A. Question Presented

For an invention to be granted patent protection, the specifications must be sufficiently disclosed in the patent application. When a prior art is used as an anticipatory prior art reference, such reference should also sufficiently disclose the technique employed. Therefore, it is appropriate to ask: Are the requirements for "sufficient disclosure" the same under the above two circumstances? In other words, if one patent application, at the stage of substantive examination, is deemed insufficiently disclosed for its failure to include some information (such as the data relevant to the application of the invention), and therefore rejected, whether the specification disclosed in said patent application can be used as the anticipatory prior art reference for patent applications filed after the date of disclosure?

B. Analysis

As to the above-presented question, many people may unhesitatingly believe that the requirement of sufficient disclosure in the patent specification is certainly the same as the disclosure requirement in the prior art reference. However, after analyzing some relevant cases decided by the American Federal Court of Appeals, I found that the situation in America is different from our expectations and that there are obvious differences in the criteria for "sufficient disclosure" under these two circumstances.

1. There are three requirements as to patent specifications: (a) the written description requirement¹; (b) the enablement requirement²; and (c) the best mode requirement³. Among the three, the judgment made concerning the "enablement requirement" depends on whether the application for the said invention is based on the specification that goes through the "undue experiment". The following eight Wands' factors⁴ further demonstrate the methods for judging whether the "undue experiment" is required:

a. the amount required for the experiment;
       b. the instructions or guidelines given;
       c. the existing example for the experiment;
       d. the nature of the invention;
       e. the status quo of the state of the art;
       f. the level of the professional technical personnel;
       g. the predictability or the unpredictability of the technique;
       h. the scope of the claims.

2. In Smithkline Beecham Corp. (hereinafter referred to as "SK") v. Apotex⁵, the rule applied by the Court is as follows: as concerns a prior art reference, as long as it discloses "all limits" of the invention, it will anticipate the novelty of the patent applications filed afterwards; the criteria for judging the anticipation of novelty is the same as the criteria for judging whether infringement exists. "If the application of the prior art constitutes literal infringement, such prior art will certainly anticipate the novelty of the said patent."

In Smithkline Beecham Corp. v. Apotex⁶, SK argued that it was entitled to US-patent No. 4721723, the patent for PHC hemihydrate. SK's Claim 1 was for "Crystalline paroxetine hydrochloride hemihydrate ". Apotex produced PHC anhydrate with the methods specified in US- patent No. 4007196 whose protection period had expired, and it also filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). After SK learned of this, it filed a lawsuit against Apotex, alleging that Apotex had infringed upon its patent, US- patent NO. 4721723. Apotex countered that what it applied for was the prior art of anhydrate, without infringing the patent of hemihydrate. SK argued that the anhydrate produced by the defendant unavoidably contained at least a trace amount of hemihydrate because while anhydrate was produced or stored, it would certainly absorb some water, and then a small amount of anhydrate would convert into hemihydrate, resulting in infringement. The District Court for the Northern District of Illinois as the court of first instance held that a "trace amount of hemihydrate" was not commercially significant. As a result, there was no infringement on the part of the defendant. After both of the parties appealed to the Federal Court of Appeals, the Court held that the patent protected an invention "with no limitation on amount contained", and therefore, even "trace amounts" constituted infringement. However, since what the defendant applied for was a prior art,, and since the production of PHC anhydrate with methods provided by US- 4007196 definitely contained or converted into "PHC hemihydrate", such prior art should be considered an anticipatory prior art reference to the patent subsequently applied for. As a result, US- 4721723 was ruled invalid for lack of novelty. Consequently, there was no infringement found on the part of Apotex.

The rules provided in this case are:
       a. Before a prior art discloses a given feature of an invention for which protection has been applied for, if the feature lacking is necessarily present or inherent in a prior art, it will anticipate the novelty of the said invention. [the Court cited Schering v. Geneva., 339 F.3d 1373 (Fed. Cir., 2003)]

b. The inherent anticipation, that is the implied disclosure, does not require that the technical personnel in the same professional field realize such inherent disclosure from the creation of the prior art.

c. One of the principles underlying the doctrine of inherent anticipation is to ensure that the public remains free to make, use or sell the prior art regardless of whether or not they understand the complete makeup or the underlying scientific principles of such prior art.

