Patents and the Protection of Proprietary Biotechnology Information Susan Haberman Griffen Anna Tsang Finnegan, Henderson, Farabow, Garrett & Dunner, LLP May 20, 2005 Page 1 2005
DISCLAIMER These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of American intellectual property law. These materials reflect only the personal views of the author and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the author and Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. cannot be bound either philosophically or as representatives of various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the author or Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. Page 2 2005
New Restriction Practice Training at the USPTO Page 3 2005
Requirements for Proper Restriction There are two criteria for a proper requirement for restriction between patentably distinct inventions: The inventions must be independent or distinct as claimed; and There must be a serious burden on the examiner if restriction is required. Page 4 2005
Independent Inventions Independent Inventions Not disclosed as capable of use together Not disclosed as connected in design, operation or effect Page 5 2005
Related Inventions Distinct Inventions Subcombinations useable together Combination/Subcombination Process and Apparatus for its Practice Product and Process of Making Apparatus and Product Made Product and Process of Using Intermediate/Final Product Special case: Product, Process of Making and Process of Using Page 6 2005
Don t forget burden is required! Criteria for Burden 1. Separate classification 2. Separate status in the art 3. Divergent field of search Page 7 2005
Linking Claims What are they? Definition: One or more claims inseparable from claims to two or more otherwise properly divisible inventions. Effect: When found allowable, linking claims prevent maintaining a restriction requirement between inventions that are otherwise divisible. Page 8 2005
Types of Linking Claims Genus claims linking species claims Claim to the necessary process of making a product linking proper process and product claims Claim to means for practicing a process linking proper apparatus and process claims Claim to the product linking a process of making and a process of using Page 9 2005
If there is a linking claim? If a generic or linking claim is subsequently allowed, the restriction requirement MUST be withdrawn, even where claims to non-elected linked inventions have been canceled. The indication of withdrawal must also be clearly stated on the record. When a restriction requirement is withdrawn, 35 USC 121 no longer shields claims from double patenting considerations Page 10 2005
Example Claim 1. A composition for reducing HIV viral load in an HIV infected patient, comprising an agent inhibiting viral replication and a pharmaceutically acceptable carrier. Claim 2. The composition of claim 1, wherein the agent is a polypeptide having the amino acid sequence of SEQ ID NO:2. Claim 3. The composition of claim 1, wherein the agent is a polynucleotide having the sequence of SEQ ID NO:5. Claim 4. The composition of claim 1, wherein the agent is 3,3 -methoxysilyl-3,3 -organophosphate. Page 11 2005
Example Restriction: Group I: claim 2 Group II: claim 3 Group III: claim 4 Claim 1 is a linking claim. If claim 1 allowed, restriction is withdrawn and the linked inventions are rejoined together. Page 12 2005
Markush Practice Markush Practice: selected from the group consisting of, or any of A, B or C or chosen from A, B, or C It is improper for the Office to refuse to examine unless claim lacks unity of invention. Page 13 2005
Markush Practice Apply In re Harnish test for unity of invention Compounds have a common utility Compounds share a substantial structural feature disclosed as being essential to that utility. If members of Markush group sufficiently few in number or so closely related that search can be without serious burden, examiner must examine even though directed to independent and distinct inventions. Page 14 2005
Don t Forget Rejoinder Restriction between product and process claims Applies only where the product claims are elected Requires allowable product claim Applies only to process claims that depend from or include all the limitations of the allowable product claim. If product and process of making and/or using is disclosed but only the product is claimed, and a product claim is allowed, process claims may be entered prior to final rejection. Or use RCE (less expense than new case). Page 15 2005
Restriction Practice If you receive a restriction requirement, you can traverse it or acquiesce in it If you acquiesce in the requirement, you will need to file separate divisional applications for the claims in each of the groups Traversal means to argue against the restriction requirement If you traverse, you are arguing that the inventions of the different groups are not patentably distinct. This could have limit your ability to later argue that prior art relevant to the claims of one group is not relevant to all of the claims Page 16 2005
