Kenneth D. Sibley Myers Bigel Sibley & Sajovec, PA, Raleigh NC Senior Lecturing Fellow, Duke University School of Law

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1 Kenneth D. Sibley Myers Bigel Sibley & Sajovec, PA, Raleigh NC Senior Lecturing Fellow, Duke University School of Law 1

2 The Congress shall have power to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries. United States Constitution, Art. I, 8, cl. 8. 2

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4 Every patent shall contain a grant to the patentee of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States. Title 35 of the United States Code, 154(a)(1). 4

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6 Copies are available from (for example): The US Patent and Trademark Office The World Intellectual Property Organization (WIPO) GOOGLE Patents 6

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12 Parts 1-5 together (along with Examples if included) are sometimes referred to as the specification. 12

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14 Claim drafting is itself an art, an art on which the entire patent system today depends.. The public generally, and in particular, the patentee's competitors, are entitled to clear and specific notice of what the inventor claims as his invention. That is not an easy assignment for those who draft claims, but the law requires it, and our duty demands that we enforce the requirement. Exxon v. Lubrizol, 64 F.3d 1553, 35 USPQ2d 1801 (Fed.Cir.1995), cert. denied, 518 U.S (1996). JUST ASK EXXON! 14

15 Judge Giles S. Rich, Court of Customs and Patent Appeals and Court of Appeals for the Federal Circuit. J. Rich, The Extent of the Protection and Interpretation of Claims-American Perspectives, 21 Int'l Rev. Indus. Prop. & Copyright L., 497, 499 (1990). 15

16 Preparation and filing of an application in the US Patent and Trademark office. And foreign counterpart filings. Negotiation through to issuance as a patent. Aka patent prosecution Optionally, licensing or transfer of ownership. Enforcement in Federal Court. Numerous detours possible! 16

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18 101: Eligible subject matter. 102: Novelty. Defines the prior art. 103: Non-obviousness. obviousness 112: Disclosure requirements. Fully disclosed. Clearly defined (claimed with particularity). Sometimes referred to as the four doors or four hurdles to obtaining a patent. 18

19 101: Eligible subject matter. 102: Novelty. Defines the prior art. 103: Non-obviousness. obviousness. 112: Disclosure requirements. 19

20 A patent application written with a clear picture of the prior art is much more likely to issue from the USPTO. The validity of an issued patent is much more secure if the best or closest prior art was of record at the USPTO. 20

21 Most significant update since Filings After March 15, 2013 subject to new act. Changes United States from a first to invent to a first to file jurisdiction. Derivation from inventor still a no-no. Retains a 1-year grace period. The grace period is narrowed compared to what was available under the first to invent system. Creates the Patent Trial and Appeal Board (PTAB). 21

22 Under the AIA s new first-inventor-to-file inventor to file framework, prospective patentees are under tremendous pressure to file their applications early. Chief Judge Randall Rader, dissenting in Gilead Sciences v. Natco Pharma (Fed. Cir. April 22, 2014). Widely suggested: File early and file often. Early: Beat potential competitors. Often: Describe and cover most refined and commercially important technology. 22

23 Early, yes. Serial provisional filings, yes. Highly cost effective. Allows focus on your best technology (more on this later). Disorganized, NO! Search the prior art. Develop a theme. Keep different inventions separate. Start early, not late, in preparing cases for foreign filing. 23

24 Created to give US applicants PATENT TERM PARITY with foreign applicants. D NOT relax any statutory bars. Do NOT relax any disclosure requirements. Do NOT waive statutory prohibition against adding new matter after filing. DO initiate the treaty year DEADLINE for corresponding foreign filings. p g g g DEFINITELY DO NOT create a place holder for important t details filed later. 24

25 "The bitterness of poor quality lingers long after the sweetness of low price is forgotten. A Good Tattoo Isn't Cheap, A Cheap Tattoo I 't G d Isn't Good. 25

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27 Infringement actions in US District Court; Declaratory judgment actions in US District Court; Various proceedings at the USPTO s Patent t Trial and Appeal Board; and Combinations of the above. Most appeals to the Court of Appeals for the Federal Circuit. But not all. 27

28 Discovery phase: Interrogatories, requests for admissions, i requests for production (of documents, s, electronic records, etc.), depositions, etc. Pre-trial hearings (Markman hearing; bifurcation of damages phase, evidentiary disputes, location disputes, etc.). Trial (or partial trial). Appeal (affirm, reverse, vacate & remand, or a combination thereof). 28

29 Expensive. Time-consuming. Uncertain. Protracted. 29

30 (1) Foster awareness of potential competitor s patents and applications: Specific searching; Ongoing monitoring. Opportunity to challenge prior to issuance. (2) Write and pursue your patents with future litigation in mind: For enforcement of your patents; and For enforcement of 3d party patents against you. (3) Couple functions (1) and (2) in a patent committee. 30

31 Giles S. Rich, The Proposed Patent Legislation: Some Comments, 35 Geo Wash. L. Rev. 641, 644 (1967). 31

32 What does this mean? Some examples to help clarify. 32

33 FDA Approved for Hepatitis C (Dec. 2013). Cost: $1,000 per pill; $84,000 per treatment. $ 2.1 billion sales in first full quarter (April 2014). 33

