|Busy week? Luckily is Friday!!!|
Friday, 9 December 2016
What better way to spend a Wednesday December evening than tucked up at the British Museum for Hogarth Chambers Festive Patent Seminar. On the menu was "Obviousness over the common general knowledge", followed by mulled wine and mince pies, all served up by chair Michael Hicks, the man behind the successful obviousness over CGK challenge way back when in Pozzoli SpA v BDMO SA & Others  EWHC 1398 (Pat) (first instance) and  EWCA Civ 588 (Court of Appeal).
Thursday, 8 December 2016
|The AmeriKat never loves in haste, unless|
you happen to be a tasty little mouse...
"Now hatred is by the far the longest pleasure;It is a wonderful quote, illustrating that the speed in which decisions are made can mask, temporarily, the ultimate sorry fate for having made such a decision. As a keen observer of people, the AmeriKat has seen this in action in various guises. From the banal - watching the regret soaking down someone's face as their hastily ordered dish is placed next to their dining companion's more riveting platter - to the more serious. Then there are those who Lord Byron need never worry about where a decision, much less a hasty one, is unlikely to ever be forthcoming (you know who you are...).
Men love in haste, but they detest at leisure".
However, where on the spectrum will the UK's announcement of their intention to ratify the Unified Patent Court Agreement fall? Does it fall into the "ratify in haste, repent at leisure" camp?
As IPKat readers will be aware there has been significant discussion, albeit a lack of concrete action (as of yet), about the need to ensure that, if the UK does ratify, it can continue to participate post-Brexit. However, the UPCA is silent on the scenario where a signatory ceases to be a EU Member State and the ambiguity (or stone cold clarity, depending who you ask) of Opinion 1/09 does not help matters.
Over the past several months on the European patent law conference circuit, prior to the UK's announcement, everyone was agreed that continued UK involvement was desired. However, two factions began to emerge. One faction was cooing that UK industry need not worry, everything would be fine - the UK need just ratify. The litigators among you who have ever received an 11PM cold call from a transactional colleague asking whether you can "just approve this IP-heavy transaction, we are signing tomorrow" will have experienced the nervousness of the second faction. "If I have to sign this off, I just know that in a few years I or some other litigator will be cleaning up a mess...." Cue Lord Byron's "love in haste, detest at leisure" adage.
Against this backdrop, the question of what happens when the UK ceases being a EU Member State was subject to the commissioning of the Gordon-Pascoe opinion. That opinion suggested that for the UK to remain part of the UPC, additional agreements and amendments would be needed. A key issue concerns the power of courts of EU Member States to refer matters to the CJEU under Article 267 TFEU. The UPC, as a court common to EU MS, also has this power to refer questions to the CJEU (see Article 1 and 21 UPCA). However, if a contracting party to the UPCA ceases to be a Member of the European Union, the court is not common to EU MS - it will include a non-EU MS interloper, the UK. Does this mean that the UPC will not be able to refer questions to the CJEU contrary to the UPCA and EU law (see Article 20 UPCA)? The UPCA does not deal with this at all. Indeed, the UPCA does not even contemplate that a signatory will be a non-EU Member State. The UPCA refers to a party to the agreement as a "Contracting Member State" defined as "a Member State of the European Union party to the Agreement" (see Article 2(b) and (c) UPCA). This is not surprising given that, in 2013 when the UPCA was signed, no one had envisaged that the UK would, in the very near future, cease being a Member of the European Union.
So something further seems to be needed to ensure, with "sufficient degree of certainty" (to adopt the language of Article 62(4) UPCA), the UK's continued UPC participation post-Brexit. Without such measures, the impact on UK industry could be significant. For example, if the UK can no longer participate in the UPC, what happens to the coverage of Unitary Patents in the UK? What about pending UPC litigation or the enforcement of orders already granted by the UPC in the UK? Yet when the UK Government published its announcement at the end of November, no reference was made for the need for a transitional protocol to be prepared as part of its steps towards ratification.
