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A Reexamination Case Taught Us How to Avoid Going beyond the Scope
Hao ZHANG
Chinese Patent Attorney
Suzhou Office
Linda Liu & Partners
As Rule 42.1 of the Implementing Regulations of the Chinese Patent Law says, where an application for a patent contains two or more inventions, utility models or designs, the applicant may, before the expiry of the term of going through the registration formalities after the patent administration depart of the State Council issues the notification to grant the patent right, submit to the administration department, a divisional application, but where an application for a patent has been rejected, withdrawn or is deemed to have been withdrawn, no divisional application may be filed. Accordingly, generally speaking, whether a divisional application may be filed is closely associated with whether there is unity among inventions, utility models or designs included in the parent application: if the inventions, utility models or designs share unity, they may be filed in a sole application, or else a divisional application has to be filed on the basis of the parent application.
When a parent application has a unity defect, which is a direct reason for filing a divisional application, the applicant may have to passively file a divisional application so as to remove the examiner’s objection. However, there are some other reasons that the applicant may consider to file a divisional on his own initiative. For example, the parent application seeks protection for several independent claims, but only some of the independent claims are patented after the substantive examination. If the applicant does not wish to forsake the technical solutions for which no patent has been granted, filing a divisional application for them is a possible approach. In this case, it is likely but risky that those technical solutions will be patented, because different examiners usually use different criteria for evaluating a same one claim. Here is another example. When the applicant thinks the scope of protection covered by a claim of the parent application to be unreasonably narrow, broadening the scope by filing a divisional application may maximize the applicant’s benefits. There were really applicants who did that and got favorable effects.
A divisional application, as an extension to the parent application, has the filing date of the parent application—it’s in the genes, and is entitled to the right of priority if the parent application is entitled. But every coin has two sides. While enjoying the benefit of the parent application, a divisional application needs to satisfy some conditions. For example, a divisional application must be of the same type as the parent application: the divisional application should be an application for a patent for utility model if the parent application is filed for a patent for invention, and vice versa. Or else, the divisional applicant will not be accepted. Here is another example. A divisional application should not go beyond the scope of the disclosures contained in the parent application, or else the divisional application will be rejected under Article 33 of the Chinese Patent Law or Rule 43.1 of its Implementing Regulations. Here is a reexamination case, which I will use to discuss how a beyond-the-scope defect occurs.
The applicant filed a PCT application titled “Polymorph of a Pharmaceutical” on July 19, 1999 (the application number of which is PCT/US99/16334). The application includes 30 claims which are directed to a new crystalline polymorph of ritonavir (termed crystalline Form II) and a process for preparing it, amorphous ritonavir and a process for preparing it, and a new process for preparing a known crystalline polymorph of ritonavir (termed crystalline Form I). A patent was granted for the PCT application in China on November 3, 2010 (the application number of which is 99808927.3 in the Chinese national phase). The following is the claim in the specification of the Chinese patent:
1.The crystalline polymorph, greater than 90% pure, of (2S,3S,5S)-5-(N-(N-((N-methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)-L-valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane with characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67°±0.1°, 9.51°±0.1°, 9.88°±0.1°, 10.97°±0.1°, 13.74°±0.1°, 16.11°±0.1°, 16.70°±0.1°, 17.36°±0.1°, 17.78°±0.1°, 18.40°±0.1°, 18.93°±0.1°, 19.52°±0.1°, 19.80°±0.1°, 20.07°±0.1°, 20.65°±0.1°, 21.49°±0.1°, 21.71°±0.1°, 22.23°±0.1°, 25.38°±0.1°, 26.15°±0.1°和28.62°±0.1°.
