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SJ Berwin Novelty in Selection? A Review of the Court of Appeal’s Decision in the Olanzapine Litigation David Rose 16 November 2010
SJ Berwin
Novelty in Selection? A Review of the Court of Appeal’s Decision in the Olanzapine Litigation
David Rose 16 November 2010
Novelty in Selection?
• Novelty in Selection?• Statutory Basics• Merrell Dow – what is prior art?• Synthon – requirements for novelty• Olanzapine• Obviousness• Conclusions
Novelty in Selection?
"Where does a wise man hide a leaf? In the forest. But what does he do if there is no forest? He grows a forest to hide it in… And if a man had to hide a dead body, he would make a field of dead bodies to hide it in."
G.K. Chesterton, The Innocence of Father Brown
Novelty in Selection?
• Statutory Basics• Article 54 EPC (UK equivalent at section 2 Patents Act):
(1) A patent shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.
(3) Additionally, the content of European patent applications as filed, of which the dates of filing are prior to the date referred to in paragraph 2 and which were published under Article 93 on or after that date, shall be considered as comprised in the state of the art.
Novelty in Selection?
• Merrell Dow v. Norton (1995)• Was MD's patent for the acid metabolite of terfenadine invalid
for lacking novelty?• T is a pro drug: the activity lies in the acid metabolite which is
formed when T is metabolised in the liver• T was patented by MD in the UK. The patent expired in 1992• Subsequently MD patented the acid metabolite• However, all along it had been the acid metabolite that was
responsible for the anti-histamine effect• Was MD entitled to, in effect, extended patent protection for
the same drug?
Novelty in Selection?
• Merrell Dow v. Norton (1995)• "The state of the art shall be held to comprise everything
made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application"
• Was the acid metabolite part of the state of the art?• In infringement proceedings brought by MD, the Defendant
generic firms argued that the acid metabolite lacked novelty:• Prior use – volunteers in clinical trials had made the metabolite
when ingesting T• Prior publication – there existed a document explaining how to
make T and that it could be used for its anti-histamine effect
Novelty in Selection?
• Merrell Dow v. Norton (1995)• Prior Use – held to be a hidden/secret/uninformative use and
therefore the metabolite not made available to public• Prior Disclosure – held to invalidate the patent because the
inevitable result of following the prior art disclosure led to the making of the metabolite
• MD made point that there was no novelty destroying disclosure because the chemical composition of the metabolite was not in the public domain - House of Lords disagreed…the prior disclosure allowed the public to work the invention
• Difference between prior use and prior disclosure – in both cases the metabolite was being made?
Novelty in Selection?
• Merrell Dow v. Norton (1995)• "In the case of anticipation by use, however, the acts relied upon
conveyed no information which would have enabled anyone work the invention, i.e. to make the acid metabolite…It disavows any reliance upon extraneous information, such as the formula for making terfenadine and the instructions to take it for its anti-histamine effect. Anticipation by disclosure, on the other hand, relies upon the communication to the public of information which enables it to do an act having the inevitable consequence of making the acid metabolite. The terfenadine specification teaches that the ingestion of terfenadine will produce a chemical reaction in the body and for the purposes of working the invention in this form, this is a sufficient description of the making of the acid metabolite. Under that description the acid metabolite was part of the state of the art."
Novelty in Selection?
• Synthon v SKB (House of Lords) (2005)• Synthon sought to revoke SKB patent on the ground that the
crystalline form of paroxetine methanesulfonate (PMS) was not novel as disclosed by its own patent application (under section 2(3) PA).
• To anticipate, two distinct requirements must be shown:• Did the prior art disclose the invention patented in claim 1
of the patent?• Would an ordinary skilled man be able to perform the
disclosed invention if he attempted to do so by using the disclosed matter and common general knowledge (enablement)?
Novelty in Selection?
• Synthon v SKB (House of Lords) (2005)• Disclosure
• Matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent
• Awareness is not a requirement - requirement satisfied whether or not would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed (“The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so”).
Novelty in Selection?
• Synthon v SKB (House of Lords) (2005)• Disclosure (cont.)
• If more than one possible consequence, performing the disclosed invention will not necessarily infringe.
• If performance of prior art invention would not infringe the patent but prior art would make it obvious to skilled person how he might make adaptations which would result in an infringing invention, patent may be invalid for lack of inventive step but not for lack of novelty.
Novelty in Selection?
• Synthon v SKB (House of Lords) (2005)• Enablement
• Would the ordinary skilled person have been able to perform the invention which satisfies the disclosure requirement?
• Test of enablement of a prior disclosure for purpose of anticipation is the same as test of enablement of the patent itself for purpose of sufficiency (though may be differences in application of test to the facts).
• Person skilled in the art is assumed to be willing to make trial and error experiments to get it to work.
Novelty in Selection?
• Synthon v SKB (House of Lords) (2005)• The two concepts must be kept distinct and each must be
satisfied (albeit that the same disclosure may satisfy both requirements)
• Application to facts:• Synthon application disclosed existence of PMS crystals
of 98% purity and claimed that they could be made = disclosure (did not matter that disclosure attributed to PMS crystals an IR spectrum which was wrong).
• Skilled person would have been able to make crystalline PMS (question of fact) = enabled.
• Held anticipated.