34 The FDA s ORANGE BOOK Lists FIVE US Patents for Sofosbuvir. 34

35 Sofosbuvir 35

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38 Gilead obtained a variety of patents containing claims of varying scope, style and approach to protect their product. What can happen when a company puts all of its eggs in one basket? 38

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40 Claims at issue recited A hollow syringe body A dependent claim recited a one-piece body. Chief Judge Rader: The Doctrine of claim differentiation indicates that the claims at issue are not limited to one-piece. Hence the patentee (Retractable) should win. 40

41 Majority: Body limited to one-piece based on the specification. Hence the defendant (BD) won. Stated reason? [A] construction of body that limits the term to a one-piece body is required to tether the claims to what the specifications indicate the inventor actually invented. But the claim tethering doctrine is at odds with the claim differentiation doctrine! 41

42 Judge Plager, agreeing with the majority, further commented: However much desired by the claim drafters, who want claims that serve as business weapons and litigation threats, the claims cannot go beyond the actual invention. I have written elsewhere about the curse of indefinite and ambiguous claims, divorced from the written description, that we regularly are asked to construe, and the need for more stringent rules to control the curse. 42

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44 Certainly not it just isn t enough! What do the courtswanttosee? How is this achieved? 44

45 Possible members: Senior management (key); R&D; Legal; Business development & marketing; Financial; Manufacturing & operations; Information specialist. 45

46 Monitor both patent filings and defensive functions. Establish procedures & insure compliance. Adapt procedures to specific business. What works for a multi-national may not work for a startup; what works for drug development might not work for open- source software; etc. A patent strategy to fit business strategy; not vice versa. See, e.g., Gunnar Wieboldt s case study of IP Management at Talecris (full citation in references). 46

47 Copyright; Trademark; Design Patent; t and Trade Secret. A caution on derivation, state remedies, and other federal remedies. 47

48 Example: University of Colorado v. American Cyanamid (Fed. Cir. 2003). Cyanamid employee E sponsored research of CU doctors into improving prenatal vitamin supplement. CU doctors delivered manuscripts to E describing reformulation. E filled out invention disclosure describing reformulation, naming himself as the inventor. 48

49 Cyanamid filed and issued patent containing significant portions of manuscript, naming E. Cyanamid enforced patent SIX times. CU Doctors noticed patent and brought suit. Cyanamid CEASED enforcing patent. CU doctors (not E) found to be inventors and awarded $23M for unjust enrichment under COLORADO law. Federal Circuit found Colorado law not preempted by US patent statute and affirmed. 49

50 Burroughs Wellcome v. Barr Laboratories, 40 F.3d 1223 (Fed. Cir. 1994). Inventorship dispute tried in EDNC over AZT for treatment of HIV. X-IT Products v. Walter Kidde, (E.D. Va. June 25, 2002). Students idea for home fire escape; settled for about $17M. Volumetrics Medical Imaging v. Philips, (M.D.N.C. 2003). 3D ultrasound trade secret; settled for about $180M. Duke v. Elan (filed M.D.N.C. June 2004). Patent filing on use of zonisamide for treating obesity; settled. THEMES: (1) Confusion over inventorship law; (2) lack of awareness of state law remedies; (3) possible lack of monitoring/oversight. 50

51 Economic Espionage Act of 1996 (EEA). 1831: Theft of trade secret for benefit of foreign power. 1832: Theft of trade secret related to interstate commerce (no foreign power required). Foreign and Economic Espionage Penalty Enhancement Act of Enhances 1831 penalties. Theft of Trade Secrets Clarification Act of Expands scope of interstate commerce for

52 CEO received alleged trade secret information via from pen-pal chemist at competing company. Chemist testified against CEO in plea bargain. CEO convicted of conspiracy to steal trade secrets. Conspiracy to obviated need to prove accused actually received trade secret, or even show it actually existed. CEO also convicted of wire fraud, mail fraud, and conspiracy to transport stolen property in interstate commerce. All affirmed on appeal. 52

53 I. PATENTS GRANT A RIGHT TO EXCLUDE ONLY, AND NOT AN AFFIRMATIVE RIGHT TO DO ANYTHING. II. THE NAME OF THE GAME IS THE CLAIM. III. DO AGGRESSIVELY SEARCH COMPETITIVE TECHNOLOGY, AND ALL PRIOR ART. IV. DO NOT PRE-JUDGE OBVIOUSNESS. OUS SS V. FILE EARLY AND FILE SMART. 53

54 VI. THE BALM OF CHEAP PROVISIONALS IS SNAKE OIL. VII. PATENT LITIGATION = AGONY. VIII. THE STRONGER A PATENT THE WEAKER IT IS AND THE WEAKER A PATENT THE STRONGER IT IS. IX: THE COURTS WANT LESS DRAFTSMANSHIP; MORE CRAFTSMANSHIP. X. A PATENT COMMITTEE IS ESSENTIAL. XI. IT ISN T ALL ABOUT PATENTS. 54

55 G. Wieboldt, How Much Value is Your Company Losing? Implementing Effective Intellectual Property Management, 1 International In-House Counsel Journal, 431 (2008). Economic Espionage and Trade Secrets, United States Attorney s Bulletin, Vol. 57 (Nov. 2009). S. Murphy & K. Sibley, Avoiding the obvious, 27 Nature Biotechnology 117 (2009). Patent Searching Tools, In: Myers Bigel Sibley & Sajovec Summer Newsletter (2011). 55