UK Patent Case Lowers Bar on Utility (Industrial Application)

Human Genome Sciences v. Eli Lilly (UK Supreme Court, 2 Nov 2011) [Decision] Case No. [2011] UKSC 51.

The Supreme Court of the United Kingdom (UKSC) began hearing cases in 2009 — taking on the role of court-of-last-resort formerly played by the House of Lords. The UKSC normally sits in five-member panels — here the panel consisted of Lords Hope, Walker, Neuberger, Clarke, and Collins. 

This decision focuses on EPC and UK version of the utility doctrine — the requirement that a patentable invention be “susceptible of industrial application“. In a unanimous decision, the court determined that US utility doctrine creates an unduly high bar of patentability.  Thus, rather than requiring proof of specific, credible, and substantial utility at the time of filing, the UK court agreed that HGS’s genetic sequence coding for Neutrokine-α was patentable even though there was no known use of the protein at the time the patent application was filing. The patent did not reveal how the protein “could be used to solve any particular problem” nor did it identify “any disease or condition which it could be used to diagnose or treat.”  Yet, the UK court held that the industrial application requirement was met because the protein a member of a “TNF ligand superfamily” and all members of that family have been associated with important biologic activity.  ”[A]ll known members of the TNF ligand family were expressed on T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be expected to have a similar function.”  The UK Court of Appeals (Sir Robin Jacob) had previously held the patent invalid.

In his opinion, Lord Neuberger explicitly rejected the US cases of Brenner v Manson, 383 U.S. 519 (1966) and in re Fisher, 421 F 3d 1365 (2005) — finding that “there are obvious risks in relying on US jurisprudence when considering the precise nature of the requirements of Article 57 in relation to a claim for a patent for biological material under the EPC.” 

There have been moves over the past fifty years (and more) to harmonise patent law across jurisdictions (the EPC and TRIPS – the Trade-Related Aspects of Intellectual Property Protection – being two important examples), and it is a laudable aim to seek to ensure that all aspects of the law of patents are identical throughout the world. However, the achievement of such an aim is plainly not currently practicable, and, although they have a great deal in common, there are significant and fairly fundamental differences (over and above the different words used in Articles 52 and 57 of the EPC and section 101 of 35 USC) between US patent law and the EPC (two notorious examples being the first to file rule in Europe, and file wrapper estoppel in the US).

Accordingly, particularly when it comes to a nice question such as the precise delineation of boundaries between patentability and unpatentability on the ground of industrial application, it would be unsurprising if the law was not identical under the two jurisdictions.

Instead of following US law, the panel instead latched onto the jurisprudence of the EPO — the body that also interprets the European Patent Convention (EPC).

Notes:

  • The UK court of first instance (Kitchin J) found the patent invalid while the EPO Board had held the patent valid.
  • The patent in question is European Patent 0,939,804
  • IPKAT
  • Of course, it is interesting that both HGS and Lilly are US-based companies.
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39 thoughts on “UK Patent Case Lowers Bar on Utility (Industrial Application)

  1. Please act. I am sure that one act will bring upon your soul a new difference that only song birds would understand. I swirl about and see the funny way that you speak and bring out the truth of the thread and the contemplatable means of achieving the ends of bringing about the act that will begin the long road to your salvation and the beginning of the clarity to express our needs in the world of patents so that we can all sing and play together again with the need or want of fight.

  2. I have had the same SS# my whole life. Someone else has put their SS# on my Property. So to say my number is not mine is ridiculous. But to say the SS number on My Property does not match my SS number is more like it.
    I’m tired of the BS. I must act! No one else seems to want to. So I must!

  3. Mooney has never been disrespectful to me even though we differ on a large number of issues. You might ask yourself, why?

    As to me, I do blow my top at the antics of some folks here, particularly the condescending attitude they exhibit in treating other people. Malcolm also gets angry as well. I see that. But it is not simply because he disagrees with people. He hammers people who play games and are no better than trolls.

  4. Ned,

    You are the biggest hypocrite of them all.

    You seriously post: “do not want to engage in respectful conversation, but who seem to willfully misstate a previous poster’s statement or position for the very purpose of creating an argument.

    Not only me, but with many others have I seen you play your dirty little games when your particular viewpoint on things faces an obstacle that you cannot overcome with any sense of “respectful conversation.”

    Now your jumping on the bandwagon of support for MM is beyond any sense of credibility. No one, and I mean ansolutely no one, not even the infamous Ping, is meaner, cruder and more disrespectful than Malcolm Mooney, aka MM. The fact is that you choose to be blind because you share some philosophical viewpoints (and some gameplaying attributes).

    Your posts speak more loudly than I ever can, but I type now in utter outrage at the position you take.

