In This Issue:
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Letter from the Chair
Since the start of 2012, the many volunteers that help make this committee great have been very busy on several new projects that you will hear about in the coming months. First, many thanks to Randi Karpinia, who continues to provide strong leadership to the Electronics and Communication Subcommittee.
Under Randi’s guidance, the committee has revamped our committee blog and AIPLA microsite, has put together this newsletter, and has maintained the active discussions we have on Twitter, Linked-In and our committee Facebook page. Make sure to take a few minutes to subscribe to the blog and sign-up to receive updates from Linked-In or Facebook to stay informed on all the committee’s happenings.
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Editoral Team Members:
Randi Karpinia
Arlene Neal
Sonsy P Rajan
Debora Plehn-Dujowich
Bea Koempel-Thomas |
Sub-committee Happenings
Electronic Sub-Committee
If you are looking to establish and/or grow new relationships with other women professionals of the intellectual property field, keep up on the latest intellectual property news, or stay up to date on the happenings within the AIPLA Women in IP Law committee, the communications and electronic outreach subcommittee is there for you.
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Mentoring Sub-Committee
The Women in IP Law Committee is pleased to announce the formation a Mentoring Sub-Committee to address specific mentoring requests from our members. Our mentoring sub-committee will work with the AIPLA Mentoring Committee to match mentors and mentees within in the Women in IP Law Committee, if a specific request for such pairing is made by either a mentor or a mentee.
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Helpful Links
Guidelines on how to submit an article for publication in the newsletter
Mark your calendar
AIPLA Spring Meeting, Austin, TX
----May 10-12, 2012----
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Featured Article
SONSY PULIKOTIL RAJAN analyzes the impact of biosimilars on the biotechnology industry.
More than 30 years ago, recombinant insulin, the first biological drug (biologic) was approved in the United States. Today, more than 170 biologics are approved for therapeutic use around the world. Generally biologics are manufactured using biotechnology techniques as opposed to chemical synthesis techniques used for the manufacture of traditional small molecule compounds. The traditional small molecule compounds are not unique from a chemical standpoint; they are relatively cheaper to manufacture and their safety and efficacy profiles indicate the method of interaction in vivo. Biologic are much more complex; they exhibit specific interaction profiles unique to the manufacturing process. Minor variations in the process of manufacturing could impact the safety and efficacy of biologic in vivo.
The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) provided abbreviated mechanism for commercialization of generic drugs. On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (PPACA) into law. Among other provisions, Title VII, Subtitle A of the PPACA established the Biologics Price Competition and Innovation Act of 2009 ('Biosimilar Act'). The Biosimilar Act created a new regulatory scheme that allowed the FDA to authorize approval for biosimilars to enter the biologics market. By signing the Act into law, the President and the Congress intended to replicate a system for biologics that are similar to that of the Hatch-Waxman Act. On February 9, 2012, the FDC published three draft guidance documents that describe the agency's approach to making the determination whether two biological products are "biosimilar" or "interchangeable".
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Member Spotlight
 Ms. Carey Jordan is a force to be reckoned with and an inspiration for many young IP attorneys. She was named one of Houston’s "40 Under 40" Business Leaders by the Houston Business Journal in 2009, recognized by Law & Politics as a "Texas Rising Star," five times between 2004 and 2009, named a "Lawyer on the Fast Track" by H Texas in 2004, and recognized as a Leading Lawyer by Chambers USA, America's Leading Business Lawyers from 2005 – 2009.
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News and Notes
The first ever Women in IP Law Committee Webinar tackled tough questions around client relationship development. This webinar was conducted as a facilitated roundtable discussion featured four of our members (Maya Eckstein, Baila Celedonia, Maria Eliseeva and Randi Karpinia) who shared their own experiences and wisdom from both outside and inside counsel perspectives. Stewart Hirsch, Principal of Strategic Relationships and long-time friend of our Committee facilitated the webinar program, and shared his perspective as a business development and executive coach. Themes running through the program were:
- We are responsible for our own success and have to invest in ourselves
- Client relationship development has to be a focus, both internally and externally
- To be successful, we need to frame our thinking around people, and think getting business as a by-product of our relationships with people and doing good work.
Over 100 women signed up for this webinar. We’re delighted with the attendance, and the success of this webinar and look forward to our members suggestions for and participation in future webinars.
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