Novartis fails the priority test - more patents fall

This moggy (having started calling myself this I cannot stop) was perusing BAILII and saw a judgment that came out on Friday that he had not seen up until now.
It is another weighty Arnold J special stretching to 187 paragraphs.  The IPKat has given it only the briefest of reviews, but wanted to share a limited report with his dear readers straight away.

The claimants in the case are Hospira and Generics t/a Mylan, who sought to revoke (and have now succeeded in revoking) two patents of Novartis relating to use of the bisphosphonate zoledronate for treatment of osteoporosis.  The patents are EP(UK) 1296689 and its divisional 1591122.  The claims of the two cases were similar, the parent having Swiss form claims, and the divisional EPC 2000 medical use claims, in both cases the administration being specified to be "intravenously and intermittently and in which the period between administrations is at least about 6 months".

It was conceded by Novartis that if the claims were not entitled to priority then the patents are invalid in the light of the intervening publication Reid et al, "A single annual injection of the bisphosphonate, zoledronic acid, stably reduces bone turnover and increases bone density in postmenopausal osteoporosis", Bone 28(5), S89 (2001) ("Reid").  Although Reid is not one of the named inventors of the patents, as far as the IPKat can see this paper originated from the inventors and names them as co-authors.

Sure enough, Mr Justice Arnold found the priority claim invalid and therefore held the patents invalid.  He rejected the other obviousness argument that had been put forward, but also found the patents invalid for insufficiency.

There is doubtless much that could be said about this decision.  The IPKat shall for today limit himself to one observation - just one week earlier in two cases between Apple and Samsung (here and here), Mr Justice Floyd found a number of Samsung patents invalid in the light of an invalid priority claim and admitted invalidity in that event.

Is the priority system a false comfort, allowing applicants to publish or allow publication when in fact the protection provided is illusory?  Or is it just applicant behaviour that needs to be modified?  Is it possible to envisage a system better able to accommodate the requirements of novelty of patents on the the one hand, and the commercial imperative to publish on the other?

As usual, dear readers, over to you.

Jeremy's note: I am not going to accept any more spiteful and mean-spirited anonymous comments about the function of this blog in drawing the early attention of readers to the publication of cases which members of the blogging team may not yet have had the time or the opportunity to read. Will any reader who wishes to continue this line of commenting please give a verifiable name.
Novartis fails the priority test - more patents fall Novartis fails the priority test - more patents fall Reviewed by Darren Smyth on Tuesday, March 19, 2013 Rating: 5

10 comments:

  1. Darren
    Did you read it? It has 187 paras not 187 pages! Actually it'a rather short!

    ReplyDelete
  2. I haven't read the decision yet but feel compelled already to write something on the priority issue.

    It reaches its apex with the "poisonous divisional" caselaw, under which the parent kills the div and the div kills the parent.

    Note that this is special to Europe. Everywhere else Applicant's own filings don't "count" as Art 54(3) art.

    But is not the strict line on priority the price we in Europe pay, for our simple and elegant jurisprudence that says what a document "discloses" is always the same, whether for the purposes of Art 54 or Art 87 or Art 123(2) of the EPC.

    What's the alternative? That a doc discloses something different, depending what EPC Article we are operating under? Can that be the way forward? Surely not.

    And anyway, where exactly is the mischief, in saying you only get your priority when your claimed invention is (Paris Convention) the "same" as is the subject matter which you are applying to protect in your prio doc?

    ReplyDelete
  3. Yet another case of a blogger/emailer determined to be the first to let the world know something is now published. Rather than race to prove how great one is, why not simply read the judgement and learn from it? If there is anything newsworthy/contradictory/educational then feel free to comment.

    Otherwise, for those keen to know when new judgements publish then go to bailii every day rather than ipkat.

