K&P's Intellectual Property High Court Decision Report in May, 2012

Sawai Pharmaceutical Co. Ltd. v. Warner-Lambert Company LLC, Case No. 2011 (Gyo-Ke) 10091 (Decision rendered on May 7, 2012)

The Patentee, Warner-Lambert, obtained a patent relating to a stable pharmaceutical composition for the peroral treatment of hypercholesterolemia or hyperlipidemia in 2001, against which Sawai filed an invalidation trial before the JPO in 2009. The JPO dismissed Sawai's demand in 2011, followed by Sawai's appeal against the JPO's decision to the IPHC in 2011.

Claim 1 of the patent in issue claims as follows:

"A pharmaceutical composition for the peroral treatment of hypercholesterolemia or hyperlipidemia characterized by improved stability comprising in a mixture, [R-(R*, R*)]-2-(4-fluorophenyl-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt as active ingredient and at least one stabilizing pharmaceutically acceptable basic metal salt additive". (The claimed acid is hereinafter referred to as "CI-981")

The main issue in this case was the inventive step over one's own prior art application, on which the IPHC decided as below.

Firstly, the IPHC found (1) that the difference between the present invention and the invention disclosed in prior art document 1 was that the former comprised CI-981, which was a ring-opened hydroxycarboxylic acid, while the latter comprised pravastatin, which was a ring-closed lactone of CI-981, and (2) that the JPO's decision was based on the premise that CI-981 hemicalcium salt was an advantageous compound compared to the lactone, and this was first discovered in the patent invention.
The IPHC reviewed the JPO's premise and found that prior art document 2, which was a Patentee's different patent application, disclosed (i) that both the lactone and the ring-opened acid were able to be used similarly for treating hypercholesterolemia, and (ii) that the acid was the most preferable embodiment, which were not substantially different from the disclosures of the specification of the present patent.  That is, the IPHC found that the specification of the present patent only abstractly showed that CI-981 hemicalcium salt was most preferable in a similar manner with prior art document 2, but it did not specifically show that CI-981 had any advantageous effect over the lactone.
On the basis of the above finding, the IPHC denied the JPO's premise.
Additionally, the Patentee argued that the instability of CI-981 hemicalcium salt could not have been known without experimentations, and that such a problem had been first revealed during the drug formulation of CI-981 hemicalcium salt and had not existed as a publicly known problem at the time of the priority date.  However, the IPHC rejected the Patentee's arguments by pointing out that there was no specific consideration in the specification as to how the claimed "stabilizing metal salt additive" acted to stabilize CI-981 and thus the Patentee's arguments were not supported by the disclosure of the specification.
Conclusively, the IPHC upheld Sawai's appeal and cancelled the JPO's decision.

An appeal to the Supreme Court was not filed against this decision, and thus the decision is now final and binding.

This decision teaches that we should pay a careful attention when asserting a new effect over one's own prior art applications since two or more applications belonging to the same applicant often have quite similar disclosures, and thus any specific distinction between them should be made in the specifications as filed in advance.

Yissum Research Development Company of The Hebrew University of Jerusalem v. Commissioner of JPO, Case No. 2010 (Gyo-Ke) 10203 (Decision rendered on May 28, 2012)

The Applicant, Yissum, filed a patent application relating to a vector for specific expression of heterologous genes in tumor cells and the like in 1998, but the application was finally rejected by the Appeal Board of JPO in 2010.  Against the JPO's decision, Yissum filed a cancellation action before the IPHC in 2010.

Claim 1 of the patent application in issue claims as follows:

"A vector for expressing a sequence in a tumor cell, the vector comprising a polynucleotide comprising an H19 regulatory sequence operably linked to a heterologous sequence encoding a cytoxic gene product, wherein the tumor cell is a bladder carcinoma cell or bladder carcinoma".

The main issues in this case were (A) the consideration of the general technical recognition of those skilled in the art, and (B) the acceptability of additional data showing the effect of the invention, on which the IPHC decided as below.

As to issue (A), the IPHC found on the basis of several scientific papers (1) that it had been the general technical recognition of those skilled in the art at the time of the priority date of the present application that no sufficient success had been achieved in spite of various trials of delivering exogenous genes into tumor (cancer) cells to destroy them, and (2) that desirable result had not been obtained in some cases due to the silencing notwithstanding the introduction of exogenous genes with the corresponding promoter and enhancer.
On the basis of the above findings, the IPHC found that although prior art document 3 disclosed the expression of H19 gene, there had been unsolved points as to whether the desirable result could have reached at the time of the priority date simply by applying prior art document 3 to prior art document 1, and thus it was doubtful that those skilled in the art could have easily conceived the present invention even if they had applied prior art document 3 to prior art document 1.

As to issue (B), the working example of the present application showed that "the bladder tumors in the experimental group of mice are reduced in size and necrotic as compared to the bladder tumors in the control group of mice", while it did not present any specific numerical data.  In this connection, the Applicant submitted additional several numerical data specifically showing the unexpected advantageous effect of the present invention during the court procedures.  The IPHC accepted them as data supplementing the result of the working example which were clearly within the effect disclosed in the specification.

Finally, the IPHC concluded that the present invention did not lack the inventive step on the basis of prior art document 1 in view of prior art document 3 and the like.  The IPHC cancelled the JPO's decision.

An appeal to the Supreme Court was not filed against this decision, and thus the decision is now final and binding.

This decision teaches (A) that it is important to adequately understand the technical level of those skilled in the art at the time of the priority date to determine the inventive step, and (B) that it would be effective to supplement additional data in order to support the inventive step when the specification only discloses the effect qualitatively.

In May 2012, the IPHC handed down 29 decisions including the above 2 cases on patent and utility model, and overturned the previous decisions in 5 cases.