Hague Court of Appeal sets Dutch approach to equivalence, reversing District Court in pemetrexed saga

Hot off the press is a decision by the Hague Court of Appeal (CoA) of 27 October 2020 handing Eli Lilly another win in its pan-European battle over infringement of its pemetrexed patents [here, in Dutch].

Eli Lilly's patent enforcement campaign has resulted in numerous decisions, including landmark rulings on the doctrine of equivalents in the UK and Germany. The ruling by the Hague CoA contributes to this bounty of legal fodder on the doctrine of equivalence in two important ways.

First, it reverses the District Court's 2019 decision which, in rejecting Eli Lilly's claims, constituted an outlier among European decisions in this dispute [here]. Second, the CoA laid down the Dutch approach to the doctrine of equivalents, synthesizing prior decisions and bringing it in line with approaches taken elsewhere in Europe. To this Kat's knowledge, this is the first time that the CoA has so explicitly set out a principled application of the doctrine of equivalents.

The CoA's formulation of the equivalence test

The crux of the pemetrexed cases is that Eli Lilly's patent claims a combination of vitamin B12 (claim 1) and B12 with a folic binding protein binding agent (claim 2) together with a specifically specified salt: pemetrexed disodium. The question is whether generic companies can avoid infringement of these claims by using a different salt (in the case of Fresenius, the Dutch defendant: tromethamine).

The CoA began its analysis by citing Article 69 of the European Patent Convention and its Protocol. Section 1 of the Protocol stipulates that in the interpretation of a patent, a position must be taken that "combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties". Section 2 adds that "due account shall be taken of any element which is equivalent to an element specified in the claims."

In applying these principles, the CoA performed a two-step test: in the first step, the question is whether the accused product conforms to all features of the claim. If not, the second step inquires whether differing features are nevertheless equivalent to the claim features. According to the CoA [at 4.4], this is currently the "leading" approach in most European jurisdictions. Dutch courts, however, had previously also taken a one-step approach whereby account is taken of equivalents in the initial interpretation of the claim. While not explicitly disapproving the one-step approach, the CoA's application of the two-step approach and its emphasis on its conformity with the law of other EPO states suggest that going forward, the two-step approach will become the standard also in the Netherlands.

The CoA laid down four principles for application of the second step:

  1. The differing feature must be technically equivalent to the claimed feature. This is the case if "the product or process with the differing feature also solves the problem that the patent solves, and the differing feature performs the same function as the claimed feature in this context" [at 4.7].

  2. From the point of view of fair protection for the patent proprietor, it must be appropriate to take into account equivalents when determining the patent's scope of protection. This means that the invention must be disclosed such that "it is apparent to the skilled person that the invention can also be performed with elements that differ from the feature of the patent claim" [at 4.8]. The CoA noted that "the degree of novelty" brought by the patented invention is relevant here, "because a high degree of novelty can inhibit the applicant's possibilities to adequately foresee and describe all embodiments" [at 4.9].

  3. Next, protection by way of equivalence must not be at odds with the reasonable degree of legal certainty due to third parties. This requirement will be satisfied where "the skilled person understands that the patent claims leave room for equivalents, because the teaching of the patent is clearly broader than the wording of those claims and the skilled person sees no good grounds to limit the scope of protection to the feature listed in the claims" [at 4.10].

  4. Lastly, in appropriate cases it must be examined whether the allegedly infringing product is novel and inventive in relation to the prior art. In light of the Gillette principle, it would not be justified to grant the patent holder protection against products that are not novel or inventive over the prior art (an issue that was also touched upon by Arnold LJ in FibroGen v. Akebia, Katpost here).
Cosimo and Lucrezia may seem almost equivalent, but they have very different features

Application of the principles to the case

The CoA first found that Fresenius did not "literally" infringe Eli Lilly's patent, i.e. under the first step in the CoA's approach. "Literal" is perhaps somewhat misleading as the scope of protection under the first step is not limited to the literal text of the claims, but to the claims as interpreted under Article 69 EPC and the first – though not second – section of the Protocol. Because Eli Lilly had itself argued that the skilled person would understand that pemetrexed disodium differs from the salt used by Fresenius, it was clear that the patent claims could not be "literally" infringed.

However, the CoA considered Fresenius' product equivalent to the claimed composition and applied the four principles set out above as follows.

As to the first principle, the CoA held that the salt used by Fresenius was technically equivalent to pemetrexed disodium. Although each salt has different specific properties that may be more or less advantageous in the treatment of specific cancers, the function of the salt in the composition was the same in both cases: neutralisation of pemetrexed-anions to make the product suitable for storage and sale. Because the salt in Fresenius' product performs this particular function in the same manner, it was considered technically equivalent to pemetrexed disodium.

As to the second principle, the CoA held that the skilled person reading the patent would understand that the claimed invention could also be performed using a different salt. In fact, the patent would encourage the skilled person to search for alternative salt forms. The CoA dismissed Fresenius' objection that the skilled person would not have found the formulation with tromethamine because Fresenius was granted a patent on its formulation: the CoA held that a follow-up product may well contain a further feature that is inventive, but still apply the teaching of the patent. That was the case here, and in these circumstances it would be unfair to deny the patentee protection for this application of their invention.

As to the third principle, the CoA held that the skilled person would not see grounds to assume that the protection sought by the patentee was specifically limited to pemetrexed disodium. Having already established that the patent itself, in combination with the common general knowledge, would provide no grounds for assuming this limitation, the CoA focused on the prosecution history of the patent. The limitation to pemetrexed disodium was introduced during prosecution and because the District Court could find no compelling reasons for introducing it, the District Court had considered it a conscious limitation of the claims to, specifically, pemetrexed disodium.

The CoA disagreed: the limitation was introduced to overcome an objection on the basis of Art. 123(2) EPC (added matter), which cannot limit the patent's scope of protection (otherwise it would add matter). According to the CoA, the fact that including equivalents in the patent document during prosecution is prohibited on the basis of Art. 123(2) EPC does not preclude claiming protection for those same equivalents under Art. 69 EPC [at 4.45]. This is because (i) including equivalents in the patent itself would arguably extend the scope of protection to "equivalents of equivalents"; and (ii) including equivalents in the patent may help confer novelty or inventive step on the patent, which the original application may have lacked.