In cases such as Gary H. Rasmusson v. SK⁷, and Novo v. Teva⁸, the Federal Court of Appeals pointed out that if the prior art lacks enablement, it cannot anticipate the novelty of the patent applications filed subsequently. However, the criteria for the "enablement requirement" in the prior art reference and the criteria for the "enablement requirement" in the patent specification are different. If a prior art has disclosed the formula of the chemical compound, but it fails to specify how to "use" such a compound; or if a prior art has disclosed the various conditions or features of manufacturing the compound, but fails to disclose the application of the compound produced in a given manner; the prior art under such circumstances can adequately anticipate the novelty of the product of the compound or the manner and process of making such a compound. However, if a prior art written in such a way is used as the specification for a patent application, it cannot support the claim for the product or the process. The reason is that Article 112 of the Patent Law of America (35 USC §112), which governs specifications for patent applications, requires that disclosures made in the specification should be so sufficient that professional technical personnel can "use" such an invention, while Article 102 of the Patent Law of America (35 USC §102), which defines novelty, only requires that the prior art reference disclose the technical program and its various features. There is no provision on whether it can be "used".

The prior art reference does not need to prove its practicability so as to become the anticipatory prior art reference to novelty.

As an anticipatory art reference, it neither needs to be proved "enabled" by the efficacy of the evidence nor does it need to have the suggestion in the prior art reference put into practice.

C. Conclusion

 According to the above referenced cases decided by the American Federal Court of Appeals, if a prior art discloses a product (such as the formula of a compound and the manner or process of making the compound), although it fails to disclose the usage (such as the data of biological activity) of such a product, as long as the features of the product for which protection is claimed are the same with those disclosed (such as the structural formula or the standard nomenclature of the compound), the said prior art reference will anticipate the novelty of the patent application. This is not different from the examination criteria in China. However, what deserves our attention is:

1. If the product disclosed in the prior art reference fails to provide the data regarding the crystalline structure or features, but what can be obtained with the methods provided by the prior art is the very type of crystal for which protection is claimed in the patent (or patent application), such reference will make the patent application filed after the date of disclosure of the reference void of novelty.

2. If a patent application discloses a scope (such as the compound manifested by a general formula), and such a scope is generally recognized as patentable (or has been granted a patent), the said scope will anticipate the novelty of the patent application filed subsequently. This is consistent with the principle that a patent cannot be granted twice. By analogy, the scope disclosed in a prior art reference that is not a patent reference can also anticipate the novelty of the patent application filed subsequently. I advanced such a view several years ago.⁹

§5.1(4) of Part 2, Chapter 10 in the Examination Guidelines of Patent, 2001 edition in China, provides: "a general formula cannot anticipate the novelty of one particular compound in such a general formula". This not only results in repeated grantings of a patent and greatly extended periods of protection, but also differs widely from the understanding and expectation of the public with regard to novelty. Many domestic developers of medicines often focus on the original patent of compounds with a general formula. When the protection period of such a patent has expired, or there is no such patent existing in China, most people think that the particular compounds developed afterwards lack novelty, and as a result, there is no risk of infringement to develop these compounds. As the top creator of new technology in the world, the United States attaches great importance to the protection of invention and innovation. Since America adopts very strict standards in determining novelty, it is not inappropriate for China to make similar provisions in the Examination Guidelines of Patent and in relevant judicial interpretations.

Endnotes: 
    1. Univ. of Rochester v. G. D. Searle & Co., 375 F.3d 1303 (Fed. Cir., 2004)；
    2. Glaxo Inc. v. Novopharm Ltd., 34 USPQ 2d 1565 (Fed. Cir., 1995)；
    3. Smithkline Beecham Corp. v. Apotex Corp., 365 F.3d 1306 (Fed. Cir., 2004)；
    4. Gary H. Rasmusson v. Smithkline Beecham Corp., 413 F.3d 1318, (Fed. Cir. 2005)；
    5. Johns Hopkins University v. Cellpro, 152 F.3d 1342 (Fed. Cir., 1998)；
    6. In re Wands, 858 F.2d 731 (Fed. Cir., 1988)；
    7. Smithkline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir., 2005)；
    8. Novo Nordisk Pharms. Inc. v. Bio-technology Gen. Corp., 2005 US App. Lexis 21518, (Fed. Cir., 2005) 
    9. "Novelty and Repeated Granting of Patent", Zeng Wuzong, Intellectual Property, 2001/ Supplementary Issue

About the author
    By Zeng Wuzong, Deputy Director of the Examination Department of Chemical Inventions, Patent Office of the State Intellectual Property Office of China

                                                                                               (Translated by Li Yan)