Whaaat, is it Wednesday already?
PREVIOUSLY ON NEVER TOO LATE
Passionate about IP! Since June 2003 the IPKat has covered copyright, patent, trade mark, info-tech, privacy and confidentiality issues from a mainly UK and European perspective. The team is Neil J. Wilkof, Annsley Merelle Ward, Darren Smyth, Nicola Searle, Eleonora Rosati, David Brophy, Alberto Bellan and Merpel, with contributions from Mark Schweizer. You're welcome to read, post comments and participate. You can email the Kats here
Whaaat, is it Wednesday already?
|Montis' Chaplin chair|
Cancellation of the filing of a design or model of outstanding artistic character or the extinction of the exclusive right derived from the filing of such a design or model entails the simultaneous extinction of the copyright relating to that design or model, provided that the two rights belong to the same person; that extinction will not however take place if the proprietor of that design or model submits, in accordance with Article 24, a special declaration seeking to maintain his Copyright.In other words, to benefit from copyright protection, the author or his successor needed to file an explicit declaration (and pay a fee), generally before the five year term of protection as registered model expired. Montis and Mr van den Berg failed to file such declaration, and therefore both design and copyright protection in the Charly and Chaplin chair designs lapsed in the Benelux in 1993.
|Montis' Charly chair|
Is the term of protection referred to in Article 10, in conjunction with Article 13(1), of Directive 93/98 applicable to copyright that was originally protected by national copyright law but which lapsed before 1 July 1995 on the ground that a formal requirement had not been satisfied (or was not satisfied in due time), more specifically because a maintenance declaration, as referred to in Article 21(3) of [the Uniform Law] had not been filed …?
|Now that's a work of outstanding artistic |
character. I needed some eye bleach.
|Hotel life: not all about TV|
|Buying a beer: NOT|
a mandatory fee to watch sports on TV
|London Taxi CTM|
This is the second report covering Monckton Chambers' seminar last Wednesday (see previous report on the Lundbeck decision here).
The latter part of the presentation covered recent cases on medicines regulation, focussing on R(Roche Registration Ltd) v Secretary of State for Health  EWCA Civ 1311 (although this English Court of Appeal decision was handed down on 21 December 2015, it may have escaped your radar due to seasonal festivities and/or the mad rush to tie up loose ends before the Christmas vacation...) The judgment considered issues of procedural fairness in the context of Commission Regulation EC No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations (known as the Penalties Regulation) - the first case where the Penalties Regulation has been addressed by the English Courts.
While this moggy was struggling to get back from Indonesia, the Court of Appeal handed down its decision in the pregabalin appeal Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Ors  EWCA Civ 1006 (13 October 2016), and finally the IPKat has managed to blog about it (the lateness by no means reflecting on the importance of the judgment).
It is very much a judgment of three halves.
In the first part of the judgment (up to ), which substantively disposes of the case, Lord Justice Floyd (with whom Lord Justic Kitchin and Lord Justice Patten agreed) upheld the decision of Mr Justice Arnold on the validity of the patent. Arnold J had considered that the claims of the patent that were alleged to be infringed were insufficient, and in particular claim 3 directed towards use of pregabalin for neuropathic pain, because the patent did not render it plausible that pregabalin would be effective at treating central neuropathic pain, only peripheral neuropathic pain. Floyd LJ agreed with Arnold J's construction of the claims, and rejected the challenge to the finding that claim 3 was not plausible across its breadth.
On the other hand, Floyd LJ also rejected a cross-appeal from Mylan and Actavis challenging the finding that the patent did make a plausible claim that pregabalin was effective to treat peripheral neuropathic pain (that is, seeking to widen the scope of the finding of invalidity of the patent). Thus, the first instance judgment on validity was completely upheld.
The second part of the judgment, which procedurally disposes of the case (subject to any appeal to the Supreme Court, which Pfizer is reportedly seeking) relates to the refusal to allow Warner-Lambert (the patentee and Pfizer subsidiary) the opportunity to amend claim 3 after the end of the trial. Arnold J considered that this was an abuse of process. After a detailed analysis, Floyd LJ concluded "I therefore do not consider that there is any basis for this court to interfere with the judge's evaluation on the issue of abuse of process."
Then we come to the third part of the judgment, relating to infringement. Merpel gleefully reminds the IPKat that this part of the decision is strictly obiter and therefore non-binding (since the findings on validity and abuse of process make the infringement issue moot), but only a fool would disregard it. Moreover, this is really where it starts to get interesting.
In the Court of Appeal decision relating to interim relief before the main trial before Arnold J, Floyd LJ had examined the proper interpretation of Swiss-form, second medical use claims (the present judgment states that this was at the behest of the parties: "The court was invited by both parties at that stage to decide the issue of law so that the parties knew where they stood for the purposes of the trial"). The problem was, the parties disagreed on what was the test that the Court of Appeal had laid down. At the first instance interim proceedings, faced with a choice of foreseeability and intention, Arnold J had in his substantive decision in the case plumped for the latter: for a Swiss form claim to be infringed, it had to be not just foreseeable to the manufacturer that his product would be used for the claimed indication, but the manufacturer had to actively intend (or, as Arnold J put it "subjectively intend") that it be so used. The Court of Appeal judgment had referred to both foreseeability and intention, and Arnold J thought the test laid down by the Court of Appeal was that it had to be foreseeable to the manufacturer that this product would be intentionally administered for the claimed indication, the intention coming from a doctor, or, under rare circumstances, a pharmacist.
It now turns out that when referring to "intention" in the earlier judgment, Floyd LJ had not meant what Arnold J understood, but rather a much narrower sense that: "Intentional use is to be distinguished from use where the drug is prescribed for a different indication and, without it in any sense being the intention of the treatment, a pain condition is in fact treated." Thus, unsurprisingly in the present judgment, Floyd LJ thought that "the judge [Arnold J] fell into error in seeking to dissect the requirement for intentional treatment of pain in this way". Instead, for a Swiss form claim to be infringed "it is only essential that the manufacturer is able to foresee that there will be intentional use for the new medical indication" (where "intentional use" has the meaning just stated).
Thus, Floyd LJ has now clearly laid down a test which is close to the pure "foreseeability" test that Warner-Lambert originally contended for:
The issue which the judge was called upon to decide was whether Actavis knew or could foresee that at least some of the prescriptions written generically for pregabalin to treat pain would in fact be fulfilled with Lecaent. Had Warner-Lambert succeeded in upholding valid claims on which they relied for infringement, it would then have been necessary to decide whether, at any of the various dates analysed by the judge, that test of knowledge or foresight was satisfied. If so the judge should have gone on to consider whether Actavis had taken all reasonable steps in their power to prevent Lecaent from being used to treat pain.
If that is the basic test to be adopted, what is sufficient to negative the existence of intention? In my judgment the absence of the patented indication from the label cannot conceivably be sufficient to negative the intention. ...
Viewed in this way I think the answer becomes clear. The intention will be negatived where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring. In such circumstances his true objective is a lawful one, and one would be entitled to say that the foreseen consequences were not intended, but were an unintended incident of his otherwise lawful activity.
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