Recently, our firm won the first instance of an administrative litigation case for invalidation of an invention patent, in which it is ruled that the invention patent should be comp...
Introduction In the chemical field, it is difficult to seek invalidation of a patent claiming to have achieved unexpected technical effect. This case provides a strategy for success...
On Invalidation of the Patent “Pharmaceutical Composition Comprising Valsartan and NEP Inhibitors” No. 201110029600.7
Yan WANG
Chinese Patent Attorney
Chemistry & Biotechnology Department
Linda Liu & Partners
On September 15, 2017, the Reexamination Board performed oral proceedings for request for invalidation No. 4W105696. This is the fifth case included in the activity of public hearings for important cases conducted by the Reexamination Board. It relates to the invention patent numbered 201110029600.7, of which the title is “Pharmaceutical Composition Comprising Valsartan and NEP Inhibitors” and the patentee is NOVARTIS AG. The requester for invalidation is Jinliang DAI.
This case involves significant economic interests and incurs dramatic social influence. Therefore, the Reexamination Board formed a collegial panel consisting of five persons to perform public hearings.
The major dispute of the two parties involved in this case includes the following aspects: based on the experimentation disclosed in the description of the present patent and the evidences submitted by both parties, whether the description provides sufficient disclosure, whether claim 1 possesses inventiveness, what the relation is between fulfilling the requirement of sufficient disclosure and fulfilling the requirement of inventiveness, whether the prior art teaches to combine Sacubitril with Valsartan, whether the technical effect obtained by the foresaid combination exceeds reasonable expectation of one skilled in the art and the conditions to be met by the unexpected technical effect, etc..
It is known that according to the provisions of Guidelines for Patent Examination, for inventions in chemical field, the technical effect can be hardly expected, and thus, the invention always need to be proved by experimental results. For new pharmaceutical compositions, the specific medical use or pharmacological effect should be described, as well as the effective amount and usage. If one skilled in the art cannot predict that the invention has the medical use or pharmacological effect, there should be sufficiently described the qualitative or quantitative data of laboratory test (including animal test) or clinical trial so that it is proved for one skilled in the art that the technical solution of the present invention is capable of addressing the technical problem to be solved or achieving the expected technical effect.
In view of the essence of the patent system, patent aims to sufficiently disclose a technical solution in exchange for market exclusivity protected under the national laws. As the term of market exclusivity based on a patent starts from the application date, it is required that the technical solution is sufficiently disclosed in the application document submitted by the applicant on the application date so that the public is enabled to sufficiently acquire the associated contents of the technical solution. Experimental data, as an important component of patent application document, effectively helps the public to sufficiently understand the technical solution disclosed in the patent. However, if the standard of experimental proof is not regulated, it will be inevitable that the applicant intentionally or unintentionally omits some technical details in the application document filed on the application date, which makes it difficult for the public to acquire sufficient technical information in the application document filed on the application date.
As for this case, the pharmaceutical compositions involved in this case include Sacubitril and Valsartan, both being an optional compound in this field for treating hypertension. Therefore, to determine whether the pharmaceutical compositions of the present invention possess inventiveness, major consideration should be given to the problem whether the pharmaceutical compositions achieve an unexpected technical effect. According to the disclosure of the description of the present invention, two biological models are adopted to verify the technical effect, namely SHR and DOCA-salt rats. The description further discloses in paragraph [0063] that “the results shows that the composition of the present disclosure has unexpected therapeutic effect”. However, the description does not disclose the specific experimental results.
Generally, any related technical content that cannot be obtained by one skilled in the art from the prior art should be disclosed in the description. For example, if a technical effect is hard for one skilled in the art to expect based on the prior art, foresaid technical effect should be verified in the description, accompanied with specific experimental effects. As for the present case, although the patent claims to “have unexpected therapeutic effect”, the description does not disclose specific experimental results to verify the technical effect. In this case, is it permitted to verify the technical effect by additional experimental data? According to Guidelines for Patent Examination, it is not prohibited to submit additional experimental data for proving a technical effect after the application date. The amended Guidelines for Patent Examination provides that “where additional experimental data is submitted later than the application date, the examiner shall perform an examination on the additional experimental data; the technical effect verified by the additional experimental data shall be acquirable for one skilled in the art according to the contents disclosed in the patent application”.
Therefore, whether the additional experimental data is accepted is determined by the matter whether the technical effect verified by the additional experimental data can be acquired by one skilled in the art according to the contents disclosed in the patent application. The reason why the scope of additional experimental data as proof is limited includes two aspects. On one hand, in view of the essence of the patent system, patent aims to sufficiently disclose a technical solution in exchange for market exclusivity protected under the national laws. As the term of market exclusivity based on a patent starts from the application date, it is required that the technical solution is sufficiently disclosed in the application document submitted by the applicant on the application date so that the public is enabled to sufficiently acquire the associated contents of the technical solution. On the other hand, additional experimental proof is, fundamentally, evidence. It is the entitlement of an involved party to submit evidence that effectively helps the involved party verify the associated technical effect. Thus, the right of the involved party to submit additional experimental data should not be deprived. Whereas, if the standard of experimental proof is not regulated, it will be inevitable that the applicant intentionally or unintentionally omits some technical details in the application document filed on the application date, which makes it difficult for the public to acquire sufficient technical information in the application document filed on the application date and thus, hard to represent the technical solution disclosed by the invention.
Nevertheless, there still exists controversy in the patent examination and judicial practice over what kind of technical effect can be deemed as “acquirable for one skilled in the art according to the contents disclosed in the patent application”. For example, in this case, the following problems arise: i. whether the technical effect merely described in words can be deemed as “acquirable for one skilled in the art according to the contents disclosed in the patent application”; ii. whether the additional experimental data should be obtained under completely the same experimental conditions (e.g., using the same animal models) as those described in the description; iii. whether there is a need for the additional experimental data to prove that the whole protection scope of the claims has an unexpected technical effect; iv. where the additional experimental data is provided solely by the patentee, the authenticity of which is not recognized by the requester, and yet the request cannot provide counterevidence, whether foresaid additional experimental data can be used as effective evidence for the final decision.
With regard to the above issues, through this case, the Reexamination Board made the following comments in the subsequent Decision of Examination: “conclusive assertion”, without experimental data as proof, cannot be deemed as a technical effect that can be obtained by one skilled in the art from the original description. On this basis, the collegial panel further determined that the additional experimental proof submitted later than the application date, if merely submitted for proving the “conclusive assertion” in the original description, will not be accepted. Eventually, the patent involved in this case is declared invalid wholly due to defects in the experimental data.
In addition, in terms of the presentation manner of the claims, this case triggers the following thoughts. According to the description, this case relates to pharmaceutical compositions for treating multiple deceases including hypertension. Therefore, the involved patent takes the presentation manner of non-limiting compositions, which complies with relevant provisions of Guidelines for Patent Examination. Moreover, the patentee holds the opinion that the key of the present invention is to choose the components in the compositions and it is unnecessary to limit the content of each component, which also complies with relevant provisions of Guidelines for Patent Examination. However, the description merely discloses the experimentation relating to the treatment of hypertension; and it is difficult to prove with the additional experimental data that the unexpected technical effect can be obtained by the compositions with random content of each component. In view of the above, it is a feasible option to incorporate features of definition by use into the claims and adding dependent claims defining various content ranges, so as to benefit to patent stability.
