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© 2010 Banner & Witcoff, Ltd. 1 Obtaining US Patents and Avoiding IP Disputes John P. Iwanicki, Esq Patent Information Annual Conference of China
© 2010 Banner & Witcoff, Ltd. 2 Banner & Witcoff. Ltd. Strictly IP (Patents, Trademarks, Copyrights) Full Service IP –All technology areas –Pharmaceutical, Biotechnology, Electrical, Computer Software, Manufacturing Processes, Chemical, Mechanical, Design –Patent Prosecution, including PCT/EPO –Opinions (infringement, validity) –Licensing –Litigation (jury trials, appeals, ITC) –Trademarks –Copyrights
© 2010 Banner & Witcoff, Ltd. 3 Office Locations Chicago, IL –(43 Attorneys) Washington, DC –(36 Attorneys) Boston, MA –(7 Attorneys) Portland, OR –(2 Attorneys) Total Attorneys: 88 All offices linked via networks
© 2010 Banner & Witcoff, Ltd. 4 Practical Advice for Real-World Situations Every major technology-based company has a patent strategy Investment in innovation must be protected Patents are the tools of protection Good fences make good neighbors and good patents make good business partners
© 2010 Banner & Witcoff, Ltd. 5 Practical Advice for Real-World Situations Obtain Strong US Patents –Consider US Requirements for Patentability When Drafting Your Chinese Application Avoid IP Disputes When Doing Business in the US –Conduct Freedom To Operate Due Diligence BEFORE Selling in the US
© 2010 Banner & Witcoff, Ltd. 6 Patent Types Utility Patents –Protect Utilitarian Inventions, Both Animate and Inanimate Design Patents –Protect New, Original and Ornamental Designs for Goods Plant Patents –Protect New Plant Varieties
7 © 2010 Banner & Witcoff, Ltd. Patent Basics Contract With The Government: You disclose your invention to the public, we grant you a patent Right To Exclude Others From Making, Using, Selling, Offering to Sell, Importing, Exporting Parts Overseas No Affirmative Right To Practice The Invention Yourself Claims (Numbered Paragraphs) at the End of the Patent Define the Invention
8 © 2010 Banner & Witcoff, Ltd. Patent Basics Limited in Duration: 20 Years from Earliest Referenced US Application Limited Duration a Critical Issue in Drug Development The Patent Portfolio Grows as Further Discoveries Made Treated Like Personal Property: Can be Licensed, Assigned, Sold, Given Away, Inherited or Mortgaged
9 © 2010 Banner & Witcoff, Ltd. Case Study #1 Do Patents Make Sense for My Company? –Protect Investment in R&D –Protect NEW Technology –Defend Against Competitor Patent Law Suits –Patents Needed for Investor Funding –Market Exclusivity Provides the Return on Investment
10 © 2010 Banner & Witcoff, Ltd. Case Study #2 How Do I Identify and Gather My New Technology?
11 © 2010 Banner & Witcoff, Ltd. Gathering New Technology What we want to do: Identify New Technology Capture New Technology Evaluate New Technology Protect New Technology
12 © 2010 Banner & Witcoff, Ltd. Record Keeping by Company Personnel Research and Development Recorded in Lab Notebooks –Paper, Bound, Pages Numbered, Dated, Witnessed –Electronic Lab Notebooks Invention Disclosure Forms Invention Incentive Programs
13 © 2010 Banner & Witcoff, Ltd. Case Study #3 Now That I Have Gathered My New Technology, How Do I Decide What Merits A Patent Application?
14 © 2010 Banner & Witcoff, Ltd. Not Everything You Do Gets Patented Advances in Knowledge That Do Not Meet Statutory Requirements of an Invention Inventions That Have No Direct Revenue Stream or Royalty Stream Follow-On Data To Support Original Inventions What Does Get Patented?
15 © 2010 Banner & Witcoff, Ltd. The Intersection Method for Deciding What to Patent Patents Technically Feasible ! Commercially Interesting
16 © 2010 Banner & Witcoff, Ltd. Case Study #4 Now That I Have Decided What Inventions Merit A Patent Application, What Do I Do Next?
