Scientific Evidence and Expert Testimony Patent Litigation LAW

Scientific Evidence and Expert Testimony: Patent Litigation LAW 343 Prof. Roberta J Morris Room 208 Crown Quad 723 -9505 rjmorris@stanford. edu Course Materials on the Web: course website http: //www. stanford. edu/~rjmorris/sciev. 08/ And Stanford’s coursework site for posting assignments: https: //coursework. stanford. edu/portal/site/F 08 -LAW-343 -01 Email Group scievseminar 08@lists. stanford. edu 2008 - Sci. Ev. - rjm Week 02 1

Today’s Agenda • From last week: a few more basic patent law notes. • Making Claim Charts (Assignment 1 A) • The Cordis Counterclaim in Boston Scientific v. J&N/Cordis – Fontirroche ‘ 594 Patent, claim 7 v. Design arounds (Assignment 2 A) v. Making a claim evolution chart (Assignment 2 B-Grad) • Your Patents (Assignment 1 B): applying your new/renewed knowledge. Discuss after the break. • Law students educating grad students (Assignment 2 B-Law): defer to next class. • Next Week: No class. • Next CLASS: 10/13: Claim construction order on Fontirroche claim 7. Transcript of expert testimony from trial. 2008 - Sci. Ev. - rjm Week 02 2

Introduction/Review of patent law Other interesting information: The first patent the PTO issued on 9/23/08 was 7, 426, 753. On 9/16/08 the PTO issued 1989 utility patents, 12 Reissues (35 USC 251+), 35 Plant Patents (35 USC 161+) and 400 Design Patents (35 USC 171+) (2435 total) Last year for the same week (9/18/2007) the PTO issued 2992 utility patents, 12 Reissues, 35 Plant Patents, and 499 Design patents (3540 total). In the year ending 9/16/2008, the PTO issued 154, 893 utility patents. 2008 - Sci. Ev. - rjm Week 02 3

How does this affect you, the litigator, and you, the scientific expert? Law students: Please explain the questions and the answers to the Grad Students. WHO HAS THE BOP? Validity AI C&C Infringement PO Preponderance 2008 - Sci. Ev. - rjm Week 02 WHAT IS THE QOP? 4

Reading a Patent Why do I require for the simulation that you choose a patent whose number appears on something you can buy? (Or, if you really, can’t find anything suitable, a patent referenced in a peerreviewed journal article? How do you read a patent? Always ask: who wants to know? PO, PAppl, AI, VC their commonalities, differences and priorities 2008 - Sci. Ev. - rjm Week 02 5

Reading a Patent • AI – to design around (to avoid infringement) – to challenge validity or enforceability • PAppl – – 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 2008 - Sci. Ev. - rjm Week 02 6

Clients (temporary assignments) Experts Lisandra WEST* Sarah JARCHOWCHOY Lawrence KLEIN* Andrew HELLMAN Sondra HELLSTROM Brett STAAHL Samantak GHOSH Aqua for ACCUSED INFRINGERS Purple for PATENT OWNERS *Arbitrary assignments for those who hadn’t made up their minds as of last week 2008 - Sci. Ev. - rjm Attorneys Jen ROBINSON David LYDON Tim SAULSBURY* Karni CHAGAL Julie KANE* Mark MELAHN Julia KRIPKE Andy PARK Greg SOBOLSKI Week 02 As you re-read your patent, did you find yourself more sympathetic to the inventor or to a potential infringer? 7

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 Is the Old patent infringed by over the Old patent? someone practicing the New patent? New Patent Look at New's CLAIMS Look at New's SPECIFICATION Old Patent Look at Old's SPECIFICATION (what it "teaches") Look at Old's CLAIMS 2008 - Sci. Ev. - rjm Week 02 8

