History of Written Description as Separate from Enablement. The purpose of the "written description" requirement is broader than to merely explain how

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1 Agenda Technology Transfer Practice Today: Scope of Upstream Inventions Andrew T. Serafini, Ph.D. History of Bayh-Dole Act What is patentable subject matter in basic science? 35 U.S.C U.S.C. 101 Discussion 2 Bayh-Dole Act 35 U.S.C. 202 (a) Each nonprofit organization or small business firm may, within a reasonable time after disclosure as required by paragraph (c)(1) of this section, elect to retain title to any subject invention Bayh-Dole Act 35 U.S.C. 201(e) The term subject invention means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement 3 4 Bayh-Dole Act 35 U.S.C. 201(d) The term invention means any invention or discovery which is or may be patentable or otherwise protectable under this title or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C et seq.). Thus, no new definition of patentable was created by Bayh-Dole. However, the nature of basic research is more likely to bring issues of enablement, possession and patentable subject 5 matter to the fore. 35 U.S.C The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 6 1

2 History of Written Description as Separate from Enablement. The purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date [*1564] sought, he or she was in possession of the invention. The invention is, for purposes of the "written description" inquiry, whatever is now claimed. Vas-Cath Inc. v. Mahurkar (935 F.2d 1555, 1563 (Fed. Cir. 1991) 7 UC v. Eli Lilly 119 F.3d 1559 (Fed. Cir. 1997) UC s patent claimed a plasmid comprising mrna from a vertebrate encoding insulin So claiming by function Examples were for rat No description of what part of mrna encoding for insulin is the conserved between various vertebrates Did not meet written description requirement 8 Tronzo v. Biomet 156 F.3d 1154 (Fed. Cir. 1998) Claim to an artificial hip socket that recites cup implants Specification describes the advantages of the conical shape of the cup implants Fails on written description University of Rochester v. Searle 358 F.3d 916 (Fed. Cir. 2004) Claim 1 - A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment. Described a method for screening for selective COX-2 inhibitors No description of an actual compound Insufficient written description 9 10 Lizardtech v Earth Resource Mapping 424 F.3d 1336 (Fed. Cir. 2005) Claim to generic process for creating a seamless discrete wavelet transform Specification describes one way of creating a seamless discrete wavelet transform Failed on written description and enablement Ariad v. Lilly Ariad sues Lilly on 516 patent based on sales of Evista and Xigris Jury trial on infringement and validity finds infringement of claims 80 and 95 (Evista ) and 144 and 145 Xigris ). finds claims not invalid for anticipation, lack of enablement or lack of written description Bench trial on Lilly s 101 defense (law of nature), inequitable conduct, and prosecution laches Court rules in favor of Ariad on all Lilly moves for JMOL loses Lilly appeals

3 Procedural History Panel upholds finding no inequitable conduct Panel reverses jury verdict on written description Claims invalid for lack of adequate written description under 35 U.S.C. Section 112, first paragraph. Ariad petitions for rehearing en banc Patent filed based on discovery of NF-κB and role in disease Claims USPN 6,410,516 : 95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells NF-κB Pathway Specification 3 classes of NF-κB inhibitors hypothesized, none of which actually reduced to practice: Specific inhibitors (I-κB inactivates NF-κB) Dominantly interfering molecules (truncated form of NF-κB) Decoys designed to mimic region of gene whose expression would be inhibited En banc Issues 1. Whether 35 U.S.C. Section 112, paragraph 1, contains a written description requirement separate from an enablement requirement? 2. If a separate written description requirement is set forth in the statute, what is scope and purpose of that requirement? En banc Issues Lilly s argument: 112/ 1 requires first, written description of invention, and written description of how to make and use the invention so as to enable one of skill in the art to make and use it. Separate written description requirement applies to all claims both original and amended to ensure that inventors have actually invented claimed subject matter

