Nanotech for MedTech: Nanotechnology’s Impact on Medical Device Innovation “An Overview”

1. MassMedicApril 10, 2007 Nanotech for MedTech:Nanotechnology’s Impact on Medical Device Innovation“An Overview” Chinh H. PhamGreenberg Traurig, LLP(617) 310-6239phamc@gtlaw.comwww.gtlaw.com

2. MassMedicApril 10, 2007 • Overview 1. Definition 2. Impact of Nanotech on Med Devices 3. Current Nanotech Applications in Med Devices 4. Opportunities 5. Capitalizing on Nanotech IP 6. Viable IP Strategies for Capitalization

3. MassMedicApril 10, 2007 • Definition nanotechnology: a term referring to a wide range of technologies that measure, manipulate, or incorporate materials and/or features with at least one dimension between approximately 1 nm and 100 nm; such applications exploit the properties, distinct from bulk/macroscopic systems, of nanoscale components. (ASTM International – Standard Terminology Relating to Nanotechnology, November 2006)

4. MassMedicApril 10, 2007

5. MassMedicApril 10, 2007 • Impact of Nanotech on Med Devices - Surgical and diagnostic tools can be elegantly and inexpensively made Sensor can be small enough to fit into a living cell Hundreds of diagnostic tests can be built into a single inexpensive hand- held device Providing single molecule detection technology

6. MassMedicApril 10, 2007 • Impact of Nanotech on Med Devices - Diagnosis and detection can be performed quickly and more efficiently Real time monitoring allows for rapid response Detect onset of diseases far earlier than before symptoms appear More datapoint can be gathered quickly

7. MassMedicApril 10, 2007 • Impact of Nanotech on Med Devices - Devices can be implanted on a permanent basis Continuous monitoring and recording of a person’s state of health Permit sensitive adjustment Allow for early detection of problems

8. MassMedicApril 10, 2007 • Impact of Nanotech on Med Devices - Replacing or augmenting organs Sensory organs Bones Skin & muscles

9. MassMedicApril 10, 2007 • Current Nanotech in Med Devices - Surgery Suture needle with stainless steel nanocrystals (1-10 nm) (AB Sandvik, Sweden) Diamond-coated surgical blade (surface roughness 20-40 nm) (Gesellschaft fur Diamantprodukte mbH, Germany)

10. MassMedicApril 10, 2007 • Current Nanotech in Med Devices - Cancer Therapy Photothermal ablation using gold coated silica nanoshells (Nanospectra Biosciences Inc., US) Magnetic field-induced thermotherapy using superparamagnetic iron oxide nanoparticles (Triton BioSystems Inc., US)

11. MassMedicApril 10, 2007 • Current Nanotech in Med Devices - Biosensors Glucose detection and analysis from nanovolume sample for diabetes monitoring (Agamatrix, MA) Nanoscale structure array for biochip applications (multiple biological tests on a chip) (Inanovate, MA)

12. MassMedicApril 10, 2007 • Current Nanotech in Med Devices - Molecular Imaging MRI using superparamagnetic iron oxide nanoparticles (50-500 nm) (Advanced Magnetics Inc., US) Ultrasonic imaging using nanobubbles (ImaRex Therapeutics, US) Nuclear imaging using radionuclides attached to perfluorocarbon nanoparticles (Dow Chemical, US)

13. MassMedicApril 10, 2007 • Current Nanotech in Med Devices - Implantable Devices Bone replacement materials (Angstrom Medica, MA) Nano-structured coatings for orthopedic implants (Spire Biomedical, MA) Retinal neuroprotheses for vision rehabilitation (Optobionics, US)

14. MassMedicApril 10, 2007 • Opportunities • Global demand for nanoscale materials, devices and tools will hit around $28 billion by 2008 • U.S. nanotechnology market is predicted to reach around $3.3 billion by 2008 and around $19.8 billion by 2013 • U.S. has the largest share of global investment in nanotechnology • Patent filings have increased as companies are in an IP land-grab • Companies forming collaboration with labs, fabs, and partners to generate revenues • Companies looking at IP as a product - inventing and out-licensing IP

15. MassMedicApril 10, 2007 • Capitalizing on Nanotech IP • Companies are looking to recoup R&D expenses • Enhance market share • Create a premium for product pricing • Generate barrier to entry for competitors

16. MassMedicApril 10, 2007 • Capitalizing on Nanotech IP - Patents are key to control nanotech industry - Patent strategy is critical to stake claims in nanotech patent gold rush

17. MassMedicApril 10, 2007 • Capitalizing on Nanotech IP - Nanotech patents tripled between 1996 and 2004, and trend continues in 2005 and 2006

18. MassMedicApril 10, 2007 Nanotech Patents by Application in 2004 Instrumentation, Tools, Metrology, Standards Medical11% Environmental Science 9% Nanoelectronics31% 2% Medical Nanoscale Science in Materials Chemical21% Chemical Instrumentation 26% Nanoelectronics Source: Nanotechnology Researchers Network of Japan

19. MassMedicApril 10, 2007 • Capitalizing on Nanotech IP - Companies must develop careful strategies to stake patent claims in ever changing nanotech patent landscape

20. MassMedicApril 10, 2007 • Capitalizing on Nanotech IP - Patent Aggressively - Nanotech patent filings will continue to increase due to 21st Century Research & Development Act - File applications early and often - Strong patent portfolios attract investors and help avoid litigation

21. MassMedicApril 10, 2007 • Capitalizing on Nanotech IP - Only small percentage of nanotech patents have shown commercial value - Investors look closely at patent quality to determine value - Applicants should want defensible patent with claim scope as broad as prior art allows

22. MassMedicApril 10, 2007 • Viable IP Strategies - Understanding the Patent Landscape 1. Know the competitors (based on ownership/ assignee information) 2. Know the trends (based on issued patents and filings) 3. Determine whether competitive position exists (# competitors (low) vs. # of patents and/or filings (low)) 4. Determine – based on citation information - where viable opportunities may lie - whether licensing (or cross-) opportunity may exist (repeated citation of patents in an area) - whether roadblock exists

23. MassMedicApril 10, 2007 • Viable IP Strategies - Strengthen Your IP Portfolio Build picket fence around core tech to prevent design around Determine gaps in competitor’s portfolio and file where gaps exist - Block competitors from expanding outward and create cross-licensing opportunities Acquire a portfolio that can put company in immediate competitive position or where trends may be heading toward (if a late comer)

24. MassMedicApril 10, 2007 • Summary • Many medical and medical device applications involving nanotechnology in the short term and long term • Market for nanotech in medtech is tremendous • One constant in nanotechnology is fervor over nanotech patents • Developing portfolio that protects and leverages nanotech inventions is critical to success

25. MassMedicApril 10, 2007 THANK YOU! Chinh H. PhamGreenberg Traurig, LLP(617) 310-6239phamc@gtlaw.comwww.gtlaw.com