Methods for the diagnosis or treatment of diseases are subject matters excluded from patentability in all nations except a few countries such as the US. In most nations and regions such as Europe, Japan and China, however, protection has been made available for new medical or pharmaceutical uses of known compounds/compositions if presented in a Swiss-type claim. This has also been expanded to protect new dosage regimens of known medicaments in Europe.

In response to such an expansion, the Chinese Patent Office (CPO) takes a very conservative position. For example, in its office actions, the CPO typically comments as the following: "A daily dose of 10mg and oral dosing are both an administration feature of a medicament. As a general rule, such a feature of administration per se does not serve as a definition of, or limitation on, a technical solution of any process/use for preparing the medicament".

Faced with comments like this, many patent applicants get confused. Superficially, such features are related to the prescription by a doctor and the dosing of the medicament for a patient. As such, are these features related to process/use for preparing the medicament? Or, what features do Swiss-type claims relate to?

The traditional format of a Swiss-type claim is: "use of substance X in the manufacture of a medicament for the treatment of condition Y." Literally, this claim presents or includes four features: substance X, medicament, the treatment of condition Y, and use.

The above features may be further interpreted as including the structural feature of a compound, such as the chemical name and the structural formula of the compound; the dosage form of the medicament, such as that for oral administration, intravenous injection, or external use; the plurality of specific diseases; and how the medicament is put to use.

As the practice of examination in China shows, use claims fall under the category of process claims – hence a Swiss-type claim is regarded as one of a process for the preparation of a medicament.

For a more enlightening discussion on the technical features of Swiss-type claims or processes for the preparation of a medicament, it is necessary to look into the whole process of the research, development, and manufacture of a new medicament. In general, the research and development (R&D) of a medicament includes six phases: (1) the discovery of the entity of a new compound; (2) preclinical research; (3) application for research and clinical trials of a new medicament; (4) clinical trial plus supplementation by preclinical research; (5) application for a new medicament; and (6) marketing and monitoring.

In the first phase, for example, the active compounds are synthesised based on one or more leading compounds, which have possibly been obtained by any of the following routes: extraction from animals or plants, modifications of existing active compounds, simulating targets by computer, or use of high-throughput screening thousands or even tens of thousands of known compounds, to name just a few.

In the second phase, tests on the effect of the compound are conducted, for example, on an in vitro cultured cell-line model followed by animal tests for testing the pharmacological, pharmacokinetic, and toxicological performances of the new compound, and then the initial route of administration, dosage, and dosage regimen are determined.

In the third phase, clinical research schemes are worked out or formulated, and the application for the clinical trial is filed with the authority for drug administration.

In the fourth phase, clinical trials are conducted in three phases named Phase I, Phase II and Phase III clinical trials.

The Phase I clinical trial is usually conducted on healthy volunteers for the fundamental purposes of observing possible resultant acute toxic side effects, identifying proper safe dosages, and making preliminary studies on the absorption, metabolism and eccrisis of the medicament in human body.

The Phase II clinical trial is made on patients for the fundamental purposes of observing whether the new medicament is therapeutically effective, further observing the safety, and optimising the prescription (dosage and dosage regimen).

The Phase III clinical trial is done also on patients for the fundamental purposes of identifying the therapeutic effects, safety of the medicament, and the suitable dosage and dosage regimen.

With the completion of Phase III clinical trial, a pharmaceutical company will file an application for marketing approval with the authority for drug administration, i.e., the State Food and Drug Administration (SFDA) of China. After the relevant medicament passes the examination of the SFDA, an approval will be granted for marketing said medicament, with a New Drug Certificate and Letter of Approval for Drug Registration issued for the new drug.

With regard to new uses of existing active compounds as medicaments, or changes of the administration regimen for the treatment of a disease (for example, changing the conventional regimen of three doses a day into a Sustained-release regimen of one dose a day, corresponding clinical trials and corresponding request for approval are needed.

Thus, for launching a new drug, as a special product, one has to undergo two phases: R&D and manufacture, with all the inventive work focusing on the former. In the process for manufacturing a medicament, the equipments and processes used are essentially known in the prior art. The steps in the process of manufacturing said medicament should proceed strictly in accordance with the Letter of Approval for Drug Registration, which, signed and issued by the SFDA, specifies the dosage form, dosage, quality specifications, package insert, and label of the medicament.

