America Invents Act: Recent Changes to US Patent Law and Practice
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The document summarizes changes brought by the America Invents Act to U.S. patent law and practice. Some key changes include transitioning from a first-to-invent system to a first-inventor-to-file system, expanding the definition of prior art, creating new post-grant review proceedings like post-grant review and inter partes review, expanding prior user rights, and changing treatment of errors in inventorship. The changes aim to harmonize the U.S. system with other countries and improve patent quality and challenge procedures.
![Prior User Rights
– State Street Bank v. Signature Financial Group
(CAFC 1998)
– Court affirmed USPTO and rejected theory that
“method of doing business” was excluded subject
matter
– Prior User Defense (Nov. 29, 1999)
– 35 USC § 273
– It shall be a defense to an action for infringement under
section 271 of this title with respect to any subject matter that
would otherwise infringe one or more claims for a method [[of
doing or conducting business]] in the patent being asserted
against a person, if such person had, acting in good faith,
actually reduced the subject matter to practice at least 1 year
before the effective filing date of such patent, and
commercially used the subject matter before the effective filing
date of such patent.](https://image.slidesharecdn.com/americainventsactrecentchangestouspatentlawandpractice06feb12-13288180369158-phpapp02-120209140829-phpapp02/85/America-Invents-Act-Recent-Changes-to-US-Patent-Law-and-Practice-5-320.jpg)
![The CREATE Act
– 35 U.S.C. § 103(C)(3)
– “Joint Research Agreement”
• “[A] written contract, grant, or cooperative
agreement entered into by two or more
persons or entities for the performance of
experimental, developmental, or research
work in the field of the claimed invention.”
41 2/9/2012](https://image.slidesharecdn.com/americainventsactrecentchangestouspatentlawandpractice06feb12-13288180369158-phpapp02-120209140829-phpapp02/85/America-Invents-Act-Recent-Changes-to-US-Patent-Law-and-Practice-41-320.jpg)
![Stanford v. Roche
583 F3d 832 (CAFC 2010)
• Inventor begins work on quantifying HIV levels in
blood using PCR
• Inventor is unfamiliar with PCR technology so he
performs research at Cetus with Cetus employees
• Cetus requires that Inventor sign a Visitor’s
Confidentiality Agreement
– Inventor “will assign and does hereby assign”
to Cetus his “right, title and interest in each of
the ideas, inventions and improvements”
made “as a consequence of [his] access” to
Cetus](https://image.slidesharecdn.com/americainventsactrecentchangestouspatentlawandpractice06feb12-13288180369158-phpapp02-120209140829-phpapp02/85/America-Invents-Act-Recent-Changes-to-US-Patent-Law-and-Practice-47-320.jpg)
America Invents Act: Recent Changes to US Patent Law and Practice
- 1. America Inventors Act: Recent Changes to U.S. Patent Law and Practice University of Washington School of Law Advanced Patent Law P545 Gary M. Myles, Ph.D. February 6, 2012
- 2. Introduction • Patent Reform Act of 2011 (a/k/a “Leahy-Smith America Invents Act”) – Signed into Law by President Obama on September 16, 2011 – Most significant change in U.S. patent law since U.S. Patent Act of 1952
- 3. Goals of the Act • “Enhance and encourage innovation that improves American competitiveness, economic prosperity and job growth.” USPTO Commissioner Stoll • International harmonization – Refined definition of prior art – Replace first-to-invent with first-inventor-to-file • Improve the quality of patents – Third-party pre-grant submissions – Changes to post-grant review
- 4. America Invents Act Timing: Effective Immediately
- 5. Prior User Rights – State Street Bank v. Signature Financial Group (CAFC 1998) – Court affirmed USPTO and rejected theory that “method of doing business” was excluded subject matter – Prior User Defense (Nov. 29, 1999) – 35 USC § 273 – It shall be a defense to an action for infringement under section 271 of this title with respect to any subject matter that would otherwise infringe one or more claims for a method [[of doing or conducting business]] in the patent being asserted against a person, if such person had, acting in good faith, actually reduced the subject matter to practice at least 1 year before the effective filing date of such patent, and commercially used the subject matter before the effective filing date of such patent.
