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

Abiomed Europe GmbH v. Commissioner of JPO, Case No. 2011 (Gyo-Ke) 10364 (Decision rendered on June 13, 2012)

The Applicant, Impella Cardiotechnik AG, filed a patent application relating to an electric motor cooled by a fluid in 1999, but the application was finally rejected on the ground of not satisfying the enablement requirement by the Appeal Board of JPO in 2011. Impella assigned the application to Abiomed, which filed a cancellation action against the JPO's decision before the IPHC in 2011.

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

"A fluid-cooled electric motor with a motor housing made of polymer material and enclosing a stator, the length of the motor housing being at least twice the outer diameter of the motor housing, characterized in that a pump portion flowing a pump fluid along an outer surface of the electric motor housing is driven and the polymer material of the motor housing contains a thermally conductive, electrically insulating filler in an amount of at least 40% by weight to facilitate thermal diffusion from the stator to the pump fluid flowed along the motor housing".

One of the main issues in this case was whether or not a one-sided numerical limitation, i.e. "at least 40% by weight" satisfied the enablement requirement. The IPHC answered to the issue as follows.

During the court proceedings, the JPO asserted that the claimed motor could include the motor wherein the amount of the filler in the motor housing was nearly 100 wt.%, and that in such a case those skilled in the art could not easily produce the motor housing.
However, the IPHC did not accept the JPO's assertion by pointing out that it was clear that the claimed motor housing was a structural member, and it was an obvious premise that the claimed motor had enough strength for use, and thus that the JPO's premise of using the material containing nearly 100 wt.% of filler and a tiny amount of the polymer was used was unreasonable.

Conclusively, the IPHC upheld Abiomed'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 would teach that a one-sided numerical limitation, i.e. a numerical limitation having only the upper limit or the lower limit but not both, could satisfy the enablement requirement on the basis of the premise that the claimed one-sided numerical limitation should cover only the range wherein the claimed article is feasible even if the limitation could literally include an unfeasible range.

Dow Corning Toray Silicone Co., Ltd. v. Commissioner of JPO, Case No. 2011 (Gyo-Ke) 10316 (Decision rendered on June 26, 2012)

The Applicant, Dow Corning Toray Silicone (DCTS), filed a patent application relating to a method of manufacturing a semiconductor device in 2003, but the application was finally rejected on the ground of lacking inventive step by the Appeal Board of JPO in 2011. Against the JPO's decision, DCTS filed a cancellation action before the IPHC in 2011.

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

"A method of manufacturing a semiconductor device sealed in a cured silicone body by placing a semiconductor device into a mold and subjecting a curable silicone composition that fills the spaces between said mold and said semiconductor device to compression molding, wherein said curable silicone composition comprises at least the following components: (A) ... (omitted), (B) ... (omitted), (C) ... (omitted) and (D) ... (omitted). "

The main issue in this case was how a difference in the problem to be solved between the present invention and the cited inventions should be considered. The IPHC answered to the issue as follows.

First, the IPHC found that the problem to be solved by the present invention was to prevent semiconductor chips and printed-circuit boards from increasing warping when sealing the semiconductor device by a resin, while prior art document (p.a.d.) 1 had no disclosure about the problem of the present invention and the specific composition of sealing resin.
Further, the IPHC found that although both p.a.ds. 2 and 3 disclosed the same curable silicone composition as that of the present invention, (1) p.a.d. 2 only disclosed using the composition for fillers or adhesives for waterproofing LED displays, and (2) p.a.d. 3 only disclosed using the composition for covering the surface of semiconductor elements, which was made before sealing the semiconductor elements.
On the basis of the above findings, the IPHC decided (1) that those skilled in the art could not have easily conceived to use the composition disclosed in p.a.d. 2 as the sealing resin of the present invention by incorporating the content of p.a.d. 1 into that of p.a.d. 2 since there are differences in purpose and use between the sealing resin for semiconductor device and fillers and adhesives for LED displays; and (2) that those skilled in the art could not have easily applied the composition disclosed in p.a.d. 3 to the invention disclosed in p.a.d.1 since there is a difference in purpose between "covering" step and "sealing" step.

Conclusively, the IPHC upheld DCTS'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 is based on a so-called "problem-solution approach", which is generally adopted in the EPO. In Japan, some approaches have been adopted in determining inventive step, and the "problem-solution approach" is among them. The recent IPHC's decisions tend to place more emphasis on the "problem-solution approach". One of the leading cases is Hitachi v. Commissioner of JPO, Case No. 2008 (Gyo-Ke) 10096 (Decision rendered on January 28, 2009 by Judge Iimura, who is now the Chief Judge of the IPHC).

Genentech Inc. v. Commissioner of JPO, Case No. 2011 (Gyo-Ke) 10179 (Decision rendered on June 28, 2012)

The Applicant, Genentech, filed a patent application relating to a hVEGF antagonist for treating age-related macular degeneration (AMD) in 1996, but the application was finally rejected on the ground of not satisfying the enablement requirement and the support requirement by the Appeal Board of JPO in 2011. Against the JPO's decision, Genentech filed a cancellation action before the IPHC in 2011.

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

"A use of a hVEGF (human Vascular Endothelial cell Growth Factor) antagonist in the preparation of a medicament for the treatment of age-related macular degeneration".

The main issue in this case was whether or not the medical use invention in the case where no pharmacological data was demonstrated in the text of specification as filed satisfied the enablement requirement. The IPHC answered to the issue as follows.

First, the IPHC found that the specification of the present application disclosed no explanation directly showing that a hVEGF antagonist was therapeutically effective for age-related macular degeneration on the basis of the working examples and the like. Further, the IPHC found that the prior art document 9 showed that (i) not only a VEGF but also a FGF and a HGF had been known as the factors promoting angiogenesis, and that (ii) there had been still many unknown matters as to what kind of growth factor had been associated with angiogenesis under what kind of pathological conditions, although the mechanism of angiogenesis had been in the process of being discovered.
On the basis of the above findings, the IPHC decided that it had not been known or established as a common technical knowledge at the time of the priority date of the present application that the angiogenesis at choroid had been promoted by a VEGF, and thus it could not have been reasonably understood from the prior art document 9 that the angiogenesis at choroid could have been inhibited by inhibiting the action of a VEGF with a hVEGF antagonist.
In this connection, the Applicant asserted that those skilled in the art could have understood that a hVEGF antagonist could have been used for treating AMD on the ground that the specification read "(t)he exudative form of AMD is characterized by choroidal neovascularization and retinal pigment epithelial cell detachment. Because choloidal neovascularization is associated with a dramatic worsening in progress, the VEGF antagonists of the present invention are expected to be especially useful in reducing the severity of AMD".
However, the IPHC rejected the Applicant's assertion by pointing out that this description only meant that there had been a possibility that a VEGF antagonist could have been used for treating AMD, and it could not have been understood that this description clearly and sufficiently disclosed the effectiveness of a VEGF antagonist for treating AMD.
Conclusively, the IPHC dismissed the Applicant's appeal and upheld the JPO's decision.
The period for appeal to the Supreme Court has not expired as of July 30, 2012, and thus the decision is not final and binding.

This decision confirms that it is extremely difficult to obtain a patent on medical use invention without pharmacological data or their equivalent in the specification as filed although the enablement requirement is examined by taking into consideration not only the specific experimental data but also the whole disclosure of the specification and the common technical knowledge at the time of the priority date of the application.