As shown above, only the new crystalline polymorph of ritonavir (crystalline Form II) was patented after the PCT application entered the Chinese national phase. Before the examination of the parent application was completed, the applicant filed a divisional application on April 13, 2010, possibly because while the parent application was undergoing the long substantive examination, the applicant had a feeling that some of the technical solutions (especially the preparation processes) have little prospect of being patented. The publication of the divisional application includes the following claims:
1. A process for preparing a composition comprising ritonavir, said process comprising dissolving Form II crystalline ritonavir in a solvent, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67°±0.1°, 9.88°±0.1°, 16.11°±0.1°, 16.70°±0.1°, 17.36°±0.1°, 17.78°±0.1°, 18.40°±0.1°, 18.93°±0.1°, 20.07°±0.1°, 20.65°±0.1°, 21.71°±0.1° and 25.38°±0.1°.
2. The process of claim 1, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67°±0.1°, 9.51°±0.1°, 9.88°±0.1°, 10.97°±0.1°, 13.74°±0.1°, 16.11°±0.1°, 16.70°±0.1°, 17.36°±0.1°, 17.78°±0.1°, 18.40°±0.1°, 18.93°±0.1°, 19.52°±0.1°, 19.80°±0.1°, 20.07°±0.1°, 20.65°±0.1°, 21.49°±0.1°, 21.71°±0.1°, 22.23°±0.1°, 25.38°±0.1°, 26.15°±0.1° and 28.62°±0.1°.
3. The process of claim 1, wherein said solvent is ethyl acetate.
4. The process of claim 1, wherein said solvent is isopropyl acetate.
5. The process of claim 1, wherein said solvent comprises ethanol and oleic acid.
For the divisional application, the examination department of the State Intellectual Property Office (hereinafter “SIPO” for short) issued a first office action on June 27, 2011, pointing out that claims 1-5 go beyond the scope of the disclosures contained in the initial description and claims—that is, they go beyond the scope of the disclosures contained in the parent application, on the following grounds:
Claim 1 is directed to a process for preparing a composition comprising ritonavir. In the initial description and claims, the corresponding disclosure is merely a process for preparing a soft gelatin capsule of a composition which comprises ritonavir Form II and other specific ingredients in specific amounts. Without features about the ingredients and specific preparation steps, the claimed technical solution is actually not disclosed in the initial description and claims. Besides, since a composition comprising ritonavir may cover a variety of dose forms, and a process for preparing the composition may include various steps, claim 1 apparently covers a broader scope of protection. Such a general technical solution cannot be determined directly and unequivocally from the initial description and claims. Therefore, claim 1 and claims 2-5—which are dependent on claim 1 directly or indirectly—do not comply with Article 33 of the Chinese Patent Law.
The applicant did not agree with the examiner’s objection. In the opinion statement submitted on January 10, 2012, the applicant argued as below: The description of the parent application discloses not only preparing ritonavir Form II through recrystallization of a mixture of ritonavir Form I and ritonavir Form II from a solution of them in a suitable solvent—i.e., dissolving ritonavir Form II in a solvent—but also solvents that dissolve ritonavir Form II, such as ethyl acetate, isopropyl acetate and an oleic acid-based solvent. In other words, the process of dissolving ritonavir Form II in a solvent, as evidenced by many of the examples in the description of the parent application, inevitably results in a composition comprising ritonavir. Therefore, the technical solutions defined in claims 1-5 are determinable directly and unequivocally from the initial description and claims, so they comply with Article 33 of the Chinese Patent Law.
In reply to the applicant’s arguments, the examination department of the SIPO adhered to the original objection and issued a decision of rejection on April 17, 2012. The applicant stuck to its arguments as well and filed a request for reexamination with the Patent Reexamination Board (hereinafter “Board” for short) on August 2, 2012.
