This ruling relates to an interim skirmish regarding the admissibility or otherwise of certain evidence. Specifically, the Opposer is entitled to the last word consisting of a rebuttal of the evidence presented by the Applicant. At that stage the Opposer is not supposed to raise new issues. The grounds for opposition in the evidence should not exceed those in the statement of case. During the period of Opposition, the allowed but opposed patent is unenforceable. The regulations attempt to referee the opposition proceedings so that it moves forwards at a reasonable pace and there are deadlines for each stage. However, the deadlines have some flexibility…
IL 169358 is the National Phase Entry of PCT/JP2003/016724 to Otsuka Pharmaceutical Co. Ltd. On 20 April 2013 the Application was allowed and published for opposition purposes. On 29 July 2013 Teva Pharmaceutical Industries Ltd. opposed the patent, submitting their statement of case on 1 December 2013. The Applicant responded on 26 March 2014 and the parties then submitted their evidence.
On 22 December 2014 the Opposer (TEVA) submitted an Opinion by Professor Paul Harrison. On 29 June 2015, OTSUKA submitted an Opinion by Professor Michael Thase. and one by Professor Abraham Weizmann. A counter-response for the Opposer (TEVA) comprising a second Opinion by Professor Paul Harrison was submitted on 13 December 2015.
After the round of submissions as defined in the Patent Regulations 1968 was over, the mutually acceptable dates of 8-10 November 2016 were set aside for a hearing in consultation with the parties and the various expert witnesses.
On 14 January 2016, Applicant (OTSUKA) filed for deletion of paragraphs 78-84 and 86, and appendices 22-26 of Professor Harrison’s opinion as submitted in the second opinion in the response of 13 December 2015. As an alternative submission, OTSUKA requested permission to respond to the issues raised.
On 15 February 2016, the Opposer (TEVA) submitted their response to the deletion request arguing that it was to be rejected. As an alternative, they requested permission to correct their statement of case to relate to the issues in the evidence in dispute. On 7 March 2016, the Applicant counter-responded to the response.
The Application describes pharmaceutical formulations for treating moodiness. Particularly depression. The applications includes 9 examples, of which examples 3 and 9 describe clinical trials on mice with serotonin reabsorption inhibitors and with Aripiprezol to test anti-depression effects.
During the Examination of the patent, the Applicant submitted a letter of 6 April 2011 with examples detailing the additional combinations of serotonin reabsorption inhibitors and aripiprezol in order to overcome prior art rejections by the Examiner and to show, as they put it, “…that the combination as presently claimed in the Application, has an excellent therapeutic effect for treating mood disturbances”.
In Example 3 of the Application and supplementary experimental evidence, use was made of the so-called Forced Swimming Test (FST). In Example 9, use was made of the so-called Tail Suspension Test (TST).
In Section H of the second opinion submitted in response to the Applicant’s evidence, Professor Harrison responded to Professor Weizmann’s claims that what was allegedly surprisingly found in combining aripipre or dihydro-aripiprezol with serotonin reabsorption inhibitors resulting in an enhanced symbiotic effect was fairly obvious.
The Applicant does not deny that Professor Weizmann said this. They claim that the synergistic effect appeared in the statement of claims and that the Opposer could have related to it as they saw fit in their first evidence filing rather than by way of response.
In response to the synergy claim, Professor Harrison raised three points in his second expert opinion as filed in response:
- The claims of the patent application are not restricted to formulations having a synergistic effect and the clinical trials described in the application do not demonstrate any synergetic effect between ariprezol / hydro-aripiprezol and the serotonin reabsorption inhibitors. In this regard, Professor Harrison went on to state his finding that examples 5-8 of the application, which related to the combinations, do not provide evidence to any synergy.
- The examples described in the clinical trials do not include any relevant control groups that can enable deriving the conclusion that there is a synergistic effect. In his second opinion, Professor Harrison refers to the first opinion and explains that there is no evidence that any improvement in patients being treated by the combination can be attributed to a synergetic effect of the combination.
- The examples allegedly showing a synergistic effect do not necessarily show this. One cannot determine a synergetic effect from the Tail Suspension Test.
Appendices 22-26 are references that are cited by Professor Harrison to demonstrate and to provide a basis for that claimed in paragraphs 78-86 of his second opinion. From the above, one can regard the challenged evidence as evidence submitted in response to the synergistic effect raised by Professor Weizmann in his submission of evidence.
The Applicant does not see this as evidence submitted in response. In the Statement of Case, paragraph 46 relates to the tests performed in examples 3 and 9 and stresses that there is no evidence of a surprising synergy:
The tests described in the Application relate to the combination of ariprezol / hydro-aripiprezol and serotonin reabsorption inhibitors selected from a specific group of chemicals for treating depression and major depression. There is nothing in these tests that demonstrates, even implicitly that the combination has an advantageous or surprising effect over that previously known which describes combining neurolifts with SRI. Specifically, these tests do not prove an advantage in the claimed combination over any combination of ariprezol with SRI.
