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Supreme Law issued 2016 years of the top ten 10 major intellectual property cases of "heat stable glucoamylase" patent invalid case

2017-4-26 23:06| Announcer: admin

The State Intellectual Property Office Patent Reexamination Board, Novozymes and Jiangsu Baili Biological Products Co., Ltd. invention patent invalid administrative disputes reconsideration case[Supreme People's Court (2016) Supreme Administrative Judgment 85)

 

Case Summary:This case deals with the invention patent (hereinafter referred to as the patent) entitled "Thermostable Glucose Amylase", which was authorized by the State Intellectual Property Office on June 28, 2006, and the patentee is Novozymes. On March 11, 2013, at the request of Shandong Longda Bioengineering Co., Ltd. and Jiangsu Boli Biological Products Co., Ltd., the Patent Reexamination Board of the State Intellectual Property Office (hereinafter referred to as the Patent Reexamination Board) made the decision on the invalidation request of No. 17956 ( Hereafter referred to as the decision of the defendant), on the basis of the modified claims submitted by Novozymes on November 10, 2011, declare that the claims part of the patent is invalid and that some of the claims are valid. Part of the claims relating to the subject matter of the dispute in this case are as follows: "6. An isolated enzyme with glucoamylase activity, at least 99, is homologous to the full length sequence shown in SEQ ID NO: 7 %, And having an isoelectric point of less than 3.5 as determined by isoelectric focusing ... 10. An isolated enzyme according to any one of claims 6 to 9, said enzyme being derived from a filamentous fungal Talaromyces, The fungus is a T. monersonii strain. 11. The enzyme of claim 10 wherein the filamentous fungus is T.emersonii CBS 793.97.12 A DNA sequence of the cloned DNA encoding an enzyme exhibiting glucoamylase activity , The DNA sequence comprising: (a) the glucoamylase coding portion of the DNA sequence shown in SEQ ID NO: 33; (b) the DNA shown in positions 649-2724 of SEQ ID NO: 33 Sequence or a complementary strand thereof; 13. The DNA sequence of claim 12, wherein said DNA sequence is derived from a filamentous fungal Talaromyces, wherein said filamentous fungus is a strain of T. monersonii. DNA sequence, wherein the filamentous fungus is T.emersonii CBS 793.97. & Quot; & quot; For example, it has been demonstrated on the basis that the enzyme derived from T.emersonii CBS 793.97 has glucoamylase activity and can be expected by a person skilled in the art from T. monersonii strain and having a full length sequence of SEQ ID NO: 7 At least 99% of the homologous polypeptides also have the activity of glucoamylase, so that claims 10 and 11 are capable of obtaining support for the specification; the claims of claims 13 and 14 refer to the technical solutions of (a) and (b) of claim 12 Can also get the support of the instructions. The decision to maintain the dispute is valid. The first instance argues that the disputed claim is limited to a specific strain, but where the homology and openness are written in such a way that the defined amino acid sequence and DNA sequence include other sequences that may produce various variations, and in this patent specification Without the support of sufficient experimental data, the summary of the disputed claim is clearly beyond the contents of the specification. The court of first instance decided to revoke the decision, the court of second instance to maintain the first instance verdict. Patent Reexamination Board and Novozymes apply for retrial. The Supreme People 's Court after the verdict to revoke the first and second instance verdict, to maintain the decision.

 

Typical meaning:In the present case, the Supreme People's Court held that, according to Article 26 (4) of the Patent Law, the technical scheme required for the protection of the claims should be obtained or summarized by the technical staff in the technical field from the full disclosure of the instructions Of the technical program, and shall not exceed the scope of the manual. For SEQ ID NO: 7, having a total length of 591 amino acids, there are still about 5, 6 amino acid sites differing from sequences having 99% or more homology, but in addition to the homology characteristics, Claims 10, 11 further define that said enzyme is derived from T. monersonii strain and a specific strain T.emersonii CBS 793.97. One of ordinary skill in the art is generally believed that species is the basic unit of taxonomy, and in some basic features, individuals in the same species exhibit a high degree of similarity to each other. The same fungus or the same fungus encodes a gene sequence of an enzyme in the body that is generally determined, and occasionally there are very few homologous sequences with very high homology. Accordingly, the enzymes encoded by the gene are also identified or Minority. In this case, more than 99% homology and the dual limitation of the origin of the strain or strain have reduced the scope of protection of claims 10 and 11 to an extremely limited enzyme. Moreover, claims 10 and 11 also include those as defined in claim 6 Enzyme isoelectric point and has the function of glucoamylase activity. Thus, in the case where the above-described SEQ ID NO: 7 has a glucoamylase activity in the specification of Examples 1 to 4, the protection ranges of claims 10 and 11 can be supported by the specification. The technical proposal of claim 12 (a) (b) in claims 13 and 14 can also be supported by the specification. In the present case, the Supreme People's Court has made clear the use of homology with the source and function of the way the biological sequence of the claims obtained by the instructions to support the rules of judgment and the patented patent for biological inventions, the preparation of proteins, gene-related patent applications and review Has a guiding significance, but also conducive to the promotion of biotechnology industry innovation and development.

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