It should be understood that the package insert and label of the medicament including the contents thereon, such as indications to be treated and administration regimens, are all the essential and inseparable parts of the medicament. Besides, attaching them with, or placing them on, the medicine bottle should also be counted as a step in the process of manufacturing the medicament – in other words they pertain to the process for the preparation of the medicament.

As such, a Swiss-type claim should protect the inventive work done in the R&D phase in connection with the compounds used, the diseases to be treated, the selection of adjuvants, the administration regimen, the dosage, and the frequency of administration.

Recent changes to European patent law and practice make the Swiss-type claims in Europe less important.

In Europe, a Swiss-type claim based on a drug regimen was once deemed to be an improper Swiss-type format. Recently, however, things have changed quite remarkably. A recent decision issued by the Technical Board of Appeal of the European Patent Office legitimates that new routes of administration, administration regimes, or mechanisms of action may constitute possible features characterising second medical indications. According to this decision, novelty could arise from the disease to be treated, the selection of a group of patients, the administration mode, or dosage regimen applied.

European patents shall not be granted for methods for the treatment of a human or animal body by surgery or therapy, nor for diagnostic methods practiced on the human or animal body. However, any known substance or composition for use in such a method should not be excluded from patentability (see Article 53 of EPC). The amended Article 54(5) EPC effective as of December 13 2007 further specifies that any known substance or composition is patentable for any specific use in therapeutic methods, thus removing the legal uncertainty with regard to the patentability of further medical uses and allowing purpose-related product protection for each further medical use of a substance or composition already known as a medicine. Thus, "substance or composition X for use in the treatment of disease or condition Y" is now allowable in Europe and the protection of the format is tantamount to that of Swiss-type claims.

Under current practices of patent examination in China, although there is no controversy on the eligibility of the patent for the use of new compounds, or known compounds, in the manufacture of medicaments for treating new diseases; there is on that for the improvements of administration regimens of known compounds for the treatment of known diseases.

As a case in point, an application filed for a patent for the method of administration of IGF-1, related to the use of insulin-like growth factor-1 (IGF-1) in the treatment of diseases, such as heart failure, diabetes and renal failure.

Use of IGF-1 to treat such diseases was known prior to the filing date of said application. However, the prior art also showed that treatment with IGF-1 often led to undesirable side-effects, and that continuous IGF-1 treatment could render it ineffective. The application was therefore directed to an allegedly novel and nonobvious dosing regime, which was asserted by the applicant to maximize IGF-1 activity while minimising the side-effects, something achieved by administering IGF-1 intermittently.

Under the existing practice in China, it is difficult for such an application to be granted a patent right even though it indeed represents a technical improvement. However, it is the writer's opinion that preclusion of the invention from patentability would discourage people to make researches in this field, which would be detrimental to the advancement of technology and the health of the general public.

Nevertheless, in a very recent decision concerning invalidation, Beijing Higher People's Court takes a very flexible position over the dosage regimen featuring Swiss-type claims. In the decision, the court's judicial view showes that a claim drafted in the form "use of compound X in the manufacture of a medicament for the treatment of condition Y" is intended to overcome the problem resting with the form "compound X used in the treatment of condition Y" as a method for treatment of diseases is precluded from patentability under the patent law. What it virtually protects is tantamount to that of the format "a process for the manufacture of a medicament for the treatment of condition Y, characterized in that compound X is used". A technical feature relating to how a medicament is used – the so-called "feature of the administration of a medicament" like dosage form and dosage should fall under the category of technical features on the method for the use of compounds and thus be incorporated in the claims.

The court further indicates that, in practice, it remains necessary for making improvements of the so-called "features on the administration of the medicament", such as dosage form and dosage, to obtain unexpected technical effects. Besides, the manufacture of a medicament is not one of the active ingredients or the bulk drug. It should include all the working procedures prior to packing the same delivery from the plant, and it certainly also includes the so-called "features of the administration of the medicament" such as dosage form and dosage.

Given that the patentee has made an improvement on the dosage form and the dosage used, disregarding the so-called "features of the administration of the medicament" is detrimental to the development of the medical and pharmaceutical industry and the health of the general public, and, as well, contrary to the tenet of the Patent Law.