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (2009)• Claim 3 of Patent is for single
chemical entity, olanzapine
• A previous Lilly patent had disclosed a class of compounds (Markush formula encompassing at least 1019 compounds, with preferred subclass of 86,000 compounds (olanzapine mentioned in ‘preferred’subclass)).
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (2008/9)• Dr Reddy’s claimed that the prior disclosure anticipated the
claim to olanzapine or, if it was a selection patent, the specification did not disclose the advantages as required by I.G. Farbenindustrie’s Patent (1930) (see Appendix)
• On latter point – old law of selection has gone. Jacob LJ in Court of Appeal in olanzapine:
• I.G. Farbenindustrie rules not part of patent law under Patents Act 1977 and not used by EPO
• “…best thing to do is to regard them as part of legal history, not as part of the living law”.
• Question for consideration: is the novelty of olanzapine destroyed by the earlier Markush formula?
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (2008/9)• Floyd J at trial (2008) followed EPO case law and held:
• Prior disclosure does not take away novelty of claim to a specific compound unless the compound is disclosed in "individualised form"
• “a general formula with multiple substituents chosen from lists of some length will not normally take away the novelty of a subsequent claim to an individual compound”.
• Floyd J concluded that the novelty of olanzapine was not, therefore, destroyed by earlier disclosed Markush formula
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (2008/9)• Court of Appeal agreed with Floyd J. – leading judgment from
Jacob L.J. • Jacob held: Disclosure of a large class is not a disclosure of
each and every member of it – as a matter of a priorireasoning and because inconsistent with settled EPO Board of Appeal case law.
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (2008/9)• Jacob LJ:
• “An old question and answer runs as follows: “Where does a wise man hide a leaf? In a forest.” It is, at least faintly, ridiculous to say that a particular leaf has been made available to you by telling you that it is in Sherwood Forest. Once identified, you can of course see it. But if it is not identified you know only the generality: that Sherwood Forest has millions of leaves”.
• Listing out of great number of compounds makes no difference: “to say a particular book is identified by saying “the books in the Bodleian” is no different from saying it is identified by providing access to the catalogue of the Bodleian”.
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (Court of Appeal) (2009)• Jacob LJ:
• Like Floyd J. adopted EPO reasoning in Hoechst Enantiomers: there must be an “individualised description”of the later claimed compound or class of compounds.
• Reasoning accords with judgment in Synthon on disclosure:
• “where you have a patent for a particular chemical compound and a prior art general disclosure, performance of the general disclosure (which means no more than using anything within it) does not necessarily result in infringement of the patent. In this case, for instance, you can “perform” 235 in any of 1019 ways – only one of them would result in infringement of the later patent”.
Novelty in Selection?
• Dr Reddy’s v Eli Lilly (2008/9)• Note that in olanzapine both trial judge and Court of Appeal
relied upon EPO case law which has determined that disclosure of a racemate does not in itself amount to a disclosure of each of its enantiomers (EPO decisions T0296/87 (Hoechst Enantiomers), T1048/92 and T1046/97).
• This is supported by Court of Appeal in Lundbeck v Generics (Court of Appeal) (2008): "It is settled jurisprudence in the European Patent Office that disclosure of a racemate does not in itself amount to disclosure of each of its enantiomers"(Lord Hoffmann)
Novelty in Selection?
• The Role of the Law of Obviousness:• Where a novelty claim fails, it remains open to a patent
challenger to claim that the invention is obvious over the stateof the art i.e. the claimed invention lacks an inventive step.
• Requires consideration of the state of the art at the priority date of the patent as understood by the skilled person/team and whether, set against the prior art, the claimed invention isobvious to the skilled team (i.e. it was an obvious thing to make or do)
• A fact intensive enquiry; requires consideration of motivation of notional skilled team
• Also, for obviousness challenge, have to rely upon matters in public domain c.f. for novelty challenge, can rely upon an unpublished patent application filed before the date of the patent in question (see EPC Art.54(3) above)
Novelty in Selection?
• The Role of the Law of Obviousness:• For example:
• Olanzapine – invention not considered obvious against the Mukesh formula disclosure and a number other published documents
• Lundbeck v. Generics (2008) (escitalopram) – claimed enantiomer was new and not obvious.
• Generics UK v Daiichi (2009) (levofloxacin) – disclosure of racemic product ofloxacin did not anticipate enantiomer even if skilled person would have recognised that it was a racemic mixture and would have been able to resolve it using conventional techniques.
Novelty in Selection?
• The Role of the Law of Obviousness:• For example:
• Warner-Lambert v Ranbaxy (2005): The calcium salt of atorvastatin was obvious over the prior art disclosure
Novelty in Selection?
• Conclusions• Synthon is the leading authority on novelty • Selection Patents
• Law clarified by Dr Reddy’s – test is one of disclosure by “individualised form”.
• Floyd J at first instance:• I do not think it can be said that the prior document
"contains a clear description of, or clear instructions to do ormake, something which would infringe the patentee's claim". The description is not clear because of the need to make a combination of substituents before the compound could be regarded as "unalterably established"".
• Ultimately a dual policy decision: follow EPO case law and identify a clear demarcation line by reference to individual disclosure
Novelty in Selection?
• APPENDIX • I.G. Farbenindustrie’s Patent (Maugham J) (1930)
• (1) a selection patent must be based on some substantial advantage to be secured by use of the selected members.
• (2) the whole of the selected class must possess the advantage in question.
• (3) the selection must be in respect of a quality of a special character which can fairly be said to be peculiar to the selected group.
