In Japan, inventions related to medical treatments are excluded from the scope of patentable inventions for bioethical reasons, etc. However, reflecting on the lumbering pace of R&D for pharmaceuticals composed of new compounds, industry is demanding a broader scope of protection via patent rights for approved drugs if those drugs bring about improvements in dosage and administration and have enhanced pharmacological effects and drug safety. In November 2004, a specialized investigative committee of the Intellectual Property Strategy Headquarters, a governmental organization set up by the Cabinet in accordance with Article 24 of the Intellectual Property Basic Act, discussed measures for obtaining patent protection for medical treatments. The committee contended that a medicine with a specific dosage and administration should be identified as an invention of a product and be protected by a patent right in order to provide incentives to develop new drugs related to their dosage and administration. In response, the Japanese Patent Office (JPO) revised the Examination Guidelines: medical inventions which specify a use including its dosage and administration and a combination of pharmaceuticals composed of two or more drugs are newly regarded as an “invention of a product”.
In recent years, the Courts handed down two decisions on patent rights related to a combination of two or more medicines regarding whether the act of manufacturing and selling these drugs separately does not constitute indirect infringement of a patented invention, which is set forth in Article 101, Number 2 of the Japanese Patent Law.
Court: Osaka District Court
Case Number: 2011(wa)-7576 and 7578
Plaintiff: Takeda Pharmaceuticals
Defendant: Sawai Pharmaceuticals, and seven other companies
Judgment Date: September 27, 2012
Court: Tokyo District Court
Case Number: 2011(wa) 19435 and 19436
Plaintiff: Takeda Pharmaceuticals
Defendant: Nissin Pharmaceutical, and nine other pharmaceutical companies
Judgment Date: February 28, 2013
In this article, we introduce the above two court cases regarding “drugs produced through combination” for a pioglitazone preparation, providing an analysis from a judicial perspective and taken in light of patent examination practice for “drugs produced through combination” claims.
Overview of the court cases regarding "drugs produced through combination" for a pioglitazone preparation
The drug, “pioglitazone”, is publicly known as a therapeutic and preventive medicine for diabetes. The plaintiff owns the patent right of a drug produced through combination of “pioglitazone” and other drugs, which are also publicly known as therapeutic and preventive medicines for diabetes such as alpha-glucosidase inhibitor (Japanese Patent Nos. 3148973 and 3973280). The plaintiff claims that the act of manufacturing and selling of the defendants’ products containing “pioglitazone” is regarded as direct or indirect infringement. The plaintiff filed a request for injunction against the manufacturing and selling of the defendants’ respective products, and sought disposal of the products and compensation for damages.
Claim 1 of Japanese Patent No. 3148973
Pharmaceutical composition for treatment and prophylaxis of diabetes and diabetic complications which combines (1) pioglitazone or its pharmacologically acceptable salt and (2) an α-glucosidase inhibitor such as acarbose, voglibose, and miglitol.
Claim 1 of Japanese Patent Number 3973280
Pharmaceutical composition for treatment and prophylaxis of diabetes and diabetic complications which combines pioglitazone or its pharmacologically acceptable salt and biguanide agents.
The plaintiff manufactures and sells pioglitazone hydrochloride (product name: Actos®) as a drug for treatment and prophylaxis of diabetes. After expiration of the patent term of the plaintiff’s basic patent right related to a pharmaceutical composition containing pioglitazone as an active ingredient , the defendants obtained manufacturing approval for generic medicines of pioglitazone.
This article mainly focuses on whether the defendants’ acts of manufacturing and selling pioglitazone preparation are regarded as indirect infringement as stipulated in Japanese Patent Law, Article 101-2*.
* Japanese Patent Law, Article 101-2
The following acts shall be deemed to constitute infringement of a patent right or an exclusive license:
(ii) where a patent has been granted for an invention of a product, acts of producing, assigning, etc., importing or offering for assignment, etc. any product (excluding those widely distributed within Japan) to be used for the producing of the said product and indispensable for the resolution of the problem by the said invention as a business, knowing that the said invention is a patented invention and the said product is used for the working of the invention;
Although the plaintiff also claimed direct infringement in both cases arguing that the defendants worked the invention by controlling, using, or inducing the acts of medical experts (doctors and pharmacists) and patients, the Courts ruled that the defendants cannot be said to have used the medical experts as a mere tool, that inducement itself is not regarded as an act of infringement, and that there is no evidence to find that the act of inducement itself actually occurred.
"A product to be used for producing the said product"
The Osaka District Court had deliberated whether a pioglitazone preparation, which the defendants manufacture and sell, falls under the concept of “a product to be used for producing the said product” of the patented invention (the Patent) related to prophylaxis and treatment agents for diabetes and diabetic complications. The plaintiff asserted that the Patent includes a “drug produced through combination” of “pioglitazone or its pharmacologically acceptable salt” and the concomitant drug of the Patent. In addition, the plaintiff also asserted that the act of prescribing “pioglitazone or its pharmacologically acceptable salt” and the concomitant drug for the combined therapy by a doctor falls under the concept of “production of a product” of the Patent.
