Blog

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).

 

 

 

Pharmacokinetics of NanoPharmaceuticals

I have posted slides from two presentations (2008 and 2013) on this topic  at the Rensselaer Polytechnic Institute.

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.

Will America break up?

Today, after a divisive campaign (to say the least) is election day  when Americans will elect their next president.  The bi-partisan distrust of the two major political parties, namely, the Democrats and Republicans, the power brokers of this nation, raises the question: How long can such a divided and acrimonious United States of America last as one country?  Indian history offers a not so optimistic answer.

 

india-map
Religion-Based Division of A Country (1947)
usa-red-and-blue-states
Red and Blue States of America (2016)

 

 

 

 

 

To explain, I shall show two maps – a geographical map of British India  at the time of partition (top, left) and the  political (“Red and Blue States”) map of America (top, right).  What is important is that you see the distribution of the two colors – yellow and green on the map to the left, and red and blue on the map to the right.

Serious religious differences resulted in the breakup of British India into two countries – predominantly Hindu India (shaded yellow)  with predominantly Muslim Pakistan (shaded green) on either side of India (East and West Pakistan). East Pakistan became the new country of  Bangladesh in 1971.

So, coming back to the political discord in America, blue states (mostly on the two coasts), have more than the necessary 270 electoral votes to elect a president – no red states (the middle part) needed.  A rather  discomforting thought!

Laurel, Hardy and Elections

After she has been (finally?) cleared of those “damn emails”* by the FBI,  a likely refrain from hopeful HRC, if she should win tomorrow, might be “It’s another fine mess I have gotten into“, made famous by Laurel and Hardy.  Enjoy their election-stress reducing  shenanigan titled “Chickens Come Home”.

  • Bernie might be thinking he gave up too soon

What is patentable?

Hi all,

I have attached a short 2015 article on the threshold question on what kind of inventions are eligible for patent protection?  Hope you find it useful.

Sri

Can intellectual pusillanimous wussies be spirited?

Lying in bed several Sunday mornings ago,  I browsed NY Times review of  three religious books (or, should it be “books on religion”, to be more politically correct*).   One of them titled AGNOSTIC: A Spirited Manifesto caught the attention of my drowsy mind: spirited agnostics?

I know this contribution of mine does not match the gravitas of René Descartes who, also lying in bed, developed the Cartesian coordinate system after observing the movements of a housefly.

* Please await my soon forthcoming post on the phrase “people of color“.  Thanks for your patience.


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)

 

The GOP . . .

is in trouble.  So, what else is new.   There is an old song that goes well with  title of the NY Times article.  In this case, the threesome are the people and the nominee – who in love with himself, counts for two.

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.