Biotechnology/Chemical/Pharmaceutical Customer Partnership Topic: Biotechnology/Chemical/Pharmaceutical Customer Partnership Topic: Biological Deposits Gary Benzion, Ph.D. Supervisory Patent Examiner 1 United States Patent & Trademark Office Notice of Proposed Rule Making Revision to the Time for Filing of a Biological Deposit and the Date of Availability of a Biological Deposit

Notice of Proposed Rule Making Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Proposed Rules –Period for comment ended on April 21, 2008 –Final rules have not been published. 2

What is Biological Material Under 35 USC 101? 37 CFR states: –“For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 USC 101, the term biological material shall include material that is capable of self- replication either directly or indirectly. ” (emphasis added) 3

Biological Material Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles and other non-living material existing in and reproducible from a living cell may be deposited by deposit of the host cell capable of reproducing the non- living material. 4

Proposed Rules Changes Directed to inventions involving biological material Where written description alone does not sufficiently describe how to “make and use” the invention The invention must provide a meaningful disclosure in exchange for excluding the public from practicing the invention 5

Proposed Rule Changes To bring USPTO practice regarding the deposit of biological material in line with the publication of patent applications under American Inventors Protection Act. AIPA requires that most patent applications are published at 18 months from date of filing. Publication means that issue date is no longer the date that the patent disclosure is made public. 6

Proposed Rule Changes In the public interest –Inform public of the existence of deposited material at publication date –Ensure that patent application publication qualifies as prior art as of publication date –Prevent issuance of patents which do not represent a contribution to public knowledge. –Provide a significant step toward harmonizing USPTO practice with that of the European Patent Office (EPO). 7

Proposed Rule Changes Patent application publications that do not comply with the disclosure requirements of 35 U.S.C. 112, first paragraph –Are not entitled to provisional rights under 35 U.S.C. 154(d) –May not serve as anticipatory prior art under 35 U.S.C. 102(a) and (b), and possibly (e) 8

Anticipation & Enablement Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354, 65 USPQ2d 1385, 1416 (Fed. Cir. 2003) ‘‘To serve as an anticipating reference, the reference must enable that which it is asserted to anticipate.’’ Elan Pharms., Inc. v. Mayo Found. for Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373, 1375 (Fed. Cir. 2003) “ A claimed invention cannot be anticipated by a prior art reference if the allegedly anticipatory disclosures cited as prior art are not enabled.’’ Bristol-Myers Squibb v. Ben Venue Labs., Inc., 246 F.3d 1368, 1374, 58 USPQ2d 1508, 1512 (Fed. Cir. 2001) “To anticipate, the reference must also enable one of skill in the art to make and use the claimed invention.” 9

Provisional Rights Under 35 USC 154(d) … a patent shall include the right to obtain a reasonable royalty from any person who, during the period beginning on the date of publication of the application for such patent under section 122(b), or in the case of an international application filed under the treaty defined in section 351(a) designating the United States under Article 21(2)(a) of such treaty, the date of publication of the application, and ending on the date the patent is issued — –(A) (i) makes, uses, offers for sale, or sells in the United States the invention as claimed in the published patent application or imports such an invention into the United States; or (ii) if the invention as claimed in the published patent application is a process, uses, offers for sale, or sells in the United States or imports into the United States products made by that process as claimed in the published patent application; and –(B) … substantially identical to the invention claimed in the publication. –… 10

Proposed amendments to 37 C.F.R –1.77: Arrangement of application elements –1.163: Arrangement of elements in plant applications –1.804: Time of making deposit –1.808: Furnishing of samples –1.809: Examination procedures 11

§ 37 C.F.R Arrangement of Application Elements Current Practice No requirement for reference to bio- logical deposit in a specific location in the application. Proposed Practice New paragraph (b)(6) having a section heading for a reference to a biological deposit. 12

§ 37 C.F.R Specification and arrangement of application elements in plant applications No requirement for reference to biological deposit New paragraph (c)(6) To include a section heading for a reference to a biological deposit. Proposed Practice Current Practice 13

§ 37 C.F.R Time of making an original deposit Current practice Whenever a biological material is specifically identified in an application for patent as filed, an original deposit thereof may be made at any time before filing the application for patent or, subject to § 1.809, during pendency of the application for patent Proposed practice … 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 14

