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

Teva Gyogyszergyar Rt. v. Tohri & Company Ltd., Case No. 2011 (Ne) 10057 (Decision rendered on August 9, 2012)

The Patentee, Teva filed an infringement suit against Tohri on the basis of a patent relating to a pharmaceutical compound, which was defined by a so-called "product-by-process" claim in 2008, but Teva's complaints were dismissed by the Tokyo District Court in 2011. Teva appealed against the decision before the IPHC in 2011.

Claim 1 of the patent in issue claims as follows:

"Pravastatin sodium prepared by a process comprising the steps of:
  a) forming an enriched organic solution of pravastatin,
  b) precipitating pravastatin as its ammonium salt,
  c) purifying the ammonium salt by recrystallization,
  d) transposing the ammonium salt to pravastatin sodium, and
  e) isolating the ammonium salt to pravastatin sodium;
wherein the amount of pravastatin lactone* is less than 0.5 wt.% and
the amount of epiprava* is less than 0.2 wt.%".
(Pravastatin sodium: a drug for reducing cholesterol in blood. *: Impurities)

The main issue in this case was how the scope of a product-by-process claim should be construed in determining the patentability. The IPHC answered to the issue as follows.
Under the Japanese Patent Law, the court may examine the invalidity of the patent in the infringement litigation, and if the court recognizes that the patent should be invalidated, then the court may decide that the patent is unenforceable against the adverse party.
In the present case, the IPHC examined the invalidity of the patent at issue and presented with a principle of the construction of a product-by-process claim. Namely, (i) when there was any "special reason" for being impossible or considerably difficult to directly define a product by its structure or properties at the time of filing the application and thus having no other way but to define the product by a process, the scope of the invention should be construed as to cover any product regardless of the limitation by the claimed process, while (ii) when there was no such "special reason", the scope of the invention should be construed as to cover only the product produced by the claimed process. On the basis of this principle, the IPHC found that there was no such special reason in the invention at issue, and thus the scope of the invention should be construed as to be limited to the product produced by the claimed process. Nevertheless, the IPHC decided that the invention at issue did not involve the inventive step over the prior art in view of the common technical knowledge.
Conclusively, the IPHC dismissed Teva's appeal and upheld the decision by the Tokyo District Court.

An appeal to the Supreme Court was filed against this decision, and thus the decision has not been conclusively affirmed.

This decision follows the leading case law made by the Grand Panel** of the IPHC on January 27, 2012. In that case, the Grand Panel decided that there was no special reason as stated above and thus the product-by-process claim in issue should have been construed as to cover only the product produced by the claimed process, but that the process at issue did not employ one step provided in the claimed process and thus the accused product did not infringe the patent.
**: Grand Panel is an ad hoc special division of the IPHC which is formed to hear and decide the cases involving a complex and controversial legal issue and/or having a huge impact on business or society, which is somewhat similar to en banc of CAFC in the U.S.A.

Pfizer Products Inc. v. Commissioner of JPO, Case No. 2011 (Gyo-Ke) 10352 (Decision rendered on August 28, 2012)

The Applicant, Pfizer, filed a patent application relating to a method of treating or preventing a disease in 2002, 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, Pfizer filed a cancellation action before the IPHC in 2011.

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

"A method of treating or preventing a disease or disorder in an animal other than human caused by infection with Mycoplasma hyopneumoniae comprising administering to the animal at from 3 to 10 days of age, an effective amount of a single dose of an inactivated Mycoplasma hyopneumoniae vaccine".

One of the main issues in this case was how a general description of the prior art reference (p.a.r.) should be interpreted. The IPHC answered to the issue as follows.

The IPHC found (i) that the p.a.r. stated that "(t)his invention also provides a method of immunizing a swine against infection by Mycoplasma hyopneumoniae comprising administering to the swine at least one dose of the bacterin so as to immunize the swine against Mycoplasma hyopneumoniae infection" as a general description, and (ii) that there was a preferable working example where the inactivated vaccine was administered twice, while there was no working example where the inactivated vaccine was administered only once.
On the basis of these findings, the IPHC decided (i) that the general description should have been interpreted as to include a method of immunizing a swine by administering to the swine one dose of the bacterin, and (ii) that the p.a.r. should not have been interpreted as disclosing only a method applying two doses even though there was only a preferable working example of a method administering two doses.

In this connection, during the court proceedings, the Applicant asserted that the preferable working example demonstrated that the antibody titer acquired by the first dose of the vaccine was very low, and thus it taught that multiple dose was required. However, the IPHC rejected the Applicant's assertion by pointing out that the working example was not sufficient grounds for denying a method applying single dose.

Conclusively, the IPHC dismissed Pfizer's appeal and upheld the JPO's decision.

The period for appeal to the Supreme Court has not expired as of September 28, and thus the decision is not final and binding.

This decision confirms the JPO's current practice of the interpretation of the p.a.r. Namely, even if any specific working example is not demonstrated in the specification, the general description of the p.a.r. may be interpreted as to include such an example in principle.