However, the Court affirmed that a "drug produced through combination" should be regarded as a “newly developed product which combines two or more active ingredients”, and ruled that merely using drugs together does not fall under the concept of production of a new product. In addition, if the technical scope of the patented invention includes merely using multiple drugs together, it cannot be regarded as an invention of a product but can be regarded as an invention of a medical method. However, the aforementioned patented invention is not an “invention of a medical method” but an “invention of a product”. Thus, the Court dismissed the plaintiff’s assertion that the Patent is related to combined therapy.
A product "indispensable for the resolution of the problem by the said invention"
The Tokyo District Court had deliberated whether the pioglitazone preparation manufactured and sold by the defendants is regarded as “indispensable for the resolution of the problem” of the plaintiff’s Patent.
The plaintiff asserted that pioglitazone is a distinctive ingredient characterized by the means for resolving the problem in question and is indispensable to resolve the problems to be solved by the patented invention because only pioglitazone can provide the distinctive technical means for resolving the problem which is the combination of pioglitazone and the concomitant drug which is not seen in the prior art, and pioglitazone cannot be replaced with another active ingredient.
However, the Tokyo District Court handed down a judgment stating that, in an invention related to a combination of existing medicines like in the patented invention, an existing constituent element cannot be recognized as “indispensable for the resolution of the problem by the invention” because the existing constituent element itself had been needed, irrespective of the problems to be solved by the patented invention unless there are specific circumstances, for example, in which the existing constituent element is manufactured and sold for the patented invention. In addition, considering the above circumstances, the Court indicated in this judgment that the contents of the medical package insert of the pioglitazone preparation made by the defendants cannot serve as evidence that the defendants manufactured and sold the relevant pioglitazone preparation for the patented invention for the following reasons.
- The package inserts describe that the pioglitazone preparation is potent and effective for Type 2 diabetic patients who could not sufficiently benefit from medical treatment by α-glucosidase inhibitor or biguanide agents and thus are assumed to have insulin resistance.
- The package inserts explain about dosage, dose frequency, timing of dose, and precautions for Type 2 diabetic patients.
- The package inserts do not describe recommendations of combined administration with each of the concomitant drugs or that the defendants’ products are for combination with each of the concomitant drugs.
- Even if a patented invention has a distinctive technical feature in the combination of drugs A and B, any invention related to a “medicine which is a combination of each concomitant drug A and B” is literally regarded as an invention of a product, i.e., a “medicine that is physically used together with A and B”; thus, the “act of concomitant administration of A and B” is not included in the technical scope of the Patent.
- In principle, the act of manufacturing and selling either concomitant drug A or B is not regarded as direct or indirect infringement of the Patent.
- If there are special circumstances, for example, if it is evident, from a package insert or sales form, that concomitant drug A manufactured and sold separately is for concomitant administration with concomitant drug B, then the act of manufacturing and selling the drug A is regarded as indirect infringement of the Patent.
Although judgments for both court cases were handed down within the District Courts, it is worthy to note that the Tokyo District Court and Osaka District Court came to a similar conclusion and these judgments represent the judicial perspective toward patent examination practice regarding “combined medicines”. The JPO revised the Examination Guidelines for medical inventions in order to provide patent protection for inventions whose technical features are combined administration of drug A and drug B. However, due to the fact that the Japanese Patent Law has not yet been revised, the judicial interpretation regards the scope of the patent right as literally a “product claim”. Considering judicial independence, it is rare to say that the judicial view of an invention related to a “drug produced through combination” has not changed and, therefore, a revision to the Japanese Patent Law will be required to the effect that a pharmaceutical composition whose technical feature is a combined therapy is effectively protected.
Under the current situation, if any invention constituting a technical feature of “combined administration of drug A with drug B” is protected, the claims should add the description “drug A which is administered together with drug B” to a “pharmaceutical composition which combines drug A and drug B”. If the patent had had the following claim in both court cases, then a ruling of direct or indirect infringement would have been made with regard to the defendants' manufacturing and selling of the pioglitazone preparation which is administered together with an α-glucosidase inhibitor and biguanide agents. The plaintiff would have been entitled to an injunction for describing the combined administration with α-glucosidase inhibitor or with biguanide agents on the package inserts of the defendants’ pioglitazone drug.
Pharmaceutical composition for treatment and prophylaxis of diabetes and diabetic complications which contains pioglitazone hydrochloride or its pharmacologically acceptable salt as active ingredients and which is administrated together with an α-glucosidase inhibitor, such as acarbose, voglibose, and miglitol, or biguanide agents.