The CoA also dismissed Fresenius' reference to "circumstantial" evidence of a conscious limitation, which the District Court had found persuasive. Thus, the fact that Eli Lilly did not oppose the examiner's request to introduce the limitation or that it is a "pharmaceutical giant" with thorough expertise of patent prosecution did not mean that third parties could reasonably assume the limitation to pemetrexed disodium signaled a waiver of protection for other salts that could be equivalent.

Lastly, as to the fourth principle, Fresenius had not contested that its product was novel and inventive over the prior art (they had a patent after all), so that this principle provided no basis for rejection of Eli Lilly's claims.

The CoA thus concluded that Fresenius infringed the patent. It subsequently upheld the patent in an elaborate inventive step analysis, noting that its conclusion on validity diverged from the findings of the German Federal Patent Court, but that on the basis of the submissions before it, the CoA could not subscribe to the view of its German colleagues.

And so, yet another win for Eli Lilly was secured. In addition to setting the standard for equivalence in Dutch law, the decision provides a prime example of judicial dialogue. The CoA refers to other European decisions and explains its diverging views where possible: the outcome is a further step towards a harmonized European approach to equivalence - with our without a Unified Patent Court…
Hague Court of Appeal sets Dutch approach to equivalence, reversing District Court in pemetrexed saga Hague Court of Appeal sets Dutch approach to equivalence, reversing District Court in pemetrexed saga Reviewed by Léon Dijkman on Thursday, October 29, 2020 Rating: 5


  1. To my mind, there is something to be regretted in the divergence of patent law, between the EPO's "Gold Standard" and the DoE promulgated all over Europe by the national Supreme Courts. I mean, the EPO comes down ultra-hard on any drafting deficiencies. deserving applications disappear, all the time, in the notorious Bermuda Triangle formed by the vertices of Art 54, Art 84 and Art 123(2) EPC. Yet, if you can get through to issue a claim that withstands attacks under Art 54 EPC, you can look forward to a generous scope of protection, reaching way beyond what you claimed, regardless how negligent was your original claim drafting and how unclear was your description.

    In other words, the EPO does not forgive poor original drafting but the national courts condone it, even encourage it. is that how others see it? If so, is it good or bad for promoting technological innovation in Europe?

    1. Hi MaxDrei, thanks for this. In the Netherlands, the doctrine of equivalents is at least partially seen as a "compensation" for how hard it is to draft claims, especially for breakthrough inventions. This is certainly apparent in older case law and the CoA's decision echoes this sentiment as well. I think courts do not so much "condone" poor drafting, but acknowledge that the "Bermuda Triangle" you mention can restrict patentees who, after filing their priority application, further develop their invention and may only later realize its full potential. In my view, that seems fair: the EPO's rigidity acts to prevent abusive prosecution practices (such as writing claims to cover competitors' products) as much as possible, whereas courts seek to establish a fair scope of protection. Note that the CoA's second principle implies that poorly drafted applications won't normally be entitled to a broad scope of protection: the CoA is saying that equivalence is only appropriate if your invention as disclosed warrants it.

  2. The decision on at least the 4th principle appear to be somewhat problematic.

    The allegedly infringing product may well have been novel and inventive. However, neither novelty nor inventive step can ever be assessed in an abstract sense. That is, both assessments require a date to be fixed for the claimed subject matter, so that the disclosures that represent prior art can be determined. Further, inventive step requires consideration of the disclosure of the specification and, especially for claims directed to a medical use, the effect(s) rendered plausible (and for which embodiments of the invention) by that disclosure.

    I have always struggled to understand why the latter aspect of inventive step assessment has received so little attention by national courts in the Eli Lilly saga. As I recall, that issue (and not just added subject matter) underpinned objections raised by the EPO examiner against the broad claim scope that was initially pursued by Eli Lilly during prosecution.

    Equally, I struggle to understand why the issue of sufficiency of disclosure would not limit (in one way or another) the equivalents that can be protected by a patent claim. If the disclosure of a patent does not enable the invention to be performed using the purported equivalents, then how on earth are third parties provided with "a reasonable degree of legal certainty" if the equivalents are nonetheless protected by the patent?

    Based upon its decision in the Regeneron case, at least the UK Supreme Court appears to believe that the sufficiency of disclosure requirement should be satisfied across substantially the whole scope of the claims. If the scope OF PROTECTION provided by those claims includes equivalents, then why on earth should the same (or at least similar) principles governing sufficiency not apply to that whole scope? This ought to be particularly pertinent to those alleged equivalents that are inventive over the disclosure of the patent in question, ie to embodiments that were only developed as the result of a later inventive step. In this respect, it seems to me a little ironic that the existence of a (presumably later) patent to the allegedly infringing embodiment was held to support the contention that said embodiment was protected as an equivalent.

    I am all for providing patentees with a reasonable scope of protection, including for equivalents. However, the way in which courts in Europe are currently going about doing this appears to be based upon some very dubious "logic" indeed!

    1. Hi Proof, thank you for this. You raise an intriguing question! The CoA held that the equivalent must be novel + inventive over the patent's prior art (fourth principle). I think you question is directed to the issue that Fresenius' product was (let's suppose) novel + inventive over Eli Lilly's own patent.

      But does that necessarily mean Fresenius' equivalent is not enabled and/or made plausible by Eli Lilly's patent? It seems to me that the Fresenius salt may well have some novel and inventive properties over Eli Lilly's salt, and still satisfy the first + second principles in the CoA's test. That is, even if it has some novel and inventive properties, it may still act to solve the same technical problem (make the product suitable for storage and sale), and fall within the disclosure of Eli Lilly's invention (adding salt to pemetrexed solves the technical problem, regardless of the type of salt). Then, if Eli Lilly's patent satisfies the tests for plausibility and sufficiency, the same can be said of this equivalent.

      This is also apparent from the decision--an aspect I didn't include in the post because of constraints of space. At 4.27, the CoA found that (1) Fresenius' patent did not claim pemetrexed and tromathemine as such, but rather in a specifically balanced mixture with some process steps added; and (2) in fact the EPO stated during prosecution that combining pemetrexed with tromathemine as such was obvious.

