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Recent Developments Affecting U.S. Patent Prosecution And Their Impact On Global Portfolios

Presentations
  • What are ways to avoid/ overcome obviousness-type double patenting (ODP) rejections?
    • In the US, ODP can arise in "related" continuation applications or applications that do not share priority (requires at least one common inventor, but can have different assignees)
    • Three ways to overcome ODP rejection:
      • Safe Harbor protection under §121 (only for divisional applications)
      • On the merits (claims are nonobvious)
      • File a terminal disclaimer (TD), which requires common ownership for duration of patent term
    • Pre-filing/drafting considerations: 
      • Know scope of already claimed subject matter (including dependent claims)
      • Distinguish improvements or selections from prior filings during preparation of new unrelated applications (e.g., unexpected properties of or results produced by a species)
      • Draft and pay for diverse claim set (likely to prompt a restriction requirement)
      • If you think you might need a TD, maintain common-ownership
    • Prosecution strategies:
      • Do not assume Examiner's ODP rejection is proper
      • Same non-obviousness rebuttals as you would use for §103, including secondary considerations
      • Carefully consider risk to patent term before filing TD (and must remain co-owned)
      • If patent issues with large PTA, consider risk of continuation application (Gilead)
  • How do you leverage fast-track examination tools to streamline global prosecution?
    • Goal is reduction in overall cost and efficiency of building patent portfolio
    • Track One Prioritized Examination
      • $4k/$2k USD; no more than 4 independent claims and 30 total claims
      • Months to First Office Action:  Track One – 1.8; Traditional – 15.7
      • Months to Final Disposition:  Track One – 7.2; Traditional – 24.3
    • Patents 4 Patients (fast-track review for cancer immunotherapy-related applications without fee)
    • Patent Prosecution Highway
      • Accelerate prosecution in related second application based on an allowed first application in another country
      • Applications must share a common priority date; claims must “sufficiently correspond” to the allowed claims
      • Higher allowance rate compared to non-PPH cases; shorter pendency; fewer Office Actions
      • Combine tools to quickly generate global portfolio (Track One; PACE; PPH; PPH-PCT)
  • What prosecution strategies are life sciences companies implementing to create IPR and PGR resilient patents?
    • Seeking high quality patents: goal is non-institution
    • 7,704 IPR Petitions:  68% institution rate; 76% of claims canceled at FWD; 10% in bio/pharma
    • 110 PGR Petitions:  58% institution rate; 85% of claims canceled at FWD; 27% in bio/pharma
    • Pre-filing:  robust patentability searching
      • Know best art before competitors; objective assessment of patentability
      • Help distinguish invention from prior art during preparation; better define claim scope
    • Application drafting considerations:
      • Compelling patentability story in the face of most pertinent prior art (problem/solution)
      • Provide clear definitions for claim terms (glossary)
      • Numerous claims of varying scope and format that are clearly supported by the specification ($15,500 IPR fee up to 20 claims; $300 each additional claim)
    • Prosecution strategies:
      • Get key art on the record and considered by the Examiner during prosecution
      • Well drafted declarations addressing art, claim construction and/or secondary considerations (evidence must be commensurate in scope with claims)
      • Create patent thicket to extent possible around product including separate patents only including claims specifically directed to approved product
      • Expedited prosecution (e.g., Track One) and judicious use of reissue applications to gain additional patents prior to patent owner estoppel; keep pending continuation
  • How do you navigate the narrowing subject matter eligibility threshold in the life sciences?
    • In the US, product and process claims can be found patent ineligible if directed to laws of nature or natural phenomenon (product and diagnostic claims are more frequently at risk)
    • While addressing different subject matter (diagnostic drug correlations, isolated genes, and algorithms), each of Mayo/Myriad/Alice aimed to exclude tools of research from eligibility
    • Considerations for drafting patent eligible products and/or process claims:
      • Include characteristics distinct from the natural counterpart (not just isolated or purified)
      • Add significantly more than what is found in nature (structure and/or functional differences)
      • Once natural phenomenon is removed from the claims, the remaining elements cannot be merely routine, conventional, and well-understood components or steps
      • If all elements of the claim were well known and in common use, consider whether the combination of these elements is inventive
      • Use of diagnostics and/or products in methods of treatment
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