Homework 1 A. Your claim charts. What you – and I – learned from this exercise. 1 B. Your essays about the introduction/review of patent law and your patent. To be discussed after break. 2 A. Reading a patent and its file history. The Fontirroche ‘ 594 patent. - How would you design around the invention of claim 7 to avoid infringement? - What words have uncertain or squishy meaning? - Get into your roles: lawyer or expert for PO or for AI. -- What statements (and omissions) in the file history make you happy? Why? -- Anything make you unhappy? 2 B. How Claim 7 Evolved: Grad students’ 3 column charts. More legal education: Law students’ slides. – Defer to next class. I’ll send you comments on your slides and you’ll revise them. 2008 - Sci. Ev. - rjm Week 02 9

Homework – Claim Charts Your claim charts. What did you learn from doing this assignment: - about your patent - about how to read a patent - about what you will look for when you choose a patent for the simulation projects. Let’s discuss the concept and purpose of a CLAIM CHART and improving our skills at making VISUAL DISPLAYS of LINGUISTICALLY COMPLICATED information (with apologies to Edward Tufte). 2008 - Sci. Ev. - rjm Week 02 10

Homework – Claim Charts YOU – not the poor judge and the poorer jury – must pick out - what to skip, - what goes with what, - what explains what, - what are alternatives to each other, - etc. Then when you display the claim in the chart, the visual reinforces the conceptual. Meanwhile, claim charts are a great vehicle to learn some basics of patent prosecution. 2008 - Sci. Ev. - rjm Week 02 11

Homework – Claim Charts Pick out things that are parallel. I have devised this procedure for dealing Pick out words, phrases and clauses that you might with complicated language – claims, replace with ellipses if you were quoting statutes, regulations - over many years. the claim. Indent what you taught wouldit omit the words Nobody to me, from and you may not you would quote. Use this trick different find that your bosses or at other professorslevels of detail to decide what getsit. indented and how much. consciously follow But you will find that the best trial litigators Keep intactand thestrategic grammatical structure and meaning. counselors do something like it Thus, all the phrases that are within x tabs of the even though they may not be able to margin should make nothing articulate whysense they dogrammatically: what they do. else should be needed. This should also be the result of the parallel rule + the ellipsis rule. 2008 - Sci. Ev. - rjm Week 02 12

Making a Claim Chart – Example 1 Greg Sobolski’s 5, 955, 422 Production of Erythropoietin A pharmaceutical composition comprising: a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture. How many items go into the composition? What (how many items) does therapeutically effective amount modify? What (how many items) does pharmaceutically acceptable modify? In the wherein clause, what might be the controversial words? 2008 - Sci. Ev. - rjm Week 02 Handout 13

Making a Claim Chart – Example 1 (cont’d) Greg Sobolski’s 5, 955, 422 Production of Erythropoietin A pharmaceutical composition comprising: - a therapeutically effective amount of human erythropoietin and - a pharmaceutically acceptable -- diluent, -- adjuvant or -- carrier, wherein said erythropoietin is purified from mammalian cells grown in culture. Why is this better than this What’s the difference? 2008 - Sci. Ev. - rjm Week 02 ? 14

Making a Claim Chart – Example 2 Jen Robinson’s KSR v Teleflex Patent 6, 237, 565 indentations in thecomprising; original. An adjustable. The pedal assembly for are a vehicle a support (18) foruse mounting a vehicle You can those, toand insertstructure; bracketed an adjustable pedal assembly (22) having a guide member (62) rotatably letters tobyhelp you keep of things. supported said support (18)track for pivotal movement a pivot The numbersabout in parentheses axis (26); patents and Some will have numbers are or the numerals from the a pedal arm (14) supported on said guide member (62) for rectilinear figures. Including those letters toindesignate parts of the movement fore and aftparallel directions relative to said support (18), numbers used tovarious be said guide member (62) and said pivot axis (26) between claim. prohibited in the US, adjusted positions; although wasresponsive common in an electronic control (28) supported on said support (18)itand to pivotal movement of said pedal arm (14) and said membera Europe and guide occasionally (62) about said pivot axis (26), US patent with a foreign said electronic control (28) being fixed relativecounterpart to said support (18) would slipsuch that said pedal arm (14) moves in fore and aft directions with through withcontrol numbers in the respect to said electronic control (28), said electronic (28) Now the PTO being responsive to pivotal movement of claims. said guide member (62) about said pivot axis (26) for providing apermits signal (32) thatmay even it, and corresponds to pedal arm (14) position asencourage said pedalit. arm (14) pivots said guide member (62) about said pivot axis (26). 2008 - Sci. Ev. - rjm Week 02 15

