the UPC represents an exceptional opportunity for the adoption of new measures on litigation rules in general and also on cost-shifting provisions in particular. Although the different traditions of each Member State may and should be considered, the creation of the UPC could allow the adoption of creative measures, as long as they comply with EU rules. The UPC should therefore make use of costs scales, profiting from the German experience, and of an issue-based approach, benefiting from the English and Welsh practice. Moreover, the UPC should reformulate the English and Welsh experience with certificates of contested validity and create a modulated two-way fee-shifting system, which may help improve the patent system.
This is obviously of interest to readers of PatLit who litigate patents in Europe, or may find themselves doing so under the new European patent regime in the near future.

Thursday, 18 December 2014

Supreme Court To Hear Challenge To Brulotte Rule

On December 12, 2014, the U.S. Supreme Court granted certiorari in the third patent case to be heard this term, this one presenting an issue at the intersection of patent law and antitrust law. In Brulotte v. Thys Co., 379 U.S. 29 (1964), the Supreme Court ruled that a patent license requiring the licensee to pay royalties after the licensed patent expires is a per se violation of the antitrust laws. In addition, the same conduct constitutes patent misuse, and may render a patent unenforceable in a subsequent infringement action. Now, 50 years later, the petitioner in Kimble v. Marvel Enterprises, Inc., No. 13-720, asks the Court to overturn that per se rule. 

Kimble is the inventor of a "Spiderman" toy that allows children (and perhaps some adults) to shoot foam webs from their wrists. He licensed the patent to Marvel. The license included a royalty based on sales of the toy, but did not provide for the royalties to end when the patent expired. Marvel relied on Brulotte to stop paying post-expiration royalties.

The Brulotte Rule has been widely criticized as outdated. For example, Scheiber v. Dolby Labs., Inc., 293 F.3d 1014 (7th Cir. 2002), Judge Richard Posner criticized the rule as being wrong, lamenting that the Seventh Circuit had “no authority to overrule a Supreme Court decision no matter how dubious its reasoning strikes us, or even how out of touch with the Supreme Court’s current thinking the decision seems.” The U.S. Department of Justice and Federal Trade Commission also have criticized the rule in recent guidelines analyzing anticompetitive provisions in intellectual property license agreements. In recent years, the Supreme Court has modernized its analysis of antitrust concerns relating to intellectual property. See, e.g., Illinois Tool Works, Inc. v. Independent. Ink, Inc., 547 U.S. 28 (2006) (overruling its prior decisions that, in an antitrust tying claim, a patent does not necessarily confer market power upon a patentee). The Kimble case may be a vehicle for it to dispense with the Burlotte rule as well. Oral arguments have not been scheduled.

Friday, 12 December 2014

DDR Holdings: A New Perspective On Patenting Internet Processes?

The Supreme Court’s decision in Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) created perplexing issues for those hoping to patent computer-implemented processes and associated systems. The Court described a potentially broad (but effectively undefined) notion of “abstract ideas,” and held that a patent that implicates an abstract idea is eligible for patenting under 35 U.S.C. § 101 only if the claims recite an “inventive concept” that restricts the claimed subject matter to something significantly different from the abstract idea per se. Routine and conventional computer hardware and functions are insufficient to provide this inventive concept.

Following Alice, a series of cases have invalidated patents covering computer-implemented inventions as ineligible abstract ideas. Ultramercial, Inc. v. Hulu, LLC, ___ F.3d ___, 2014 WL 5904902 (Fed. Cir. Nov. 14, 2014)(process for using advertising as a currency for accessing media content over internet); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350 (Fed. Cir. 2014)(use of computer to create a transaction performance guaranty); Accenture Global Servs., GmbH v. Guidewire Software, Inc., 728 F.3d 1336 (Fed. Cir. 2013)(system to perform insurance-policy-related tasks on a computer); Bancorp Servs. LLC v. Sun Life Assur. Co. of Canada, 687 F.3d 1266 (Fed. Cir. 2012)(use of computer to perform repetitive insurance value computations). In light of those decisions, the outlook for internet-related computer patents appeared bleak.

On December 5, however, the Federal Circuit signaled that some hope still exists by affirming the eligibility of a software patent involving commerce on the internet. DDR Holdings, LLC v., LP, No. 2013-1505 (Fed. Cir. Dec. 5, 2014). Slip opinion HERE. In a 2-1 decision written by Circuit Judge Chen, the Federal Circuit ruled that an invention directed to merchandising on the internet was patent-eligible.