- 6. Prior User Rights – Prior User Rights • Extends existing defense for business method patents to all patents where accused infringer demonstrates – Reduction to practice – Commercial use – One year before patent’s effective filing date
- 7. Best Mode Requirement – Patents not invalid/unenforceable where fail to disclose a best mode
- 8. Ex parte Re-exam – Ex parte re-exam remains, but appeals now are directly to the Federal Circuit
- 9. False Marking and Virtual Marking – False Marking and Virtual Marking • False marking claim requires competitive injury • Expired patent number not false marking • Virtual marking OK – Associate product/service with internet address containing patent number
- 10. America Invents Act Timing: 10-days After Enactment (September 26, 2011)
- 11. USPTO Fee-setting Authority • Most PTO fees increase by 15% • Microentity status gets 75% reduction in fees – Individual inventors and small entities with no more than four of their own US patent applications, less than median household income, and no obligation to assign/license to a non-micro entity – Institutions of higher education • Prioritized examination for $4,800 ($2,400 small entity) – 4 independent/30 total claims
- 12. America Invents Act Timing: 12-months After Enactment (September 16, 2012)
- 13. Current Options for Post-Grant Patent Review through the PTO • Reissue – Available only to patentees – Used to correct errors in specification or drawings, or to change scope of claims • Can broaden claim scope within two years of issuance • Can narrow claim scope at any time during life of patent
- 14. Current Options for Post-Grant Patent Review through the PTO • Ex parte and Inter partes Reexamination – Available to patentees and to 3rd parties – Analysis of issued patent • Based on substantial new question of patentability • Based only on patents and printed publications • Only relevant to claims • Claims cannot be broadened • Brought at any time during enforceability of patent
- 15. Third-party Submissions – Pre-issuance, third-party submissions of prior art • Showing of relevance + fee • Timing restrictions, earlier of: – Notice of Allowance, or – Later of » 6-months post publication, or » Date of first rejection
- 16. Post-grant review • Post-grant review – Third-party can challenge patent within 9-months of issuance – Not limited to invalidity based on prior art – Only for first inventor to file patent applications
- 17. Recent Changes to Post-Grant Review • General Provisions – Proceeding before the PTAB to review patent validity – Based on any available patentability ground • contrast with current reexamination – based on patents and printed pubs – Patentee can cancel claims or add claims to substitute challenged claims – Claim scope cannot be broadened; no new matter may be introduced
- 18. Recent Changes to Post-Grant Review • Timing – Initiated within nine months of issuance of patent/reissue – Review completed within one year • possible six-month extension for cause – Cannot be initiated if petitioner has brought civil action alleging invalidity
- 19. Recent Changes to Post-Grant Review • Threshold showing to initiate action – More likely than not that at least one of the claims is unpatentable or – Raises novel/unsettled legal question important to other patents/apps
- 20. Inter partes review • Inter partes review – After post-grant review period – Initiated by third-party where “reasonable likelihood” of prevailing • Replaces “substantial new question of patentability” standard – Patent Trial and Appeal Board must complete within 18 months
- 21. Recent Changes to Inter Partes Review • General Provisions – Proceeding before PTAB to review patent validity • Replaces inter partes reexamination • ex parte reexamination remains – Basis limited to patents or printed publications and to issues of novelty/obviousness under 35 U.S.C. §§ 102/103 – Patentee can cancel claims or add claims to substitute challenged claims – Claim scope cannot be broadened; no new matter may be introduced
- 22. Recent Changes to Inter Partes Review • Timing – Life of patent after later of nine months from issuance or termination of post-grant review – Review completed within one year • possible six-month extension for cause – Cannot be initiated if petitioner has brought civil action alleging invalidity – Proceeding cannot be initiated if petition is filed more than six months after petitioner is served with complaint alleging infringement of patent
- 23. Recent Changes to Inter Partes Review • Showing – Reasonable likelihood petitioner would prevail with respect to at least one claim
