Practical Strategies for Managing Patent Rights for Biotechnology and Medical Device Companies

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1 Practical Strategies for Managing Patent Rights for Biotechnology and Medical Device Companies Timothy A. Worrall, Ph.D. Partner Dorsey & Whitney LLP Brad J. Hattenbach Of Counsel Dorsey & Whitney LLP Thomas A. Beaton Senior IP Counsel Covidien

2 Patent Basics: Anatomy of a Patent A Patent gives the right to exclude others Specification Abstract Detailed Description Figures Claims - Define the inventive technology owned by the patent holder

3 Patent Basics: Pharmaceutical Claims 1. A compound of Formula (V): Cl R 1 O O O R 2 R 3 O (V) H N or a pharmaceutically acceptable salt, hydrate or solvate thereof, wherein: R 3 and R 4 are each hydrogen; R 1 is selected from the group consisting of methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, tert-butyl, n-pentyl, isopentyl, sec-pentyl, neopentyl, 1,1-diethoxyethyl, phenyl and cyclohexyl; and R 2 is selected from the group consisting of hydrogen, methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, phenyl and cyclohexyl. O O R 4 U.S. Patent 7,109,239 To XenoPort, Inc.

4 Patent Basics: Antibody Claims 1. A purified anti-cd30 antibody, said antibody comprising a heavy chain and a light chain, wherein said heavy chain comprises a VH CDR1 comprising the amino acid sequence of SEQ ID NO: 23, a VH CDR2 comprising the amino acid sequence of SEQ ID NO: 30, and a VH CDR3 comprising the amino acid sequence of SEQ ID NO: 25, and wherein said light chain comprises a VL CDR1 comprising the amino acid sequence of SEQ ID NO: 33, a VL CDR2 comprising the amino acid sequence of SEQ ID NO: 34, and a VL CDR3 comprising the amino acid sequence of SEQ ID NO: A method of inhibiting proliferation of a cell expressing CD30, wherein said method comprises contacting said cell with a anti- CD30 antibody according to claim 1. U.S. Patent No. 7,973,136 to Xencor, Inc.

5 Patent Basics: Medical Device Patents Feature(s) of Device Methods of Assembly or Manufacture Surgical Procedure Using Device No direct infringement (exception), but Contributory infringement for competitor device makers Design Patents

6 Patent Basics: Medical Device Claims Device claim: A catheter for ablating a surface of endocardial tissue of a beating heart, the catheter comprising: a distal section of a first material hardness; an ablation electrode positioned on the distal section of the catheter, said ablation electrode comprising a brush tip; a proximal section of a second material hardness; and a suspension arm of a third material hardness, the suspension arm being coupled to the proximal section, wherein the third material hardness is less than each of the first material hardness and the second material hardness, whereby the suspension arm is adapted to facilitate contact between said ablation electrode and the surface of endocardial tissue while said ablation electrode is tracing a linear lesion along the surface.

7 Patent Basics: Medical Device Claims Surgical method claim: A method comprising inserting an endotracheal tube into a patient's trachea, wherein the endotracheal tube comprises an inflatable balloon cuff with a gas barrier layer; and sealing the patient's trachea with the inflatable balloon cuff, wherein the inflatable balloon cuff is adapted to maintain a substantially constant intracuff pressure while in the patient's trachea.

8 Life of a U.S. patent application Year -1: Provisional application filing Year 0: File non-provisional patent pending, description substantively frozen 18 months after first filing patent application publishes Year 2 Claims are examined and, often, rejected Years 2-3.5: Patent Prosecution back and forth with Patent Office, arguing law and technology, amending claims Year 3.5: Notice of Allowance Year 4: Issued U.S. Patent Patented mark with patent #

9 Foreign Patents U.S. patents provide NO rights outside the U.S. Do bar importation of patented material Patent Cooperation Treaty (PCT) application Foundation for later filing (30 months from priority) in many other countries Nonbinding search and examination Cost $$$

10 Patent Strategy Consider the Company Context Goals of portfolio management Protect current and future product developments Innovation Maintain competitively-sized portfolio with attention to patent expiration dates Evaluate competitive IP landscape and protect areas that will likely be valuable to the industry as a whole New Opportunity Cash Flow Corporate IP Lifecycle Strong Intellectual Property Position Manage COST - $$$ Leverage IP Portfolio

11 Patent Strategy Business Goals Defensive Patents protect what Company is doing or wants to do Define against licensed-in patents Offensive Patents protect what others are doing or might do to get around Company Publication of applications serves as prior art against others seeking broad coverage Many companies and lawyers stop here Savvy companies and lawyers implement these IP strategies Transactional Uses Patents as Corporate Assets (Attract Investors, Strategic Alliances, Marketing)

12 Patent Strategy Extending Exclusivity New class of Compounds Lead Clinical Compound Crystalline Form Of Compound Dosage Form Filing Date (years) Length of Exclusivity dramatically increases valuation 20 years from filing Additional Exclusivity Periods Patent term adjustment (delay by the Patent Office) Patent term extension (delay by the FDA) Non-Patent regulatory extensions (new chemical entity, orphan drug, pediatric drug) 12

13 Patent Strategy Portfolio Development Consider Competitive Strategy and Cost Early Define your market present and future Core technology vs. tangential or expansive Define your competitors Use process (e.g., PCT) to reassess scope and value Assess Inventions Early Institute an Internal Patent Review Perform patentability searches internally File Patent Applications Early Before public disclosure Assess IP Position on a continued basis e.g., continuation patents

14 Patent Strategy Costs How important is each patent application? File PCT Applications Delay the decision to enter national phase until later Be selective about countries and regions Work with your patent attorney to handle some things inhouse Searches Competitive research

15 Patent Strategy Freedom to Operate If we make this device, will we infringe anyone s patents? Compare Claims of 3 rd Party Patents vs. Proposed Device Does the device meet all the limitations of any claim? May be able to find design-around to minimize risk May be able to identify Patents to buy or license 15

16 Patent Strategy Patent Infringement Are we infringing this patent? Compare Claims of Patent vs. Product or Activity Formal opinion may be used to help protect a client against a willful infringement claim (treble damages) 16

17 Patent Strategy Exit Strategy Investors/Acquirers will ask: Is technology feasible and clinically relevant? Do you have a strong patent portfolio? Coverage (e.g., types of claims) Breadth (can claims be designed around?) Freedom to Operate (can you actually practice the technology?) Do you actually own the technology? Assignments from employees and consultants University tech transfer Licenses (Assignable? Exclusive? Field of use restrictions? Other obligations? What is market/revenue potential? Reimbursement Issues? Regulatory issues?

18 Timothy A. Worrall, Ph.D. Partner Dorsey & Whitney LLP Brad J. Hattenbach Of Counsel Dorsey & Whitney LLP Thomas A. Beaton Senior IP Counsel Covidien Questions? Thank You