      I think your point might hold where the equivalent is covered by a product claim, which suggests that the salt/combination as such is novel and inventive over the invoked patent. But that doesn't seem to have been the case here. And of course for equivalence it doesn't matter whether the inventive effect of the later patent is actually achieved: i.e. Eli Lilly's patent would cover any combination of pemetrexed with a salt, regardless of whether the specific mixture of Fresenius' patent is used. The fact that it is can't render it non-equivalent to Eli Lilly's patent, since it still uses its basic inventive concept (pemetrexed + salt).

      I wonder what you think!

  3. Léon: with respect, I think that you missed the main point that I was making.

    During prosecution, shortcomings of the disclosure of the description and drawings can lead to adverse findings on sufficiency and/or inventive step. For example, if a specification does not disclose the suitability for a medical use of substantially all active ingredients encompassed by a medical use claim, then the EPO is likely to raise objections on the grounds of implausibility (either for putting the invention into practice or for solving the objective technical problem).

    As confirmed by the UK Supreme Court in Regeneron v Kymab, the requirement to enable performance of the invention across substantially the whole claim scope applies to ALL inventions, even those that are allegedly "ground-breaking". Thus, any claim whose literal scope encompasses a substantial number of non-enabled embodiments will be invalid for lack of sufficiency and/or lack of inventive step.

    The question is why should this standard not also apply to NON-literal claim scope (ie equivalents)? If it does not, then a patentee can improve their position by relinquishing non-enabled (or non-inventive) claim scope during prosecution ... and then recapturing that same claim scope after grant by asserting the doctrine of equivalents.

    The ability to relinquish and then recapture insufficient and/or non-inventive claim scope in this way is hardly consistent with the principle of legal certainty for third parties. Indeed, if one accepts that added matter was not the sole reason for relinquishing claim scope during prosecution (as it was certainly not the only ground of objection against that claim scope), then one could argue that is precisely what has happened in the Eli Lilly saga.

    1. Hi Proof, I see your point, but questioned your underlying assumption that Eli Lilly's claims were not enabled over the whole breadth of the claim, including equivalents (such as Fresenius' product). I don't know the prosecution history of the patent, but I take from the CoA's decision that it found that Eli Lilly's patent disclosed, in an enabling manner, the use of a combination of pemetrexed and (not just disodium, but) a salt. If that is correct, then I don't see why Eli Lilly's patent can't be considered an enabling and plausible disclosure of the equivalent that now allegedly infringes it, i.e. Fresenius' product.

      So, I think we're in agreement that a patentee should not be allowed to capture non-enabled embodiments through the doctrine of equivalents, but I wonder if this case is an example thereof. The CoA's decision makes me suspect it's not, though the prosecution history could perhaps suggest otherwise.

    2. Based upon expert evidence, Arnold J concluded, in Actavis v Lilly [2014] EWHC 1511 (Pat), that:
      "If the proposed source of pemetrexed anions is not sufficiently soluble or is not pharmaceutically acceptable for some other reason, then as a practical matter the skilled team cannot make that medicament or product and therefore cannot obtain the benefit of the patented invention. To that extent, therefore, it would not be obvious to the skilled team that pemetrexed diacid would have no material effect on the way the invention works. The same goes for pemetrexed dipotassium and ditromethamine".

      Whilst this finding related to one of the so-called Improver questions, it is clear that, at the priority date of the patent, those skilled in the art would not have known whether the alleged equivalent salt forms would work. The patent therefore does not disclose the suitability of those salts for the claimed medical use.

      This ties in with an Article 56 objection during prosecution, where the examiner stated that "When the inventive step is based solely upon the achievement of a technical effect, such as use in combination therapy for inhibiting tumor growth in the present case, substantially all embodiments of independent claims 1, 13 should exhibit this effect".

      When securing grant of their patent, Eli Lilly never demonstrated the relevant technical effect for the allegedly equivalent salt forms. Indeed, the demonstration of that technical effect now rests upon subsequent (and potentially inventive) work conducted by the alleged infringers.

      This is where the key point that I am making comes into play. This is because it is not entirely clear whether it is permissible for Eli Lilly to rely upon that post-filing data to support sufficiency and/or inventive step for the non-literal scope of their patent claims. To answer that question, one needs to decide whether, based upon the evidence, the disclosure of Eli Lilly's patent renders PLAUSIBLE the relevant technical effect (of inhibiting tumor growth) for the "equivalent" salt forms. This is a question that, to date, the national courts in Europe appear not to have considered in any depth. Personally, I find this alarming, as it suggests that the patentability standards for non-literal claim scope are much lower than those for literal claim scope ... which simply cannot be right.

    3. That's an interesting point of divergence between the decisions. The CoA held that "The invention is disclosed in the patent document in such a manner that the skilled person, using common general knowledge, could and also would apply it with other pemetrexed combinations than the claimed pemetrexed disodium".

      And a few paragraphs down, the CoA refers to the decision you cite and the argument made, but finds that even though the therapeutic effects of individual salts were unpredictable, "the skilled person would have a reasonable expectation of finding an alternative salt that is suitable for putting the invention into practice".

      So it would appear that the case was argued differently than before the EWHC or, perhaps more likely, that the CoA came to a different conclusion on the basis of the evidence by concluding that finding another salt was within the skilled person's common general knowledge.

      Even if that finding can be criticized as a factual matter, from a legal point of view your concern was thus addressed by the CoA: if it was common general knowledge to search for equivalent salts, including the salt Fresenius used, then its technical effect must also be plausible. Or am I overlooking something?

    4. By concluding that "the skilled person would have a reasonable expectation of finding an alternative salt that is suitable for putting the invention into practice", it is clear that the CoA was not posing the correct question.

      In medicinal chemistry, the skilled person ALWAYS has a reasonable expectation of finding alternatives to a claimed active ingredient. But whether or not some UNSPECIFIED alternative is certain to be discovered after further research is not a question that is pertinent to ask in connection with patentability (or scope of protection). The relevant question is instead whether, at the priority date, those skilled in the art would have reasonably expected the SPECIFIC alternative(s) under consideration (here, the allegedly infringing alternative form(s) of pemetrexed) to achieve the technical effect of inhibiting tumor growth (in combination therapy).

