Patent Protection Technology Transfer By Todd L

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? l l l 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 ($10 K to $40 K) A tool for corporations to define markets A tool for Universities to raise money

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

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

Claims define the property

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

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

Compounds … l Breast Cancer Genes l US 5, 747, 282 which covers BRCA 1, chromosome 17 l US 5, 837, 492 which covers BRCA 2, chromosome 13 l ‘ 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 BRCA 2 polypeptides, PCR primers

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

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

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

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

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

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

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 l an optical system in the protective element having a distal lens for observation of the protective surface from the inside, l 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 l

Riek et al. … there being inside the protective surface a domeshaped interior hollow cavity, l the lens of the optical system inside the protective element being at an axial distance from the protective surface, l 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. l

Technology Transfer formal transferring of new discoveries and innovations resulting from scientific research conducted at universities to the commercial sector l 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 l

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

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

Technology Transfer l 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) l Medical Device, Diagnostic, Kit Development – Generally less expensive to develop – Faster to approval

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

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

University Licensing l Name R&D (millions) U of Washington $528 MIT $713 Stanford $391 Univ of CA. System $1, 580 Penn. State $353 Cal. Tech. $153 Rutgers $154 # of patents 34 134 64 206 19 40 25 # of start-ups 25 17 15 13 9 9 7 l Univ of Minnesota 66 6 l l l l $247

Product Stories 8 Mbps transmission in copper phone lines Cohn Cardiac Stabilizer Cyber. Mark Smart Card® Fast For. Word® Training Program Fibre. Kor® Dental Material Google Internet Search Engine Green Steel Lycos® Internet Search Engine MG 98 Cancer Therapeutic l 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Natura. TM Hearing Aid Ni. Al Memory Material OXSILAN®: Non-Toxic Corrosion Prevention Panretin® Topical Treatment Periostat® Permeable Preactive Barrier Wall Technologies Pink Beauty Potentilla Quad 7 TM Weed Control Storm. Vision. TM Software Taxol® Cancer Drug

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

Thank You www. nathlaw. com