Merck & Co Inc v John F. Niblack

[1991] APO 44

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application no. 42954/89 by MERCK & CO. INC, and a request under regulation 3.25 by JOHN F. NIBLACK.

Background

Application no. 42954/89 was filed by Merck & Co. Inc on 17 October 1989 as a Convention Application claiming priority from US application no. 259563. The application became OPI on 26 April 1990. The application relates to Anthelmintic Conversion Products, and includes a reference to a particular deposited microorganism; the specification states

This microorganism is publicly available from American Type Culture Collection at 12301 Parklawn Drive, Rockville, MD 20852 under the accession no. ATCC 53814 (Deposited 28 September 1988).

This deposit was made before the filing date of the application. Prima facie, the deposit requirements of section 6(c) of the Act have been met. I am also reasonably satisfied that the applicant is entitled to rely upon the deposit for the purposes of the Act.

On 5 July 1991, John F. Niblack, of Pfizer Inc., Eastern Point Road, Groton, Connecticut 06430, U.S.A., filed a document purporting to be a request under regulation 3.25; the request was for the Commissioner's certification (referred to in Rule 11.3(a) of the Budapest Treaty) authorizing release of a sample of the microorganism referred to above. Following correspondence from the Office, a revised request was filed on 29 August 1991.

A copy of the revised request was sent to the patent applicant on 6 September 1991. Both the requestor and the patent applicant were invited to indicate, within 14 days, whether they wished to be heard in the matter or to provide written submissions. The requestor provided written submissions, and indicated a desire to be heard only if the applicant wished to be heard. The applicant provided written submissions, and did not request to be heard.

Submissions

The submissions filed by the patent applicant are as follows:

The applicant contends from a perusal of the documents filed there appear to (be) a number of inconsistencies.

Firstly, the undertaking by Pfizer makes no mention of the specific microorganism or the patent application and there is nothing in the undertaking which refers to the patent request. As such, the undertaking is of much broader scope than the request.

Secondly, the request specifically states that the release is for experimental purposes only which would appear to be contrary to the undertaking which also includes other uses.

Decision

Regulation 3.25(4) sets out the issues the Commissioner must consider when deciding whether to comply with the request. In the present case, I am satisfied there is no basis under any of the sub-paragraphs of 3.25(4), other than sub-paragraph (c), for not complying with the request.

The first objection of the applicant relates to whether the undertaking given is sufficiently related to the request for the certification. The approved form issued by the Patent Office is a double-sided sheet. The request is on one side, and provides for identification of the microorganism; the undertaking is on the reverse side. The undertaking has no explicit identification of the microorganism; however, as a result of the double-sided nature of the form, the undertaking is clearly specific to the deposit identified on the request.

In the present case, the requestor has provided the request and undertaking on different sheets of paper; however the wording used in the undertaking is unchanged from the form issued by the Patent Office. As a result there is no explicit or implicit linkage of the undertaking to the deposit given in the request. This is a fatal deficiency in the undertaking as presently given. There must be no doubt that the undertaking is being given in respect of the deposited microorganism for which a sample is sought. I note, however, that this deficiency may be readily overcome, either by including in the undertaking a specific reference to the deposit, or by including the undertaking on the same sheet of paper as the request.

The patent applicant has also suggested that the undertaking should be restricted by way of reference to the present patent application. I agree. The undertaking given in sub-paragraphs (i), (ii), and (iii) of regulation 3.25(4)(c) is specific in its reference to the patent application or patent in which the reference to the microorganism occurs. If the undertaking includes the sub-paragraphs which enable the use of the sample in the circumstances there provided, the undertaking must likewise clearly identify the relevant application or patent. Paragraphs (1) to (3) of the undertaking by Niblack [which correspond to sub-paragraphs (i) to (iii) of regulation 3.25(4)(c)] do not include a reference to the present application; this is a fatal deficiency in the undertaking as presently given.

I additionally note that paragraph (2) of the undertaking by Niblack refers to "a petty patent"; the use of the indefinite article means that this undertaking is not restricted in the manner specified in sub-paragraph (ii) of regulation 3.25(4)(c). As the present application is not an application for a petty patent, the inclusion in the undertaking of a paragraph equivalent to sub-paragraph (ii) of regulation 3.25(4)(c) does not seem to be appropriate.

I also note that the current approved form also uses the indefinite article in paragraph 2 of the undertaking.  However the approved form cannot override the express requirements of regulation 3.25(4)(c) on this matter.

The second objection of the applicant relates to an inconsistency between the reasons stated on form requesting the certification, and the undertaking given by the requestor. Specifically, the reason stated on the request is "To use the microorganism for experimental purposes", whereas the undertaking repeats the words of regulation 3.25(4)(c) - ie permits its use for opposition and other similar matters.

While there may be some merit in requiring the reasons for requesting a certification of release to be completely consistent with the undertaking, in my view the essential requirement is that the requestor undertakes to restrict his use of the microorganism to the extent specified in regulation 3.25(4)(c). I do not believe that a request is invalidated merely because the statement of reasons for seeking release of the deposit given on the request form is narrower in scope than the undertaking given. In my view, such a difference would only invalidate the request if there was a good reason - such as, perhaps, an inference that the inconsistency is related to some lack of good faith; in the present case there is no allegation of lack of good faith, and no lack of good faith is apparent to me.

Conclusion

I have found that the request under regulation 3.25 for the Commissioner's certification is deficient, as the undertaking does not identify the relevant deposit to which the undertaking is being given, and does not identify the relevant application in paragraphs (1) to (3) of the undertaking. Additionally, paragraph (2) of the undertaking is not appropriate to the present application. As a result I refuse to issue, at this time, the requested certification. However, I will reconsider issuing the certification if the requestor files a new undertaking.

If the requestor files a new undertaking, (or a new request under regulation 3.25 for the Commissioner's certification in respect of that microorganism) the requestor should serve a copy on the patent applicant. Both parties should, within 14 days of that service, indicate whether they wish to be heard further in the matter, or file written submissions.

Finally, I note the requestor has not supplied the relevant form required under the Budapest Treaty - that is, form BP/12. The Commissioner will not issue a certification (which forms part of that form) until the form (in duplicate) has been supplied to the Commissioner with pages 1 and 2 correctly completed.

(David Herald)

Assistant Commissioner of Patents

Patent Attorney for the applicant: Spruson & Ferguson, Sydney
Patent Attorney for the Requestor: Davies & Collison, Melbourne

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application       :   No. 42954/89 in the name of MERCK & CO. INC

Title:   Anthelmintic Bioconversion Products

Action:   Request under Regulation 3.25 for the Commissioner's certification authorizing release of a sample of a microorganism

Decision          :   Issued             . Defects found in the undertaking required by regulation 3.25(4)(c). Request refused.

SPRUSON & FERGUSON
SYDNEY    NSW

RE:  Patent application No 42954/89 in the name of
            MERCK & CO. INC.

and

Request under Regulation 3.25 for the Commissioner's certification authorizing release of a sample of a microorganism

Your ref: 105567:JOC:RMC

Gentlemen,

Please find attached a copy of the Decision of a Delegate of the Commissioner in the above matter.

Senior Clerk, Patents.

DAVIES & COLLISON
MELBOURNE   VIC   3000

RE:  Patent application No 42954/89 in the name of
            MERCK & CO. INC.

and

Request under Regulation 3.25 for the Commissioner's certification authorizing release of a sample of a microorganism

Your ref: PAS:WM

Gentlemen,

Please find attached a copy of the Decision of a Delegate of the Commissioner in the above matter.

Senior Clerk, Patents.