MassMedic MeetingMarch 6, 2008

Omar Amirana, MDOxford Bioscience Partners222 Berkeley Street, Suite 1650Boston, MA 02116617-357-7474 GeneralOAmirana@oxbio.comwww.oxbio.com

Patent Portfolios that Attract Venture Capital Investment

Oxford BioScience Partners

• Boston based life science venture capital firm

• OBP Brand spans 20 years in the industry

• Five Funds totaling $1B of committed capital

• Team of 5 general partners and 5 investment professionals & Executives-In-Residence group

• Invest in Therapeutics, Medical Devices, Research Tools, and other Life Science Breakthroughs

• Invest in all stages; Find & lead over 60% of deals

• Invest worldwide

Is IP still the Wild West of Innovation?

?

Goals of IP

• Protect a Potential Product

• Protect a Path to Market

• “Own a Space”

• Create Exclusivity and Desire

• Block Competition

• Funding

• Exits

IP: “Intellectual” PropertyIP: “Intellectual” PropertyIntellectual – adjective 1. appealing to or engaging the intellect: intellectual pursuits. 2. of or pertaining to the intellect or its use: intellectual powers. 3. possessing or showing intellect or mental capacity, esp. to a high

degree: an intellectual person. 4. guided or developed by or relying on the intellect rather than upon

emotions or feelings; rational.

Property – noun1. that which a person owns; the possession or possessions of a

particular owner: They lost all their property in the fire. 2. goods, land, etc., considered as possessions: The corporation is a

means for the common ownership of property. 3. ownership; right of possession, enjoyment, or disposal of anything, esp.

of something tangible: to have property in land. 4. something at the disposal of a person, a group of persons, or the

community or public: The secret of the invention became common property.

Intellectual Property: Attention at all StagesIntellectual Property: Attention at all Stages

Litigation

EnforcementTransactions

Prosecution

IP: Asset or Liability?

• Timing of Corporate Events: Funding / Exits

• Pending vs. Issued

• Competitors; IP Landscape

• “Freedom” – To FTO or Not?

• Value Inflection Curves

• Timing to Market vs Funding vs IP Costs

• Global vs Domestic

• “Types” of IP: Method vs Device Claims

• IP can reflect on management

Example 1: Stents In 1994, there were ~400 Stent Patents*

In 2005, there were 7000+ Stent Patents* The Palmaz Stent Patent was Purportedly Worth $1M/Day

Medical Device Patent Landscape is Exploding

Results of Search in US Patent Collection database for:TTL/stent: 1981 patents. ACLM/stent: 3887 patents.

*Based on a Keyword searches Source: Townsend and Townsend

    Example 2: Guidewires         In 1974, a Modified VW Clutch Cable was used (and then Patented for use) as a Vascular Guidewire         In 2005, there were 5700+ Guidewire Patents*

Medical Device Patent Landscape is Exploding

*Based on a Keyword searches Source: Townsend and Townsend

Results of Search in US Patent Collection database for:TTL/guidewire: 491 patents.ACLM/guidewire: 2265 patents.

PercuSurge: Distal Embolic Protection

PercuSurge: IP Evolution1 6,558,401 Low profile catheter for angioplasty and occlusion (May 2003)2 6,500,147 Flexible catheter 3 6,468,230 Core wire with shapeable tip 4 6,454,741 Aspiration method 5 6,398,773 Aspiration system and method 6 6,375,629 Core wire with shapeable tip 7 6,375,628 Hollow medical wires and methods of constructing same 8 6,355,016 Catheter core wire 9 6,355,014 Low profile catheter valve 10 6,338,709 Intravascular radiation therapy device and method of use 11 6,325,778 Low profile catheter valve and inflation adaptor 12 6,325,777 Low profile catheter valve and inflation adaptor 13 6,319,229 Balloon catheter and method of manufacture 14 6,312,407 Occlusion of a vessel 15 6,273,878 Shaft for medical catheters 16 6,270,477 Catheter for emboli containment 17 6,234,996 Integrated inflation/deflation device and method 18 6,231,588 Low profile catheter for angioplasty and occlusion 19 6,228,072 Shaft for medical catheters 20 6,217,567 Hollow medical wires and methods of constructing same 21 6,190,332 Core wire with shapeable tip 22 6,159,195 Exchange catheter and method of use 23 6,156,054 Medical wire introducer and balloon protective sheath 24 6,152,909 Aspiration system and method 25 6,135,991 Aspiration method 26 6,068,623 Hollow medical wires and methods of constructing same 27 6,050,972 Guidewire inflation system 28 6,022,336 Catheter system for emboli containment 29 5,997,562 Medical wire introducer and balloon protective sheath 30 5,893,867 Stent positioning apparatus and method 31 5,833,650 Catheter apparatus and method for treating occluded vessels 32 5,833,644 Method for emboli containment (Nov 1998)

PercuSurge: 1st Issued Patent in 1998

Financing history($, millions)

9

7

21

15

5

25

57

100

125

110

16

80

50

2.250

75

150

225

1995 1996 1997 1999 2000 2000

Start-up Dev Beta Commercialization

225

Product Launch

Source: Venture Source

• Developed and commercialized embolic protection devices

• Raised $54M in private capital

• Bought by Medtronic in 2000 for $225M

• Without revenues, would have likely been valued at $100M

• Investors doubled their return by launching product

100-120

Pioneer

1st Patent issues: Nov. 10, 1998 5,833,644 Zadno-Azizi, et alMethod for emboli containment

Medical Devices Have an Almost "Ideal" Business Cycle for Patenting: 

High Value ProductsTypically ~3 to ~9 Year Cycle

Initial Product Development / FDA ApprovalInitial Patent Application/Broad Patent CoverageSignificant Product Commercial Life (Often 10+ Years) Incremental Product Improvements after initial Approval

Absent IP, Reduced Barriers to Entry for Second in Field

Why the Medical Device Patent Explosion?