Last week, the IP Federation published their response to the UK's announcement to ratify. In the statement, the IP Federation expressed the need to ensure that the "UPC functions effectively in the long term". They have importantly called on the UK and the other contracting Member States to urgently start work to ensure there is:
".... a legally secure route by which the UK can remain in the UPC after Brexit. If this work also makes it possible for other states which are not part of the EU but which are part of the European Patent Organisation to join the UPC this would be welcomed.".If, for whatever reason, the UK cannot remain part of the UPC on Brexit, then:
"[t]he UK government needs to provide assurances that any Unitary Patents will be recognised as UK national patents. The UK and other contracting states will also need to produce transitional arrangements to govern what will happen to ongoing litigation at the UPC and to ensure the continued functioning of the court.
Given that the clock is now ticking for the commencement of the UP and UPC, the IP Federation calls on both the UK and the other contracting states to commence work on the legal framework that will be needed for both of these options as soon as possible. It will be vital for the UK and other contracting states to provide opportunities for industry to provide input into the shape of this legal framework. The IP Federation looks forward to playing a constructive part in this process."The AmeriKat agrees Given that the purpose of the UPC is to "enhance legal certainty" in the enforcement of patents (see Recital 5 of the UPCA), it would seem perverse that the UK's ratification of the UPC would result in increased uncertainty for industry post-Brexit in patent law. So for those wishing for a quiet holiday period, get your sleeves rolled up and quills at the ready....
"Indian trademark law recognises well-known marks and it has adopted the criteria set out in Article 6 of the TRIPS agreement to determine if a mark is well-known.
To address the concerns of brand owners, the Trade Marks Registry has proposed an amendment to the current Trade Mark Rules, 2002, to provide a specific reference to a declaration to record a mark as well-known. As s result, as per the proposed amendment, a rights holder will be able to make a request to the Registrar of Trade Marks to determine a trade mark to be a “well-known” mark. Such a request shall be accompanied by a ‘statement of case’.
In addition, the applicant shall be required to file relevant evidence and documents in support of such a claim, which may include evidence of use and promotional documents. The Registrar may fix criteria in this regard. It is apparent that the proposed amendment confers significant discretionary powers on the Registrar in determining whether a mark is ‘well-known’, based on the adduced evidence by the Applicant along with the statement of case. The provision also empowers the Registrar to remove a trademark that has been erroneously or inadvertently included in the list.
The trade marks Registry intends to charge hefty fees, as set out below, for an application for requesting inclusion of a mark in the list of well-known trademarks.
E-Filing INR 100,000; USD $1455 (approximate)
Physical filing INR 110,000; USD $1600 (approximate)
The new Rules are likely to come into force as early as next week. Still, the new Rules open certain matters, as various practitioners and brand owners have pointed out. Some of the concerns expressed by stakeholders are:
1. The basis for stipulating the criteria for determination of a well-known mark is not clear. The Trademarks Registry should have clearly spelled out that criteria laid down in Sections 2 (1) (zg) 11 (6) and (7) and 11(9) of the Act will apply.However, despite these issues, the Trademarks Registry is likely to proceed with the new Rules as currently set out."
2. It is not apparent whether ‘determination’ by the Registrar is required if the mark has already been recognized as well-known mark by a Court/Intellectual Property Appellate Board/Registrar in a contentious proceeding.
3. As there is already a list of well-known marks published by the Trademarks Registry, it is not clear whether a ‘new’ list shall be created or the existing list updated.
4. The fees, 100,000 Rupees for e-filing (approximately US$ 1455), and even more for physical filing, are unreasonable and without justification.
5. To safeguard rights of an aggrieved person, a procedure for publication and opposition/intervention against a determination that a trademark as well-known should be provided.
A list of the recordals on the Trade Marks Registry, here.
Mediaplayers and streaming: AG Campos Sánchez-Bordona in Filmspeler proposes broad interpretation of notion of 'indispensable intervention'
|AG Campos Sánchez-Bordona|
We shall see if the CJEU follows the AG Opinion: if this happens - and with the same nuances - then Filmspeler is going to be an additional step towards an even broader interpretation of what the elusive concept of 'communication to the public' entails.