- 24. Benefits of Changes • Post-Grant Review Procedures – Broaden scope of review by PTO (as opposed to courts) – Reduce costs to challenge patents – Increase patent quality – Expedite PTO review process – Encourage early review and analysis by affected parties
- 25. Failure to Obtain Advice from Counsel • Failure to Obtain Advice from Counsel – No longer grounds to find that a party willfully infringed or intended to induce infringement of a patent – Codifies Seagate (CAFC)
- 26. Errors in Inventorship • Errors in Inventorship – No longer grounds for holding patent unenforceable if error is remedied at any time w/ supplemental/corrected declaration of inventorship
- 27. America Invents Act Timing: 18-months After Enactment (March 16, 2013)
- 28. First-Inventor-to-File • First-to-Invent v. First-Inventor-to-File First-to-Invent Conception RTP File App Jan. 1, 2013 Jan. 10, 2013 Jul. 1, 2013 Conception RTP File App Feb. 1, 2013 Feb. 10, 2013 May 1, 2013 First-Inventor-to-File
- 29. First-Inventor-to-File • First-Inventor-to-File • 35 U.S.C. § 102(a)-(g) replaced with § 102(a)-(d) • Almost absolute novelty requirement • One year grace period for any inventor publication, public use, offer for sale, or sale in the U.S. • Does not apply to third party disclosures, unless after inventor’s disclosure w/in one year grace period
- 30. First-Inventor-to-File • First-Inventor-to-File • 35 U.S.C. § 102(a)(1) replaces § 102(a) and (b) – Defines prior art • 35 U.S.C. § 102(a)(2) – Defines “derived” prior art • 35 U.S.C. § 102(b)(1) identifies exceptions to prior art under § 102(a)(1)
- 31. Prior Art
- 32. Prior Art HISTORICALLY – the limits on 102 (i.e., the public policy reasons) for determining “use” or “on-sale” “in this country” were tied to what was feasible for an inventor to determine in an era of limited communications around the world. EFFECT – “Use”, “on sale” or “available to the public” under the Act now extends this implied knowledge to anywhere in the world. In this internet age, this does not seem to be such an onerous burden.
- 33. Prior Art (a) NOVELTY; PRIOR ART. – A person shall be entitled to a patent unless – (2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was filed before the effective filing date of the claimed invention.
- 34. Prior Art • Overall effect – – SECRET PRIOR ART – • Historically related to 102(e) – a U.S. national application. • Under the Act – Extends to foreign filings
- 35. Prior to the CREATE Act • Historical Context – In re Bass, 474 F.2d 1276 (CCPA 1973) – In re Clemens, 622 F.2d 1029 (CCPA 1980) – Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437 (CAFC 1984) • Non-public, confidential disclosures may be prior art under 35 U.S.C. § 102 (g) (prior invention) for validity challenges under 35 U.S.C. § 103 35 2/9/2012
- 36. Prior to the CREATE Act • Historical Context, cont. – 1984 Amendment to 35 U.S.C. • Excluded from the prior art, for purposes of an obviousness challenge, subject matter communicated between intra-institutional research collaborators which qualifies as prior art only under 102(f) or (g), when: – At the time of invention – Subject matter and the claimed invention were » Owned by the same person, or » Subject to an obligation to assign the same person 36 2/9/2012
- 37. Prior to the CREATE Act • Historical Context, cont. – Oddzon Products v. Just Toys, Inc., 112 F.3d 1396 (CAFC 1997) • Non-public communications between inter- institutional research collaborators, where no right of ownership existed in a single institution, could be used as prior art under 35 U.S.C. § 102(f) (derived from another) to challenge patent validity under 35 U.S.C. § 103 37 2/9/2012
- 38. The CREATE Act • Cooperative Research and Technology Enhancement (CREATE) Act of 2004 – Rectifies the OddzOn ruling by excluding from the prior art, for the purposes of an obviousness challenge, “secret” prior art resulting from inter-institutional research collaborations so long as there is a pre- existing (and conforming) agreement 38 2/9/2012
- 39. The CREATE Act • 35 U.S.C. § (c)(1) – Subject matter developed by another person – Qualifies as prior art only under 35 U.S.C. § 102(e)(secret), (f)(derived from another), or (g)(prior invention) – Shall not preclude patentability under 35 U.S.C. § 103 where • Subject matter and claimed invention • At the time the claimed invention was made • Owned by the same person or subject to an obligation of assignment to the same person 39 2/9/2012
- 40. The CREATE Act – 35 U.S.C. § 103(C)(2) – “Owned by the same person” • Subject matter developed by another person and a claimed invention are deemed owned by the same person or subject to an obligation of assignment to the same person if: – (A) Claimed invention was made by or on behalf of parties to a joint research agreement (JRA) in effect on or before the date the claimed invention was made; – (B) Claimed invention was made as a result of activities undertaken within the scope of the JRA; and – (C) Application for patent for the claimed invention discloses parties to the JRA 40 2/9/2012