      At this point, I have to completely disagree with Max Drei. The evidence before the UK courts suggests that those skilled in the art would not necessarily have expected the specific alternative forms (potassium and tromethamine salts and pemetrexed diacid) to inhibit tumor growth in combination therapy. The question here is whether those forms would have been capable of (safely) providing a sufficient concentration of (bioavailable) pemetrexed ion at the tumor site. Given how much PK / PD profiles can vary between different (salt) forms, efficacy for any specific (untested) form is far from a foregone conclusion.

      Perhaps Eli Lilly can demonstrate that the disclosure of their patent was PLAUSIBLE with regard to a tumor growth-inhibiting effect for pemetrexed diacid and the potassium and tromethamine salts of that acid. However, I find it alarming that the CoA (in common with many other courts across Europe) did not see fit to give detailed consideration to the evidence on this point.

  4. It is good to see that applicants/proprietors are not being disadvantaged in enforcement proceedings by the strictness of EPO practice in examination. We must remember that infringement proceedings are a dispute between 2 parties and the Courts must be free to decided on a 'just' outcome without the technical aspects of patent law interfering too much. In the US also there are different interpretations in examination and litigation, and essentially that system is coming into development now across Europe based on the practical experience of the Courts in deciding on infringement

  5. This is where the key point that I am making comes into play. This is because it is not entirely clear whether it is permissible for Eli Lilly to rely upon that post-filing data to support sufficiency and/or inventive step for the non-literal scope of their patent claims. To answer that question, one needs to decide whether, based upon the evidence, the disclosure of Eli Lilly's patent renders PLAUSIBLE the relevant technical effect (of inhibiting tumor growth) for the "equivalent" salt forms. This is a question that, to date, the national courts in Europe appear not to have considered in any depth. Personally, I find this alarming, as it suggests that the patentability standards for non-literal claim scope are much lower than those for literal claim scope ... which simply cannot be right.

  6. WARNING: I'm going to be provocative here. But I do it deliberately, to stimulate further debate, because I think that would be beneficial.

    I welcome the exchange of views prompted by my Comment #1 but have an uneasy feeling that Mr Dijkman lacks long years of experience drafting pharmaceutical patents and so is not in a position to judge what an elementary goof occurred in the drafting of the patent here in suit.

    What I'm suggesting is that it is not a good idea for the courts to rescue Applicants who make egregious drafting errors. It is not good for the health of the patent system to excuse such grotesque failures of drafting.

    The point is that in the invention we have here there is an anion and a cation, of which the anion is the active complex organic principle (pemetrexed) and the cation is merely a necessary but trivial electrical charge-balancing positively charged inorganic counterpart particle (sodium ion, potassium ion, or something similar). Nothing could have been more self-evident or obvious than to claim at the level of generality of "pemetrexed salt". Had Applicant claimed that invention, the true invention, at that level of generality ie precisely the level of generality supported by the disclosure and rendered plausible by the disclosure, litigation would not have been needed. No hindsight was needed, to see that a claim to pemetrexed was indicated, right from the get go, the blank sheet of paper on which the claims are first drafted. Any qualified European Patent Attorney would have seen that instantly. The problem here is that the case was drafted and filed in the USA, which when it comes to patent drafting is "on a different planet" from the rest of the world.

    Now, Mr Dijkman, and other readers, my question to you. Should the courts be in the business of fomenting more patent litigation or should they instead concern themselves with efforts to damp down the amount of patent litigation? I ask because the way this case has turned out is, in my opinion, a potent generator of more litigation, arising from a reduced level of legal certainty about how claims are to be construed in Europe, and what counts as an infringement.

    I see you are an associate of a leading patent litigation firm. Your assessment then as to what attitude the patent courts of Europe should take towards levels of quality in patent drafting interests me greatly.

    1. Dear Max, thanks for your thoughts--and I appreciate you being outspoken, even provocative.

      I agree with you that the doctrine of equivalence should not be relied upon to correct sloppy drafting. The patent social contract places great power in the hands of patentees by allowing them to draft their own claims, and I think they should be subject to strict scrutiny when doing so. This has been recognized in Dutch case law for a long time, and a 2016 decision by the Supreme Court serves to illustrate this (Bayer/Sandoz, ECLI:NL:
      HR:2016:196). There, the patent claimed a method and the claims specified that it should be performed with an acid. But the description mentioned it could just as well have been applied with a base. The Supreme Court (and the CoA before it) refused to apply the doctrine of equivalents in this case, since an acid is simply not a base, and if the patentee would have wanted to claim protection for both, they should have done so.

      Now, let's take a look at what happened in the present case.

      The initial claim 1 read as follows: 1. Use of a methylmalonic acid lowering agent in the preparation of a medicament useful in lowering the mammalian toxicity associated with an antifolate, and the medicament is administered in combination with an antifolate.

      This claim therefore generally covered antifolates, but because a combination of vitamin B12 and an antifolate was not novel, the claim was subsequently amended to cover only pemetrexed, which was understood to mean pemetrexed in combination with any acceptable salt, including (as specified in claim 4), pemetrexed disodium:

      1. Use of pemetrexed in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof.

      4. Use according to any one of claims 1 to 3 wherein pemetrexed is pemetrexed disodium.

      Now comes the crucial part. The examiner raised a 123(2) objection because the only working example of pemetrexed that had been disclosed was pemetrexed disodium:

      The subject matter of present claims 1 reading “use of pemetrexed…” and claim 13 “a product containing pemetrexed…” do not find base in the application documents as filed. The term “pemetrexed” in the wording of these claims and the corresponding passages on amended description is certainly a distinct compound (CAS Registry number 137281-23-3) of the “pemetrexed disodium” (CAS Registry number 150399-23-8) expressed on original document description page 2, line 6 and page 6, line 16. Said amendment beyond the content of the original document is therefore not allowable (Art. 123 (2) EPC).

      Consequently, the claims had to be limited to pemetrexed disodium. However, the CoA held (and I understand that this was not really disputed) that (i) the skilled person would, on the basis of the common general knowledge, know that the invention would also work with different salts; and (ii) the application clearly said so much, even as filed in the PCT stage.

