This post is based on a previous article on IPKat.
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).
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. 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
We are 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)