DDR concerned U.S. Patent No. 7,818,399 (entitled “Methods of expanding commercial opportunities for internet websites through coordinated offsite marketing”). The ‘399 patent addressed the problem facing internet stores with websites that include ads for third-party merchants. In prior art systems, a customer clicking on an ad on a host website would be directed to a third-party site, often being lost to the host site forever. The ‘399 patent claims a process involving stored data concerning the visual elements responsible for the “look and feel” of the host website, so that upon clicking an ad the customer is directed to a webpage on the host website that is a composite of the third-party merchant’s product information and the look and feel elements of the host website.

The Federal Circuit applied the two-step test for patentability set forth in Alice. First, it considered whether the ‘399 patent claims were directed to a patent-ineligible abstract idea. It noted that distinguishing between a patentable invention and an abstract idea “can be difficult, as the line separating the two is not always clear.” Slip op. at 16. After reviewing Supreme Court cases characterizing (without defining) abstractness, the Federal Circuit side-stepped the issue by noting that, even if the ‘399 patent claims included abstract ideas, they nonetheless were saved by step two of the Alice analysis.

In step two, the court must “consider the elements of each claim—both individually and as an ordered combination — to determine whether the additional elements transform the nature of the claim into a patent-eligible application of that abstract idea. This second step is the search for an ‘inventive concept,’ or some element or combination of elements sufficient to ensure that the claim in practice amounts to ‘significantly more’ than a patent on an ineligible concept.” Id. 16, quoting Alice, 134 S. Ct. at 2355.

The Federal Circuit ruled that, although the ‘399 patent was directed to internet commerce, it was limited to a particular application of any broad, abstract concept: 
As an initial matter, it is true that the claims here are similar to the claims in [earlier cases finding patents ineligible] in the sense that the claims involve both a computer and the Internet. But these claims stand apart because they do not merely recite the performance of some business practice known from the pre-Internet world along with the requirement to perform it on the Internet. Instead, the claimed solution is necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks.  
In particular, the ’399 patent’s claims address the problem of retaining website visitors that, if adhering to the routine, conventional functioning of Internet hyperlink protocol, would be instantly transported away from a host’s website after “clicking” on an advertisement and activating a hyperlink. For example, asserted claim 19 recites a system that, among other things, 1) stores “visually perceptible elements” corresponding to numerous host websites in a database, with each of the host websites displaying at least one link associated with a product or service of a third-party merchant, 2) on activation of this link by a website visitor, automatically identifies the host, and 3) instructs an Internet web server of an “outsource provider” to construct and serve to the visitor a new, hybrid web page that merges content associated with the products of the third-party merchant with the stored “visually perceptible elements” from the identified  host website. 
Slip op. at 20. The court distinguished Ultramercial, a recent case holding that an-Internet based process was ineligible: 
Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result—a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink. Instead of the computer network operating in its normal, expected manner by sending the website visitor to the third-party website that appears to be connected with the clicked advertisement, the claimed system generates and directs the visitor to the above-described hybrid web page that presents product information from the third-party and visual “look and feel” elements from the host website. When the limitations of the ’399 patent’s asserted claims are taken together as an ordered combination, the claims recite an invention that is not merely the routine or conventional use of the Internet. 
Id. at 22-23. As a result, the court ruled that the process was eligible under §101. Circuit Judge Mayer dissented, arguing that the ‘399 patent was “long on obfuscation but short on substance[,]” and that the invention disclosed was “so rudimentary that it borders on the comical.” He interpreted Alice to create a “technological arts” test for eligibility, which was not met because the ‘399 patent was not rooted in any new computer technology.

Thursday, 11 December 2014

Claim interpretation, post-grant deletions, "obvious to try" -- and much more: Hospira v Genentech

