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Drafting Biotech/Pharma Patent Claims J. Timothy Meigs Senior Intellectual Property Counsel BD Technologies Research Triangle Park, NC AIPLA Patent Prosecution Basic Training Seminar August 26, 2010 1 Overview • Prominent Issues When Claiming Biotech/Pharma Inventions – Utility – Written Description – Enablement – Others • Categories of Biotech/Pharma Claims • Biotech/Pharma Claim Examples 2 Utility • 35 U.S.C. § 101 - Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. • U.S. Sup. Ct. - Substantial utility: specific benefit exists in currently available form. Brenner v. Manson (1966) 3 PTO Utility Examination Guidelines • Technology-neutral, but frequently applied in biotech/pharma cases. • Three-pronged test for utility: – Specific to the subject matter claimed – Substantial (a.k.a. “practical utility” - defines a "real world" use) – Credible (reliability based on logic and facts) • Or well-established to one skilled in the art. • See, In re Fisher (Fed. Cir. 2005) 4 Written Description/Enablement • 35 U.S.C. § 112, ¶ 1 - 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. 5 Written Description – “Possession” • 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 sought, he or she was in possession of the invention. VasCath v. Mahurkar 6 Written Description – Biotech Cases • An adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself. Fiers v. Revel • For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Eli Lilly 7 Enablement – Case Law • The specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’ In re Wright • Many factors to be considered when determining whether experimentation is ‘undue.’ In re Wands 8 Enablement – Wands Factors • Breadth of Claims • • • • Nature of the Invention State of the Prior Art Level of Skill in the Art Level of Predictability • Amount of Direction/Guidance • Presence/Absence of Working Examples • Quantity of Experimentation In re Wands 9 35 U.S.C. § 112, ¶ 2 • The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 10 35 U.S.C. § 112, ¶ 2 Potentially Indefinite Claim Terms • • • • • • • “metabolite” “residue” “analogue” “derivative” “prodrug” “precursor” “such as” / “preferably” / “for example” Source: Brian Stanton, NIH 11 35 U.S.C. § 112, ¶ 4 • Subject to the following paragraph [concerning multiple dependent claims], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 12 35 U.S.C. § 112, ¶ 4 Pfizer v. Ranbaxy (Fed. Cir. 2006) • ANDA litigation re: Lipitor (world’s best selling drug). • Pfizer’s ‘995 patent claimed: Claim 1. (1) Atorvastatin acid; (2) atorvastatin lactone; or (3) pharmaceutically acceptable salts thereof. Claim 2. The compound of claim 1, which is atorvastatin acid. Claim 6. The hemicalcium salt of the compound of claim 2. 13 Common Categories of Biotech/Pharma “Composition of Matter” Claims • Nucleic Acids • Single Nucleotide Polymorphisms • Vectors • Cells • Antisense • Interfering RNA • Ribozymes • Proteins/Peptides • Antibodies • • • • • • • • Vaccines Transgenic Organisms Viruses Kits Combinatorial Libraries Microarrays New Chemical Entities Pharmaceutical Formulations 14 Common Categories of Biotech/Pharma “Process” Claims • • • • • • Methods of Making Compositions Methods of Using Compositions Screening Assays Diagnostic Methods Gene Therapy Methods of Treatment 15 Typical Nucleic Acid Claims • An isolated polynucleotide consisting of SEQ ID NO:1. • A probe consisting essentially of SEQ ID NO:1. – Define ‘probe’ in the specification as SEQ ID NO:1 with up to 20 additional residues on either/both the 5’ or 3’ end. • An isolated polynucleotide comprising SEQ ID NO:1. • An isolated polynucleotide encoding a protein comprising SEQ ID NO:2. 