Restriction Practice If you acquiesce in a restriction requirement and file divisional applications, those divisional applications will expire 20 years from the filing date of your application which received the restriction requirement. The exception is for divisional applications filed before June 8, 1995. These divisional applications can expire 17 years from the date of issue. Page 17 2005
Restriction Practice If you acquiesced in a restriction requirement and filed divisional applications before June 8, 1995, you must be sure that the claims you prosecute in each divisional are consonant with the restriction requirement Consonant with the restriction requirement means that the each divisional contains only claims corresponding to one of the Examiner s original groups Page 18 2005
Continuation Applications Divisional applications Continuation applications Continuation-in-part applications Page 19 2005
Continuation Applications Continuing applications under 35 U.S.C. 120 have the same effective filing date as their parent application if: It is filed before the prior application is abandoned or issued It is amended to refer to the prior application There is at least one common inventor The claims in the continuing application are supported by the specification of the prior application as required by 35 U.S.C. 112, first paragraph (best mode, written description, enablement) Page 20 2005
Continuation-in-Part Applications Continuation-in-part applications contain new matter as compared to the prior application,while divisional and continuation applications do not Page 21 2005
Continuation-in-Part Applications This new matter may or may not be necessary for the claims to be supported as required by 112, first paragraph (best mode, written description, enablement) If the new matter is required for 112 support, then those claims will not be entitled to the prior application filing date If the new matter is not required for 112 support, then those claims will be entitled to the prior application filing date Page 22 2005
Request for Continued Examination Adopted on May 29, 2000 as an alternative to filing continuation applications (not available for applications filed before June 8, 1995) To start an RCE, you need to file a request, a submission, and pay a fee. The submission includes, among other things, an IDS, a response to any outstanding Office Action, and new arguments or evidence in support of patentability Page 23 2005
Request for Continued Examination Comparison of RCE to a continuation application Fee for filing an RCE may be less depending on the number of claims Filing an RCE can lock in term adjustments An RCE is limited to the same invention that was prosecuted in the application in which the request was filed Page 24 2005
Request for Continued Examination Strategic considerations when evaluating whether to file an RCE or a continuation application If a different invention is to be examined in the future, e.g., in a divisional, you cannot use an RCE If there is an outstanding Office Action, if you file an RCE you must include a complete response to the Office Action. If such a response is not available, you must file a continuation application Page 25 2005
Request for Continued Examination Strategic considerations when evaluating whether to file an RCE or a continuation application (cont.) The filing fee for an RCE is the same as the basic filing fee for the continuation application. However, if you have many claims, the RCE would be less costly Filing a continuation could trigger publication of an application filed after November 2000. Filing an RCE does not trigger publication Page 26 2005
Request for Continued Examination Strategic considerations when evaluating whether to file an RCE or a continuation application (cont.) If you want to take advantage of 103(c) for an application filed before November 29, 1999, you must file a continuation application instead of an RCE Page 27 2005
Preparing for an Appeal Page 28 2005
Cases Pending 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 Board of Patent Appeals and Interferences Ex Parte Cases 0 1999 2000 2001 2002 2003 2004 Year Page 29 2005
Board of Patent Appeals and Interferences Cases Received 4,500 Ex Parte Cases 4,000 3,500 3,000 2,500 2,000 1999 2000 2001 2002 2003 2004 Year Page 30 2005
Requirements for Appeal Claims are twice rejected 37 CFR 1.191(a) or Final Office Action Page 31 2005
Should we appeal? Factors to Consider The Examiner is your friend. Consider your relationship with the Examiner in this and other cases. How many of your cases are with this Examiner? History with the Examiner client & attorney Page 32 2005
Preparing Case for Appeal Building a strong record Begins with drafting of application Minimizing the record Cogent and concise arguments Focus on Examiner s burden Focus on the cited art, not claimed invention Page 33 2005
Preparing Case for Appeal Amendment/Declarations If needed, file prior to final Office Action May require Request for Continued Examination to be considered Talk to the Examiner Page 34 2005