Considerable interest has been shown in a recent Patents Court, England and Wales, ruling of Mr Justice Birss, on claim interpretation and product-by-process claims.  Darren Smyth's Katpost "Hurray for judicial sense on product by process claims - Birss triumphs in Hospira v Genentech" can be read here; meanwhile PatLit has its own guest post on the subject, composed by Suleman Ali (Holly IP), who writes as follows:
Hospira UK Limited v Genentech Inc. [2014 EWHC] 3857 (Pat) is a decision by Mr Justice Birss in the Patents Court, England and Wales. This case is about a stable formulation containing the antibody Herceptin (or ‘trastuzumab’) which is used to treat breast cancer. The formulation contains Herceptin and three specified ‘excipients’. The decision concerns Genentech’s two patents EP 1516628 and EP 2275119, which are divisionals from the same parent case. Herceptin itself was protected by a different patent, EP 0590058 for which the SPC expired on 29 July 2014. Hospira now wish to sell generic Herceptin and in order to do so have to obtain a generic authorisation based on the existing marketing authorisation for Herceptin. That would require them to use the same formulation as claimed in the present two patents, and so in this action Hospira sought revocation of Genentech’s patents to ‘clear the way’ for Hospira to  sell generic Herceptin. 
Birss J noted at the onset that formulation patents are sometimes called ‘second-generation’ patents because they do not relate to the drug itself, and ‘are sometimes criticised as an attempt by the pharmaceutical company to unduly prolong its monopoly, after the first generation patent for a drug itself has expired (so called evergreening)’. However he also noted that ‘there is no legal principle that formulation patents should be treated in any way differently from any other patent’. 
Interesting points 
The decision has the following interesting points:
- the importance of common general knowledge in the field of ‘formulations’,
- the dangers of deleting features from claims post-grant and the complexity of generalising from specific examples,
- the ‘esoteric’ nature of product by process claims and how they can have different scopes for validity and infringement,
- an illustration of how to determine whether ‘new information’ is present in an amendment (which is different from the EPO’s approach to added matter),
- the relevance of the EPO’s would/could test to inventive step analysis in the present case, and
- a discussion of why the judgment has not fallen foul of the ‘Technograph’ test, in which a ‘step by step’ analysis can be based on hindsight. 
The technology and the issues to be decided 
The invention concerns a stable lyophilised (i.e. freeze dried) formulation for Herceptin which can be stored for long periods of time and which is reconstituted with water before administration to a patient. The formulation comprises four specified components: Herceptin, trehalose (a lyoprotectant), histidine (a buffer) and polysorbate 20 (a surfactant). Herceptin was known at the priority date and therefore the invention only lies in deriving this specific four-component formulation. The claims place limitations on the ratios and concentrations of the components, but these limitations were not deemed to make an inventive contribution. 
Genentech requested significant amendment to the claims of both patents, and much of the decision deals with issues raised by the amendments. The main issues that were decided were:
- whether the amended claims extend the scope of protection,
- whether the amendments should be allowed given the introduction of a product by process feature,
- whether the amended claims add matter, and
- whether the claims were obvious. 
The claims 
Claims 1 and 2 from both patents are below showing the amendments that Genentech requested (the underlining shows text that has been introduced into the claims). Similar amendments were made to generate new claims 3 and 4 for EP 2275119 which are not shown here. The amendments include deletion of the feature relating to the 200-600:1 ratio of lyoprotectant to antibody and insertion of an ‘obtainable by’ product by process feature. 
1. A formulation comprising a lyophilized mixture of a lyoprotectant, a buffer, a surfactant and an antibody, wherein the molar ratio of lyoprotectant : antibody is 200 600 moles lyoprotectant : 1 mole antibody, wherein the lyoprotectant is trehalose or sucrose wherein the buffer is histidine, wherein the surfactant is polysorbate 20 and wherein the antibody is a monoclonal antibody huMAb4D5-8, obtainable by lyophilizing a solution containing 25 mg/ml huMAb4D5-8, 5mM histidine pH 6.0, 60 mM trehalose and 0.01% polysorbate 20.
 2. A formulation comprising a lyophilized mixture of a lyoprotectant. a buffer, a surfactant and an antibody, wherein the lyoprotectant is trehalose, wherein the buffer is histidine, wherein the surfactant is polysorbate 20 and wherein the antibody is huMAb4D5-8, such that an amount of said lyophilized mixture containing 450 mg of said antibody can be reconstituted with 20 ml of BWFI (0.9 or 1.1% benzyl alcohol) to yield a concentrated protein solution containing 22 mg/ml of said antibody, 52 mM trehalose, 4 mM histidine, pH 6.0, 0.009% polysorbate 20. 
EP 2275119 
1. Use of a lyophilized formulation comprising a monoclonal antibody, a buffer, a surfactant and a lyoprotectant, wherein the molar ratio of lyoprotectant : antibody is 200 600 moles lyoprotectant : 1 mole antibody, wherein the lyoprotectant is trehalose, wherein the buffer is histidine, wherein the surfactant is polysorbate 20, and wherein the monoclonal antibody is huMAb4D5-8 an anti HER2 antibody, obtainable by lyophilizing a solution containing 25 mg/ml huMAb4D5-8, 5mM histidine pH 6.0, 60 mM trehalose and 0.01% polysorbate 20, in the preparation of a medicament for the treatment of a breast cancer characterised by overexpression of the HER2 receptor. 
