Speaking at the June NYC Conference on Biosimilars

The program is here.  I’m excited to speak at this conference, and have been spending a huge amount of time reading up on this area of the law and technology.  I’ve dealt with the issues some, but the future looks fascinating!

About David

Professor of Law, Mercer University School of Law. Formerly Of Counsel, Taylor English Duma, LLP and in 2012-13, judicial clerk to Chief Judge Rader.

8 thoughts on “Speaking at the June NYC Conference on Biosimilars

  1. 1

    It seems incongruous that one cannot make an identical copy of a patented biological product without access to the original cell line and without using the same process, which might be a trades secret. There seems to be something lacking in the quid-pro-quo.

    1. 1.1

      If the biological product is patented, and reproduction necessitates a sample, is not a sample required by law to be deposited with the USPTO?

      1. 1.1.1

        Anon, I do not practice in this area, so I do not know why there is a problem with biosimilars if the problem is linked to not having access to the original cell line. But if the original cell line is on deposit, why is there still a problem?

        Clearly, something is not being disclosed that is necessary.


          Not my practice area either, but your comment at 1 does not seem to make sense. Can you clarify the issue that you see?


            Anon, a biosimilar is not identical to the patented biologic product because the cell line or process or both are distinct.

            It appears that generics for some reason cannot or do not manufacture the patented biologic product because of these differences. Thus they cannot simply get a quick FDA approval through an ANDA.

            In 2010, Congress enacted a new procedure to approve biosimilars as part of Obamacare. According to the below article, the FDA has yet to approve even one.

            link to en.wikipedia.org


              When has “identical” been required (in patents)?

              Sorry Ned, I still have trouble understanding what issue you are having.

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