Section 46 relates to the combinatory effect or synergy between two materials. The things were stated with respect to the examples described in the Application and not specifically with respect to the additional examples.
In light of the above, Commissioner Kling could not conclude that there is no argument with respect to the synergistic effect itself. Furthermore, since the Applicant himself referred to the examples and a claimed synergetic effect, it seems that this point requires clarification and analysis in the framework of the hearing. Thus one cannot conclude that the issue is moot in light of the exchange of statements of case.
The question remains if reference to the supplementary examples is not by way of response. As the Applicant emphasized, these materials were included in the prosecution file and therefore were presumably before the Opposer when the Statement of Case and the evidence submissions were written.
That said, examination of the Applicant’s statement of case does not testify as to which specific examples were considered, and if they limited themselves to examples specified in the application or if they widened their case to include the examples within the prosecution file that were before the Examiner.
To the extent that the alleged synergy effect relates to the supplementary examples, the Opposer reasoned that the Applicant cannot give these much weight in the framework of their evidence. With respect to the supplementary examples, the Opposer stresses that the results were submitted in the evidence stage only, and reference to these in the statement of case itself was merely in a general manner. The Opposer explains that since it was not clear if the supplementary examples, that are not within the application itself, but were only submitted during the examination, would be referred to in the opposition proceedings, they did not relate to them prior to the Applicant introducing them in Professor Weizmann’s Opinion. Consequently, the Opposer claims that relating to these examples in the evidence stage is essentially by way of response.
The nature of evidence submitted in response is defined in Regulation 62:
The opposer is allowed, within three months from when evidence is submitted on behalf of the Applicant, as per regulation 59(b) or regulation 61, to submit counter-evidence that relates to the facts specifically denied by the Applicant in his evidence or to issues first raised in that evidence.
The criterion relevant to our case is the question of facts first raised in the Applicant’s submission of evidence.
The Opposer cannot grab the rope from both ends. The Opposition is a continuation of and a part of the Examination process. See Civil Appeal Shechter vs. Abmatz ltd, p.d. 44(2) 846 and Appeal 665/84 Sanofi vs. Unipharm p.d. 41(4) 729. The material within the prosecution file is available to the parties. Nevertheless, during the opposition procedure, by virtue of the issues raised during the proceedings, the parties are required to identify the material to be discussed in the hearing. Since even from the Opposer’s perspective, the supplementary examples were available in the file wrapper, one cannot relate to this evidence as facts first brought up in the Applicant’s submission of evidence. Since these are supplementary examples, one cannot consider them as evidence suddenly presented for the first time in the Applicant’s submission of evidence.
Nevertheless, in light of the discussion of the synergistic effect in examples 3 and 9, and in view of the not insignificant reference to the supplementary examples by Professor Weizmann in his expert opinion, one cannot consider the supplementary examples irrelevant. The synergetic effect as discussed by Professor Harrison is not a widening of the statement of case.
In several instances the case-law has concluded that the rules of submitting evidence before the Commissioner of Patents are more flexible than the rules governing the submission of evidence to the court. See for examples Appeal 5041/13 Einat Gabai vs. Aminach Furniture and Mattress Industries Ltd, 21 January 2014, where the court discussed the period for submitting evidence and concluded that in legal proceedings before the Patent Office, the test for accepting evidence are more flexible (see paragraph 4 of Judge Hendel’s ruling). The District Court recently reached a similar conclusion in 34039-01-14 Mifalei P.M.S. Migun Ltd cs DSM IP Assets B.V. (12 August 2014) where the court allowed new evidence to be filed during the Appeal as the desire to reach the truth and fair justice was considered over-riding the procedural issues. in that instance, the Court concluded that patents, as opposed to civil law, the rules for allowing new evidence to be submitted were even more flexible. See also 5307-10-14 Orbotech Ltd vs. Camtek Ltd, 8 December 2015.
It appears that in this instance, where the material is anyway in the prosecution file, there is room to be flexible and to allow the parties to contribute to the public interests of the register being correct (i.e. allowing or disallowing patents on the basis of the evidence, not on procedural reasons preventing relevant evidence from being submitted) and further in the interest of efficiency (see Appeal 217/86 Schechter vs. Ambatz ltd. p.d. 44(2) 846, 857) by allowing the additional examples to be considered.
in light of the above, Professor Harrison’s second opinion as submitted in response to the Applicant’s evidence is allowed to remain in the opposition proceeding file as it was originally submitted, and the Applicant is given 30 days to submit short evidence relating to the supplementary examples as discussed in the paragraphs whose deletion was sought – paragraphs 78-84 and 86 of the opinion.
Costs for this interim ruling will be awarded as part of the main ruling.
Asa Kling: intermediate ruling re submission of evidence in Opposition to IL 169358 to Otsuka, 10 July 2016.