2. Use of a formulation comprising a lyophilized mixture of a lyoprotectant. a buffer, a surfactant and a monoclonal antibody, wherein the lyoprotectant is trehalose, wherein the buffer is histidine, wherein the surfactant is polysorbate 20 and wherein the monoclonal antibody is huMAb4D5-8, such that an amount of said lyophilized mixture containing 450 mg of said antibody can be reconstituted with 20 ml of BWFI (0.9 or 1.1% benzyl alcohol) to yield a concentrated protein solution containing 22 mg/ml of said antibody, 52 mM trehalose, 4 mM histidine, pH 6.0, 0.009% polysorbate 20, in the preparation of a medicament for the treatment of breast cancer characterised by overexpression of the HER2 receptor. 
Common General Knowledge 
The expert evidence was used to establish the common general knowledge in the field of formulations, including determining how the skilled formulator would have acted. At the priority date of March 1996 a phase II clinical study of Herceptin had been published (Baselga et al) and it was known that a phase III clinical trial was happening. However Hospira could not establish that these would be known to all in the art and therefore they were not deemed to be part of the common general knowledge. 
Birss J established that in 1996 the task of providing a formulation for a large molecule such as the Herceptin antibody was a challenge and essentially empirical, but this had been successfully undertaken for a number of molecules, such as insulin, human growth hormone and erythropoietin. He felt the skilled formulator would not underestimate the potential risks and would not give up even if the early results were negative. The skilled formulator would deem the exercise well worth carrying out and worth pursuing seriously. 
Birss J also noted the ‘very different point’ that the skilled formulator could not say in advance which putative formulation would work. This seems relevant to ‘expectation of success’ but did not factor into the inventive step analysis in the decision. 
Birss J found that the general approach to identifying a formulation was established in 1996, that of testing candidate excipients in various conditions. Lyophilisation was also well known, as was the use of a buffer, surfactant and lyoprotectant in a lyophilised formulation. Histidine was known as a buffer and polysorbate 20 as a surfactant. However while the common general knowledge included the ‘idea of using trehalose as a possible lyoprotectant for proteins’ its toxicity when given as part of a therapeutic composition was not known. 
Extension of scope by post-grant amendment 
Birss J had to decide whether deletion of the feature of the molar ratio of lyoprotectant to antibody being 200-600 moles to 1 mole and insertion of the product by process feature led broadening of claim scope. Genentech argued that the product by process feature led to the ratio being 360:1 of lyoprotectant to Herceptin. However Hospira pointed out that the claims use ‘comprising’ language and therefore other proteins and lyoprotectants could be present in the composition, and that could take the ratio outside 200-600:1. Birss J agreed and found that the amended claims extended scope beyond the granted claims, but also noted that an amendment to replace ‘comprising’ with ‘consisting of’ would overcome the issue. 
Product by process claims 
In the decision Birss J introduces his discussion of product by process claims by saying they are ‘tricky’. He first discusses product by process claims which are written in the form of ‘obtainable by’ or ‘obtained by’ a defined process, which he describes as ‘overt’ product by process claims. Kirin Amgen [2004] UKHL 46, reported by IPKat here. established that the EPO position had to be followed when determining the validity of such claims. That meant that the ‘obtained by’ form of claim could be anticipated by any product that had the same features as the product obtained by the process, even if it was not made by the process, i.e. for validity the scope of the claim was being interpreted in the same way as for the ‘obtainable by’ form of claim. However Birss J noted that for infringement purposes the ‘obtained by’ feature had to be read as only covering products that had been made by the defined process. Birss J admitted this was a ‘little paradoxical’. 
He also noted that apart from ‘overt’ product by process claims (that used the language ‘obtainable by’ or ‘obtained by’) claims could have other product by process features such as ‘lyophilised’ in the present claims where again the same issues arose of the scope of the claims for validity and infringement. 
Birss J discussed the circumstances in which the EPO will allow product by process claims. They are only allowed when there is no other way of defining the product (i.e. the product cannot be adequately defined using structural features). This is essentially a trade off between clarity and fairness to the patentee. Turning to the present claims he noted that it was difficult to determine which characteristics need to be present in a product for it to be ‘obtainable by’ the defined lyophilisation process, for example it is not clear what the water content of the product could be. The reader of the claims would be faced with the ‘impossible task of having to create for themselves a list of the relevant attributes’ of the product which is covered. In these circumstances, and in line with the EPO’s approach, Birss J refused to allow the amendment. 
Added Matter 