    2. The key question for the doctrine of equivalents here is whether this limitation, clearly on the basis of art. 123(2) EPC, also limits the scope of protection. The CoA explains why not, and I think the reasoning is persuasive: after all, all patent documents (including the PCT application) must be interpreted on the basis of Art. 69 EPC, whereas the test for art. 123(2) EPC is novelty. Those methods of interpretation are different, with novelty being much more literal than scope of protection. Hence, a PCT application, and the patent subsequently filed on the basis thereof, will have a certain scope of protection, but because of the more literal test applied for the purposes of at. 123(2) EPC, that scope of protection might not be capable of being claimed as such.

      The CoA held here that this means a 123(2) EPC limitation cannot be an indication that the scope of protection is limited accordingly. I think that's right.

      It's not clear to me from your comment whether you disagree with that finding: you think this is a case of poor drafting. My question to you is: where was the drafting error made?

      I could see the argument that it happened already in the PCT stage, i.e. the original application should have disclosed more specific examples than just pemetrexed disodium (which was Eli Lilly's own product and therefore mentioned as a preferred embodiment). But at that stage, the application related to antifolates generally: was the patent holder nonetheless obligated to write down every single salt that could be used with pemetrexed? What about other antifolates? The purpose of art. 69 EPC is to avoid imposing such strict conditions on patentees, so long as the proper breadth of the inventive concept is clearly disclosed, and satisfies all material requirements for patentability. I think that is the case here, so I think the case was properly decided.

      And, having disclosed the invention in a manner that makes clear that it would work with any salt, the next question is: what reasonable expectation can third parties entertain that Eli Lilly nevertheless wanted to limit its scope of protection to pemetrexed disodium, specifically? This happened explicitly in the context of art. 123(2) EPC, so for the reasons set out above, it doesn't imply a willful limitation of the scope of protection.

      Returning to the example of Bayer/Sandoz, the case was decided differently there because the invention as initially claimed was limited to a SPECIFIC COMPOUND, even if there had been a disclosure that it would work with others as well. Here, it was not limited in that way: a general class of compound (antifolates) was disclosed and claimed, then narrowed down to pemetrexed generally, then -- on the basis of a formal objection -- narrowed down to pemetrexed disodium. It's a fine line, but I think it can clearly be drawn: in the first case the patentee signalled interest in a limited scope of protection by failing to claim the other compound as well, but here Lilly did no such thing.

      You're right that I don't have a lot of experience drafting pharmaceutical patents--I'm not a patent attorney by training. But I did think about this problem as I wrote the post, and I'd be curious to hear where you think my analysis is wrong.

      Lastly, on your point of inviting litigation. If I may, I would criticize your post for posing a false dichotomy: courts don't face just the two options you present, but instead must come to a balanced and fair decision given the circumstances. Of course I don't think that increased legal uncertainty and, as a consequence, a rise in litigation rates are a good thing. But I also don't think that fair protection for patentees should be sacrificed to maximize legal certainty. If maximum legal certainty were the purpose of the patent system, it would look very different. But instead art. 69 EPC directs us to find a middle ground, and I think the CoA did so properly in this case.

  7. OK, Leon, thanks. I want to keep this pot boiling.

    You set out this claim:

    1. Use of pemetrexed in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof.

    and explain that it appeared for the first time during prosecution. Leon, my point is, very simply that i) precisely that subject matter is the contribution to the art ii) it would have been screamingly obvious, already the day before filing the PCT application, that it should have been claimed (and stated) at that level of generality in the PCT as filed. No excuse not to (except perhaps that the lapse doesn't matter in the USA) iii) the outcome at the EPO would have been different, had that claim been there, present, in the PCT as filed. The drafting was (I say) negligent and that negligence should not have been condoned, let alone handsomely rewarded.

  8. Leon, I should have said more about why the outcome at the EPO would have been different. Against the 123(2) point, Applicant was powerless. But when that point is not available to the Examining Division, it comes down to a debate about support and plausibility, which Applicant would have easily won.

  9. As to the question why Applicant did not fight against the 123(2)objection, my explanation is that to fight on the public file, and lose, leads to worse outcomes than not to fight at all.

    Applicant got that judgement right, I think. But I'm no litigator. What do you think? Would Applicant have fared better in the courts if it had vigorously disputed the legitimacy of the Art 123(2) objection with the EPO Examining Division and then with the Technical Board of Appeal (and in the end still lost)?

  10. Hi Max, thanks for this. I think the answer to your first question is that the PCT application was initially even broader and pertained to the use of antifolates, of which pemetrexed combinations are only a single example. But because claiming antifolates with B12 was too broad -- i.e. not novel -- Lilly had to narrow down. And they couldn't narrow down to pemetrexed generally, because there was no basis for that in the PCT application. But that doesn't mean the invention behind it wasn't in there.

    The entire point in the CoA's reasoning is that it was indeed screamingly obvious that the claims were directed to pemetrexed generally, as in the claim you cite, and that this was comprised in the PCT application as filed. You can't fault the patentee for failing to list every conceivable antifolate in this original application, and it doesn't mean that they forfeit protection for other salts than those specifically listed when the disclosure clearly relates to all antifolates, including salts.

    I wish I was more versed in the underlying technology so I could better understand the relation between the salt eventually claimed and other antifolates. But the way I read the CoA's decision is that it says the original application was broad enough that it wouldn't have made sense, at that point in time, to already limit the claim in the way you suggest. This is not to say it wouldn't have been better to include it, if only as a dependent claim; and I'm curious to learn how differences in US prosecution rules may have caused this omission (is it because you have to pay per claim?).

    But I wouldn't say it is an error, as in the Bayer/Sandoz example where the claimed invention as such is directed at a different compound, and the omission was failing to claim at a broader level of generality. In fact the opposite happened here: the invention as originally claimed was broad enough, but offered no formal basis to describe the claims at a level of generality that would have best served legal certainty.

    As for the second question, I'm not sure that it would have mattered. If Lilly fights and loses the 123(2) challenge, that still doesn't necessarily compromise the patent's scope of protection--provided you subscribe, as I do, to the CoA's explanation in this respect.

    But to further clarify my question: do you think that a 123(2) challenge, regardless of whether the patentee decides to fight it, signals to third parties that the scope of protection is limited to the restricted wording from the PCT application? If so, how do you reconcile that with art. 69 EPC?