Technologically Interdisciplinary Anatomy & Physiology Mechanical Visualization: Optical, Ultrasound, MRI, CT, . . . Electrical: RF and Microwave Power, Data ProcessingDrug Delivery, Diagnostics, Implantables, . . .

Subtle Differences Result in Vastly Different Patient Outcomes

US and International Laws Distinguish Between “Medical” and Other Patents

Valuable Patents Reflect The Industry’s Business Models Disposables/Consumables and Capital Equipment

Marketing to Interv. Cardiologists vs. Cardiac Surgeons

Med. Dev. Prosecution has Become Highly Specialized

As Medical Patents Surge, So Do Lawsuits…

• Tresa Baldas The National Law Journal July 16, 2007

• A surge in patents that protect surgeries and other medical methods has triggered numerous lawsuits in recent years, with inventors fighting more vigorously than ever to protect their intellectual property rights.

• The medical community is weary of the trend, noting that threats of patent infringement litigation could interfere with effective patient care.

• Attorney John Dragseth of the Minneapolis office of Fish & Richardson said he has noticed a new trend: doctors getting their own patents, and then asserting them against medical device companies in court.

• Dragseth cited the recent case of Dr. Gary Michelson, who in 2005 received a $1.35 billion settlement after suing a medical device company over his patented spinal surgical technique that speeds recovery. Medtronic v. Michelson, No. 01cv2373 (W.D. Tenn.).

http://www.law.com/jsp/article.jsp?id=1184576791631

As Medical Patents Surge, So Do Lawsuits

• Last month, a veterinarian who sued a surgical instrument maker over his patented technique for declawing a cat also won his case when the U.S. Court of Appeals for the Federal Circuit upheld his patent. Young v. Lumenis, No. 06-1455 (S.D. Ohio).

• About 100 medical-process patents are issued a month -- double the amount in the 1980s, according to the American Association of Orthopedic Surgeons, the Georgetown Journal of Legal Ethics and other legal and academic journals.

• 1996 federal law prohibits method infringement lawsuits against doctors. But medical device makers can be sued for inducing infringement of a method by a doctor. And universities and companies are increasingly trying to impose restrictions on the use of their intellectual property.

http://www.law.com/jsp/article.jsp?id=1184576791631

• February 22, 2008 - In a landmark decision, the Supreme Court upheld initial lower court rulings that medical device manufacturers cannot be held liable in state tort cases if the device has been approved by the Food and Drug Administration. The case, Reigel v. Medtronic, is significant because it reaffirms that existing Federal device approval laws preempt individual state regulations. Specifically, the ruling applies to devices approved by the FDA under a premarket approval (PMA) application.

http://www.medicaldevices.org/public/

Supreme Court Limits Lawsuits Against Medical Device Manufacturers

Friday February 15, 3:11 pm ET By Mark Jewell, AP Business Writer

• BOSTON (AP) -- A patent judgment against Boston Scientific Corp. has jumped to $501 million after a judge tacked on an additional $69 million in interest. U.S. District Judge John Ward ruled Thursday to expand the damages award -- decided by a federal jury in Marshall, Texas -- to cover interest on royalties dating to the medical device maker's 2004 U.S. launch of drug-coated heart stents.

• After deliberating less than two hours, jurors awarded $432 million on Monday to Dr. Bruce Saffran, who argued the stents violated his 1997 patent covering technology to deliver medication within the body to heal injuries.

• Saffran, a radiologist from Princeton, N.J., filed a similar patent challenge against Johnson & Johnson over its Cypher stent. That case is pending in Ward's court, an East Texas district that is a popular venue to bring patent claims.

• Saffran's award involving Boston Scientific covers only past royalties. The judge also ordered that the question of future royalties be split into a separate case after the doctor files a new complaint covering that issue. Ward ordered Boston Scientific to file quarterly reports with the court on sales of its top-selling product, the Taxus Express stent, and the next-generation Taxus Liberte.

Damages in Stent Patent Case = $501M

• NEW BRUNSWICK, N.J. and MENLO PARK, Calif., Nov. 16 /PRNewswire-FirstCall/ -- Johnson & Johnson and Conor Medsystems, Inc. a cardiovascular device company, today announced a definitive agreement whereby Johnson & Johnson will acquire Conor Medsystems for approximately $1.4 billion.

• The acquisition of Conor Medsystems by Johnson & Johnson will provide Cordis Corporation, a Johnson & Johnson company, with a unique controlled drug delivery technology. This technology is currently employed on the CoStar® Stent System, a paclitaxel-eluting cobalt chromium stent with a bioabsorbable polymer. The CoStar® Stent is currently sold outside the United States, and enrollment in its U.S. pivotal clinical trial has been completed.

JNJ Acquires Conor Medsystems for ~$1.4B

Even with Great Advances, Caution is Prudent

Consult the Experts; Hire Excellent IP Attorneys

Summary: IP = Asset which should Build Value

• Protects a Blockbuster Product

• Protects a Path to Market

• “Owns a Space”

• Creates Exclusivity and Desire

• Blocks Competition

• Is Budgeted for; has a Strategy

• Encourages Funding

• Helps Drive Exits

MassMedic MeetingMarch 6, 2008

Omar Amirana, MDOxford Bioscience Partners222 Berkeley Street, Suite 1650Boston, MA 02116617-357-7474 GeneralOAmirana@oxbio.comwww.oxbio.com

Patent Portfolios that Attract Venture Capital Investment