The added matter issue arises because the amendments represent a generalisation from Example 1 of the patent. Hospira argued that this represented an impermissible intermediate generalisation, and cited Palmez [1999] RPC 47 . Genetech submitted that the amendment does not disclose ‘new information’ and cited AC Edwards v Acme [1992] RPC 131. Birss J noted that it was not always easy to know which cases fall on the AC Edwards side of the line and which on the Palmaz side, admitting he made that mistake in AP Racing v Alcon [2013] EWPCC 3 (the IPKat’s report of the appeal can be found here). He also noted that the ‘task of applying the law is made more difficult by the fact that the EPO does not approach added matter this way at all’. Turning to the amended claims he noted that they have the effect of only limiting the molar ratio of the components. However in the context of the original disclosure the molar ratios would be tied to particular protein concentrations, and therefore in the absence of a limitation to protein concentration the amended claims present ‘new information’ and therefore add matter. 
Carter was the primary document for determining obviousness. It disclosed that Herceptin was in phase II clinical trials for breast cancer. Birss J felt that this would provide the skilled person with motivation to produce a formulation. There was motivation to investigate lyophilisation given that it was known liquid formulations of Herceptin degraded. Hospira’s case was that the required screening of excipients was wholly conventional and the three excipients present in the formulation were obvious candidates to include in the screen. The particular concentrations and/or molar ratios specified in the claims ‘are not suggested to be the product of inventive step’. 
Birss J found that the skilled formulator would identify histidine as an appropriate buffer and polysorbate 20 as an appropriate surfactant from common general knowledge. Whether the skilled formulator would choose trehalose as a lyoprotectant was more complex to determine. Genentech argued that its toxicity was unknown and so regulatory approval would be needed for its use. Further it would not be present in a ‘first’ screen, and would only be tested after a ‘second’ screen. If the skilled formulator achieved success before that then trehalose might never be tested. Genentech also argued that the focus on trehalose was due to hindsight. 
However Birss J disagreed, viewing trehalose as a ‘very promising lyoprotectant’ and finding that concerns about toxicity would not put the skilled formulator off from testing it. In Birss J’s opinion trehalose would be in a list of eight lyoprotectants to test. That makes it an obvious ingredient to test. 
Would/Could, arbitrary selection and the Technograph test 
Before concluding on obviousness Birss J went on to deal with other points that arose as part of looking at obviousness. 
Genentech argued that the EPO’s approach of asking whether the skilled person would have arrived at the invention, not whether they could have, should be used. However Birss J felt that the law of obviousness could not be accurately summarised in this way, and that the issue was multifactorial and based on the circumstances. The well known 9 ½ inch plate is not something a skilled person would make. In this case it was more appropriate to look at whether the invention could be arrived at by using routine methods applied to excipients that were part of common general knowledge. 
Birss J also considered the issue of whether the claims represented a ‘selection’ that could be inventive. He found that it was not an ‘arbitrary’ selection as the invention does give benefits, but that does not necessarily mean it involves inventive step. At the end of their work the skilled team would not be surprised that they had made a stable formulation, and nor would they be surprised by the identity of the ingredients. 
Birss J also looked at whether the deriving the invention represented a ‘research programme’ which he interpreted as being an undue burden. However he felt that for this to be an issue it would require ‘a degree of persistence through unpromising results’, but that had not happened here. 
Finally the Technograph test was looked at (from Technograph Printed Circuits Ltd v Mills and Rockley (Electronics)Ltd [1972] RPC 346). The test found it wrong to find an invention obvious if it was arrived at after a series of steps which involved the cumulative application of hindsight, for example where knowledge of the target (based on hindsight) motivates the skilled person to take each step. In the present case Birss J found this was not the situation here, in particular because the tests are run in parallel rather than in series. 
In view of these findings the claims were obvious from Carter
The inventive step issues in the present case are similar to another recent case decided by Birss J, Teva UK Limited & Teva Pharmaceuticals Limited v Leo Pharma A/S & Leo Laboratories Limited [2014] EWHC 3096 (Pat), reported by IPKat here. In that case also common general knowledge was central to deciding that the formulation of the invention was obvious. Given that common general knowledge, rather than prior art documents, seems to be most relevant in the field of formulations, it is not surprising that such cases are granted by Patent Offices where examination is document-based. 
In his discussion of ‘arbitrary selection’ Birss J notes that the skilled team would not be ‘surprised’ by the formulation they had identified. One wonders if the result would have been different if Genentech could have identified at least one surprising feature of the formulation. In addition one wonders whether a ‘reasonable expectation of success’ argument could have been used in support of inventive step, given Birss J’s acceptance that one could not determine beforehand whether any particular formulation would work. Such an argument would probably not have succeeded but may have led to Birss J providing guidance as to when ‘expectation of success’ is relevant to inventive step.