That is to say, contrary to the CPO, the court recognizes the features of the administration as features of the Swiss-type claims.

As to the opinion that recognizing administration features as features of the Swiss-type claims might make the doctor less free choose from the various methods and conditions in his diagnosis and treatment, the court take the position that, a claim of an invention relating to the medical and pharmaceutical use usually includes features of the medicament as a substance, features of the manufacture of the medicament, and features of the indications of the medicament, whereas the practice of treatment by a doctor merely relates to the technical features on how to use the medicament, irrelevant to the features of the manufacture of the medicament, and thus does not infringe the patent right. Hence the inclusion of technical features such as dosage form and dosage in a claim of an invention of the medical and pharmaceutical use does not limit the freedom of a doctor in his or her practice of treatment.

While China is not a case law country, it is believed that the above mentioned higher court's view shows the possible convergence of the practice of examination in China with the EPO's examination practice: in other words it is possible for a feature of the administration of the medicament to be deemed as a technical feature of the Swiss-type claims.

Incidentally, the specific explanation made in the Guidelines for Patent Examination concerning the new matter issue requires that any amendment should be recited in, or can be directly or unambiguously deduced from the initial disclosure.

Some Chinese examiners mechanically interpret this explanation, which results in different views on whether the amendment made to present a method for the treatment of diseases in the form of a Swiss-type claim relates to a new matter. Although most examiners hold such amendment compatible with the provision of Article 33 of the Patent Law, to avoid problems likely to arise in the subsequent procedures, it is advisable that the applicant incorporates Swiss-type claims in the initial description or claims when drafting the documents of a new application to be filed in China or a PCT application designating China.

Although CPO takes a rather conservative stance on the administration features, the Beijing Higher Court's judicial view mentioned above foreshows a new progress favorable to the patent applicants. Let's wait and see if CPO will adaptively change its attitude towards whether the administration features are acceptable as features of the Swiss-type claims. At least, when facing such an objection to the administration features, it is worthwhile to present convincing arguments to persuade the examiners. Hopefully the points of view outlined in this article can be of assistance in this regard.

Liantao Li

Liantao Li received his BS in Polymer Chemistry in 1986 and MS in Physical Chemistry in 1989 from Shandong University. After graduation, he worked as lecturer in Peking University Health Science Center and engaged in research work in synthesis of new drags. Liantao studied in Regensburg University of Germany for two years as part of a joint PhD programme and received his PhD in Pharmaceutical Chemistry from Peking University in 2001. Liantao joined CPA in 2001 and qualified as a patent attorney in 2002. He received further training in the European and German patent law and practice in Germany in 2005. Liantao is skillful in drafting patent application documents in such fields as polymer, pharmaceutical chemistry and organic chemistry, and experienced in preparing responses to office actions in the substantive examination proceedings, handling reexamination and invalidation cases, and dealing with relevant administrative litigation. Liantao speaks fluent German and is very good at dealing with patent cases in German. He is a member of All-China Patent Agents Association.

Tina H. Tai

Tina H. Tai received her BS in Applied Chemistry in 1990 and MS in Polymer Chemistry in 1993, both from Peking University. She joined CPA in 1993 and qualified as a patent attorney in 1994. Tina was admitted to practice law in 1999. She took the LLM program at the University of London from 2002 to 2003. She received further training at a famous company in Germany in 1997 and at other German and British law firms in 2001. She participated in the Research Project on the Third Amendment to the Chinese Patent Law in 2005. As a patent attorney, Tina has represented many of important Chinese and foreign clients in renowned invalidation cases and lawsuits. She represented Pfizer as the chief attorney in both invalidation proceedings and court procedure involving the "Viagra" case. Besides, she is skillful in drafting patent application documents in such fields of technology as polymer, pharmaceutical chemistry, organic chemistry, organic synthesis, and experienced in preparing responses to office actions in the substantive examination proceedings, in handling cases of patent reexamination, invalidation and patent-related administrative litigation and infringement lawsuits, and in making infringement analysis. Tina is a member of the board of All-China Patent Agents Association, and a member of the Chinese Group of AIPPI.