Patent Protection for Medical Uses and Relevant Judicial Practice in China
(Author: Ms. Duan Xiaoling; Source: WAN HUI DA)
The Supreme People’s Court (hereinafter refers to as SPC) recently announced “2013 Top Ten Innovative Intellectual Property Cases of Chinese Court”. Among these exemplary cases, the retrial case applied by the Cubist Pharmaceuticals, Inc. (hereinafter refers to as Cubist) before the SPC is very representative in the field of patent protection for medical use inventions. This retrial case relates to the administrative disputes arising from the Invalidation Decision made on Cubist’s patent by the Patent Reexamination Board (hereinafter refers to as PRB) of the State Intellectual Property Office (SIPO).
In judicial practice of the Chinese Patent Law, the retrial case of Cubist is for the first time that the SPC has stated its opinion concerning the question of using administration features to define medical use claims. In addition, as the importance of the case, the corresponding invalidation case has been selected by SIPO as “2013 Top Ten Cases of the Patent Reexamination Board”.
This article will provide review and analysis on the patent protection for medical use inventions, especially by way of administration features, as well as explain the recent judicial practice in China on the basis of the above-mentioned exemplary case and the related court case.
1、General Situation of Patent Protection for Medical Uses
Medical use inventions can be protected by the Chinese Patent Law, however, no patent right shall be granted for “methods for the diagnosis or for the treatment of diseases” as provided for in Article 25 of the Chinese Patent Law. Therefore, application for patent protection of medical use claims cannot be based on claims such as “for the treatment of diseases”, “for the diagnosis of diseases” or “use as a medicament”. The claim structure allowed to be used for protection can be in the form of method for preparing a pharmaceutical, i.e. “Swiss-type” claims as generally referred to, expressing as “use of substance X for the manufacture of a medicament for the treatment of a disease” or the like. In practice, Swiss-type claims are more often used in the invention for the second medical use of a known substance. There have been extensive discussions in the field for a long time on what technical features can be included in the Swiss-type claims. Especially there have been different opinions on whether administration features, such as dosage, mode of administration and so on, can be used as technical features for this type of claims.
2、Review of the Prior Case in 2008 (Administrative Dispute of Merck & Co. Inc. on Patent Invalidation)
Merck & Co. Inc. (hereinafter refers to as Merck) applied for an invention patent titled “METHOD OF TREATING ANDROGENIC ALOPECIA WITH 5-ALPHA REDUCTASE INHIBITORS
” with SIPO on 11 October 1994, for which a patent right was granted on 25 December 2002 with the Patent No. 94194471.9. There are 21 claims in total in the announcement of grant, where the independent claim 1 is for the protection of medical use expressing as a Swiss-type claim:
“1. Use of 17β-(N-tert-butyl-carbamoyl)-4-aza-5α-androst-l-ene-3-one for the manufacturing of a medicament suitable for oral administration for the treatment of androgenic alopecia, wherein the medicament includes 17β-(N-tert-butyl-carbamoyl)-4-aza-5α-androst-l-ene-3-one with the dosage from about 0.05 to 3.0 mg.”
On 18 June 2004, the petitioner of Topfond Pharmaceutical Co. filed a request for invalidating the Merck’s patent with PRB based on different grounds including Art. 22 of the Chinese Patent Law with submission of the prior arts as evidence. The focus is made on analyzing how to determine the technical features of the medical use claim 1.
(1) Opinions of the PRB
The PRB held: when compared with the prior art, there are two distinguishing features: 1) the dosage is from about 0.05 to 3.0 mg; 2) oral administration. Use of a substance in preparing a pharmaceutical is in fact equivalent with the manufacturing method of a pharmaceutical, the features with direct definitive effect can only be the ones such as the raw materials, manufacture procedures and conditions, morphology or composition of a pharmaceutical, “administration” is the next step after the completion of the manufacturing of a pharmaceutical, and is not a feature for preparing a pharmaceutical. These two distinguishing features are both “administration” features, and normally cannot define this type of claims, however, if a specific administration procedure does objectively induce certain requests with the preparation of a pharmaceutical, in which case it can be deemed as a technical feature for preparing a pharmaceutical. On this basis, the PRB held that feature 1) of the dosage could not define claim 1, and it would be deemed to be non-existent in the evaluation of novelty and inventiveness; feature 2) of oral administration could define the pharmaceutical product to some extent, and might enable claim 1 to have a different feature and thus possess novelty.
(2) Opinions of Beijing No. 1 Intermediate People’s Court
Beijing No. 1 Intermediate People’s Court supported the conclusion of the PRB with basically the same opinions, and in addition held that the dosage of a pharmaceutical is a technical feature for treatment of diseases only. The invalidation decision of the PRB was upheld.
(3) Opinions of Beijing Higher People’s Court
Beijing Higher People’s Court agreed with neither the opinion of the PRB that “administration feature itself can not define the technical solution of a method for preparing a pharmaceutical”, nor the Merck’s opinion that “use of a substance in preparing a pharmaceutical is different from method for manufacturing a pharmaceutical”.
