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Patent Protection & Technology Transfer

Patent Protection & Technology Transfer. By Todd L. Juneau Washington, D.C. www.nathlaw.com Engineering Research Center for Computer Integrated Surgical Systems and Technology Seminar of 18 October 2001. What is a patent?.

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Patent Protection & Technology Transfer

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  1. Patent Protection & Technology Transfer By Todd L. Juneau Washington, D.C. www.nathlaw.com Engineering Research Center for Computer Integrated Surgical Systems and Technology Seminar of 18 October 2001

  2. What is a patent? • Grant of the right to prevent others from making, using, selling, or importing the claimed invention for 20 years from filing an application for patent • A technology asset recognized by the financial community and useful for raising capital • A two year legal odyssey for inventors • A new boat for patent lawyers ($10K to $40K) • A tool for corporations to define markets • A tool for Universities to raise money

  3. What is in a patent? • Abstract • Filing date • Background • How to make and use the invention • Examples • Claims

  4. Secrecy • Confidentiality Agreement • Determine amount to show and tell: • First Meetings, only the abstract • Due Diligence Meetings, entire application • Disclosure to public: • General Rule: Disclosure Kills • Exception: 1 year Grace period in U.S. • Exception: 6 mo. EPO, JPO research

  5. Claims define the property

  6. Compounds Compositions Formulations Processes Methods of Use in Treatment Diagnostic Methods and Kits DNA, RNA Proteins, Enzymes Genes, vaccines Industrial processes Plants Animals What is claimable?

  7. Amgen - EPO Lilly - hGH, Humulin Scios – bradykinin antagonist peptides Erasmus Univ., transgenic goat for enzyme deficiency, proteins in milk Washington University Lens cell line Onco Mouse Harvard to DuPont, DuPont to PHS for noncommercial use http://ott.od.nih.gov/textonly/oncomous.htm U.S. Pat. Nos. 4,736,866, 5,087,571 and 5,925,803 Examples of Compounds

  8. Breast Cancer Genes US 5,747,282 which covers BRCA1, chromosome 17 US 5,837,492 which covers BRCA2, chromosome 13 ‘492 patent claims normal gene & mutated gene(s) in general a specific claim to gene with 39 specifically defined mutations cloning and expression vectors, transformed cells, and methods of producing the BRCA2 polypeptides, PCR primers Compounds …

  9. Chakrabarty, bacteria US 4,535,061and US 4,259,444 Lactobacillus Doxil® (liposomal doxorubicin HCl - Alza) Engerix-B® (r-Hep B vaccine - SKB) Bioinformatics Celera Discovery System(TM) Compugen Compositions, Formulations, and Processes

  10. Diagnostics Cystic fibrosis gene patent US 5,776,677 PsA Test for Prostate Cancer US 5,242,802 Metastatin Pharmaceuticals, BPH Assay for Precursor to Prostate Cancer 6,054,320

  11. Surgical Devices • Medical Needle U.S. Pat No. 6,001,084 • Abdomino-Pelvic Lavage U.S. Pat. No. 5,336,171 • Trans-cutaneous Analyte Monitoring, U.S. Pat. No. 5,632,310 • Syringe with Retractable Needle, U.S. Pat. No. 5,843,034

  12. Robotic Surgery • 6,246,898Method for carrying out a medical procedure using a three-dimensional tracking and imaging system • 6,246,200Manipulator positioning linkage for robotic surgery • 6,231,585Device for stabilizing a treatment site and method of use • 6,231,526System and method for augmentation of surgery

  13. Robotic Surgery … • 6,223,100Apparatus and method for performing computer enhanced surgery with articulated instrument • 6,206,903Surgical tool with mechanical advantage • 6,201,984System and method for augmentation of endoscopic surgery • 6,198,794Apparatus and method for planning a stereotactic surgical procedure using coordinated fluoroscopy

  14. Claim define the Value • U.S. Patent No. 6,001,084 to Riek et al.1. Medical needle • with a cannula tube whose distal end is cut obliquely to a sharp tip, • with a coaxially mounted tubular protective element in the cannula tube • which can be moved axially from a forward position against a spring force into a rear position

  15. Riek et al. … • and which is closed at its distal end by a transparent, blunt protective surface that projects in the forward position distally beyond the tip and in the rear position is behind the tip, and • an optical system in the protective element having a distal lens for observation of the protective surface from the inside, • characterized by the fact that the protective surface is arched forward at its distal end, that the protective element is hollow up to the arched area of the protective surface

  16. Riek et al. … • there being inside the protective surface a dome-shaped interior hollow cavity, • the lens of the optical system inside the protective element being at an axial distance from the protective surface, • and in the distal, front position of the protective element, the tip of the cannula tube lies in an area in which the arched protective surface makes a transition into the cylindrical, external casing surface of the protective element.

  17. Technology Transfer • formal transferring of new discoveries and innovations resulting from scientific research conducted at universities to the commercial sector • 1) the disclosure of innovations; 2) patenting the innovation concurrent with publication of scientific research; and 3) licensing the rights to innovations to industry for commercial development

  18. Tech Transfer • Prior to 1980 - <250 patents per year • 1999 • 3,914 new license agreements • 417 new product introductions • 18,617 active license agreements • $35 billion in sales of licensed items

  19. Bayh Dole Act, 1980 • Royalties earned by academic institutions are reinvested in the University • new opportunities for graduate students, buy research equipment, or fund new research • pay for a portion of the legal fees associated with patenting and licensing as well as technology management staff • portion of the revenues is shared with the university inventor

  20. Technology Transfer • Drug Development • $500 million/drug to develop • 12-15 years from lab to approved drug in U.S • Drug Development failure rate is high (1 in 5-10,000) • Medical Device, Diagnostic, Kit Development • Generally less expensive to develop • Faster to approval

  21. Identifying the foundation technology. Client interviews. Surveying the terrain/competitors. Competitive monitoring IPR searches Developing a strategy. Identifying business goals Securing IP rights. Domestic and international Converting rights to riches. Licensing, Enforcement of Market Converting Information to Advantage

  22. Federal Grants Venture Capitalists, Usually require animal data Foundation Grants Friends and Family Incubator Facilities Corporate Partnering Law Firm Funding Personal Checkbook Raising Capital

  23. University Licensing • Name R&D (millions) # of patents # of start-ups • U of Washington$5283425 • MIT$71313417 • Stanford$3916415 • Univ of CA. System$1,58020613 • Penn.State $353199 • Cal. Tech.$153409 • Rutgers$154257 • Univ of Minnesota$247666

  24. 8Mbps transmission in copper phone lines Cohn Cardiac Stabilizer CyberMark Smart Card® Fast ForWord® Training Program FibreKor® Dental Material Google Internet Search Engine Green Steel Lycos® Internet Search Engine MG98 Cancer Therapeutic NaturaTM Hearing Aid NiAl Memory Material OXSILAN®: Non-Toxic Corrosion Prevention Panretin® Topical Treatment Periostat® Permeable Preactive Barrier Wall Technologies Pink Beauty Potentilla Quad 7TM Weed Control StormVisionTM Software Taxol® Cancer Drug Product Stories

  25. Big Winners • Michigan State University, $160 million, two cancer-related patents (Blumenstyk 1999) • University of Florida $37 million, Gatorade • Iowa State University $27 million, fax algorithm • Stanford University, $143 million, recombinant DNA gene-splicing patent, Odza 1996

  26. Thank Youwww.nathlaw.com

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