budapest-treat.jpgThe U.S. Patent and Trademark Office (USPTO) has proposed making changes to the rules regarding when an invention involves biological material.  Often, these can’t be adequately described using just words.

As a way to supplement the written description of an invention, courts have sanctioned a procedure in which biological material may be deposited with an appropriate holding facility under conditions which ensure that the sample is properly maintained, and made available to others when appropriate.

For biological inventions, for which providing a description in written form is not practicable, one may nevertheless comply with the written description requirement by publicly depositing the biological material * * *. Such description is the quid pro quo of the patent system; the public must receive meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 970, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002).

This is a requirement under 35 U.S.C. 112, first paragraph, which requires that an inventor must disclose the invention in such a manner that would allow the public to make and use it without undue experimentation. Internationally, the deposit of biological materials is governed by the Budapest Treaty.

The proposed rules would require:

(1) that any deposit of biological material be made before publication of a patent application; and

(2) that all restrictions on access to the deposited material imposed by the depositor be removed upon publication.

The proposed changes will provide that the public has access to biological materials referenced in the disclosure of a patent application to the same extent that access to the remainder of the disclosure is available. The public policy basis for allowing access to a referenced item is the same whether the item is another patent application or a deposited biological material.

The concern is that under the American Inventors Protection Act of 1999 (AIPA), patent applications publish eighteen months after the earliest priority date. In exchange for this disclosure, the AIPA also provided a provisional right under 35 U.S.C. 154(d) to obtain a reasonable royalty if the invention as claimed in the published patent application is substantially identical to the invention claimed in any patent that might issue and certain other conditions are met.

Only those patent application publications which provide an enabling disclosure of the claimed invention would be entitled to provisional rights under 35 U.S.C. 154(d). Although the AIPA allowed for certain applications to be published in redacted form, any redacted application was nevertheless required to contain a disclosure that would allow a person skilled in the art to make and use the subject matter of the claim.

The USPTO now states:

The proposed rule change brings the Office practice regarding biological deposits in line with the publication of patent applications under AIPA. Courts have consistently recognized that an applicant must have provided the Office with an enabling disclosure no later than the time an invention is disclosed to the public. Prior to publication of patent applications under the AIPA, disclosure occurred simultaneously with patent issuance. Thus, earlier court decisions held that deposits needed to be perfected at the time the patent became public, i.e., at the issue date.

In the era since Hawkins and Argoudelis were decided, Congress changed the law to require that most patent applications be published eighteen months after filing, and to grant provisional rights under certain conditions. Publication of patent applications under the AIPA means that the patent issue date is no longer ‘‘the time [the patent disclosure] is made public,’’ or the time when ‘‘the conditions of Rule 14 are met.’’

In part, Title 37 of the Code of Federal Regulations, is proposed to be amended as follows:

Section 1.804 is proposed to be amended to provide that if a biological material is necessary to preserve the availability of provisional rights under 35 U.S.C. 154(d), the deposit of the biological material must be made prior to filing an application or during the pendency of an application, provided that the deposit is made before technical preparations for publication of the application as a patent application publication have begun (see § 1.215(a)).

Section 1.808(a)(2) is proposed to be amended to provide that all restrictions imposed by the depositor will be irrevocably removed upon the earlier of publication of the application under § 1.211 and 35 U.S.C. 122(b) or grant of the patent, and to indicate that the rule applies regardless of whether the deposit was made to satisfy a statutory provision.

Section 1.808(b) is amended to add ‘‘before the patent is granted or’’ before ‘‘term of the patent.’’

Section 1.808(c) is amended to provide that the Office will, on request, certify that an application referring to the deposit has been filed, that the subject matter of that application involves the deposited biological material or the use thereof, that the application has been published or patented or is otherwise open to public inspection, and that the requesting party has a right to a sample of the biological material. This is the certification called for in Rule 11.3 of the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. A form, BP/12, is provided on the World Intellectual Property Organization’s Internet Web site ( for this purpose.

Section 1.809(e) is proposed to be amended to delete ‘‘before or with the payment of the issue fee (see § 1.312)’’ and to insert ‘‘(1) within a period of sixteen months after the date of filing of the application or, if the benefit of an earlier filing date is sought under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four months of the actual filing date of the later-filed application and sixteen months from the filing date of the prior-filed application; and (2) before or with any request for early publication (§ 1.219).’’

Comments should be sent by e-mail addressed to Comments may also be submitted by mail to: Mail Stop Comments— Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, or by fax to (571) 273–7754, marked to the attention of Kathleen Kahler Fonda. Written comments must be received on or before April 21, 2008. No public hearing will be held.

See all the details here.

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  2. I think this is right move.

  3. Problem… does ATCC have the right to license the use of the deposited biological material after it has been deposited? If it does, then enforcing a patent on the material would be problematic.

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