Reexamination and Reissue Ways to correct errors in patents Page 35 2005
Reexamination and Reissue Ways to correct errors in patents Reissue of a patent grant that is wholly or partially inoperative or invalid Reexamination to determination the patentability of claims over prior art patents or printed publications Page 36 2005
Reissue Pursuant to 35 U.S.C. 251 Available to correct errors in the specification, drawings, or claims May only be initiated by the patent owner Page 37 2005
Types of errors that can be corrected with a reissue application Reissue Translation errors Claiming the benefit of a prior application Inventorship To provoke an interference Types of errors that cannot be corrected with a reissue application Inequitable conduct Failure to file a continuing application Page 38 2005
Reissue The claims can be amended in a reissue application In a narrowing reissue, the claims are narrowed In a broadening reissue, the claims are broadened Page 39 2005
Broadening Reissue In a broadening reissue Can only broaden claims if the reissue is filed within 2 years of the issue date of the patent May trigger intervening rights Cannot recapture subject matter that was deliberately cancelled in order to secure the original patent Page 40 2005
Reissue To file a reissue application, you must surrender your original patent A reissued patent, if granted, expires on the same date as would the original patent Page 41 2005
Reissue Things to think about before filing a reissue Third parties can protest The Examiner can reject any claims of the original patent Intervening rights may attach Page 42 2005
Reexamination May be requested by anyone, including by the PTO Commissioner Limited to determining the patentability of claims over patents and printed publications Page 43 2005
Reexamination May be requested by anyone, including by the PTO Commissioner Limited to determining the patentability of claims over patents and printed publications Claims may not be broadened Page 44 2005
Reexamination Reexam may be ex parte or inter partes Inter partes reexam has been available since November 29, 1999 Page 45 2005
Reexamination or Reissue Notice of both are published in the Official Gazette Reexam is only available with respect to questions of patentability in view of patents and printed publications Members of the public can only request reexam, not reissue Continuations may be filed in reissue proceedings but not in reexam proceedings Claims can be broadened only in some reissues Page 46 2005
Overview of Interference Practice Page 47 2005
Board of Patent Appeals and Interferences Cases Pending 350 Inter Partes Cases 300 250 200 150 100 50 1999 2000 2001 2002 2003 2004 Year Page 48 2005
Board of Patent Appeals and Interferences Cases Declared 140 Inter Partes Cases 130 120 110 100 90 80 1999 2000 2001 2002 2003 2004 Year Page 49 2005
First-to-Invent vs. First-to-File United States: First-to-invent Rest of the world: First-to-file Page 50 2005
U.S. Patent Interferences What is it? The system developed to resolve conflicting assertions of first inventorship Page 51 2005
U.S. Patent Interferences USPTO: At least one patent application involved (35 U.S.C. 135) U.S. District Courts: Only issued patents (35 U.S.C. 291) Which of at least two parties is not entitled to interfering patent claims? Page 52 2005
Interfering Subject Matter Interfering subject matter is present when two or more parties present claims that are patentably indistinct from one another Page 53 2005
Interfering Subject Matter Under the New Rules An interference exists in the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa. 37 C.F.R. 41.203 A two-way test Page 54 2005
Possible Result of Two-Way Test Party A (Species) Filing Date 18 Months Issue/Publication Date Filing Date Rejected over Party A 131 Affidavit Issues(?) Party B (Genus) Remember, a species claim anticipates a claim to an encompassing genus BUT a genus claim does not necessarily anticipate a claim to an included species Page 55 2005
Interference Counts A count looks like, but is not, a patent application claim Defines the relevant interfering subject matter Describes the invention you must be first to make if you are to prevail Tells you what priority proofs are relevant Page 56 2005
Interference Counts Often derived from an application or patent claim of a party Count is not necessarily patentable to either party, but must be patentable over the prior art Phantom count Party A claims range of 60 C to 100 C Party B claims range of 75 C to 125 C Count range is 60 C to 125 C Page 57 2005
Interference Counts Or count The invention defined by Claims 1, 4, and 8 of Party A, or Claims 12 and 15 of Party B Common practice because it is easy and fair Page 58 2005
Count Conventions Usually a single count If there are multiple counts, each must be directed to a different patentable invention Priority decided separately for each count Page 59 2005