- 41. The CREATE Act – 35 U.S.C. § 103(C)(3) – “Joint Research Agreement” • “[A] written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.” 41 2/9/2012
- 42. Changes Brought on by the AIA • 35 U.S.C. § 103 Amended to Remove 103(c) • New 35 U.S.C. § 102 Includes 102(c) – Common Ownership Under JRAs • Subject matter disclosed and claimed invention deemed owned by same person in applying 102(b)(2)(C) (i.e., prior art exclusion provisions) if: – Subject matter disclosed and claimed invention made by parties to a JRA in effect as of the effective filing date of the claimed invention; – Claimed invention made within scope of JRA; and – Patent application for claimed invention discloses parties to JRA 42 2/9/2012
- 43. Best Practices after the AIA • Joint Research Agreements – Content • Must describe general scope of research that encompasses later claimed invention – Timing • Must execute JRA prior to effective filing date of patent application disclosing claimed invention • Patent Applications – Must disclose parties to the JRA • Unintended consequences of a pre-JRA non-disclosure agreement (NDA) – Does not offer the prior art protections of a properly drafted and executed JRA – For large companies, may open the door for impropriety challenges 43 2/9/2012
- 44. Derivation Proceedings – Derivation proceedings under 35 U.S.C. § 135 • Replace interferences • Heard by Patent Trial and Appeal Board
- 45. Strategic Considerations • Promptly file manuscripts and invention disclosures as provisional patent applications to establish early effective filing date • Use virtual marking on company web site to associate products/services with patent portfolio • Survey patent landscape to monitor for pre- issuance submission and post-grant review opportunities • Consider impact of pre-filing publication within one year grace period on international patent applications
- 46. Stanford v. Roche 583 F3d 832 (CAFC 2010) • 1985 – Cetus develops PCR methods for quantifying HIV levels in blood • 1988 – Cetus begins collaboration with a laboratory within Stanford’s Department of Infectious Diseases to test new AIDS drugs – Inventor (Dr. Holodniy) • Joins Stanford laboratory as a research fellow • Signs Copyright and Patent Agreement where he “agrees to assign” to Stanford his “right, title and interest in” inventions resulting from his employment at the University
- 47. Stanford v. Roche 583 F3d 832 (CAFC 2010) • Inventor begins work on quantifying HIV levels in blood using PCR • Inventor is unfamiliar with PCR technology so he performs research at Cetus with Cetus employees • Cetus requires that Inventor sign a Visitor’s Confidentiality Agreement – Inventor “will assign and does hereby assign” to Cetus his “right, title and interest in each of the ideas, inventions and improvements” made “as a consequence of [his] access” to Cetus
- 48. Stanford v. Roche 583 F3d 832 (CAFC 2010) • Inventor works with Cetus employees to develop testing method • Inventor returns to Stanford – Continues to work on testing method with support from an NIH grant – Stanford reports finding to the NIH and elects to retain title – Stanford obtains three patents on inventor’s work
- 49. Stanford v. Roche 583 F3d 832 (CAFC 2010) • 1991 – Roche acquires Cetus PCR business including rights under Visitor’s Confidentiality Agreement – Roche produces commercial test • 2005 – Stanford sues Roche for patent infringement • 2010 – Federal Circuit holds • Stanford’s “agrees to assign” language within its Copyright and Patent Agreement does not constitute a current assignment • Cetus’ “will assign and does hereby assign” does constitute a current assignment
- 50. Stanford v. Roche 563 U.S. __ (SCOTUS 2011) • 2010 – Stanford appeals to U.S. Supreme Court – Question Presented for Certiorari • "Whether a federal contractor university’s statutory right under the Bayh-Dole Act, 35 U.S.C. §§ 200-212, in inventions arising from federally funded research can be terminated unilaterally by an individual inventor through a separate agreement purporting to assign the inventor’s rights to a third party.”
- 51. Stanford v. Roche 563 U.S. __ (SCOTUS 2011) • 2011 – Supreme Court upholds time-honored tenet of patent law that an inventor owns rights to his/her invention – Bayh-Dole Act does not affect inventor’s ownership rights – Breyer dissent • Stanford should retain title because “patent law appears to have long specified that a present assignment of future inventions (as in both contracts here) conveyed equitable, but not legal, title.”