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NC State Bbs 201 Intro To Biopharmaceutical Science April 3  2009
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    NC State Bbs 201 Intro To Biopharmaceutical Science April 3  2009 NC State Bbs 201 Intro To Biopharmaceutical Science April 3 2009 Presentation Transcript

    • Introduction to Biopharmaceutical Science Intellectual Property (BBS 201) April 3, 2009 Presented by: Stan Antolin Smith Moore Leatherwood LLP 300 N. Greene St., Suite 1400 Greensboro, NC 27401 T: 336-378-5516 © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Biotechnology & Intellectual Property • A problem – osteoarthritis • Intellectual property • Osteoarthritis – finding a cure for • Biology – a basic review • Developing patent protection • Summary
    • Osteoarthritis — Aggrecan • Articular cartilage – Cushions bones of the knee – Degradation  erosion eventually bones of the joint grind or rub together • Aggrecan – Major extracellular component of articular cartilage – Responsible for providing compressibility and elasticity – Loss implicated in the degradation of articular Deluzio, Queen's University, Kingston, ON. Canada cartilage Peprotech Korea Limited. Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Osteoarthritis — Aggrecanase – Capable of cleaving aggrecan at the glu373-ala374 bond – Could contribute to aggrecan cleavage in osteoarthritis – Could be synthesized by osteoarthritic human articular cartilage J Biol Chem. 2008 Jan 18; 283(3):1501-7 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Osteoarthritis — Aggrecanase Aggrecanase – Difficult to isolate and purify – Poor stability – Generally low expression levels – Difficult to develop inhibitors and treatment therapies to treat diseases that involve aggrecan cleavage J Biol Chem. 2008 Jan 18; 283(3):1501-7 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Osteoarthritis — Aggrecanase • Aggrecanase – Identify novel forms with improved stability – Develop ways to • Produce large amounts • Isolate aggrecanase • Purify aggrecanase • Investigate aggrecanase role in disease states
    • Osteoarthritis — Aggrecanase • Aggrecanase – Develop treatments involving aggrecan cleavage • Therapies • Compositions
    • Intellectual Property: An Overview Recognizing ownership in ideas generated by creative thinkers. – FDA Exclusivities (US Food and Drug Administration) – EMEA Exclusivities (European Medicines Evaluation Agency) – Trademark or Service Mark – Copyright – Trade Secret – Patent
    • FDA Exclusivities — IND & NDA or BLA Time to develop a drug = 10–15 year Investigational New New Drug Application (NDA) / Drug Application (IND) Biologic License Application (BLA) Cost to develop a biologic Cost to develop a drug 2006 = $1.2 billion 2006 = $1.3 billion Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Trademarks and Service Marks – Trademark (goods) – Service mark (services) – Words, names, symbols, designs, or combinations – Source and quality – Standard: • Priority of use and • Likelihood of confusion – Duration: • Infinite life tied only to use Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Trade Secrets – Protect business or technical information – Actual or potential commercial value • unknown or unascertainable through ~ Independent development or ~ reverse engineering, and – Maintained secret using reasonable effort under the circumstances • Infinite protection as long as secret OR have tried to keep it that way – Once out, no protection if no reasonable efforts. • Need to have a confidentiality procedure in place, and follow that procedure, before the trade secret is disclosed to ANYONE.
    • Copyrights – Protect “original works of authorship” – Idea expressed in a tangible form – Life of author plus 70 years Registration: Receive the exclusive right to: • Protection is automatic but • Reproduce registration allows you to sue • Create derivative works infringers and receive statutory • Distribute damages plus attorneys’ fees • Perform • Easy and inexpensive • Display the work publicly
    • Patents – Protect inventions • standard: useful, novel, and non-obvious • Duration: 20 years from date of filing What A patent protects: EXCLUDSIONARY right : • Utility • EXCLUDE others from making, – Machine using, selling, offering for sale, – Process or importing in the U.S. The product or process of the claim – Article of manufacture – Composition Do not receive right : – An improvement thereof • To make or use the product or use • Design (14 years from grant) the process of the claim • Plant
    • The Patent Bargain Inventor receives : • Right to EXCLUDE others from making, using, selling, offering for sale, or importing in the US • Does NOT give the owner any right to make or use Public receives: • Disclosure of the best way to solve a problem • Right to use that solution once the inventor’s rights are exhausted
    • Design Patents Protects the appearance of an invention • Does not protect structural or functional features Duration is fourteen years from grant date There is only one claim Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Plant Patents • Protects asexually reproduced plant varieties • Duration is 20 years from date of application • There is only one claim in a plant application