  11. Thank you Leon.

    Well, Ladies and Gentlemen Readers, there you have it. Here you can see my abject failure, as a European Patent Attorney who drafts patent applications under a vigorously contested First to File patent law and well knows the sensitivity of prosecution amendments that illegitimately "improve the position" of an Applicant at its filing date, to communicate to a patent litigator the notion of an "undisclosed intermediate generalisation" under Art 123(2) of the EPC, the notion of "plausibility" and the notion of "support" under Art 84 EPC.

    Do we see here a need for more communication between the patent litigation and the patent drafting and prosecution communities. What does that tell us about the future of opposition practice at the EPO?

    Leon, you ask me for my opinion: what difference would it have made, in the litigation, if Lilly had argued against the 123(2) objection? Don't ask me, I'm not a litigator. But why should it be any different in patent disputes than in everyday life, where the general Rule is that it is better if you can to put a fight off till tomorrow than to fight it out today and be seen to have lost. And here, there is no doubt whatsoever that if they had made a fight of it at the EPO, they would have lost. But if in the PCT as filed they had competently claimed their invention, they would have won both before grant and after it, both at the EPO and (if it ever got as far as litigation) in the courts as well.

  12. Forgive me, Leon, for not yet responding to your "I am curious" sentence. You wonder whether the difference between US and Rest of the World (RoW) drafting standards is fees per claim. Well, no, that's not what I had in mind.

    Imagine claim 1 as a balloon, defining a scope of protection (namely the entire volume inside the balloon). The "best mode" here the proprietary Lilly ALYMPTA product. It can be seen as a diamond, a pin-point, somewhere within the balloon. The difference between US and RoW drafting is in expectation how much you need to write in the application as filed about intermediate levels of generality between the balloon surface and the diamond. RoW practises an "onion skin" drafting style, coming down from the balloon to the diamond in successive steps, with each step corresponding to a stated enhancement in the efficacy of the inventive concept, ie the subject matter of claim 1.

    In short, you can't just file an absurdly wide claim 1 and a single dependent ALYMPTA claim and wait until during prosecution to figure out what you have invented. You will appreciate that there is more or less infinite flexibility to squeeze the balloon skin this way and that, during prosecution, to avoid the prior art while retaining a scope of protection as close as possible to the original balloon size.

    Such behaviour is open to abuse. Can you see that? Hence, everywhere on Earth except the USA, a strict "No New Matter" standard is applied to prosecution amendments.

    It's (as so often the case) different in the USA, until recently a First to Invent country. Now that it has joined the community of First to File countries, it will slowly but surely find that it too needs (in order to do justice between rival filers) a strict New Matter standard. But for the time being, drafters in the USA still tend to think that their "Diamond in a Balloon" is the highest expresssion of the draftsperson's art because it pleases the litigators never to say in the application as filed what the subject inventive concept actually is.

    Who feels like disagreeing with me here? I am curious.

    1. Dear Max, that is super interesting. So if I understand you correctly, the US counterpart to art. 123(2) EPC is much less strict in the sense that there's no added matter so long as you add matter from within the balloon? That's certainly crazy.

      You may know that I'm writing a PhD on proportionality in patent law. As part of that, I'd like to understand the prosecution process a bit better--especially ways in which it might be open to abuse, e.g. by delaying publication or specification of the invention until competitors have come to market, etc. You seem very knowledgeable on the subject and also to have some concerns about these issues. Would you be willing to talk to me on this issue in some more detail? If so, maybe you can send me an e-mail: you'll find the address via my personal page, which is linked in my bio under "The IPKat Team" [not sharing it here b/c of spambots].

      Either way, this has been -- for me at least -- a very fruitful exchange. Maybe you're right to think that litigators, and perhaps even more so judges, should gain some experience with prosecution to better understand what tactics might be employed before a patent is granted... and I'd be grateful to take up the challenge.

  13. OK Leon, I will get in touch with you by email in due course and would be happy to help.

    Meanwhile, lest readers baulk at what I have written about how things work in the USA I should mention its statutory requirement that the patent application as filed includes a "written description" (WD) of the invention as claimed. Think of the US WD requirement as its equivalent to Europe's prohibition on adding matter after filing.

    Until now, however, the WD requirement has been interpreted liberally. But within the next 25 years or so, as the US courts gather experience in adjudicating priority contests between rival Applicants under the AIA'*s First Inventor to FILE regime, they will find that the WD has to be, in the interests of dispensing justice between the disputants, applied strictly. This will bring the WD requirement into closer conformity with the law in Europe under Art 123(2) EPC.

    That's the nice thing about patent law: the principles are simple and universal, but each country has its own patent statute under its sovereignty, and is free to choose how it expresses the principles. America, for example, always worships the individual. Until the AIA, a corporate owner of the invention had no status to file a patent application at the USPTO, only the individual, the inventor, could do that. Even now, the system introduced by the AIA is called the "First INVENTOR to File" system.

    1. Thank you very much Max, I'll be looking out for your e-mail then :)

  14. MaxDrei, I feel you are being too harsh on the US system. In my experience it is difficult to get claims there which are beyond the contribution the invention makes over the prior art. The US Examiners judge claim scope on the technical content of the spec, not the literal language. In Europe you have to be able to 'predict the future' to draft well, and often you have great data, but not adequate language to claim it once new relevant prior art is identified. EPO Examiners seem to be learning a lot from overseeing oppositions, and are making ever better added matter 'attacks' (not objections). I do not think EPO Examiners should act like opponents for added matter. This is specific to the EPO. No other courts or patent offices are as strict. I think the EPO needs to return to the system of identifying technical content and judging claim scope accordingly.

  15. Super, to get that input from Denver. Thank you.

    I agree that the EPO is tougher than any other Patent Office on the issue of whether an Applicant, by amendment during prosecution, is adding matter, thereby illegitimately improving its position relative to the one it had on its filing date. The questions are i) why is that and ii) is the EPO position untenable?

    Why is it? I think first because, alone amongst the world's leading Patent Offices, the EPO is not told what to do by the community of patent litigators, in the form of a national Supreme Court. Second, the EPO plays a role in certifying who is competent to serve as a "European Patent Attorney". There is a drafting Paper and it is hard to satisfy the Examiners that one's drafting competence is high enough for you to be "let loose on the public". In Europe, it is expected that patent attorneys will draft well enough to get for their clients a full measure of the protection their invention deserves. The EPO holds to account those who do not draft competently.