AIPPI Rapid Response Report: Debating Lyrica's recurring pain on plausibility, abuse and infringement
- The Patent in suit contains Swiss form claims to pregabalin in the treatment of pain (Claim 1) and in the treatment of neuropathic pain (Claim 3).
- Pain is difficult to define both clinically and in patent terms. Paragraph  of the Patent states that the invention is directed to chronic pain disorders. It then provides a list of conditions which the invention is said to include but not be limited to. Paragraph  of the Patent then refers to the invention as being the use of pregabalin in "the treatment of pain as listed above".
- The Patent refers to neuropathic pain as being that "which is caused by injury or infection of peripheral sensory nerves”. The patent does not draw a distinction between peripheral neuropathic pain and central neuropathic pain.
- The Patent contained data relating to animal models of inflammatory pain. None of these models were established models of neuropathic pain.
- Inflammatory pain contains a central sensitisation component which is present in neuropathic pain but not central neuropathic pain.
- The Defendants argued that Warner-Lambert must rely on the data in the animal models for the purposes of plausibility.
- Warner-Lambert responded that central sensitisation component provided the requisite link between the animal models and the claimed forms of pain.
- Mylan contended that not all forms of pain which fell within the claims contained a central sensitisation component. Furthermore, it was CGK that neuropathic pain included both peripheral neuropathic pain and that central neuropathic pain did not have a central sensitisation component.
- Warner-Lambert argued that the skilled person would in any event have understood claim 3 (i.e. to neuropathic pain) to have been limited to peripheral neuropathic pain.
although it is often said that a specification can act as its own dictionary, not every use in the specification of a term found in the claim will be understood by the reader to be a definition. On no basis can paragraph  or  or the two paragraphs read together be taken to be a definition of what the patentee means by the term "pain". They are statements exemplifying the broadest statement of invention, namely that pregabalin is suitable for the treatment of pain.
- In light of Kitchen LJ’s treatment of paragraphs  and , what is/is not to be recognised as a definition in a Patent? Claire considered that in light of this decision, Patent Attorneys must be particularly precise with definitions and the definitions must be reasonable based on the state of the art at the time.
- At what level of generality should the plausibility test be applied? In the event that certain embodiments of a claim are plausible at the priority date, should it be possible to “fill in the gaps” with later filed evidence (bearing in mind that pregabalin works in central neuropathic pain).
- Should evidence of technical effect only be rejected where nothing plausible is covered by the claim?
- Is it sometimes the case that having no data in your Patent is better than having the “wrong” data? Claire referred to the HGS v Lilly  UKSC 51 and Actavis v Lilly  EWHC 3294 (Pat) cases as examples of patents which did not have data in them and yet were found to be plausible.
(a) before a trial; (b) after trial, at which certain claims have been held valid but other claims held invalid, the patentee simply wishing to delete the invalid claims (I would include here also the case where the patentee wishes to re-write the claims so as to exclude various dependencies as in Hallen v Brantia  FSR 134. There the patentee is in effect continuing to claim which he had claimed before but in a much smaller way); and (c) after a trial in which all claims have been held invalid but the patentee wishes to insert what he hopes are validating amendments.
"we believe that whether or not a patentee's attempted reliance before this court upon a patent which has been amended pursuant to a central amendment application made after trial constitutes an abuse of process must depend upon all the circumstances, including whether it would be necessary to remit the case for retrial and, if so, what the consequences of that would be.”
- that Warner-Lambert had been the victim of procedural unfairness by the Defendants raising the peripheral/central distinction so late in proceedings;
- that the proposed amendment should not be considered to fall within Jacob LJ’s category (c) but instead was more akin to a category (b) amendment as it simply sought to excise invalid matter from an otherwise valid claim; and
- the amendments would not in any event require a retrial.
- Propose amendments at an early stage in proceedings, preferably before trial;
- Keep possible amendments in mind as the trial progresses; and
- carry out a mock trial with a view to unearthing any unexpected issues.