16 Nucleic Acid Claims Hybridization + Function • An isolated DNA molecule comprising a nucleic acid sequence, the full-length complement of which hybridizes under stringent hybridization and wash conditions to SEQ ID NO:1, wherein said nucleic acid sequence encodes a protein with X function. – Define “stringent hybridization and wash conditions” in the specification. See, e.g., U.S. Pat. No. 6,346,655 17 Nucleic Acid Claims Percent Identity + Function • An isolated nucleic acid molecule comprising a sequence at least 80% identical to SEQ ID NO:1 and that encodes a protein having X function. • An isolated nucleic acid molecule comprising a sequence that encodes a polypeptide the amino acid sequence of which is at least 80% identical to SEQ ID NO:2, wherein said polypeptide has X function. – Define algorithm or parameters used to calculate % identity in the specification. See, e.g., U.S. Pat. No. 6,346,655 • But see Ex parte Kubin and Written Description Guidelines 18 Other Nucleic Acid Claims • Probe claim: An isolated nucleic acid molecule comprising a fragment of SEQ ID NO:1 at least 10 nucleotides in length. – Specification must describe target of probe. • By reference to deposited clone: An isolated nucleic acid molecule comprising the sequence of the ~2kb XhoI fragment deposited as ATCC#____. • Promoter claim: An isolated nucleic acid promoter comprising SEQ ID NO:1, or a fragment of SEQ ID NO:1 that retains promoter activity. 19 Single Nucleotide Polymorphism (SNP) Claims • An isolated nucleic acid molecule comprising 20 contiguous nucleotides of SEQ ID NO:1, wherein the T at nucleotide 240 is replaced with C. • An isolated nucleic acid molecule comprising a sequence that encodes a protein comprising SEQ ID NO:2, except that said protein comprises a serine-toalanine mutation at position 55. 20 Chimeric Construct and Vector Claims • A chimeric construct comprising a promoter active in tumor cells operatively linked to a nucleic acid molecule according to claim 1. • An expression vector comprising a chimeric construct according to claim 2. 21 Cell Claims • A cultured cell comprising a chimeric construct according to claim 2. • A cultured cell comprising an expression vector according to claim 3 or a progeny of said cell, wherein said cell or said progeny expresses said protein. (§ 112, ¶ 4 implications?) • A biologically pure culture of a Bacillus thuringiensis strain deposited as NRRL B21060. 22 Antisense Claims • An antisense oligonucleotide complementary to SEQ ID NO:1 that inhibits the expression of a protein encoded by SEQ ID NO:1. • An antisense oligonucleotide consisting of the sequence of SEQ ID NO:1. • An isolated nucleic acid molecule comprising at least 10 consecutive nucleotides of the complement of SEQ ID NO:1. 23 RNAi and dsRNA Claims • An interfering RNA complementary to SEQ ID NO:1 that inhibits the expression of a protein encoded by SEQ ID NO:1. • An interfering RNA consisting of the sequence of SEQ ID NO:1. • An isolated ribonucleic acid molecule comprising at least 10 consecutive nucleotides of the complement of SEQ ID NO:1. • A double-stranded ribonucleic acid molecule comprising a first strand identical to 20-25 consecutive nucleotides of SEQ ID NO:1, and a second strand complementary to said first strand. 24 Protein/Polypeptide Claims • By source, function and MW: An isolated 50 kDa protein from [source organism] that [performs X function]. – Define in specification how molecular weight is determined. • By % identity + function: An isolated protein comprising an amino acid sequence at least 90% identical to SEQ ID NO:2 that [performs X function]. 25 More Protein/Polypeptide Claims • By sequence: An isolated protein comprising the amino acid sequence set forth in SEQ ID NO:2. • By functional fragment: An isolated protein comprising the amino acid sequence set forth in SEQ ID NO:2, or a fragment thereof that retains [X function]. • By antigenic fragment: An isolated polypeptide comprising an antigenic fragment of the amino acid sequence set forth in SEQ ID NO:2. 26 Transgenic Animal Claims • A mouse homozygous for a disrupted trkB gene, wherein the trkB gene is disrupted by the insertion of a selectable marker sequence and wherein said mouse exhibits a decrease in the number of neurons which comprise the facial motor nucleus, spinal cord, trigeminal ganglia and dorsal root ganglia. U. S. Patent No. 5,625,121 27 Transgenic Plant Claims • A plant, plant tissue or plant seed having altered protoporphyrinogen oxidase (protox) activity, wherein said altered protox activity is conferred by expression of a DNA molecule encoding a herbicide tolerant protox enzyme, wherein said altered protox activity confers upon said plant tolerance to a herbicide in amounts which inhibit naturally occurring protox activity. U.S. Patent No. 6,307,129 28 Virus Claims • A tissue-specific replication-conditional adenoviral virion comprising a