The request was accepted by the Board after it was subjected to formal examination and deemed to be qualified. The Board transferred the request to the previous examination department which made the decision of rejection for interlocutory examination. The interlocutory examination department gave its opinions as follows: The disclosure in the description, which the applicant alleged as basis for claim 1, does not relate to preparing “a composition comprising ritonavir” of any of claims 1-5, but rather to preparing “substantially pure Form II crystalline polymorph of ritonavir”. Moreover, preparing “substantially pure Form II crystalline polymorph of ritonavir” must be carried out in specific conditions including a specific solvent, a specific anti-solvent, a specific temperature and a specific period of time. Without features as above, which are closely linked to the disclosed technical solution, claim 1 defines a technical solution that is a result of generalizing the disclosures in the description. Obviously, such a general technical solution cannot be determined directly and unequivocally from the initial description and claims, so they go beyond the scope of the disclosures contained in the initial description and claims. The interlocutory examination department insisted that claims 1-5 do not comply with Article 33 of the Chinese Patent Law, and thereby adhered to the original decision of rejection. Subsequently, the Board formed a collegiate panel, and issued a notification of reexamination on May 13, 2013, pointing out, on the same grounds, that claims 1-5 go beyond the scope of the disclosures contained in the initial description and claims.
Due to dissenting from the Board’s views, the applicant replied, on August 28, 2012, by amending claim 1 and arguing as follows:
1. A process which comprises dissolving Form II crystalline ritonavir in a solvent, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67°±0.1°, 9.88°±0.1°, 16.11°±0.1°, 16.70°±0.1°, 17.36°±0.1°, 17.78°±0.1°, 18.40°±0.1°, 18.93°±0.1°, 20.07°±0.1°, 20.65°±0.1°, 21.71°±0.1° and 25.38°±0.1°.
The description in the parent application involves ritonavir in various forms including amorphousness, Form I crystalline polymorph and Form II crystalline polymorph and provides examples of preparing the various forms of ritonavir. The fact that ritonavir is a pharmaceutical compound has nothing to do with whether it is in an amorphous form or in a crystalline form. Hence, the method which uses Form II crystalline ritonavir to prepare a composition comprising ritonavir does not go beyond the scope of the disclosures contained in the initial description and claims.
After the collegiate panel heard the applicant’s response, the Board issued a decision of reexamination on June 18, 2014, affirming the decision of rejection issued by the SIPO’s examination department on the following grounds: Claim 1 is directed to a process which comprises dissolving, in a solvent, Form II crystalline ritonavir with characteristic peaks. However, the claimed technical solution in this divisional application is not explicitly written in the description and claims of the parent application. Besides, the expression “a process” means multiple possibilities in preparing products through the process and may even include a process that prepares any product and comprises dissolving Form II crystalline ritonavir. Generalizing like that actually broadens the scope of protection to such an extent that claim 1 goes beyond the scope of the disclosures contained in the initial description and claims.
Because of being unsatisfied with the Board’s decision of reexamination, the applicant filed a lawsuit with the Beijing First Intermediate People’s Court and then appealed to the Beijing Higher People’s Court. However, all the efforts ended in failure because the courts thought the applicant’s assertion lacks legal and factual basis. The divisional application did not survive rejection.
When I have a review of the whole case, I cannot help but feel not only the pains that the applicant took in protecting the preparation process but also the resolution that each of the authorities showed in insisting on the “beyond-the-scope” standard.
At present, China is using a rigid criterion for determining whether a divisional application goes beyond the scope. As far as I have learned from cases that I dealt with, a new claim of a divisional application should not include a technical solution that is derived, by generalization, from the initial description. In other words, even if each of the features of a new claim is supported by the initial description, the claim will still be considered to go beyond the scope when the whole technical solution defined in the claim is not disclosed in an example written the initial description or when the whole technical solution does not include all the relevant features in an example written in the initial description.
If you, whether an applicant or a patent attorney, do not wish to see what happened in the above case happen to you, it is worthwhile including all patentable technical solutions into the claims when you are preparing the application document even if there is apparently no unity among the technical solutions. That is because a technical solution is generally not considered to go beyond the scope if it exists in the initial claims. If, for some reason, you would not like to include all patentable technical solutions in the claims, you should at least write all of them in the description under the heading “Summary of the Invention” and write corresponding contents under the heading “Description of the Embodiments”. Or else, you will have to include, into a claim of the divisional application, all the features related to the technical solution defined in the claim that are written in one of the embodiments. Doing so directly leads to a narrow scope of protection.