Stuart then turned his attention to the question of indirect infringement pursuant to s60(2). As s60(2) requires the supply of “means relating to an essential element of the invention,” it is necessary to consider what the invention in a Swiss form claim is. Stuart highlighted that s125 of the Patents Act states that an invention “shall, unless the context otherwise requires, be taken to be that specified in the claim.” As such, notwithstanding the wording of the claim, it is clear that the invention in a Swiss form claim is ascribing the novel therapeutic purpose to the medicament. The invention has nothing to do with “manufacture” or “preparation”. This is a case where the context does otherwise require. By adopting this approach, the Court of Appeal were able to reach a finding that there was no requirement for a downstream act of manufacture and as such, the ascribing of purpose by, e.g. the pharmacist in applying a label to the product, was relevant to the question of infringement.
- Alerting doctors/HAs/pharmacists in advance
- Avoiding supply through certain channels
- Avoiding oversupply vs. old indication market
- Steps to update clinical software; and
- Co-operating with NHS to issue guidance.
Wednesday, 7 December 2016
In the post-Brexit referendum world, is anyone else suffering from fatigue concerning the English proverb regarding the consumption of cake? This was even before a long lens photographer caught handwritten notes from a conservative MP's aide leaving a meeting with the Department for Exiting the EU last week, apparently commenting on a preferred post-Brexit model for the UK (see here). [The IP Kitten - trained from day one to keep files and notes hidden when in public places - shudders at such wrecklessness].
What about PPDs and standard disclosure in the Patents Court? Can the patentee be pro having cake and pro eating it? Mr Justice Birss has provided the answer in Varian Medical Systems AG v (1) Elekta Limited; and (2) Elekta Holdings Limited  EWHC 2679 (Pat). This GuestKat apologises for continuing the cake idiom, but suggests it is worth it so that she can share a photo of the White Book (Volume 2) cake, as baked by her multi-talented Stephenson Harwood colleague Stephanie Wickenden.
Essential eating for all IP litigators
The claimants pleaded case included the following: "After publication of the patent, prior to the issue of the claim form and thereafter, the defendants have infringed and threatened to intend to infringe [the claims] by doing the following acts in the United Kingdom without the claimant's consent: (a) ... offering to dispose of ... a system comprising an MRI (magnetic resonance imaging) guided radiotherapy machine as claimed in at least the aforesaid claims of the patent." The defendants contend that they do not offer for disposal a machine with the relevant characteristic.
CPR Part 63 and Practice Direction 63 para 6.1
The claimants submitted that offering for disposal was in issue but that no disclosure has been given in relation to it by the defendants.
The application before Birss J concerned a discrete point of patent practice namely what the Product and Process Description (PPD) is for, and how the provision of a PPD interacts with a party's standard disclosure obligations. To the best of this GuestKat's knowledge, the issue does not appear to have been addressed head on in any other reported case. CPR Part 63 r63.9 relates to disclosure in patent cases and practice direction 63PD 6.1 is the provision which deals with product and process descriptions:
"6.1 Standard disclosure does not require the disclosure of documents that relate to –
(1) the infringement of a patent by a product or process where –
(a) not less than 21 days before the date for service of a list of documents the defendant notifies the claimant and any other party of the defendant's intention to serve –
(i) full particulars of the product or process alleged to infringe; and
(ii) any necessary drawings or other illustrations; and
(b) on or before the date for service the defendant serves on the claimant and any other party the documents referred to in paragraph 6.1(1)(a)."
Birss J concluded that paragraph 6.1 is concerned with the nature and characteristics of the product or process in issue and the question of whether the product or process falls within the claims. The fact that Elekta had served a Product Description in accordance with the practice direction did nothing to alleviate the defendants from whatever disclosure obligations they otherwise had relating to acts of infringement. In other words, the applicant's request for standard disclosure related to a different issue [more of a coffee with your cake than a second slice, muses the IP Kitten]. As a result, there was no reason why Elekta should not disclose documents which relate to communications with customers or potential customers relating to the development of its product.