heterologous tissue-specific transcriptional regulatory sequence operably linked to the coding region of a gene that is essential for replication of said virion. U.S. Pat. No. 6,551,587 • A mutant rabies virus comprising a rabies virus N protein, wherein said N protein is not phosphorylated. U.S. Pat. No. 6,706,523 29 Diagnostic Claims • A method for the detection of organism X, comprising the steps of: (a) isolating DNA from an organism to be characterized; (b) subjecting said DNA to PCR amplification using at least one PCR primer having sequence identity with at least 10 consecutive nucleotides of SEQ ID NO:1; and (c) visualizing the product or products of said polymerase chain reaction amplification, whereby detection of the product or products of said polymerase chain reaction amplification indicates that the organism to be characterized is X. U.S. Patent No. 5,800,997. 30 New Chemical Entity (NCE) Claims 1. N-[1-(Cyanomethyl-carbamoyl)cyclohexyl]-4-[4-(1-propyl)-piperazin-1yl]-b enzamide, or a pharmaceutically acceptable salt thereof. 2. A pharmaceutical composition comprising a compound according to claim 1 as an active ingredient. U.S. Pat. No. 6,642,239 31 Pharmaceutical Formulation Claims • A pharmaceutical dry powder composition comprising a TGF-β in a water soluble salt chosen from calcium chloride, calcium phosphate, potassium acetate, lithium acetate, ammonium acetate and ammonium bicarbonate. U.S. Pat. No. 6,649,168 32 Method of Treatment Claims • Claim to ultimate use: A method of treating disease Y comprising the administration, to a human in need of such treatment, of an effective dose of compound X. • Claim to underlying activity: A method of inhibiting the growth of a tumor cell, comprising contacting the tumor cell with compound X. U.S. Pat. No. 6,677,366 33 Screening Assay Claims • A method for screening a chemical for the ability to inhibit X enzyme activity, comprising: (a) combining an enzyme according to claim 1 in a first reaction mixture with [the enzyme’s substrate(s)] under conditions in which the enzyme is capable of catalyzing the synthesis of [product]; (b) combining the chemical and the enzyme in a second reaction mixture with [the enzyme’s substrate(s)] under the same conditions as in the first reaction mixture; (c) determining the amounts of [product] produced in the first and second reaction mixtures; and (d) comparing the amounts of [product] produced in the first and second reaction mixtures; wherein the chemical is capable of inhibiting X enzyme activity if the amount of [product] produced in the second reaction mixture is significantly less than the amount of [product] produced in the first reaction mixture. 34 Diagnostic Claims • A method for the detection of organism X, comprising the steps of: (a) isolating DNA from an organism to be characterized; (b) subjecting said DNA to PCR amplification using at least one PCR primer having sequence identity with at least 10 consecutive nucleotides of SEQ ID NO:1; and (c) visualizing the product or products of said polymerase chain reaction amplification, whereby detection of the product or products of said polymerase chain reaction amplification indicates that the organism to be characterized is X. U.S. Patent No. 5,800,997. 35 Method of Treatment Claims • Claim to ultimate use: A method of treating disease Y comprising the administration, to a human in need of such treatment, of an effective dose of compound X. • Claim to underlying activity: A method of inhibiting the growth of a tumor cell, comprising contacting the tumor cell with compound X. U.S. Pat. No. 6,677,366 36 Method of Treatment Claims • A method for reducing or preventing the effects of inflammation arising from injured tissue, which method comprises the steps of: a. contacting the injured tissue with a green porphyrin photosensitizing agent capable of penetrating into the injured tissue and causing the desired pharmacological effect in less than one hour; and b. exposing the contacted injured tissue to light having a wavelength absorbed by the photosensitizing agent for a time sufficient to reduce or prevent inflammation in the exposed tissue, but not so long as to cause necrosis or erythema of the exposed injured tissue. U.S. Pat. No. 6,677,366 37 Thank You! J. Timothy Meigs [email protected] 919-597-6276 38