1. 2009 - Sci.Ev. - rjm Week 01 1 Scientific Evidence and Expert Testimony: Patent Litigation LAW 343 / GENETICS 243 Prof. Roberta J. Morris Room 208 Crown Quad 723-9505 rjmorris@stanford.edu On the web: http://www.stanford.edu/~rjmorris/sciev.09/ and https://coursework.stanford.edu/portal/site/F09-LAW-343-01/ and http://sciev09.blogspot.com/ Not yet but soon: Email Group scievseminar09@lists.stanford.eduscievseminar09@lists.stanford.edu

2. 2009 - Sci.Ev. - rjm Week 01 2 Today’s Agenda Who We Are What We Will Do in this Seminar (How the Course...) Review of / Introduction to Patent Law - Jumping in with both feet: The substantive assignments - the object-or-case patent assignment - the Hologic patent Next Week: Claim charts,claim construction and file histories, especially regarding Hologic.

3. 2009 - Sci.Ev. - rjm Week 01 3 Who Are You? - 1 Handout - Student List 3 Matts out of 12 students (+ 2 auditors, neither of whom are named Matt). Show of Hands Was this the first time you looked (really looked) at a patent? Had you noticed patent numbers on objects and packaging before? Did you take calculus in high school? Have you ever seen The Visual Display of Quantitative Information?The Visual Display of Quantitative Information And as long as Tufte’s reviewer mentions it, have you ever seen The Elements of Style? the edition illustrated by Maira Kalman? The Elements of Style 2009 - Sci.Ev. - rjm 3 Week 01

4. 2009 - Sci.Ev. - rjm Week 01 4 Who Are You? - 2 Introduce Yourselves  3 Matts: Will the real Matt please stand up? For the other 2: What should we call you since we won’t call you Matt?  What should we know about you that is on your resume?  What should we know that is not on your resume?  Whose side are you on: PO or AI?

5. 2009 - Sci.Ev. - rjm Week 01 5 Who Are You? - 3 Some Thoughts on Reading your Consent Forms and Questionnaires and Such Patents and Everyday Life - e.g., Google Books and iTunes P != C != T

6. 6 ConceptPatentCopyrightTrademark CoverageInventions (Machines, Things, Processes, Mole-cules, etc.) Creative Expression (Words, Art, Video, Audio) Commercial Identity Stuff (Logos, names, slogans, product appearance,etc.) Agency associated with obtaining it Patent & Trademark Office (Part of the Dept of Commerce) Copyright Office (Part of the Library of CONGRESS) Patent & Trademark Office (Part of the Dept of Commerce) Verb associated with obtaining it APPLYREGISTERAPPLY Can Agency REJECT? YESNot oftenYES When does protection START From ISSUANCEFrom CREATIONFrom use or registration When does protection STOP 20 years from date of filing of application, MOSTLY Life of author + 70 years to the next 12/31, USUALLY Never, MOSTLY PTO Patents != Copyright != Trademarks 2009 - Sci.Ev. - rjm Week 01

7. 2009 - Sci.Ev. - rjm Week 01 7 What You Will Do in this Seminar Do A work and receive a P – and a recommendation and networking help: Grading by ContractGrading by Contract (and why I will collect, and return, your annotated copy) Weekly Assignments and Comments:

8. 2009 - Sci.Ev. - rjm Week 01 8 What You Will Do in this Seminar NO required. Better Late. thanLate That’s Never? Better Never

9. 2009 - Sci.Ev. - rjm Week 01 9 What You Will Do in this Seminar Schedule/Syllabus – short form of assignments (also next to the last tool, lefthand side, on coursework)Schedule/Syllabus coursework Only *9* Wednesdays in the law school's quarter because 10/5-7 are flyback days Attend a trial with real live examination and cross- examination of an expert – if you possibly can Simulations 5:20: Snack (healthy or not or both?) Never late. That’s required. Do A work and receive a P – and a recommendation and networking help: Grading by ContractGrading by Contract (and why I will collect, and return, your annotated copy) Weekly Assignments and Comments: 2009 - Sci.Ev. - rjm 9 Week 01

10. How the Course Will… also Communications and Websites Please hand in your annotated copy of How the…. Communications / Websites Email when I post assignments – or not? Your responses and comments: post on coursework or blog? Student Qs of interest: email, course website, coursework, blog? Deadlines My posting? Your assignment? Comment assignment? Your comment? Friday at 5 pm, Monday at 10, Monday at 11:59p, Wednesday at 9? LATE WORK IS NOT ACCEPTED. Whether or not you are able to post it, I won’t look at it.