Making a Claim Chart – Example 3 Sondra Hellstrom’s 5, 513, 562 Patent – Zyliss Garlic Press A garlic press comprising an elongated handle having a drainable press chamber at an end thereto, said press chamber having a top opening, a bottom and an inner surface, a press plate retractably moveable into said press chamber, lever means acting on a fulcrum at said end for retractably urging said press plate into said press chamber through said top opening, said press plated being joined to said lever by a pivot, a low surface friction material enameled onto said inner surface of said press chamber, and a cleaner mounted on said lever and removably secured thereto by interaction with said pivot, whereby when a clove of garlic is placed in said press chamber, its contained liquid can be extracted by said clove being cleanly crushed by said press plated being urged into said chamber by said lever, liquid so expressed drains from said chamber and following said crushing and liquid expression said cleaner can be demounted from said lever and used to dislodge debris of said crushed clove. How many parts does the press have? How many benefits follow when a clove is placed in [the] press chamber? Did they claim the clove? Why was that smart? 2008 - Sci. Ev. - rjm Week 02 Handout 16

Making a Claim Chart – Example 3 (cont’d) A garlic press comprising [1] an elongated handle having [a] a drainable press chamber at [b] an end thereto, said press chamber having a top opening, a bottom and an inner surface, [2] a press plate retractably moveable into said press chamber, [3] lever means acting on a fulcrum at said end for retractably urging said press plate into said press chamber “Whereby” introduces “functional language. ” through said top opening, This ofa pivot, functional language may not be said press plated being joined to saidkind lever by [4] a low surface friction material enameled onto said inner surface of said press chamber, and given “patentable weight. ” That is, it can’t [5] a cleaner mounted on said lever and [mostly] be said used to distinguish over prior art, removably secured thereto by interaction with pivot, whereby especially if the benefit is inherent in the when a clove of garlic is placed in said press chamber, [a] its contained liquid can be extracted structure. See the popcorn case, In re claimed by said clove being cleanly crushed by. Schreiber, said press plate being said chamber said lever, 128 urged F. 3 dinto 1473 (Fed. by. Cir. 1997). (but [b] liquid so expressed drains from said chamber and [c] following said crushing and expression seeliquid Judge Newman’s dissent. ) said cleaner can be demounted from said lever and used to dislodge debris of said crushed clove. Why explicitly claim ‘an end’? 2008 - Sci. Ev. - rjm Week 02 17

BREAK TIME: Newly Noticed What did you notice when you looked at the patent again? HANDONE Each student: Please take another student’s essay, and ask the author for the patent in question (or 5 pages of it, if it was a long one). 2008 - Sci. Ev. - rjm Week 02 18

Fontirroche 594 - Design Arounds: Impressions based only on the patent Discuss! 2008 - Sci. Ev. - rjm Week 02 19

Fontirroche 594 Patent, Claim 7 Evolution in Prosecution Handout: http: //www. stanford. edu/~rjmorris/sciev. 08/rjm_staa. doc This is a claim chart for a different purpose. Breaking out phrases is most relevant to see what phrases were added, deleted or changed. The vertical position of a phrase should stay the same for all columns, even when new language was later added before it. In that case, insert blank lines in the column for the earlier version. For example, explain this evolution: Original Amended Issued A A-1 A-2 B B C C-1 C-2 D D 2008 - Sci. Ev. - rjm Week 02 Handout 20

Next Week – NO CLASS If you want to meet with me to discuss claim charting, that’s GREAT. Please email me with times that are best for you. I am available during the day from around 10 to around 4, most days, both this week and next. This Wednesday I won’t be available at all. I can come in earlier than 10, and I can come in on the weekend, with a little advanced notice. NEXT CLASS: October 13: Law Students’ Lectures A Claim Construction Order and a Transcript of Expert Testimony – The Real Thing: Boston Scientific v. J&J/Cordis 2008 - Sci. Ev. - rjm Week 02 21