§ 37 C.F.R (a) Furnishing of samples Current Practice All restrictions imposed on the deposited material will be irrevocably removed upon the granting of the patent. Proposed Practice Grant access upon publication of the application under § and 35 U.S.C. 122(b) or grant of the patent Access to deposit applies regardless of whether the deposit was made to satisfy a statutory provision. 15

§ 37 C.F.R (b) Furnishing of samples Current practice Refers to the conditions under which a deposit is made. … depositor may contract with the depository to require that samples of a deposited biological material shall be furnished only if a request for a sample, during the term of the patent Proposed practice The depositor may contract with the depository to require that samples of a deposited biological material shall be furnished only if a request for a sample, before the patent is granted or during the term of the patent: 16

§ 37 C.F.R (c) Furnishing of samples Current practice Section 1.808(c) states that the USPTO will certify whether a deposit has been stated to have been made under conditions which make it available to the public as of the issue date of the patent grant. Proposed practice USPTO will, on request, certify that an –…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. 17

§ 37 C.F.R (c)(3) Furnishing of samples Current practice Requires that a request for certification include the patent number and issue date of the patent referring to the deposit; Proposed practice Revised to require: The application number referring to the deposit and any patent application publication number and publication date, or patent number and issue date of the patent; 18

§ 37 C.F.R (a) Examination procedures Current practice refer to rejecting the affected claims under the appropriate provision of 35 U.S.C. 112, Proposed practice Section 1.809(a) is proposed to be amended to clarify that the examiner’s rejection may be under any appropriate statutory provision. 19

§ 37 C.F.R (a) Examination procedures (a) The examiner shall determine pursuant to § in each application for patent, application for reissue patent or reexamination proceeding if a deposit is needed, and if needed, if a deposit actually made is acceptable for patent purposes. If a deposit is needed and has not been made or replaced or supplemented in accordance with these regulations, the examiner, where appropriate, shall reject the affected claims under the appropriate statutory provision, explaining why a deposit is needed and/or why a deposit actually made cannot be accepted. 20

§ 37 C.F.R (b)(1) Examination procedures Current practice Refers to how the applicant for patent or patent owner shall reply to a rejection: –Making an acceptable deposits and/or –Arguing why the deposit was not needed. Proposed practice Delete material underlined: “In the case of an applicant for patent, either making an acceptable original, replacement, or supplemental deposit or assuring the Office in writing that an acceptable deposit will be made; or, in the case of a patent owner, requesting a certificate of correction of the patent which meets the terms of paragraphs (b) and (c) of § 1.805, or” 21

§ 37 C.F.R (b)(2) Examination procedures Current practice Applicant may reply to a rejection regarding a needed deposit by: (1). Asking that the determination on the need to make of deposit be held in abeyance. Proposed practice A request to hold the making of the deposit in abeyance will not be considered a bona fide attempt to advance the application to final action (§ 1.135(c)). 22

§ 37 C.F.R (c) Examination procedures Current practice Refers to: If an application for patent is otherwise in condition for allowance except for a needed deposit and the Office has received a written assurance that an acceptable deposit will be made Proposed practice Delete: ‘‘and the Office has received a written assurance that an acceptable deposit will be made.’’ 23

§ 37 C.F.R (e) To Preserve Provisional Rights Current practice Any amendment required by paragraphs: (d)(1)-Accession number (d)(2)-The date of deposit, or (d)(4)-The name and address of the depository of this section must be filed before or with the payment of the issue fee (see § 1.312). Proposed practice Delete: –‘‘before or with the payment of the issue fee (see § 1.312)’’ 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).’’ –§ continues to apply 24

Principal Changes (1) Requires that to preserve provisional rights a deposit of biological material be made before publication of a patent application –change the time period for compliance with existing requirements of the rules of practice; (2) provide that all restrictions on access to the deposited material imposed by the depositor be removed upon publication. –ensure that the public has access to biological materials referenced in the disclosure of a patent application 25

Contact Information Kathleen Kahler Fonda Office of Patent Legal Administration Gary Benzion, Supervisory Patent Examiner Art Unit