2008 CSUCI BIOL503 Intellectual Property Class 1 part 6: Patent Process (62 slides)

Slide 1: Intellectual Property I: Patent Process CSUCI 2008 BIOL503 K. Pessin CSUCI2008 KP BIOL503 1

Slide 2: Intellectual Property I: Patent Process Field Trip CSUCI2008 KP BIOL503 2

Slide 3: Intellectual Property I: Patent Process Field Trip CSUCI2008 KP BIOL503 3

Slide 4: Intellectual Property I: Patent Process CSUCI2008 KP BIOL503 4

Slide 5: Intellectual Property I: Patent Process Old US Patent and Trademark Office CSUCI2008 KP BIOL503 5

Slide 6: Intellectual Property I: Patent Process Thomas Jefferson, former Albert Einstein, former patent examiner patent examiner CSUCI2008 KP BIOL503 6

Slide 7: Intellectual Property I: Patent Process  “The United States Patent and Trademark Office (USPTO or Office) is an agency of the U.S. Department of Commerce. . .”  Grant patents and register trademarks  Serves public interest in inventions and commercial products  Advises government on domestic and global intellectual property policy  Promotes progress by organizing and disseminating information http://www.uspto.gov/ http://www.wipo.int/portal/index.html.en CSUCI2008 KP BIOL503 7

Slide 8: Intellectual Property I: Patent Process USPTO Director Jon Dudas http://www.uspto.gov/web/offices/com/annual/2006/2006annualreport-1.pdf CSUCI2008 KP BIOL503 8

Slide 9: Intellectual Property I: Patent Process http://www.uspto.gov/web/offices/com/annual/2006/2006annualreport-1.pdf CSUCI2008 KP BIOL503 9

Slide 10: Intellectual Property I: Patent Process http://www.uspto.gov/web/offices/com/annual/2007/50304_table4.html CSUCI2008 KP BIOL503 10

Slide 11: Intellectual Property I: Patent Process  File patent application  Assignment of ownership  Inventor declaration  Fees and forms  Can be electronic  Can file under international treaty (“PCT”) CSUCI2008 KP BIOL503 11

Slide 12: Intellectual Property I: Patent Process  Patent is examined  Review as to form, fees, etc.  Review as to substance  Usually rejects claims  Applicant replies  Argument  Additional facts  Amend claims  Abandon application  Application publishes at 18 months from filing (or earliest priority date) Patent examiners CSUCI2008 KP BIOL503 12

Slide 13: Intellectual Property I: Patent Process  Why does a patent lawyer cost so much?  Sui generis nature of work  Unlike other kinds of law: e.g., same whiplash case  How to manage your patent lawyer?  Task based  Embedded  How to save money and time  Invention disclosure form, begin DIY draft  Understand your business CSUCI2008 KP BIOL503 13

Slide 14: Intellectual Property I: Patent Process  How to write a patent application  1. Understand the entire technology and business  After talking to inventor, reviewing data. . .  Read background texts  Review “state of the art”  What is within the skill of the art?  Understand competitive landscape  What claims will be valuable?  Understand law  What claims will be valid and enforceable?  Go back to inventor, discuss additional work  Draft application, ongoing inventor review CSUCI2008 KP BIOL503 14

Slide 15: Intellectual Property I: Patent Process  Market exclusivity  Market entry  IP  IP barriers to entry  Regulatory  “FTO”  Market exclusivity  License opportunities  Data exclusivity  Competitive barriers to  Commercial advantages entry  Price  Exclusive dealings  Product profile contracts  Crowded field CSUCI2008 KP BIOL503 15

Slide 30: Intellectual Property I: Patent Process  Time: About 3 years, +/-, in U.S.  Can accelerate  Money (biotechnology)  ˜ $8K-$10K : Application preparation  ˜ $10K-$30K: Patent prosecution (U.S.)  ˜$50-100K: International filing at 30 month date  ˜ $100K-$500K+: International prosecution and maintenance over life of patent CSUCI2008 KP BIOL503 30

Slide 31: Intellectual Property I: Patent process Invention disclosure Prepare Patent Application File Patent Application Continuation-in-part http://www.uspto.gov/web/offices/pac/provapp.htm Child patent Grand-Child Patent application application application Examine Patent Application Examination, etc. Examination, etc. Examination, etc. Patent Granted CSUCI2008 KP BIOL503 31

Slide 32: Intellectual Property I: Patent process, international U.S. application 12 PCT months U.S. regional 18 or 19 months European Canada China India Patent Office National validations Typical International Patent Filing Strategy CSUCI2008 KP BIOL503 32

Slide 33: Intellectual Property I: Patent process  Provisional and Utility patent applications  Utility – “real” application  Starts 20-year clock  Holds place in line for examination  Provisional – also “real” application  Formal disclosure not required, but recommended  Advantage: filing date without 20-year clock started  Disadvantage: No examination CSUCI2008 KP BIOL503 33

Slide 34: Intellectual Property I: Patent process  “Rolling Provisional” strategy while gathering data and determining financial benefit Regional Provisional 1 File PCT $1-2K – claim filing ($50- Provisional 2 priority to provisional 2 100K) $8-10K Month 0 Month 1 Month 12 Month 13 Month 31 CSUCI2008 KP BIOL503 34