Explicilty mentioning the effect won't help

The Decision Human papillomavirus vaccines/GLAXOSMITHKLINE T 1493/09 available here deals with a vaccine composition having various complicated names. No surprise so far.

The main request was rejected as being obvious over the art and the auxiliary request. The obviousness of the auxiliary request is discussed in points 20 - 22 as below (emphasis added):
Claim 1 of [the auxiliary request] differed from claim 1 of the main request in that it is directed to the second medical use of the vaccine composition, i.e. it is directed to a vaccine composition for use in the prevention or treatment of a disorder related to HPV infection, as opposed to the product as such. The appellant stated that this claim type set a higher bar with respect to evidence on the efficacy as a vaccine, in particular requiring evidence of effective protection in humans.

Claim 1 of auxiliary request 1 includes the therapeutic effect ("prevention or treatment of a disorder related to HPV infection") as an explicit feature, while claim 1 of the main request does not. In other words, claim 1 of auxiliary request 1 is directed to a “vaccine composition” characterised in that it comprises VLPs containing HPV-derived proteins which is capable of generating a protective immune response for each HPV L1 protein present in the VLPs in the composition. In the board’s view, the wording of claim 1 of the main request already implies that the claimed composition is an effective vaccine for the treatment of HPV-related disorders. In fact, this effect (the same as the one as explicitly recited in claim 1 of the auxiliary request) was already taken into account by the board when evaluating the inventive step of the subject-matter of claim 1 of the main request (see in particular points 4 to 10 above). Hence, the board considers that the assessment of inventive step for the subject-matter of claim 1 of the main request according to the problem and solution approach set out at point 2 to 19 above
applies to the subject-matter of claim 1 of the auxiliary request without any change in the reasoning.  
The subject-matter of claim 1 of auxiliary request 1 therefore lacks an inventive step for the same reasons as the subject-matter of claim 1 of the main request. The requirements of Article 56 EPC are not fulfilled.
In other words, mentioning the therapeutic effect makes life more complicated in that evidence for its existence may be required but did not help in this case.

Wednesday, 10 December 2014

Ireland contemplates hosting a UPC Local Division

The British Isles are buzzing with excitement and intrigue with regard to Europe's (anything but) Unified Patent Court. First we had the announcement that the Law Society of Scotland and the Society of Advocates were to press for Scotland to have a Local Division of their own [on which see Darren Smyth's recent post on the IPKat here]. Then, via the Mason Hayes Curran newsletter, this blogger read of Ireland's intention to host a Local Division of the Unified Patent Court. In short,
Richard Bruton, the Minister for Jobs Enterprise and Innovation, has recently announced that Ireland has elected to establish a local division of the Court of First Instance of the Unified Patent Court (“UPC”) in Ireland. Ireland’s decision is significant in that the majority of Member States of the European Union may facilitate infringement cases through a regional division where a number of Member States collaborate to service such cases on a joint basis. In the case of smaller Member States, such infringement proceedings will have to take place in the central division of the UPC in Paris, London or Munich.

The business impact of this development is as follows:

  • Once established, the Irish local division of the UPC will permit unitary and/or European patent proprietors to bring pan-European infringement proceedings in Ireland rather than abroad in appropriate circumstances thereby eliminating the need for multiple Member State proceedings and thereby reducing time and legal costs 

  • Similarly, an Irish company that is in a patent infringement dispute with a unitary or European patent holder will be proceeded against in Ireland in respect of such infringement and not abroad, again potentially reducing time and legal costs; 

  • An injunction obtained in the local division of the UPC in Ireland will be effective in all participating Member States; 

  • Parties will also benefit from the increased expertise of the dedicated judicial panel to the UPC.
PatLit will keep its eyes open for further developments in this regard.