11. Week 01 11 2009 - Sci.Ev. - rjm Throughout the term, I will use the snowflake on my slides to indicate something that is true, more or less, could be VERY complicated if you went into it deeply, and might melt if you touch it. FEEL FREE TO ASK AFTER CLASS ABOUT SNOWFLAKES (the words they accompany on the slides, or the makeaflake website)makeaflake SUBSTANTIVE PATENT LAW

12. Week 01 12 2009 - Sci.Ev. - rjm FEEL FREE TO INTERRUPT ABOUT AS WELL AS ABOUT I use the Mona Lisa to indicate TERMS OF ART. Use such terms carefully. They don’t always mean what you think they mean. Anyone who DOES know what they mean may misunderstand you if you misuse them. TERMS OF ART

13. 2009 - Sci.Ev. - rjm Week 01 13 Introduction/ Review of patent law The next patent the PTO will issue will be 7,594,278. Yesterday  the PTO issued 3243 utility patents, 4 reissues(35 USC 251+), 32 plant patents (35 USC 161+) and 450 design patents (35 USC 171+) (3729 total) On 9/17/08: 1989+12+35+400 (2435 total). On 9/18/07: 2992+12+35+499 (3540 total). Source: USPTO website + arithmetic by RJM In 2008, 157,772 utility patents were issued. In 2007, 157,282 utility patents were issued. In 1963, 45,679 utility patents were issued. Source: http://www.uspto.gov/go/taf/us_stat.htm http://www.uspto.gov/go/taf/us_stat.htm * Patents are issued once a week on Tuesdays.

14. 2009 - Sci.Ev. - rjm Week 01 14 Reading a Patent Why choose a patent whose number appears on something you can buy? Why choose a patent whose number is more than 5,000,000? (Design patents, Reissue patents) How do you read a patent? Always consider who wants to know? PO, PAppl, AI, VC their commonalities, differences and priorities

15. 5,913,813 COVER SHEET issue date filing date prior art This patent expires on Jul. 24, 2017 It did not go into effect until Jun. 22, 1999. class Assignee: Not Hologic?

16. Who is HOLOGIC? From LEXIS’ listing of the patent: ASSIGNEE-PRE-ISSUE: January 28, 1998 - ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)., PROXIMA THERAPEUTICS, INC. 1111 ALDERMAN DRIVE, SUITE 280ALPHARETTA, GEORGIA, 30005, Reel and Frame Number: 008960/0236 ASSIGNEE-AT-ISSUE: Proxima Therapeutics, Inc., Alpharetta, GEORGIA, United States of America (US) ASSIGNEE-AFTER-ISSUE: December 15, 2004 - MERGER, CHANGE OF NAME AND CHANGE OF STATE OF INCORPORATION, PROXIMA THERAPEUTICS, INC. 2555 MARCONI DRIVE, SUITE 220 (A DELAWARE CORPORATION)ALPHARETTA, GEORGIA, 30005-4143, (A DELAWARE CORPORATION), 2555 MARCONI DRIVE, SUITE 220, ALPHARETTA, GEORGIA, UNITED STATES OF AMERICA (US), 30005-4143, Reel and Frame Number: 016069/0893 November 21, 2005 - MERGER (SEE DOCUMENT FOR DETAILS)., CYTYC CORPORATION 250 CAMPUS DRIVE MARLBOROUGH MASSACHUSETTS 01752, 250 CAMPUS DRIVE, MARLBOROUGH, MASSACHUSETTS, UNITED STATES OF AMERICA (US), 01752, Reel and Frame Number: 017251/0131 October 26, 2007 - PATENT SECURITY AGREEMENT, GOLDMAN SACHS CREDIT PARTNERS L.P., 650 TOWN CENTER DRIVE, 20TH FLOOR, COSTA MESA, CALIFORNIA, UNITED STATES OF AMERICA (US), 92626, Reel and Frame Number: 020018/0529 July 29, 2008 - PATENT SECURITY AGREEMENT, GOLDMAN SACHS CREDIT PARTNERS L.P., AS COLLATERAL AGENT, 30 HUDSON STREET, 17TH FLOOR, NEW JERSEY, NEW JERSEY, UNITED STATES OF AMERICA (US), 07302, Reel and Frame Number: 021301/0879 No HOLOGIC there… But apparently it is now the owner of the patent. Perhaps CYTYC changed its name? But it is supposed to file that information with the patent office. Maybe it did, and LEXIS is at fault… No. The PTO has pretty much the same information.PTO LAW STUDENTS: If HOLOGIC were not the owner (assignee) of the patent, could it sue for infringement? And by the way, just because HOLOGIC is the plaintiff, it could be the AI not the PO. (It isn’t in this case.) How would that happen? If there is no assignee, who owns the patent? Can the assignee (say, an inventor’s employer) apply for the patent itself?