Count Conventions All patentably indistinct claims are designated to correspond to the count At risk Patentably distinct claims not designated as corresponding to count Not at risk Page 60 2005
Two-Way vs. One-Way Test of Claim Correspondence to a Count A claim corresponds to a count if the subject matter of the count, treated as prior to the claim, would have anticipated or rendered obvious the subject matter of the claim. 37 C.F.R. 41.208(b)(2) A type of one-way test Page 61 2005
Case 1 Possible Results of Two-Way and One-Way Tests Party A Claims only Species 1 Party B Claims only Genus 1, which subsumes Species 1 but does not render Species 1 unpatentable Result: Because two-way test of interfering subject matter is not met, no interference is declared Page 62 2005
Possible Results of Two-Way and One-Way Tests Case 2 Party A Claims only Species 1 Party B Claims both Genus 1, which subsumes Species 1, and Species 1 Page 63 2005
Result Possible Results of Two-Way and One-Way Tests a) Because two-way test of interfering subject matter is met (with claims of both parties to Species 1) an interference is declared with count directed to Species 1 b) Because one-way test for claim correspondence is met by Count to Species 1 and claim to Genus 1, claims to both Species 1 and Genus 1 are designated as corresponding to count and are at risk in the interference Page 64 2005
Preliminary Motions Filed before first-to-invent is decided Everyone s motions are filed on the same day You can file contingent motions Page 65 2005
Nonpriority Grounds for Decisions Unpatentability Inequitable conduct Abandoned, suppressed, or concealed Derivation 35 U.S.C. 135(b) Page 66 2005
Good Forum for Patentability Attack Can raise any patentability attack (unlike reexamination) PTO is accustomed to ruling that claims are unpatentable Fully Inter Partes (unlike reexamination) No presumption of validity Page 67 2005
Patentability Considerations Successful attack may sink your own ship Successful attack does not resolve priority issue May remain unresolved Prevailing party s patent subject to subsequent challenge under 102(g) May be resolved against party challenging validity No one wins; Perkins v. Kwon Page 68 2005
Inequitable Conduct PTO considers this issue only in interferences Not limited to conduct during interference Prior to 1985 Rules, ancillary to priority Provided basis for priority award Unrelated to who was first Page 69 2005
Inequitable Conduct Now raised by motion under 1.633(a) (Patentability) Concept of ancillary to priority abolished Doesn t resolve priority issue Heavy burden to establish Board may hear live witnesses Page 70 2005
Abandoned, Suppressed, or Concealed Can t rely on date of invention if subsequently abandoned, suppressed, or concealed Mere undue delay created presumption of suppression or concealment Length of delay necessary to create presumption depends on facts (e.g., complexity of invention) Page 71 2005
Abandoned, Suppressed, or Concealed Typically, presumption applies if unexplained delay between reduction to practice and filing reached 20 months Presumption may be rebutted Can abandon, suppress, or conceal and still rely on subsequent activity Page 72 2005
Must show First to conceive Communication to opponent prior to opponent s conception Derivation Don t need to be first to reduce to practice or diligent Discovery Page 73 2005
Date of Invention Conception Reduction to practice Diligence Page 74 2005
Conception: The Idea But not just a general idea, goal, or plan, but a definite and permanent idea of the complete and operative invention Hitzeman v. Rutter, 243 F.3d 1345, 58 U.S.P.Q.2d 1161 (Fed. Cir. 2001) Need sufficient detail and particularity to allow one skilled in the art to reduce to practice without undue experimentation In re Jolley, 308 F.3d 1317, 64 U.S.P.Q.2d 1901 (Fed. Cir. 2002) Page 75 2005
Conception Requirements Not mere hope, but reasonable expectation that the claimed invention will be produced Hitzeman, supra. But don t need a reasonable expectation that the claimed invention will work for its intended purpose Id.; Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 32 U.S.P.Q.2d 1915 (Fed. Cir. 1994) Page 76 2005
Conception Requirements Need a specific utility Single embodiment is enough Page 77 2005
Reduction to Practice Actual Constructive Page 78 2005
Actual Reduction to Practice Produce tangible embodiment of invention Single embodiment enough Demonstrate it works as intended Perfection not required Contemporaneous recognition Page 79 2005
Constructive Reduction to Practice Must be a legally sufficient patent application Involved U.S. application (or patent) Parent U.S. case Foreign priority application Different from relying on parent or priority case to overcome prior art Single adequately described embodiment is enough Nonpatent publication does not qualify Page 80 2005
Determining Priority 1 st party to reduce to practice Unless other party can show Subsequent reduction to practice (actual or constructive), Earliest conception, and Reasonable diligence from before 1 st party s conception to other party s reduction to practice Page 81 2005