17 © 2010 Banner & Witcoff, Ltd. Selecting Where to File: Global Patent Strategy First Filing in China –PCT Application –National Phase Filings –United States Application
18 © 2010 Banner & Witcoff, Ltd. Selecting A Chinese Firm Prepares Initial Application –Understands US Filing Goal –Understands US Requirements –Works With US Lawyer To Have Application Filed In The US
19 © 2010 Banner & Witcoff, Ltd. Patent Cooperation Treaty (PCT) Application Uniform filing and preliminary examination system: ISR/WO/IPRP One stop shopping, Covers 141 Nations 30 month delay of most fees 30 month delay in determining final countries for patents Allows Time for Commercial Development
20 © 2010 Banner & Witcoff, Ltd. Global Patent Strategy First Filing Goals –US Written Description and Enablement Requirement –Solid Priority Basis for Claimed Subject Matter
21 © 2010 Banner & Witcoff, Ltd. Case Study #5 How Do I Prepare a Strong US Patent Application?
22 © 2010 Banner & Witcoff, Ltd. Building Rock-Solid Patents From The Ground Up Reviewing The Invention Disclosure Interviewing The Inventor(s): The Inventor Thinks Like a Rifle Shot. Patent Lawyer Thinks Like a Shot Gun Blast Preparing a Draft Set Of Claims Drafting The Patent Application
23 © 2010 Banner & Witcoff, Ltd. Statutory Requirements 35 U.S.C. 101: Statutory Subject Matter and Utility 35 U.S.C. 102: Novelty 35 U.S.C. 103: Non-Obvious 35 U.S.C. 112: Definiteness, Written Description, Enablement, Best Mode
24 © 2010 Banner & Witcoff, Ltd. What Subject Matter Can Be Patented? 35 U.S.C. 101 Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
25 © 2010 Banner & Witcoff, Ltd. What Subject Matter Cant Be Patented? Laws of Nature: E = mc 2 A Natural Phenomenon: Northern Lights An Abstract Idea: Putting a Man on the Moon and Returning Him Safely to Earth Products of Nature: DNA?
26 © 2010 Banner & Witcoff, Ltd. Assn for Molecular Pathology v. USPTO, S.D.N.Y. (3/29/10) Claim: An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. Isolated DNA is a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome. BRCA1 is a human gene, normally integrated into chromosome 17, some alleles of which cause susceptibility to breast and ovarian cancer.
27 © 2010 Banner & Witcoff, Ltd. Assn for Molecular Pathology v. USPTO, S.D.N.Y. (3/29/10) Claims directed to isolated DNA containing sequences found in nature, are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C Products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product. Purification of a product of nature does not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product. Purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess markedly different characteristics in order to satisfy the requirements of 35 U.S.C. 101.
28 © 2010 Banner & Witcoff, Ltd. Your Invention Must be New: 35 U.S.C. 102 Your Invention Must be NEW: Cannot Take Embodiments from the Public Domain Somebody Else Publicly Knew About Your Invention Before You Conceived of Your Invention Your Invention Has Been in Print in US or Foreign Country for More Than One Year Before You Filed Your Patent Application You Have Been Commercially Benefitting from Your Invention for More Than One Year Before You Filed Your Patent Application Your Invention is Described in Either a Patent or Published Patent Application to Another With an Earlier Filing Date Old: A Single Piece of Prior Art Teaches the Entire Invention
29 © 2010 Banner & Witcoff, Ltd. Your Invention Must be Nonobvious: 35 U.S.C. 103(a) All inventions are combinations (A+B+C+D) of things that are old. If the entire invention is not described in a single prior art document, then the Examiner must find the pieces and parts in a combination of a primary reference (A+B+C) with a secondary reference (D). The question then becomes, When does the Examiner get to modify or change the elements of the primary reference with the elements of the secondary reference to arrive at all of the elements of the claims?