    If we look at the 5 Leading Patent Offices of the World, US, EP, JP, CN, KR, and rank them on a scale of 1 to 100 for the strictness with which they police the "added matter" issue, we could say that the EPO is on 100 while the USPTO is on 1. But where are the other three? Will anybody here report. For the time being, I will assert that they are all on around 80, closer to the EPO view than the US view.

    From the USA it is often advanced that I cannot know what my invention is till after I have received the First Office Action on the Merits (FAOM) . Therefore, for justice, I must have full freedom to define that invention for the first time after I get the FAOM. I started in this profession in the early 1970's. Since then I have advised Patent Applicants, Patent Owners but also Opponents. I think that, given competent patent drafting, inventors can get a full measure of protection from the EPO, even more so now that the various Supreme Courts of Europe have given their blessing to an expansive DoE. I like to think that Europe, with an EPO free from the yoke of a patent-naive Supreme Court, and with regular brainstorming sessions for the nation Appeal Court judges, can achieve for users of the patent system a level of legal certainty higher than anywhere else in the world, a fair scope of protection, rapid enforcement of claims that are not invalid and rapid revocation of any claim that in dispute is found to be invalid.

    Lest anybody mention Germany, I should say a few words, provocative, of course.

    The German Patent Office competes for business with the EPO. The German Federal Patents Court competes for business with the opposition parts of the EPO. One way to distinguish its service offer from that of the EPO, and present it as more user-friendly, is to be more liberal on the issue of added matter. There are always enough other levers in the system of patent law to compensate for any excess liberality in allowing doubtful prosecution amendments.

  16. Denver wrote about the need to "predict the future". I thought about that and in reply have two points to make.

    When patent attorneys draft patent applications, their clients rely on them to "predict the future", but not in the way that Denver contemplates. Rather, they have to imagine how courts will decide patent disputes, over the upcoming 20 year lifetime of the patent. How strict will the courts be, for example, on the issue of admissibility of amendments made during prosecution. If liberal, less effort needs to be put into the drafting of a progression of dependent claims that recite ever stronger patentability, to provide a succession of fall-back positions in the event of closer prior art emerging belatedly. If strict, then more effort is needed, to get those intermediate levels of generality/patentability in the case already at the filing date of the patent application.

    Patentability is to be assessed objectively, through the prism of the notional skilled person who knows the prior art. The EPC defines the prior art as that which has already been made available to the public by the filing date. With perfect prior art searching, the patent attorney can therefore know all the art known to the notional PHOSITA, when drafting and before filing the application at the Patent Office. The drafter is not required to "predict the future" prior art that can emerge only AFTER the filing date of the patent application.

    Otherwise in the USA, and only the USA. There, even under the AIA, obviousness attacks are routinely made on the basis of "prior art" US patent A-publications that were published only AFTER the patent application is filed. In that sense, when drafting for the USA, you are required to "predict the future". Perhaps this is the reason why the USA allows such liberality with prosecution amendments. Fair's fair, after all, eh?

    The other way to look at it is that "Two Wrongs don't make a Right."

    Denver, any thoughts in reply? Hope so.

  17. Thank you MaxDrei. I will need a little but of time to comment on every point, but if I can just for now comment on the reality of EPO search and examination. The EPO is incredibly good at searching, and often finds prior art that applicants are surprised by. So say when we were drafting we predicted about 80% of the types of amendments we would need. Still in 20% of cases we just don't have the claim language which the Examiner would want. The technical effect is demonstrated, it is enabled, it is a contribution to the field, but we got surprised. It's no one's fault. The data and technical effect are now published. Competitors will use it.

    So the skilled person is able to replicate the technology, but we just did not have the right language to claim it as per the EPO's standards. If instead the Examiner took the view that the technical teaching is there within the disclosure, so I will let them add a few words to describe it in claim language, that would fix the problem. The Examiner would just need to make sure there was no additional technical teaching introduced, and this is usually very straightforward.

    What I am advocating is that the EPO added matter test should determine the technical content of the case. I believe this more accurately reflects the purpose of the patent system. I know the test will need to be developed by case law, but once that process begins it will start to provide more certainty. At the moment we are spiralling down to more and more strictness, so that amendments based on the description only, for example, are becoming very difficult

    On another matter, have you read the UK court decision Icescape v Ice-World on doctrine of equivalence and how the Protocol questions are now being used in the UK? I think it is a complete distortion of the original test from Actavis v Lilly

  18. Denver, thanks again. I'm not going to comment here on the Icescape case because I want this thread to be as concentrated as possible. As to your point about the EPO finding better art, that doesn't impress me at all. The drafter has all the tools needed, to do as good a searching job as the EPO, and to do the drafting with the benefit of a full picture of the art. It is not as if the EPO finds stuff undetectable by the drafter. Patentability must be assessed objectively, through the prism of the all-knowing PHOSITA. Allowing it to be decided by a less than fully informed inventor or drafter is the road to nowhere.

    And now to the EPO's Gold Standard, which defines what any given document (priority document, application as filed, or prior art D1) discloses. The GS Medal has two sides. It helps Applicant striving to write a claim that is novel over D1. It is a b8gger though, when Applicant needs to amend the claim during prosecution. I have argued to the EPO for years that the GS must also be applied through the pragmatic eyes of the PHOSITA (rather than through those of a dry as dust lawyer) and there are plenty of EPO decisions that recognise this need. It is up to we advocates to ease the EPO further towards a robust, pragmatic, real world implementation of its GS.

    With 123(2), I think it's gradually getting better (in a 2 steps forward, then one step back way), helped by increasing facility with the English language among EPO Examiners. The biggest problem is EPO efforts to raise "productivity", requiring ever more inexperienced young Examiners to make ever harder examination calls. Again, we advocates should complain.

