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.

Enter your email address:

Delivered by FeedBurner

Contact the Docs

Docs on Twitter


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

« Court Report | Main | U.S. Patients Petition FDA to Regulate Genzyme Export of Fabrazyme »

January 24, 2011

Comments

Kevin,

The litigation issue you brought up is a bit of a side issue for the post, but thanks for pointing out the unintended consequences of Hatch-Waxman (the large number of ANDA suits) for those who may not have thought about it. Sometimes it appears that Hatch-Waxman benefits patent litigators more than the public, and the associated costs are definitely counter-productive to the intent of the act. I don't think I have a good proposal to address the issue, but more people need to be aware of it.

Rodney,
Regarding the large number of Hatch-Waxman suits, I think a good solution might be to simply lengthen the data exclusivity period. It's currently only 4-5 years (depending on the type of ANDA filed).
Also, here are some interesting numbers to consider:
Number of New Drugs Approved in 2009 = 24 (17 new molecular entities and 7 BLAs approved).
Number of Generic Drugs Approved in 2009: 533 (489 ANDAs and 35 505(b)(2) applications approved).

The comments to this entry are closed.

November 2020

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
29 30