    ReplyDelete
  4. Max: the judgement seems a bit harsh. The Convention document did recite all the features in the claims. Crucially, however, it did not recite them as a unique embodiment. From the judgment:

    "First, PD2 begins by saying that the invention relates to bisphosphonates for the treatment of conditions of abnormally increased bone turnover (see paragraph 52 above). It then asserts that the inventors have found that bisphosphonates can be used for prolonged inhibition of bone resorption in conditions of abnormally increased bone turnover generally by intermittent administration at intervals of at least about 6 months (see paragraph 55 above). The skilled team would not read such a broad statement as a credible technical teaching, however. In any event, it is not a disclosure of the use of zoledronate to treat osteoporosis, let alone intravenously. It is true that PD2 goes on to identify zoledronate as one of the especially preferred bisphosphonates (see paragraph 58 above). It also identifies the treatment of osteoporosis as a particularly preferred embodiment (see paragraph 56 above). It also mentions intravenous administration as one of the preferred modes of administration (see paragraph 59 above). But nowhere in the general disclosure of PD2 (i.e. apart from Example 5) is any link made between zoledronate, osteoporosis, intravenous administration and administration at intervals of at least about six months. The nearest one gets is the abstract, which links zoledronate, osteoporosis and six monthly administration, but does not mention intravenous administration (see paragraph 70 above). As for Example 5, this is limited to the intravenous administration of particular doses of zoledronate to post-menopausal osteoporosis patients six monthly and yearly (see paragraphs 65-69 above)."

    Looks like a series of prosecution amendments to a bundle of individually preferable features came unstuck, as it so often does before the OD and the BoA.

    ReplyDelete
  5. What planet is anonymous of 20:52 on?
    Blogs, not jut this one but all serious ip and law blogs, perform a great service. Bailii doesn't have an email alert, so are you going to check it, court by court, every hour/day/week or whatever in order to see what's on it? And you can't guess much about a case when all you know about it is it name, can you?

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  6. 1st anonymous, yes I did read it, but wrote the post quickly and so "pages" was typo for my intended "paragraphs". Thanks for pointing this out and I now amended the post.

    And to third anonymous, the coincidence of three decisions in a row revoking multiple patents for lack of valid priority claim with intervening prior art seemed worth a modest post. I am sorry if you feel differently.

    ReplyDelete
  7. "The IPKat has given it only the briefest of reviews". Hardly read it with due consideration so hardly a worthwhile post.

    AND

    The latest IP cases can be found under 'recent decisions', 'High Court (patents court)' or patents county court. Sorry for simplifying things for you.

    ReplyDelete
  8. Re the Anonymous comments knocking IPKat for putting up a post about a judgment without having had the time to do a full review.

    That's a bit harsh.

    IPKat is by no means purrfect, but it does a great job. I know that I speak for many an IP lawyer when I say that IPKat is one of the first websites that one looks at in the morning. It is entertaining, well informed and up to date, and the discussion forums are usually pretty good (save for the occasional excessive rants by Gibus and MaxDrei).

    IPKat - keep up the good work.

    ReplyDelete
  9. Here MaxDrei, ears pricked and whiskers twitching.

    So, for "many an IP lawyer" at least some of my contributions come across as an "excessive rant". Sorry about that. I'm only trying to provoke a reaction from which I can learn something.

    Even though my interest is largely confined to patents, I too think the IPKat blog is brilliant. Three cheers for Jeremy and team.

    ReplyDelete
  10. It is simply a case of the patentee not being entitled to priority because they the subject matter of their claim was not disclosed in the priority document. There is nothing illusory about the rights to priority, only ignorance of its correct application. For too many years, patent attorneys and applicants alike have considered priority rights akin to planting a flag in desert and claiming all that the eye can see as well as everything beneath the surface that they cannot see.

    I haven't read the other cases referred to (or blogs on the subject) but it wouldn't surprise me if the same situation applied.

    As for Max's earlier comment, aren't poisonous divisionals possible under the UK Act S.2(3)?

    ReplyDelete

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