    It is truly incomprehensible and utterly condemnable.

  5. No he’s not, Night.

    Malcolm had it exactly right that there are posters here who do not want to engage in respectful conversation, but who seem to willfully misstate a previous poster’s statement or position for the very purpose of creating an argument. This poster “lectures” us. He even tells us that the is lecturing us.

    I think the poster really is Actual Inventor, whom I’ve seen “lecture” people like Max. But his whole approach to any conversation, whoever he or she is, is to assume that he or she is some sort of superior animal who is entitled to lecture us mere mortals or common folk on patent law.

    Where does this person get off? That kind of attitude, if used in someone’s presence, would get the person a black eye pronto. So, they must know, and they have to know, that this attitude and arrogance will generate the very angry response it actually does generate among the Patently-O community against whom the tactic is used.

  6. What is MM your little brother? Remember MM is the mean grown up troll and you are the troll wannabe that can’t quite make it because you are a bit too dense.

  7. simple, perhaps it really makes no difference, but the law appears to be in the US that there is no invention until the inventor conceives of the invention's utility.  I suppose this law is still good law to the extent that rival inventors are before the office, the first filing disclosing a compound but no use and the second filer disclosing the same compound and a use.  The patent will be awarded the second filer on the theory that the first filer hasn't really invented anything.

  8. He seems to be gettnig meaner. I suspect he has been hitting the bottle to frequently.

    To frequently what? Drink from it, I assume.

    Good to see you’re still your usual self, N-Dubz. “He seems to be getting meaner. I’ll start a baseless rumor that he’s an alcoholic.”

  9. >>whereas your (MM) “banter” is foul and mean-spirited >>and you deserve to be abruptly put in your place >>or outright ignored.

    He seems to be gettnig meaner. I suspect he has been hitting the bottle to frequently.

  10. Actually MM,

    Your post is a classic example of what I lectured you on previously.

    You once again label me as a troll – without basis of any kind, no doubt thinking that I am someone that I am not (more spots of blood you do see!).

    As for the back and forth, you clearly do not understand that IANAE’s failure to simply answer my siimple questions and his insistence on being obtuse and “not getting it” is a clear sign of his not being interested in an “honest conversation.” The banter was somewhat playful and served to highlight his willingness to not “see”, so I indulged in some back and forth, whereas your “banter” is foul and mean-spirited and you deserve to be abruptly put in your place or outright ignored.

    In the future, please restrain yourself and do not comment to me unless I specifically ask you to do so.

  11. Why is it then that these “silly rants” are actually in accord with the law

    Actually, troll, your rants are rarely comprehensible and, in the rare circumstances where they are comprehensible, they are almost invariably based on your willful attempts to misunderstand and mischaracterize the banal, uncontroversial observations of other commenters.

    The back-and-forth between you and IANAE which follows is a classic example.

  12. Ned not an easy question to answer. On a sliding scale between obvious and not obvious, where does SCOTUS point?

    My suggestion: read the UK decision as a whole, from beginning to end and, as you do, pay particular attention to the word “plausible”, each time you encounter it.

  13. Not much of a limitation on Flook, really.

    You really do not get this, do you?

    Why don’t you actually read what Bilski says about Diehr’s effect?

  14. Are you aware that Flook had limitations placed on it in Diehr as recently emphasized in bBilski?

    Yes, Diehr said that if you claim a machine or a physical transformation implementing your abstract idea, you can have a patent on that. Not much of a limitation on Flook, really. Flook didn’t have a machine or a transformation (other than implicitly in the “data-gathering” steps), so Diehr is really more of a completely different case than a limitation.

    Flook itself is still good law, as recently emphasized in Bilski, and Flook’s claims would still fail 101 today. Only, the name “Flook” is already taken, so it’d have to be called something else. Like, say, “Prometheus’ claims”.

  15. Are you aware that Flook had limitations placed on it in Diehr as recently emphasized in bBilski?

    Have you seen the references posted in abundance on these threads?

    Do you enjoy being obtuse?

  16. Are you aware that several more cases were decided after Flook that changed the understanding of 101 jurisprudence?

    Are you aware that Flook was recognized as good law as recently as Bilski? If not, you could be secretly working for the Federal Circuit.

  17. If your preference is to “I prefer to side with the higher authority,” then do you want to stop your understanding of 101 jurisprudecen with Flook?

    Are you aware that several more cases were decided after Flook that changed the understanding of 101 jurisprudence?

  18. And isn’t rather obvious just who is making the “silly rants?”

    Probably the one vehemently denying the similarity of similar things.