Beijing Higher People’s Court held: medical use invention is substantially a method of application of a pharmaceutical. Features on how to apply a pharmaceutical, i.e. “administration features” such as dosage form and dosage, can be included in such claims as features of application method of a compound, manufacture of a pharmaceutical is not the same as manufacture of active ingredient or raw pharmaceutical materials, and may include all the procedures before a pharmaceutical product leaves the factory, which of course includes “administration features”. The Merck’s patent is a medical use invention patent applied with regards to the improvement of dosage. Excluding “administration features” from consideration is not only detrimental to the development of pharmaceutical industry and the needs of public health, but also not in conformity with the principles of the Chinese Patent Law. In addition, Beijing Higher People’s Court also held that including features such as dosage form and dosage in the claims of medical use invention would not restrict the freedom of doctors in terms of treatments.
Obviously, there are major differences between Beijing Higher People’s Court and Beijing No. 1 Intermediate People’s Court or the PRB with regards to the administration features included in the Swiss-type claims. Beijing Higher People’s Court intended to have a broad explanation as for the administration features of the medical use claims, however, to this specific case, after consideration of the aforesaid features, the Merck’s patent was still evaluated as lacking an inventiveness as compared with the prior art. Therefore the appeal was rejected, and the previous decision was upheld.
3、Latest Exemplary Case of the SPC (Administrative Dispute of Cubist on Patent Invalidation)
Cubist applied for an invention patent titled “METHODS FOR ADMINISTRATION OF ANTIBIOTICS” with SIPO on 24 September 1999, for which a patent right was granted on 19 May 2004 with the Patent No. 99812498.2. There are 15 claims in total in the announcement of grant (the patentee deleted claim 9 during the invalidation procedure), where the independent claim 1 is for the protection of medical use expressing as a Swiss-type claim:
“1. Use of daptomycin for the manufacturing of a medicament that does not result in skeletal muscle toxicity for treating a bacterial infection in a patient in need thereof, wherein the dosage for said treatment is 3 to 75 mg/kg of daptomycin, wherein said dosage is administrated repeatedly, wherein said dosage interval is once every 24 hours to once every 48 hours.”
The rest of the claims are dependent claims, further restricting claim 1 with dosage, administration cycle and combination of drugs.
On 4 June 2008, the petitioner Hong XIAO filed a request for invalidation of the Cubist’s patent with PRB and submitted the prior arts for challenging its novelty and inventiveness. The prior arts disclosed the medical treatment of multiple gram-positive infections by using daptomycin, but with different dosage and time interval as compared with the above claim 1. In addition, combination of drugs was disclosed. The focus of the invalidation examination is put on the following three aspects:
a) Whether the features of administration dosage and mode of administration in claim 1 can define the relevant use of daptomycin in preparing a pharmaceutical in the concerning claims (or “Swiss type” claims)
b) Whether the feature of not resulting in skeletal muscle toxicity in claim 1 can define the relevant use of daptomycin in preparing a pharmaceutical in the concerning claims
c) The evaluation of the novelty and inventiveness of the use of daptomycin in preparing a pharmaceutical…
(1) Opinions of the PRB
It is well known in the art that features of administration dosage, repeated administration and administration interval are the measures selected and determined by doctor according to the patient during the process of treatment, the said measures belong to the administration process and is irrelevant with the preparation of a pharmaceutical. For example, preparation with the same drug content can be administrated with different dosage or at different interval, while preparation with different drug content can be administrated with the same dosage, hence features of administration dosage, repeated administration and administration interval cannot define a pharmaceutical itself;
There is no evidence to demonstrate that, the further understanding of the absence of the side effect of skeletal muscle toxicity when using daptomycin can distinguish the use in pharmaceutical preparation of claim 1 from the known use in pharmaceutical preparation as disclosed in the prior art.
All claims of the Cubist’s patent do not possess novelty or inventiveness, and the whole patent is invalidated.
(2) Opinions of Beijing No. 1 Intermediate People’s Court and Beijing Higher People’s Court
The opinions of the PRB were supported by both instances, and the previous decision was upheld. In Cubist’s case (five years after Merck’s case), the opinion of the Beijing Higher People’s Court has been changed regarding the administration features of the medical use claim.
(3) Opinions of the SPC
Cubist refused to accept the administrative judgment GXZZ No. 547 (2010) of Beijing Higher People’s Court and filed a request for retrial with the SPC. However, the SPC made the administrative order on 19 November 2013, which rejected the Cubist’s retrial, and the SPC held the following:
a) The medical use claim for preparing a pharmaceutical or the “Swiss type” claim is to restrain the manufacturing act of the manufacturer of a pharmaceutical product, hence, the technical features should still be evaluated from the angle of a method claim, and features that normally have direct definitive effects are raw materials, manufacturing procedures and conditions, morphology or composition of a pharmaceutical, apparatus, etc. As for the features only concerning with application method of a pharmaceutical, such as administration dosage and interval, if there are no direct interrelations between them and the method for preparing a pharmaceutical, these features substantially belong to a specific administration method of applying a pharmaceutical to human body, after obtaining the pharmaceutical with the implementation of the preparation method, with no direct or definite interrelations with the preparation method. This type of features, embodied only during administration of a pharmaceutical, shall not be the technical features for use in pharmaceutical preparation, and cannot define the pharmaceutical preparation method itself as claimed in the medical use claim 1.
