Biosimilars Litigation in the United States: Amgen v. Sandoz

I  gave a talk  on biosimilars litigation in the US.  The June 1 program  was  sponsored by the Faculty of Law, University of Copenhagen, Denmark.  Slides from my presentation are available here.

A good part of the talk discussed the Amgen v. Sandoz case, which worked its way up to the United States Supreme Court.  The two questions before this Court were:

  • Is it mandatory for the biosimilars applicant (i.e., the generic company) to share application and information with the original developer of the biological product (i.e., the brand name company)
  • Can the 180-day notice of first commercial marketing by the biosimilars applicant to the reference product sponsor be given prior to FDA approval of the biosimilars application?

 July 9, Update: On June 12, the Supreme Court answered these questions (subject of a later post).  Yes, I am behind (an extended European trip can do that for you).

 

 

 

How the British Colonized India

I have started a new page on my website to discuss how the British colonized India and the relevance of that part of Indian history to today’s America.  I shall keep you informed as I add new material.

NY Times: Trump’s Patriotism?

The main point of this message is that every American must exercise great caution when s/he casts aspersions on another American’s patriotism. Therefore, it is quite disappointing to read a rather reckless opinion on the GOP presidential nominee’s love of country in one of its leading newspapers, of which I am regular reader.

I am NOT a Trump supporter, primarily because of his and his party’s policy positions and statements on important issues (to me, anyway) such as health care (replace “Obamacare” with what?), economics (based on the failed trickle down theory), environment (that global warming is a myth) and immigration (a religious test for entry into this country appears unconstitutional).  As for my personal thoughts,  Mr. Trump’s actions and words are, or appear to be, unethical, narcissistic, bigoted, misogynistic, clueless of solutions to serious issues that currently plague  this nation, quite crude in language and style, . . .

But, is Trump unpatriotic?  In the absence of concrete “unpatriotic” deeds by Mr. Trump, and given that I have no access to inner thoughts of people, I am obliged to at least give Mr. Trump (and, for that matter, Mr. Bruni) the benefit of the doubt.  To rebut just one of his reason’s for doubting Mr. Trump’s love of country, i.e., the unpatriotic act of  draft-dodging, it is important to note that two of our recent past presidents conveniently managed to avoid going to Vietnam.

When did, given our country’s history, being bigoted or controversial raise doubts of one’s patriotism?  In conclusion,  “Is casting unfounded aspersions on the patriotism of a politically conservative candidate the last refuge of a liberal journalist?”  (adapting lexicographer Samuel Johnson’s statement “Patriotism is the last refuge of a scoundrel” for the occasion)

 

Of learning and testing

Mindless testing of the young to improve K-12 education is the rage these days, at least in Ohio.  It is like measuring snakes with a straight edge.  Sure, you will get some numbers.  But are they meaningful?  This video about learning and passing tests from two species (crows and monkeys), should be an eye opener to those who have bet the educational farm on testing as the sole way to assess and improve education.  The big lesson:  Every child learns differently depending on his/her experiences.  The time for individualized testing, like personalized medicine,  has come.

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LawandScience.com was founded by Srikumaran Melethil, PhD, JD.

Personhood and Diamond Lane

Some -Personhood supporters- want fetus to be declared a person. If that becomes the law, one amusing question would be: Can a pregnant women legally drive in a car-pool lane? [ NPR- All Things Considered, June 1, 2011.]