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Emory University v Biochem Pharma Inc.

Emory University v Biochem Pharma Inc.

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Case Copied 5 August 1999 54 min read

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OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application : No. 658136 in the name of Emory University

Title: Method and compositions for the synthesis of BCH-189 and related compounds

Action: Opposition to the grant of a patent by Biochem Pharma Inc

Decision: Issued 5 August 1999
Abstract

The opposition succeeds on the grounds of section 40, novelty and obviousness.

The allowability of further evidence must take into account the significance of the evidence, not just its relevance (page 5 - 6).
Ferocem Pty Ltd v Commissioner of Patents (1994) AIPC 91-057; 28 IPR 243 and A Goninan & Co Ltd v Commissioner of Patents (1997) AIPC 91-330; 38 IPR 213 applied.

The specification discloses three methods of preparing enantiomerically enriched compounds. The first method does not work because the tin chloride causes racemisation of the thioketal carbon (page 11). The second method does not work because the butyryl ester is converted to an acetyl ester by DIBAL-H (page 13). The third method is a variation of the second method using borohydride as the reducing agent. This method might work, but requires a heavy burden of experimentation in order to work the process because there is no explanation of how to successfully carry out two key steps (page 15 - 16).

Section 40 matters
ØImprecise terminology in the claims is clear as its meaning would be understood by a person skilled in the art (page 17).
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 274 and Leonardis v Sartas No 1 Pty Ltd (1996) 35 IPR 23 followed.
ØClaims defining the compound by reference to a name and a different structural formula did not lead to a lack of clarity. The structural formula was precisely drawn, and was a simple derivative of the named compound. The subject of the claim was the compound represented by the structural formula (page 18).
ØClaims found to be not fairly based as the specification contains little information in relation to the invention, and this information is hidden within other misleading information (page 19 - 20).
Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1987) 15 FCR 382 followed.
ØThe specification does not fully describe the invention because the lack of detail places a burden of undue experimentation on a person seeking to work the invention (or alternatively, there is no enabling disclosure of the invention claimed) (page 23 - 24).
Sami S. Svendsen Inc v Independent Products Canada Ltd (1968) 119 CLR 156 distinguished.
Biogen Inc v Medeva plc (1996) 36 IPR 438 considered.
Vidal Dyes Syndicate Ltd v Levinstein Ltd (1912) 29 RPC 245 applied.
ØThe claims are construed in the context of the specification as a whole. Consequently claims to a specific enantiomer must be understood as directed to that enantiomer free of the other enantiomer (page 25).
International Business Machines Corp v Commissioner of Patents (1991) 22 IPR 417 applied.

Prior claiming
The claims to the…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [1999] APO 50
Decision Date: 5 August 1999

CaseChat Overview and Summary

The opposition to the grant of a patent to Emory University by Biochem Pharma Inc was heard in Canberra from 17 to 20 May 1999. The opposition was successful on the grounds of section 40 (fair basis and full description), novelty (claims 25, 28 - 31 and 37), and obviousness (claims 26 and 27). The court found that the claims were not fairly based on the matter described in the specification, as the information about the third method of preparing enantiomerically enriched BCH-189 was hidden amongst other misleading information. The court also found that claims 25, 28 - 31 and 37 were not novel due to deferred priority. Additionally, claims 26 and 27 were found to be obvious, as it would have been a matter of routine to use chiral chromatography to separate the enantiomers of BCH-189 and its derivatives. Emory University was given the opportunity to propose suitable amendments to overcome the deficiencies identified in the decision. The Commissioner awarded costs in favour of Biochem Pharma Inc.

Orders