b) The feature “Does not result in skeletal muscle toxicity” is not a symptom of a patient before the application of daptomycin, but a result of the change in certain body indexes of a patient after the application of daptomycin, indicating whether the pharmaceutical itself has toxic or side effect. For example, daptomycin is aimed at bacterial infection no matter the application of which does or does not result in skeletal muscle toxicity. As far as the use of daptomycin itself is concerned, the toxicity does not make such a use being different. Therefore, this feature in claim 1 does not distinguish its use from the known use as disclosed in the prior art, and cannot define the pharmaceutical use itself, as well as having no definitive effect of claim 1.
c) The SPC supports the analysis and conclusion made by the PRB, the first and second instances concerning the lack of novelty or inventiveness of the claims.
(4) Other relevant questions in the Administrative Oder by the SPC
a) Applicable version of the Guidelines for Patent Examination
The filing date of the Cubist’s patent is 24 September 1999 and the date for announcement of grant is 19 May 2004. The SPC did not offer clear explanation as to the applicable version of the Guidelines for Patent Examination in the concerning invalidation and administrative litigation cases. When evaluating novelty of claim 1, the SPC circumvented prudently the applicable version of Guidelines for Patent Examination, holding that there are no conflicts or contradictions as the factors needed to be considered and the principle upheld in the evaluation of novelty have been consistent for years in patent practice. Therefore, the court, on the basis of the type and the content of the claims and directly with application of the novelty provision of Art. 22 Para. 2 in the Chinese Patent Law (1992 version), made analysis of the technical solution of the patented claim 1 and determined whether there were distinguishing features when compared with the prior art.
b) Submission of new evidence by the Cubist during retrial
When filing the application for retrial with the SPC, Cubist submitted 18 supplementary evidences, 13 evidences of which were already formed before the end of the trial for the second instance. Cubist did not provide evidence (such as due to objective reasons) to prove that these evidences could not be provided during the second instance, however, the SPC accepted all of them, holding that “as the whole patent has been declared to be invalid and the said supplementary evidences submitted by Cubist are used to prove novelty and inventiveness of the concerning patent, if these supplementary evidences could be indeed used to overturn the previous determination on novelty and inventiveness in the decisions made by PRB as well as the first and the second instances, but would be rejected merely on the basis of the timing factor of submitting the evidence, Cubist would lose the final relief opportunity with regards to its patent right, such a result would be obviously unfair to the patentee”.
c) Business success
The SPC held that business success of the invention is a factor that should be considered during the evaluation of inventiveness; however, such success should directly result from the features of the invention, which is consistent with the relevant provisions in the Guidelines for Patent Examination.
4、 Influence and Trend of Patent Protection for Medical Uses and Judicial Practice
It can be seen from the above two cases concerning patents for medical use, though in Merck’s case, there were discrepancies among PRB, Beijing No. 1 Intermediate People’s Court and Beijing Higher People’s Court with regards to which features could define such Swiss-type claims. However, it seems become relatively unified opinions in the different level of courts in the Cubist’s case. Further, due to the authoritative position of the SPC in the judicial system, its opinions in the latest order for the retrial case of Cubist would be regarded by the lower courts as strongly instructive, though China does not apply case law system
(1) The SPC clearly states that a medical use claim expressing as Swiss-type belongs to a method claim, features of dosage, interval and side effect of a pharmaceutical cannot define such a use claim, and hence these features cannot be used in evaluation of whether the medical use possesses novelty and inventiveness. Further, the feature of toxicity or side effect is not considered as being definitive to the medical use claim.
The above clarification represents a relatively strict interpretation with regards to the use claims for preparing a pharmaceutical (or Swiss-type claims). In other words, in the future, it would be rather difficult for such a medical use invention to be protected if the distinguishing features only focus on the administration features and/or reduction of side effects or the like.
(2) The SPC did not, however, make any comments as to whether specific mode of administration (such as oral, subcutaneous or intravenous) could define a medical use claim (of Swiss-type) or not. In the above mentioned Merck’s case, both PRB and Beijing Higher People’s Court held that the mode of administration (relating to oral administration) could define the medical use claims and could be used in the determination of their novelty an inventiveness. Therefore, it would be possible for seeking patent protection of medical uses by way of such features.
(3) It can be seen from the retrial order of the SPC that, actually used evaluation standards with regards to the medical use claim and the novelty of the medical use invention are substantially consistent with the ones in version 2006 and version 2010 of the Guidelines for Patent Examination. Therefore, the relevant retrial conclusion of the Cubist’s case would be applicable to patent applications/patents filed before 2006.
(4) The SPC inclines to put more emphasis on the substantive contents when considering the evidences submitted by the applicant in the retrial case of Cubist, and has accepted all the evidences submitted by Cubist. Therefore in the future, for applying for a retrial case, the applicant should always try its best to submit evidences that could possibly overturn previous decisions for the SPC’s review, no matter they might be formed before or after the trial for the second instance.