  19. MaxDrei, you have given the benefits of a strict approach and better trained Examiners. I can't argue with that. But your analysis does not take into account real-world situations of how we provide good research with the best support for commercialising the invention and making the world a better place. I get objections to intermediate generalisations at the EPO that I do not get in any other territory. Usually no one benefits from this. My client has to spend more money. Often there are no direct competitors. Your reference to a gold standard is good, but the penalty is paid by research companies, not the EPO or the patent attorney. And patent attorneys clearly do not see themselves as part of the solution. We have an 'academic' approach that does not seem to see that we live in a bubble of our own culture and rules that does not serve industry well. I believe there are less strict tests for added matter that could be adopted which would ultimately result in greater resources being used for research and not ending up as attorney fees.

  20. Denver, I feel I must reply, on your point about the real world of research. We could not wish for a better example of a priority contest in the real world of ground-breaking and life-saving medical research than the battle for priority between the East and West Coast USA CRISPR-Cas Teams. Let's watch how that pans out at the EPO, in the multiple opposition proceedings just getting under way. Which Coast was First to File is going to be a fascinating battle under the EPC.

    Many a time, my client is Opponent at the EPO and looking at the file wrapper of the patent I am to oppose I witness in the EPO file a battle to amend during prosecution. Through the eyes of an opponent, one sees how vital it is, to preserve the Principle of "First to File" that the EPO maintains a strict approach on the issue of adding matter to an already filed application. The courts in England are at least as strict as the EPO, on this vital issue of patent law. This, I would say, gives the lie to the assertion that the EPO is uniquely perverse on the issue of "new matter".

    I seriously doubt there is any legitimate criticism of the Patents Courts of England, that they lack real world awareness of the vital necessity that the patent system shall positively promote the progress of useful arts. Less so the US courts these days. I have in mind not only their negative attitude to eligibility in the field of diagnostic methods, in breach of GATT-TRIPS, but also a tendency to construe claims through the eyes of a lawyer rather than a person skilled in the art. I cite the Chef America case, where the court decided that the claim, to a method of baking bread, specified not the temperature of the oven but, rather, the temperature in the heart of the baked dough (which would have resulted in a block of carbon rather than bread). How perverse is that then? This is not at all "real world" is it?

    Many criticise the EPO's Problem/Solution Approach and its Gold Standard as artificial, not Real World. I say that such criticism is unfounded. There is nothing wrong with these legal constructs, but a great deal that is less than satisfactory in the individual cases, where poor advocacy results in poorly reasoned individual EPO decisions.

    I agree with you, that too many patent attorneys fail to see themselves as part of the solution I hope this thread can change that for the better.

  21. MaxDrei, just to respond to your point on the strictness of the UK Courts. They are not as strict on added matter as the EPO, and the test is essentially one of 'new information' being present. Certainly the UK Courts have a more lenient test for combinations, selection from lists, etc. It is almost unheard of for a patent to go down on added matter in the UK.

    I would also add that if we think about all possible patent systems that could exist, your defence of the 'Gold Standard' would hinder new thinking on how to look at IP. I am an admirer of what the US Supreme Court did on eligibility, but the subsequent failure to develop new case law is the fault of the Federal Circuit, that could not change its way of thinking appropriately. The US Supreme Court was redefining the 'commons' in important areas of activity. I think that was a good thing to attempt, but the reaction was too negative for it to have worked. The Federal Circuit was unable to take on 'visionary' thinking when it got the opportunity, which I think continues to be a lost opportunity.

  22. Denver, we are quite close in our thinking. Yes, the UK is better than the EPO in the enquiry into the mind of the skilled person, what exactly is "new" information and what is not. This is, I think, a result of the process of fact-finding under English law, through rigorous cross-examination, before the eyes and ears of a judge with decades of experience as an advocate in patent cases. The Gold Standard is there, but the fact-finding is more sophisticated and more "real world" than at the EPO. I like to think that the EPO can get better, under pressure from the rest of the world to take a more "real world" assessment of what really is "new" information for the skilled addressee.

    As to the turf war between SCOTUS and the Federal Circuit, I feel unqualified to make any comment. I defer to those who know better.

    The only thing in your post that raised my eyebrows was your "almost unheard of". That's certainly not my perception. I wonder, do you routinely offer opinions on the validity of patents in the UK.

    I suspect you practise in the chem/bio field. My practice is in engineering/materials/devices. I remember in the UK the Palmaz stent case and the ECB banknote case, where the EPO did not revoke for added matter but the UK courts did, and I don't see the UK courts as any more lenient than the EPO. The "new information" test is in principle brutally strict, I think.

    Not sure what you mean by "new thinking". Well-known patent litigator Heinz Bardehle and others have advocated a replacement for the Gold Standard which defines disclosure as lying somewhere intermediate between novelty and obviousness. Interesting, even lucrative, territory for litigators but I'm not sure it obeys the maxim KISS. If you have something else in mind, do tell.

  23. I would replace the Gold Standard with one related much more to the technical teaching apparent to the skilled person, which could be seen as 'implicit disclosure', if one was trying to fix the present system.

    However I believe we are now at the point of completely needing to overhaul how IP works and interacts with the economy in order to more accurately reflect what R&D is about. I would therefore change the system so that patent term and patent scope was linked to the most efficient economic working of the R&D system. So in my proposal the Patent Office would draft the claim for you once they saw your data and understood the contribution. There would not be any added matter test for this. You would instead get the scope your data deserved with perhaps some added consideration of the amount of money you spent and the nature of the risk you took. The patent term would also be decided at the same time based on such factors. The immediate reaction to this is that it is very difficult to do. And that is true, it would take a long time to make the system work properly, and a huge culture change. However it would allows Mankind to revisit the fundamental questions as to what an IP system should be about, and how it could benefit the planet most. The Examiner would first and foremost be an economist, with scientific and legal skills.

  24. Well, well, Denver, you do surprise me. You suppose that the Gold Standard takes no account of the disclosure of a document that is "implicit". But that isn't so. It does. To repeat: it isn't the Gold Standard that is flawed. Rather, it's the advocacy and the reasoning behind individual panel decisions at the EPO that sometimes leave much to be desired.

    Coincidentally, we have an item on another blog running concurrently, with which we can explore how the courts of the USA decide priority contests. I just posted a comment on it. Perhaps you would like to respond there (as this thread is surely now at the point of exhaustion/closure). I do hope so:


  25. Thank you MaxDrei for your detailed responses. I will look at the other conversation.


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