About the Authors

  • The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.
2018 Juristant Badge - MBHB_165
Juristat #4 Overall Rank

E-mail Newsletter

  • Enter your e-mail address below to receive the "Patent Docs" e-mail newsletter.

Contact the Docs

Disclaimer

  • "Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.
Juristat_165
Juristat #8 Overall Rank

Pharma-50-transparent_216px_red

« USPTO Proposes More Rules for Implementing AIA Provisions | Main | USPTO to Hold Hearing on Genetic Diagnostic Testing »

February 14, 2012

Comments

"The draft guidance also advocates a "risk-based" approach, which will permit variances in biologic drug properties and characteristics (including primary amino acid sequence) if justified by the biosimilar applicant." Changes in the primary amino acid sequence are VERY concerning for any of us who want to rely on our patent during the PTE period. Not good at all.

The comments to this entry are closed.

February 2025

Sun Mon Tue Wed Thu Fri Sat
            1
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24 25 26 27 28