Kimberly Weinreich is an associate in the Intellectual Property Practice Group in the Washington, D.C. office of Haynes and Boone. Her practice focuses on preparation and prosecution of U.S. and foreign patent applications, along with intellectual property counseling, patent procurement and management, licensing and opinions, including patentability, freedom to operate, validity and non-infringement opinions.
Ms. Weinreich has expertise in a broad range of fields including chemical compositions, material sciences, genomics, therapeutics and diagnostics and pharmaceuticals.
Prior to joining the firm, she worked as a research teacher as well as a research assistant working on transgenic NF1 organisms in a neuroscience laboratory.
Recent Speeches and Publications
- Weinreich, K. and Wolfson, J.A., "Efficacious and Safe Drug Labeling Strategies - The Access to Affordable Medicines Act," 3(2) Bloomberg Law Reports - Health Law 10, (2010)
- "The Bioethics of Generic Drugs and Follow-on Biologics," University of Pennsylvania, Philadelphia, November 3, 2008
- Weinreich, Kimberly, The Divergent Application of Patent Law Exceptions 271(e) and (g) in Section 337 Proceedings, 24 337 Reporter 137 (2008)
Публикации
02/14/2012 -
Biosimilars: Draft Guidance Documents Issued by FDA
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action.
06/28/2010 -
Accelerated Patent Examination Plan Extended
Most patent applicants can now accelerate the examination of a select number of patent applications in exchange for abandoning an equal number of unexamined, pending applications, according to an announcement issued by the U.S. Patent and Trademark Office (“PTO”) on June 24, 2010. The PTO’s official notice, titled “Expansion and Extension of the Patent Application Backlog Reduction Stimulus Plan” (the “Plan”), eliminates the requirement whereby only small entity applicants could participate in the Plan.
02/01/2010 -
Efficacious and Safe Drug Labeling Strategies - The Access to Affordable Medicines Act
This article discusses U.S. drug labeling strategies used by brand (also referred to as innovator) and generic pharmaceutical companies, including the most recent proposed drug labeling changes in the Access to Affordable Medicines Act (AAMA).
10/12/2009 -
PTO Seeking Rulemaking Authority Despite Rescinding Proposed Claims and Continuation Rules
The U.S. Patent and Trademark Office (“PTO”) has announced that the director has signed a Final Rule, which has not yet been published, that rescinds the hotly contested proposed claims and continuation rules. These rules would primarily have limited the number of patent applicant filings of: (i) continuation applications, (ii) Requests for Continued Examination (“RCEs”), and (iii) claims without examination support documents (“ESDs”) within a single application. The proposed rules were at the heart of a two-year legal battle that pitted co-plaintiffs Triantafyllos Tafas and GlaxoSmithKline (“GSK”) against the PTO and its director.