17. But also (and always) remember, in a variation on famous words from 1992: IT’S THE _______ STUPID. 2009 - Sci.Ev. - rjm Week 01 17 Reading a Patent 2009 - Sci.Ev. - rjm 17 Week 01 CLAIM

18. 2009 - Sci.Ev. - rjm Week 01 18 Reading a Patent – Who asked you to? AI –to design around to avoid infringement –to challenge validity or enforceability PAppl – –to see if you need to disclose (and claim around) –to see if you should buy/license it M&A – to evaluate an asset PO – to evaluate whether you can sue within the bounds of Rule 11 Why? AVOID inequitable conduct COMPLY with Rule 56 and your duty of candor Obtain a solid patent

19. Major Issues of Liability in Patent Law Validity Infringement The other part of a patent case, after liability is determined, is DAMAGES, or more generally REMEDIES

20. 2009 - Sci.Ev. - rjm Week 01 20 Validity Infringement AI Preponderance C&C PO WHO HAS THE BOP? WHAT IS THE QOP? How does this affect you, the litigator, as you work with a scientific expert?

21. 2009 - Sci.Ev. - rjm Week 01 21 P-I-S v P.A. Situation A Patent-in-suit = NEW Prior Art Patent = OLD Situation B Patent-in-suit = OLD Patent on accused device = NEW Is the New patent valid over the Old patent? Is the Old patent infringed by someone practicing the New patent? New PatentLook at New's CLAIMSLook at New's SPECIFICATION (to see what people do who would PRACTICE New’s invention) Old PatentLook at Old's SPECIFICATION (to see what it "teaches") Look at Old's CLAIMS Q.When do you look at the CLAIMS? A.When the patent is ________

22. 2009 - Sci.Ev. - rjm Week 01 22 Your Patented Objects/Cases Have you looked at what your colleague said about your claim? What was good about having someone comment on your work? What was not? What else would you have liked to comment on, either in your patent or in your colleague’s assignment?

23. 2009 - Sci.Ev. - rjm Week 01 23 Your Patented Objects/Cases Your Object/Case and patent and its claim 1 Hologic Comments on someone else’s claim You may choose 1 of the above to discuss, but try to keep it varied. Everyone else: please interrupt with questions. MattT BumQ Dmitry Aaron Ryan David Guillaume MattP Riti Emily Tiffany MattB Denise Ben - Random ized by the Random izer Random izer

24. 2009 - Sci.Ev. - rjm Week 01 24 Next Week Claim Interpretation and File Histories - ideas for design arounds/noninfringement arguments - ideas for invalidity arguments - questions for which experts would be needed Reading a judicial decision: The Hologic Claim Construction Order