Malta: a ratification ... and a problem?

Malta has now definitely ratified the Unified Patent Court Agreement, this event taking place yesterday, 9 December 2014. Malta's accession has been the subject of both speculation and confusion, as reported on earlier PatLit posts here, here, here and here.

Readers might like to consider the ramifications of this ratification in light of what Keltie's Emily Weal and Mark Richardson, writing on the IPCopy blog, call the "Malta Problem", here.

Hat-tip to Darren Smyth (EIP) for spotting this item!

Demonstration at the EPO

About 1500 or 1600 individuals (according to estimates of the organizers) including EPO employees, sympathizing professional representatives, curious bloggers and chimeras of these categories have demonstrated in front of the EPO's Isar building today, where the meeting of the Administrative Council is about to take place. The calls for negotiations between the staff committee and the EPO management were more and more drowned by louder calls for a demission of Mr. Batistelli.

Representatives of the staff committee made various proposals on how to make sure that the fundamental human rights including the freedom of speech and the guarantee of judicial review are respected. One proposal was to establish an independent committee reviewing the managerial decisions in view of their compliance with human rights, the other one was that the EPC should access the European Council.

For more background information, see here and here.

What do our readers think? How can the fundamental rights be preserved in an international organisation where employees do not trust any longer that the management takes these rights for granted? 

Friday, 5 December 2014

U.S. Supreme Court Agrees To Hear Case Regarding Defenses To Active Inducement Liability

On December 5, 2014, the U.S. Supreme Court granted certiorari in Commil USA v. Cisco Systems, Inc., No. 13-896. See Order. The arguments will be limited to one issue in the petition:

Whether the Federal Circuit erred in holding that a defendant’s belief that a patent is invalid is a defense to induced infringement under 35 U.S.C. § 271(b).

This appeal stems from a 2-1 opinion at the Federal Circuit. The trial court ruled that Cisco was liable for active inducing its customers to infringe Commil’s patent. A split Federal Circuit panel reversed, because Cisco had a good faith belief that the patent was invalid. The majority reasoned that an invalid patent cannot be infringed, so a belief that a patent is invalid precludes the required intent to cause infringement required under § 271(b). Commil argues in the appeal (and the dissenting Federal Circuit judge agreed) that a determination of invalidity may dispose of liability, but infringement is “an entirely separate question capable of determination without regard to its validity[.] ” Medtronic, Inc. v. Cardiac Pacemakers, Inc., 721 F.2d 1563 (Fed. Cir. 1983). Thus, the intent to infringe required under §271(b) can exists independent of the validity issue.

Monday, 1 December 2014

Using cookies on trade fair need not be unfair

Unfair Competition?
Infringement disputes often start with the display of allegedly infringing products on a trade fair. Trade fairs are primarily meant to sell products. This is why displaying infringing products has hitherto been considered entailing a "risk of a first offence" (Erstbegehungsgefahr) for selling or offering the same product.

However, further aims of a trade fair include making contacts and displaying the skills of the exhibitor. In the case of the international trade fair on confectionery ISM with the headline
"Sweets as always. More snacks than ever before.", both of these aims may obviously include using cookies (real ones with flour and a lot of butter, not the ones in your web browser ...).

In the decision Pralinenform II, the BGH had already ruled that displaying pralines with a 3-dimensional shape protected as a trademark on a trade fair does not as such imply that the praline is offered for sale.

According to the press release relating to the (yet unpublished) decision I ZR 133/13, this has now been confirmed for the question whether displaying counterfeit cookies amounts to unfair competition.

As discussed here, the this jurisdiction has been applied to patent law in some instances. As a rule, the German courts judge the nature of the activities on a trade fair by taking account of detailed secondary indicia such as the overall external appearance of the booth, the kind of fair and the details of the display (see e.g. here), which risks to increase the complexity of the case beyond what is manageable in a preliminary ruling.

Obtaining a preliminary injunction based on activities on a trade fair in intellectual property matters will become more and more complicated  following the decision I ZR 133/13. In any event, it is essential to gather detailed evidence on how the offer or display was perceived.