Boards of Appeal back rejection of special criteria for the novelty of purity inventions, but the Guidelines remain out of step (T 0043/18)
Historically, the EPO has used a higher bar to assess the novelty for purity of compound inventions. A recent decision from the Boards of Appeal has confirmed that this approach contradicts the overarching principles of novelty. The decision in T 0043/18 particularly agreed with the 2018 decision T 1085/13 that novelty can only be destroyed by a clear and unambiguous disclosure in the prior art (G 2/88, G 2/10). Previously, purity inventions were only considered novel if a high purity could not be achieved by conventional means. The Boards of Appeal have now rejected this requirement as being more of an inventive step assessment than one of novelty. Unfortunately, the EPO Guidelines are still out of step with the Boards of Appeal.
Legal Background: Purity as convention
In assessing the novelty of a claimed invention, the burden of proof is normally placed on the patent office (or opposing third party) to find evidence of at least an implicit disclosure of the claimed subject matter in the prior art (G 2/88, G 2/10). Historically, however, the novelty of purity was considered a special case. It was thought that the increasing purity was conventional. The burden of proof was therefore shifted to the applicant to show that all prior attempts to achieve the particular degree of purity by conventional purification processes had failed (T 0990/96, T 0219/98, T 0455/13, T 360/07).
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| Unconventional science |
The special treatment of the novelty of purity was questioned in T 1085/13. This decision found that treating purity as a special case was contrary to the principle that novelty is destroyed only by a clear and unambiguous disclosure in the prior art (G 2/10). T 1085/13 was the first Board of Appeal decision to depart from the “special criteria” for purity inventions established in T 0990/96.
T 0043/18: "Decision T 1085/13 followed"
T 1085/13 left us with the question of whether other Boards of Appeal would follow suit with rejecting the treatment novelty of purity as a special case (IPKat). The recent decision T 0043/18 shows Boards of Appeal are content to follow the reasoning in T 1085/13.
T 0043/18 related to the opposition division decision to revoke EP 2305683 for lacking novelty. The patent related to a purer dosage form of oxycodone hydrochloride. The Opposition Division applied the "purity is conventional criteria" from T 0990/96, and found that the prior art disclosure of oxycodone hydrochloride per se had effectively made oxycodone hydrochloride available at all levels of purity.
On appeal, the patentee cited T 1085/13, which was published after the Opposition decision. On appeal, the Board agreed with the rationale and the conclusion of T 1085/13. Particularly, the Board of Appeal found that considerations of whether increasing the purity of a compound would have been conventional were appropriate for inventive step but not for novelty. Both T 1085/13 and T 0043/18 cited the EBA decisions G 2/88 and G 2/10 establishing that novelty is destroyed only by a clear and unambiguous disclosure in the prior art. The Board of Appeal thus found the claim novel and remitted the case back to the Opposition Division.
Final thoughts
The Kat is not aware of any Board of Appeal decisions contradicting T 1085/13 in its rejection of the unconventionality novelty criteria for purity established in T 0990/96. As well as T 0043/18, the reasoning of T 1085/13 was supported in T 1914/15.
The EPO Guidelines for Examination, on the other hand, are still out of step with T 1085/13 and therefore G 2/88 and G 2/10. Nearly 3 years on from the decision in T 1085/13, the Guidelines continue to state that "A known compound is not rendered novel merely because it is available with a different degree of purity if the purity can be achieved by conventional means (see T 360/07)" (G-IV, 7).
Given the clear reasoning in G 2/88 and G 2/10, and its application in T 1085/13 and now T 0043/18 it is unclear why the EPO Guidelines continue to cling to this language. The Guidelines historically lag behind changes in the established case law of the Boards of Appeal. Patentees and applicants of purity compound inventions can only hope Examiners and Opposition Divisions are prepared to ignore the Guidelines and to instead follow the EBA and Boards of Appeal case law.
Further reading
Purity can be unconventional, a new position for the EPO boards of appeal (T 1085/13) (18 Feb 2019)
Image credits: Kelly Standford
Reviewed by Rose Hughes
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Tuesday, August 30, 2022
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Purity should absolutely be assessed under inventive step, but only after the novelty assessment has been determined correctly.
ReplyDeleteOdd thing about this case is how the patentee acquiesced to it being assessed under novelty of oxycodone purity. The claim is to a pharmaceutical composition - a mixture. Previous oxycodone compositions, I assume, contain 14-hydroxycodeinone, hence a "pharmaceutical composition" with a different "composition" of constituents (i.e. less than the known quantity of 14-HC) is novel without invoking any purity criteria. Either that, or every other previous composition patent would have lacked novelty under T990/96 unless the components themselves were novel.
Known = Composition of 50% A + 50% B. Composition comprising >60% A and <40% B = novel under "old rules".
However, the disclosure of a patent is not simply the products of the experimental. If a prior patent/article discloses the structure of oxycodone, that structure represents a sole compound, not a mixture, not an impure compound, hence the disclosure of the structure is of the compound in 100% purity. A claim to "oxycodone comprising less than 25ppm 14-HC" would therefore lack novelty over the prior disclosure because the claim encompasses an amount of 0% 14-HC. The pharmaceutical composition would also lack novelty if the standard composition claim was included in the prior patent.
Is such a prior disclosure enabling? Absent special circumstances (T990/96), absolutely it is enabling. Oxycodone could readily be purified at the priority date to remove 14-HC by a variety of known techniques, such as HPLC and GC. The patent claim points to one such enabling method itself - "the HPLC method of Example 6".
The claim may be better drafted as covering a preferred range of 14-HC such as 1 to 24ppm.
Absurd: The Board remits the case to the OD to say exactly the same they said under section Novelty now under section Inventive step. What’s the difference?
ReplyDeleteN and IS are separate criteria to be both met, but not independently met. Only what inventively solves a problem makes a true progress in the art and can be a truly novel contribution.
Old case law of BOA had this implicit understanding e.g. novelty of numerical ranges. This is all being thrown out of the window by new BOA members who think that novelty is only rather a formalism for photographic identity.
The Board acknowledged inventive step!
DeleteNo, the BOA found the claim novel and remitted the case back to the Opposition Division to deal with inventive step.
Delete"T 1085/13 left us with the question of whether other Boards of Appeal would follow suit with rejecting the treatment novelty of purity as a special case (IPKat). The recent decision T 0043/18 shows Boards of Appeal are content to follow the reasoning in T 1085/13."
ReplyDeleteT 0043/18 and T 1085/13 seem to be issued by the same Board (3.3.02) with the same Chair (M.O. Muller)!