    • Utility Patents “Anything under the sun that is made by man” (Almost) – Machine – Process – Article of manufacture – Composition – An improvement thereof Diamond v. Chakrabarty, 447 U.S. 303 (1980),
    • Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • International Patent Protection Patents are Territorial: Each Country Gets An Application. Different Laws: Variations of the Same Application. Treaties: PCT and Paris Regional Patent Offices: WIPO, EPO, OAMPI, EAPO . . . . United States: Everywhere Else: – First to Invent – First to File – Publication One Year – No Prior Publication in Advance
    • Utility Patents Utility patents are the most common type of patent granted by the USPTO. Duration: 20 years from date of application (Plus Up to 5 years FDA Exclusivity)
    • Aggrecan Monomer — Aggrecanase • Aggrecanase – Identify novel forms with improved stability – Develop ways to • Produce large amounts • Isolate aggrecanase • Purify aggrecanase • Investigate aggrecanase role in disease states Peprotech Korea Limited. 18; 283(3):1501-7 J Biol Chem. 2008 Jan Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Truncated Aggrecanase Aggrecanase X X TSP TSP partial or complete thrombospondin (TSP) deletion can stabilize aggrecanase Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Now What? Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Courtesy: U.S. Department of Energy Genome Program Smith Moore Leatherwood LLP 24 © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Primary (a), secondary (b), tertiary and quaternary (c) structure of HCC Nature Structural Biology 8, 316 - 320 (2001) Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Eukaryotes Transcription  mRNA Courtesy: National Human Genome Research Institute. Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • DNA is transcribed into RNA and RNA is translated into Protein Courtesy: National Human Genome Research Institute. Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Degeneracy of the Genetic Code Of the 64 codons, 61 specify one of the 20 amino acids. The other 3 codons are chain-terminating codons and do not specify any amino acid. AUG, one of the 61 codons that specify an amino acid, is used in the initiation of protein synthesis. Smith Moore Leatherwood LLP 28 © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Eukaryotes Transcription  mRNA Courtesy: National Human Genome Research Institute. Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Reverse Transcriptase (RT): mRNA  cDNA • Reverse transcriptase (RT) & DNA polymerase used to make a complimentary DNA (cDNA) strand – Contains no introns – Complimentary to a mRNA Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Truncated Aggrecanase X X TSP TSP partial or complete thrombospondin (TSP) deletion can stabilize aggrecanase Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Truncated Aggrecanase X X TSP Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Biopharmaceutical Production Process Insert gene into DNA vector Transfer into host cell Express desired protein Grow cells in bioreactors Extract, Purify, Dilute Kleinberg M, et al. Am J Health-Syst Pharm. 2004;61:695-708. protein therapeutic Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Protecting Nucleic Acid Sequence 1. An isolated DNA comprising the sequence set forth as SEQ ID NO: 33. 2. A cDNA comprising the sequence of SEQ ID NO: 33. 3. An isolated nucleic acid comprising the nucleotide sequence of SEQ ID NO: 33, or a degenerate variant of SEQ ID NO: 33. Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Protecting Amino Acid Sequence 1. A polypeptide comprising the amino acid sequence of SEQ ID NO: 13. 2. A truncated aggrecanase comprising the sequence set forth as SEQ ID NO: 13. 3. An amino acid comprising SEQ ID NO: 13, wherein the polypeptide cleaves aggrecan. Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Requirements for Patentability • Patentability over the prior art – Novelty – Non-obviousness • Disclosure requirements – Utility – Specification • Enablement • Best mode • Written description 36
    • Patentability over the Prior Art —Novelty • single reference • discloses every element of claimed invention Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Abbaszade, I. et al. J. Biol. Chem. 1999;274:23443-23450 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patentability over the Prior Art — Non-obviousness • Multiple references • Predictability • Motivation to combine • Teach or suggest claimed invention • Reasonable expectation of success Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patentability over the Prior Art — Non-obviousness Sites of cleavage of aggrecan monomer by aggrecanase Tortorella, M. et al. J. Biol. Chem. 2000;275:25791-25797 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patent Summary Patentability over the prior art – Novelty – Non-obviousness • Disclosure requirements – Utility – Specification • Best mode • Enablement • Written description
    • Patent Summary • Specification – Best mode – Enablement • Teach one skilled in the art • Make and use the claimed invention • Without undue experimentation • Disclose nascent technology – Written description • Demonstrate applicant’s possession of the claimed invention • Provide disclosure of structure, formula, chemical name, or physical properties 43
    • Ways of Recognizing Ownership in Ideas Generated by Creative Thinkers: – FDA exclusivities (US food and drug administration) – EMEA exclusivities (European medicines evaluation agency) – Trademark or service mark – Copyright – Trade secret – Patent