30 © 2010 Banner & Witcoff, Ltd. KSR International v. Teleflex Inc., 550 U.S. 398 (2007) The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results If a person of ordinary skill can implement a predictable variation, section 103 likely bars its patentability Inventions... A court can take account of the inferences and creative steps that a person of ordinary skill in the art would apply.
31 © 2010 Banner & Witcoff, Ltd. KSR International v. Teleflex Inc., 550 U.S. 398 (2007) One of the ways in which a patents subject matter can be proved obvious is by noting that there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patents claims. Common sense teaches, however, that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.
32 © 2010 Banner & Witcoff, Ltd. KSR International v. Teleflex Inc., 550 U.S. 398 (2007) When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. The facts that a combination was obvious to try might show that it was obvious under section 103.
33 © 2010 Banner & Witcoff, Ltd. KSR – Invention is not Ordinary Results of ordinary innovation are not the subject of exclusive rights under the patent laws. Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may, in the case of patents combining previously known elements, deprive prior inventions of their value or utility.
34 © 2010 Banner & Witcoff, Ltd. Written Description 35 USC sec. 112, first paragraph The specification shall contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains... To make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
35 © 2010 Banner & Witcoff, Ltd. Written Description Ariad Pharmaceuticals v. Eli Lilly, (March 22, 2010) Written Description is Separate from Enablement. The purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventors contribution to the field of art as described in the patent specification. Test: Whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. The specification must describe an invention understandable to the skilled artisan and show that the inventor actually invented the invention claimed.
36 © 2010 Banner & Witcoff, Ltd. Take Home Tip #1 Written Description Describe species structure/formula actually reduced to practice Describe generic structure/formula Describe sequence portions required for function Describe relationship between structure and functional properties Use Examples/Actual Prophetic
37 © 2010 Banner & Witcoff, Ltd. Enablement 35 USC sec. 112, first paragraph The specification shall contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains... To make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
38 © 2010 Banner & Witcoff, Ltd. Enablement Must Teach One of Skill to Make and Use In Method of Treating Prostate Cancer, While the Method Steps are Taught, One of Skill Would Not Have Accepted Without Question the Effects of the Claimed Drugs. No Data Was Presented to Demonstrate the Effects of Finasteride on Prostate Cancer. Nothing in the Art to Suggest the Anti-Tumor Effect. The Method of Treating Prostate Cancer was Not Enabled. Rasmusson v. SmithKline Beecham, 413 F.3d 1318 (Fed. Cir. 2005)
39 © 2010 Banner & Witcoff, Ltd. In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (Undue Experimentation) Quantity of Experimentation Necessary Amount of Direction or Guidance Presence or Absence of Working Examples Nature of the Invention State of the Prior Art Relative Skill of PHOSITA Breadth of the Claims
40 © 2010 Banner & Witcoff, Ltd. Case Study #6 Now That I Have Prepared a Strong Patent Application, What Is The Patent Application Procedure In The US?
41 © 2010 Banner & Witcoff, Ltd. US Patent Prosecution Strategy US Application is Filed US Application Is Published Within 18 Months of Earliest Priority Date Examiner Searches and Examines Claims Examiner Issues An Office Action Rejecting or Accepting The Claims
42 © 2010 Banner & Witcoff, Ltd. Common Rejections Claims Are Not New In View Of A Single Prior Art Reference Claims Are Obvious Over A Combination Of Prior Art References The Application Does Not Teach How To Make Or Use The Invention The Invention Does Not Work
43 © 2010 Banner & Witcoff, Ltd. Common Responses Claims As Filed Are New And Nonobvious Claims Are Amended And Argued To Be New And Nonobvious Declarations Filed Demonstrating That The Invention Works and/or Provides Unexpected Or Advantageous Results The Application Teaches How to Make and Use The Invention
44 © 2010 Banner & Witcoff, Ltd. Notice of Allowance If The Examiner Believes That Your Claims Are Patentable, He Will Issue A Notice of Allowance You Must Pay An Issue Fee To Have The Patent Issue The Application Issues Into An Enforceable United States Patent What To Do Before The Patent Issues?