4 En banc Issues Ariad s argument: 112/ 1 requires specification to describe (i) what the invention is, and (ii) how to make and use it. But first identifying step applies only in context of priority Claim amendments during prosecution, priority under sections 119 and 120 and interference Doesn t apply to original claims since these constitute their own description. WD exists, not as independent statutory requirement, but only to identify the invention that must comply with the enablement requirement. En banc Holding Section 112, first paragraph, contains two separate description requirements: a written description [i] of the invention, and [ii] of the manner and process of making and using the [the invention]. Requirement applies to all claims (original and amended) Purpose of WD requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor s contribution to the field of art as described in the patent specification Discussion Decoys 1990 publication reported use of decoy molecules to reduce NF-ΚB activity Because priority date was 1989, disclosure in later publication cannot, as matter of law, establish that inventor possessed using decoy molecules to reduce NF-ΚB when patent application filed in After all, it is in the patent specification where the written description requirement must be met. Rochester, 358 F.3d at 926 Discussion Constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement Actual possession or reduction to practice outside of the specification is not enough Written Description vs Enablement Wands Factors (MPEP (a)) Guidelines for Written Description (MPEP 2163) The breadth of the claims; Determine what the claim as a whole The nature of the invention; covers The state of the prior art; How does application provide support for The level of one of ordinary skill; the claimed invention including each element or step The level of predictability in the art; Determine whether there is sufficient The amount of direction provided by the written description to inform a skilled inventor; artisan that applicant was in possession of The existence of working examples; and the claimed invention as a whole at the time the application was filed The quantity of experimentation needed to make or use the invention based on the Adequacy of Written Description (Ariad v. Lilly content of the disclosure. citing Capon v. Eshhar, 418 F.3d 1349, (Fed. Cir. 2005)) Existing knowledge in the particular field Extent and content of the prior art Maturity of the science or technology Court s Views on Policy Issues Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of invention that is conceive of the complete and final invention with all its claimed limitations and disclose the fruits of that effort to the public. p. 28 Predictability of the aspect at issue

5 Machine or transformation not exclusive test 101 limits bounded by three exceptions Laws of nature Physical phenomena Abstract ideas Section 101 is a dynamic provision designed to encompass new and unforeseen inventions. [T]he machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals Pre-emption analysis cited in context of claims that included algorithms practical effect to patent algorithm itself Application of law of nature or mathematical formula to known structure or process may be patentable Stevens concurrence Great hostility to business method patents On one side of the balance is whether a patent monopoly is necessary to motivate the innovation Prometheus Labs, Inc. v. Mayo (Fed. Cir. 2009) Administering drug meets transformation prong of Bilski 1. A method of optimizing therapeutic efficacy for treatment of an immunemediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 29 Prometheus v. Mayo Remand Decision December 17, 2010 Administer drug (this step omitted in claim 46) Determine level of metabolite Compare to pre-determined level, wherein measured metabolite levels indicate need to increase or decrease dose Held patentable subject matter under 101 in light of Bilski Administering and determining steps were transformative not merely data gathering 30 5

6 Prometheus v. Mayo Remand Decision December 17, 2010 Are claims drawn to natural phenomenon, patenting of which would wholly pre-empt its use, or just an application? Specific diseases, specific drugs, and therefore do not pre-empt abstract idea of calibrating drug doses to treat disease Prometheus v. Mayo Remand Decision December 17, 2010 Also reaffirmed that administration and determining steps are transformative considered claims to be essentially method of treatment claims always transformative. Same result w/ claim 46 determining step transformative Classen Immunotherapies v. Biogen Idec (Fed. Cir. 2008) A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group. Classen Immunotherapies v. Biogen Idec (Fed. Cir. 2008) In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court s grant of summary judgment that these claims are invalid under 35 U.S.C Dr. Classen s claims are neither tied to a particular machine or apparatus nor do they transform[] a particular article into a different state or thing. Bilski, 545 F.3d at 954. Therefore we affirm. Awaiting Fed. Cir. Remand decision post Bilski Strategic Patent Filings Useful for Downstream Applications of Upstream Discoveries Acknowledgments Understand the difference between a discovery and an invention and make sure to write the application to the invention. In order to fully describe the invention and thus have useful claims, additional experiments beyond those that are otherwise interesting to an academic researcher may be necessary. Use patent committee to review discoveries to analyze which discoveries lend themselves to inventions for patent applications to avoid spending resources writing applications which are less likely to lead to useful claims. Michael J. Shuster, Ph.D., Esq. Partner, IP Group mshuster@fenwick.com Pauline Farmer-Koppenol, M.S., Esq. Associate, IP Group pfarmer@fenwick.com

7 Contact Information Andrew T. Serafini, Ph.D. Partner, Intellectual Property Group