    • Thank you Stan Antolin stan.antolin@smithmoorelaw.com T: 336-378-5516 F: 336-433-7591 © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Intellectual Property Overview Links • United States Patent Office (USPTO): – www.uspto.gov – FAQs: http://www.uspto.gov/main/faq/index.html – Trademark Search Engine: http://www.uspto.gov/ebc/tess/index.html – Patent Search Engine: http://www.patentfetcher.com/ – Patent Search Engine: http://www.google.com/patents – Trademarks Basic Information: http://www.uspto.gov/web/offices/tac/doc/basic/ • NC State Trademarks available at: http://www.ncs.ncsu.edu/trademark/index.html Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Why IP Is Important Links • Bessen, James E. & Meurer, Michael J.,The Private Costs of Patent Litigation, available at http://ssrn.com/abstract=983736 • USPTO 2007 Annual Report available at http://www.uspto.gov/web/offices/com/annual/index.html Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patent Primer Links • USC: http://www.gpoaccess.gov/uscode/index.html • CFR: http://www.gpoaccess.gov/cfr/index.html • MPEP: http://www.uspto.gov/web/offices/pac/mpep/mpep.htm • USPTO’s general design patent page http://www.uspto.gov/web/offices/pac/doc/general/design.htm • USPTO’s general plant patent page http://www.uspto.gov/web/offices/pac/doc/general/plant.htm • USPTO’s general treaties and foreign patents page http://www.uspto.gov/web/offices/pac/doc/general/treaties.htm • Bessen, James E. and Meurer, Michael J., The Private Costs of Patent Litigation, available at http://ssrn.com/abstract=983736 • Article on the AIPLA survey regarding cost of litigation. http://lawdepartmentmanagement.typepad.com/law_department_managem ent/2005/03/costs_of_patent.html • Ronald Schutz and Ken Hall, Strategies for Patent Holders Contemplating Litigation, available at http://www.rkmc.com/Strategies_for_Patent_Holders_Contemplating_Litigati on.htm Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patent Update Links • Licensing – MedImmune v. Genentech, available at http://www.supremecourtus.gov/opinions/06pdf/05- 608.pdf – O'Connor, Sean M., Using Stock and Stock Options to Minimize Patent Royalty Payment Risks After Medimmune v. Genentech, available at http://ssrn.com/abstract=977342 – http://www.law.com/jsp/article.jsp?id=1169806049217 • Injunctions – eBay v. MercExchange, available at http://www.supremecourtus.gov/opinions/05pdf/05- 130.pdf – Eric Wesenberg & Peter O'Rourke, The Toll on the Troll: The Implications of 'eBay v. MercExchange‘, available at http://www.law.com/jsp/article.jsp?id=1147943132930 • Obviousness – KSR v. Teleflex, available at http://www.supremecourtus.gov/opinions/06pdf/04-1350.pdf – J. Matthew Buchanan, KSR International v. Teleflex Inc., fedcirc.us, available at http://www.fedcirc.us/case-reviews/ksr-international-v.-teleflex-inc.html – USPTO guidelines on examination in light of the KSR decision, http://www.uspto.gov/web/offices/com/sol/notices/72fr57526.pdf – Jay Sandvos, How KSR v. Teleflex should change your patent strategies, available at http://www.edn.com/index.asp?layout=article&articleid=CA6442383 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patent Update Links • Patent Infringement: – http://www.mwe.com/index.cfm/fuseaction/publications.nldetail/o bject_id/2fc2350a-5379-42f7-a9f5-4faa65146c32.cfm • Biotechnology: – Janis K. Fraser, Ph.D., U.S. Gene Patents in Legal Limbo –– for Now, available at http://www.ipfrontline.com/depts/article.asp?id=18311&deptid=4 – Harold C. Wegner, Biotechnology Law Report, available at http://www.liebertonline.com/doi/pdfplus/10.1089/blr.2007.9915 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patent Update Links • Software/Business Methods: – Hung H. Bui, In Re Bilski, No. 2007-1130 (Fed. Cir. Feb. 15, 2008, available at http://www.ipfrontline.com/depts/article.asp?id=20898&deptid=7 – USPTO guidelines November 22, 2005, available at http://www.uspto.gov/web/offices/com/sol/og/2005/week47/patgupa.htm – Foundation for a Free Information Infrastructure, http://www.ffii.org/ – Non profit: http://www.spi.org/home.jsp – Deputy Commissioner’s May 18, 2008 memo: http://www.uspto.gov/web/offices/pac/dapp/opla/preognotice/section_10 1_05_15_2008.pdf – Anti-software patent: http://www.out-law.com/page-9447 – ecommerce patents, Arner, Erika Harmon, Yoches, E. Robert, Recent Developments of E-Commerce Patents: The Ever Precarious Nature of E-Commerce Patent Protection in the U.S., available at http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=d3 faffe2-c076-49bc-bffa-b1c74d37a6a0 Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.
    • Patent Update Links • Evaluation: – Intellectual Property valuation article: www.ipmetrics.cc/IPVT.pdf – Michael Fitzgerald, A Patent Is Worth Having, Right? Well, Maybe Not, available at http://www.nytimes.com/2007/07/15/business/yourmoney/15prot o.html?_r=1&ref=yourmoney&oref=slogin – Pro-trade secrets: http://www.jordasecrets.com/ – Checklist comparing trade secret and patent protection: http://www.iphandbook.org/handbook/chPDFs/ch11/ipHandbook- Ch%2011%2005%20Jorda%20Trade%20Secret%20Licensing.p df • Smith Moore Leatherwood, LLP: http://www.smithmoorelaw.com/ Smith Moore Leatherwood LLP © 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.