45 © 2010 Banner & Witcoff, Ltd. Continuation Applications: Advantages Continued Threat To Potential Infringers Better and Better Claims: Learning from Prior Prosecution Stronger and Stronger Claims: New Art Identified and Blessed Potential for Interferences
46 © 2010 Banner & Witcoff, Ltd. Case Study #7 I Dont Have a US Patent Yet, But I Want to Sell My Product in the United States. How Can I Avoid IP Disputes?
47 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion Considerations –Size of the Client –Importance Of The Product –Investment In Product Development –Likelihood Of Willful Infringement –Product Life Cycle –Degree of Risk Adverse
48 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion The Purpose of the Opinion –To Guide Product Development –To Provide Awareness of Patent Issues –To Insulate the Client Against a Finding of Willful Infringement, Enhanced Damages and Attorney Fees
49 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion Understand The Product Search Issued US Patents Understand The US Patent Rights of Third Parties Analyze Which Patents Pose A Risk Of Infringement And Suit From The Third Party Before You Begin Selling Your Product
50 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion Your Product Does Not Infringe –The Claims Do Not Read On Your Product –You Have Redesigned Your Product To Avoid Infringement Preponderance Of The Evidence Standard
51 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion The US Patent Is Invalid –Prior Art Search Conducted –The Claims Are Not New –The Claims Are Obvious –The US Patent Is Not Enforceable Clear and Convincing Evidence Standard
52 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion Purchase Or License The Patent –The Product Likely Infringes –No Redesign Options –The Patent Cannot Be Invalidated –Negotiate Rights For Royalty Fee
53 © 2010 Banner & Witcoff, Ltd. Freedom To Operate Opinion Gauge Likelihood Of Being Sued –The Patent Is Obscure –The Patent Is About To Expire –The Owner Lacks Money To Pay For A Suit –The Owner Likely Isnt Monitoring The Commercial Industry
54 © 2010 Banner & Witcoff, Ltd. Case Study #8 Weve finally got an issued patent. It cost a lot of money to get. Now we need to justify the expense. How can we use our patent OFFENSIVELY to our commercial advantage?
55 © 2010 Banner & Witcoff, Ltd. Enforcing Your Patent: Thrusting The Sword Opinion of Counsel The Notice Letter With Offer To License Infringement, Validity and Enforceability Preventing The Declaratory Judgment Suit Coercing a Licensing Situation Laches and Estoppel
56 © 2010 Banner & Witcoff, Ltd. Enforcing Your Patent: Thrusting The Sword (cont.) Suing in Federal District Court Sending a Message to Further License Negotiations Damages and Injunction Relief The Button-Down Presentation of a Complaint Suing First and Asking Questions Later: The First to File Rule
57 © 2010 Banner & Witcoff, Ltd. Enforcing Your Patent: Thrusting The Sword (cont.) Stops Imports Only No Damages Can Be Brought in Addition to Suit in Federal District Court Generally Quicker Than a Suit in Federal District Court No Personal Jurisdiction Needed, In Rem Proceeding Bringing An Action Before The ITC
58 © 2010 Banner & Witcoff, Ltd. Case Study #9 Weve finally got an issued patent. It cost a lot of money to get. Now we need to justify the expense. How can we use our patent DEFENSIVELY to our commercial advantage?
59 © 2010 Banner & Witcoff, Ltd. Defending Against Your Competitors: The Patent as a Shield The Size and Strength of Your Portfolio May Prevent Suits From Being Filed Damages and Injunctive Relief Counterclaims License Negotiations Cross Licenses as a Settlement Option Sharing the Market: Partnering, Joint Venture, Acquisition
60 © 2010 Banner & Witcoff, Ltd. Defending Against Your Competitors: The Patent as a Shield (cont.) Using a Pending Application to Have the USPTO Declare an Interference Prior Art Invalidating Your Competitor s Patent
61 © 2010 Banner & Witcoff, Ltd. Xie!
62 © 2010 Banner & Witcoff, Ltd. Thanks for your time! Any questions? John P. Iwanicki, Esq.
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