Slide 35: Intellectual Property I: Patent Process, U.S. Administrative and Judicial Proceedings, Oversimplified Q: Why do some companies have a building full of patent lawyers? A: This is why: CSUCI2008 KP BIOL503 35

Slide 36: Intellectual Property I: Patent process NEW http://www.uspto.gov/web/patents/peerpriorartpilot/ CSUCI2008 KP BIOL503 36

Slide 37: Intellectual Property I: Patent process NEW Myspace friends! Examine my patent! Meh!* CSUCI2008 KP BIOL503 37

Slide 38: Intellectual Property I: Patent process  * Meh  1.Meh Indifference; to be used when one simply does not care.A: What do you want for dinner? B: Meh.  7. Meh A random word when people either don't know what to say, don't care, can't answer a question or are too drunk to form a coherent english phrase.-Are you gonna come with us on saturday? -Meh. http://www.urbandictionary.com/define.php?term=meh CSUCI2008 KP BIOL503 38

Slide 39: Intellectual Property I: Patent process http://www.uspto.gov/web/patents/accelerated/  Accelerated examination  Burden falls to applicant to explain why invention is patentable vs. ordinary examination, where burden is on PTO to state reasons for denying patentability CSUCI2008 KP BIOL503 39

Slide 40: Intellectual Property I: Patent process John Singleton Copley, Watson and the Shark, 1778 CSUCI2008 KP BIOL503 40

Slide 41: Intellectual Property I: Patent process  A patent application is unlike other “applications”  Other applications lose their importance once granted;  A patent application becomes an issued patent – which is then a legal instrument.  An issued patent is forensically analyzed by others with a financial interest in its unenforceability CSUCI2008 KP BIOL503 41

Slide 42: Intellectual Property I: Patent Process, U.S. Administrative and Judicial Proceedings, Oversimplified v . Patent denied: Patent granted: can appeal up can sue, risk through court losing patent, system and appeal up through court system CSUCI2008 KP BIOL503 42

Slide 43: Intellectual Property I: Patent Process, U.S. Administrative and Judicial Proceedings, Oversimplified  Post-grant challenge: After patent is issued and enforceable, patent may be challenged via administrative proceeding in the patent office  US: Re-examination  Europe: Opposition Patent Patent office issues judges decide Patent is amended or Challe Challenger kept as is nger Challenger CSUCI2008 KP BIOL503 43

Slide 44: Intellectual Property I: Patent process Field Trip CSUCI2008 KP BIOL503 44

Slide 45: Intellectual Property I: Patent process CSUCI2008 KP BIOL503 45

Slide 52: Intellectual Property I: Patent process  Post grant challenge: Opposition  Theory: If competitors challenge your patent, it’s really super valid.  Other considerations:  No one place to sue for infringement in Europe  Each country has own way of doing things CSUCI2008 KP BIOL503 52

Slide 53: Intellectual Property I: Patent process  European Patent Opposition Procedure  European patent examined, claims allowed  9 months for anyone to file opposition papers  Can be undisclosed principal  Grounds:  Lack of patentability, e.g., novelty, inventive step (obviousness), enablement  Can amend claims  Can appeal CSUCI2008 KP BIOL503 53

Slide 54: Intellectual Major Property I: Patent of three senior Opposition panel: Panel process competitor: patent office examiners or supervisors attempting to invalidate or severely limit Patentees – patent defending patent Some guy – could be newspaper reporter, could be junior lawyer Illustration only: An Opposition oral proceeding may another competitor sent look something like this. to see what’s what CSUCI2008 KP BIOL503 54

Slide 57: Intellectual Property I: Patent process “Pluripotent colony stimulating factor” later called granulocyte colony stimulating factor Owned by joint venture between Kirin and Amgen Four opponents who wanted to enter the G-CSF market CSUCI2008 KP BIOL503 57

Slide 58: Intellectual Property I: Patent process Argument: Claims to the protein are not novel because there was naturally occurring G-CSF in the prior art. Decision: The naturally occurring G-CSF has two species: a 177 amino acid version and a 174 amino acid version. The non-naturally occurring material is CSUCI2008 novel. KP BIOL503 58

Slide 59: Intellectual Property I: Patent process Argument: The polypeptide claims lack inventive step because one of ordinary skill would have simply isolated the N-terminal amino acid sequence, prepared a probe, and found the entire DNA sequence – which could then have been expressed. There was plenty of natural protein to prepare the N- terminal sequence. Decision: The Opponent’s expert, Dr. Lottspeich, miscalculated Dr. Souza’s experiments – he didn’t use 25pmol, he used 250pmol, and still didn’t get the N-terminal sequence. CSUCI2008 KP BIOL503 59

Slide 60: Intellectual Property I: Patent process  International patent processes  Expensive  Requires local lawyers in jurisdictions  Local patent offices want money to keep patents pending  May be “hometown advantage” CSUCI2008 KP BIOL503 60

Slide 61: Intellectual Property I: Patent process  Patent Process  Requires strategy  Substantive examination in detail  Important to strong patent position  International coordination  Expensive  Slow CSUCI2008 KP BIOL503 61

Slide 62: Intellectual Property I: Patent Process CSUCI 2008 BIOL503 K. Pessin Next: How to read a patent CSUCI2008 KP BIOL503 62

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