Case 1 Party A C No Diligence R Party B C No Diligence R Case 2 Party A Party B Case 3 C Diligence R C No Diligence R Party A C Diligence R Party B C Diligence R Case 4 Party A C No Diligence R Party B C Diligence R Determining Priority Page 82 2005
Case 5 Party A C No Diligence R Party B C No Diligence R Case 6 Party A C Diligence R Party B C No Diligence R Case 7 Party A C No Diligence R Party B C Diligence R Case 8 Party A C Diligence R Party B C Diligence R Determining Priority Page 83 2005
Determining Priority Case 9 Party A C No Diligence R Party B Party C C Diligence R C Diligence R Page 84 2005
Reasonable Diligence Standards of finding are harsh Show virtual continuous (daily) activity during entire relevant time period Evidence must show What acts Specific dates of acts Excused sometimes Page 85 2005
Reasonable Diligence To constitute diligence, activity relied upon must be directed to reducing to practice the subject matter of the count Page 86 2005
Exceptions Reasonable Diligence Work on closely related invention disclosed in involved application or patent Work on closely related patent applications Either a direct attachment to subject matter of Count, or part of an overall scheme... Directed to reducing the invention [of the Count] to practice. Page 87 2005
Engineering Diligence (Actual reduction to practice) Types of Diligence Stringent requirements for virtual continuous activity on invention of count Attorney Diligence (Constructive reduction to practice) Greater latitude to work on other matters (reasonable backlog of work taken up in chronological order and carried out expeditiously) Page 88 2005
Corroboration Basic theory: Guard against incentive to falsely allege earlier dates Evidence independent of inventor One inventor cannot corroborate another Need for conception; reduction to practice; diligence But not needed for all steps or details Only applies to inventor s testimony Page 89 2005
Rule of Reason test Considering all the evidence, is the inventor s story credible? Corroboration Does not alter requirement that evidence of corroboration must not depend solely on the inventor Reese v. Hurst, 661 F.2d 1222, 1226, 211 U.S.P.Q. 936, 940 (C.C.P.A. 1981) Page 90 2005
Rule of Reason test Corroboration Independent corroboration may consist of testimony of a witness, other than the inventor,... Or it may consist of evidence of surrounding facts and circumstances independent of information received from the inventor. Id.: see also Cooper v. Goldfarb, 154 F.3d 1321, 1330, 47 U.S.P.Q. 2d 1896, 1903 (Fed. Cir. 1998) Page 91 2005
Possible Adoption of U.S. Opposition Procedure USPTO 21 st Century Plan Proposal for Post-Grant Review of Patent Claims help assure that those potentially affected by the economic burdens of patents with invalid claims can obtain prompt redress. http://www.uspto.gov/web/offices/com/strat21/action/sr2.htm Page 92 2005
Possible Adoption of U.S. Opposition Procedure Goal of resolution within a year: Direct cases could be presented by documents, and live crossexamination allowed where necessary. Present proposal would eliminate inter partes reexamination entirely and make initiation of third-party requested reexamination discretionary. Page 93 2005
Possible Adoption of U.S. Opposition Procedure Public could petition the USPTO to cancel one or more claims in a patent within one year of its issue date. Also allows anyone who is threatened with a patent infringement suit to petition for review within four months of being threatened. review petitioner may file a petition not later than 4 months after the review petitioner is placed in substantial apprehension of being sued for infringement of the challenged patent claim. To prevent misuse, the review petitioner would be required to make a sufficient initial showing of unpatentability; otherwise the petition would be dismissed. Page 94 2005
Possible Adoption of U.S. Opposition Procedure If the showing is found to be sufficient, a fact-finding proceeding leading to a hearing by the Board of Patent Adjudication (current BPAI) on the merits would follow. Mandatory disclosure of all relevant information, followed by discovery as permitted by the Board of Patent Adjudication, ie, limited Discovery. Patent owner would have a single opportunity as of right to make a narrowing amendment of the challenged claims. Page 95 2005
Possible Adoption of U.S. Opposition Procedure Allow any and all grounds that may be brought in a district court to challenge patent validity, but not to challenge patent enforceability. Allow appeal from final decisions to Federal Circuit only. Page 96 2005
Susan Haberman Griffen Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. 901 New York Ave., N.W. Washington, D.C. 20001-4413 Telephone: (202) 408-4000 Facsimile: (202) 408-4400 susan.griffen@finnegan.com Anna Tsang Fei Han Foreign Legal Affairs Law Firm 12D 167 DunHua N. Road Taipei, 105 Taiwan Telephone: 886-22-712-7001; Facsimile: 886-22-712-7080 anna.tsang@finnegan.com Page 97 2005