  19. especially given the jurisprudence on 101

    If you’re trying to say that the Federal Circuit has not yet harmonized to US law, I completely agree. It’s hard to make confident statements about 101 when Prometheus v. Mayo refuses to follow Flook despite the obvious similarities. I prefer to side with the higher authority, but I guess I’m old-fashioned that way.

    And in particular to this area of law, that such blanket categorical statements are inherently false?

    If you’re trying to say that all generalizations are false, I don’t believe that’s ever been a true statement.

  20. Hasn’t it also been the staple of common law since time immemorial (and patent law in particular, especially given the jurisprudence on 101), that one cannot always make a categorical statement as you are attempting to do? And in particular to this area of law, that such blanket categorical statements are inherently false?

  21. Why is it then that these “silly rants” are actually in accord with the law

    There’s no law that says that when a bunch of things are the same, you need to look at each one individually to check if it’s the same as the others.

    Quite the opposite, in fact. The law is very much to the effect that similar results should obtain on similar facts. That’s been a staple of the common law since time immemorial.

  22. Despite the silly rants

    Why is it then that these “silly rants” are actually in accord with the law and those that label these as “silly rants” are left pounding tables?

  23. Anybody there who still wants to challenge the EPO standard?

    Do you really think this about “challenging” the EPO standard?

    Do you not recognize the greater point that there still exists substantial differences in legal systems and that one cannot simply point blank say “Use our system?”

  24. will affect decisions on the recognition of utility, which was somewhat tied into first to invent

    How was utility tied into first to invent? Are you talking about the US First Inventor to File system, the previous First Inventor system, both?

  25. Some may call it capitulation.

    Sure, but less jingoistic people might call this an isolated, expressly non-precedential decision that is entirely reasonable in its holding that “if it’s a member of a class that is known to have utility for the same reason that defines the class, it probably has that utility”.

    Y’know, for the same reason that we can discuss all Beauregard claims or all financial method claims or all methods of dosing medication or all DNA/RNA/AA sequence claims, and any discussion that applies to the class by definition/construction applies equally to every member of the class. Despite the silly rants about treating each claim individually on its own merits. Because to a certain extent, these things all have the same merits.

  26. We went through years of agonizing debate to adopt ftf because we wanted to be “harmonious.” Hmm, it seems that the ROW does not want to reciprocate.

    Some may call it capitulation.

  27. Thanks, Max, I didn’t get that nuance from Dennis’s opening post.

    So on a sliding scale between known potential use and known specific use, where does the UK opinion adjust its pointer?

  28. We this side of the pond are constantly told that First to File encourages premature speculative filings. The consistent EPO jurisprudence now ratified by the UK Supreme Court, gives drafters detailed guidance exactly what level of disclosure in the app as filed will be found useful and sufficient (and what will not pass muster). Anybody there who still wants to challenge the EPO standard?

  29. Ned, keep your wig on please. The court stresses, over and over, that the decision is based on its peculiar facts, special to the TNF superfamily. Further, it reveals in its decision that it is well aware of the need painstakingly to balance the need of innovative bio for a patent portfolio to attract investment with the imperative that patents shall not fence off entire fields of research.

    So no, I decline to “take” the human genome project thanks.

  30. So let me get this straight? The first to discover a chemical with potential use gets the patent on the chemical and the first to discover the use of the chemical gets a patent on the chemical again, but limited to the use.

    Now how does this promote the progress of the useful arts?

    Take for example the human genome project. Let’s suppose a private company sequenced and patented every single gene of a human based upon the potential use theory. How this is promote research into the actual use of these genes if the discover of a use cannot get a patent on the gene itself because of the prior patent? – to whom, the discoverer of the use must now also pay royalties?

  31. Max,

    I would view your UKSC as “enlightened” on the utility issue versus our courts “across the pond.”

  32. it would be unsurprising if the law was not identical under the two jurisdictions…

    I had to read that three times. Perhaps “it would be surprising if the law was identical under the two jurisdictions” would be easier on slow readers like myself? Or perhaps even better, “it is not suprising that the law differs under the two jurisdictions,” since you’re addressing a real scenario rather than a hypothetical one.

  33. It’ll be interesting to see whether the US move to first to file will affect decisions on the recognition of utility, which was somewhat tied into first to invent.

  34. How about that? Public policy trumps everything else, and the UK Supreme Court reverses its own first and second instance courts, instead deferring to EPO Technical Board of Appeal Decision on the same patent. Note:

    1. the influence on the noble lords of the intervention by the Bio Industry Association (interesting, given the traditional criticism by the English courts of the arrival of additional expert opinions in parallel EPO appeal proceedings)

    2. the message about industry need for harmonisation, addressed to to the German Supreme Court in Karlsruhe.

    Me, I think we are seeing an international effort to help bio with more patent protection, and at the same time help EE with less.

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