For Lawyers, Scientists & Other Inquisitives

An America watcher's observations about "life": Science, Law, Politics, Education, Humor, . . .

The Debt Limit Dance

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The insane, ritualistic and potentially disastrous economic dance of destruction has been going on in earnest for the last several days.

The disagreement centers around two issues: 1. One must pay one’s bills. 2. One must live within one’s means. Even little kids know these basic truths. But the negotiating team led by a senior adult on one side and by a relatively younger adult on the opposing side, our national leaders (I know I am being generous), don’t want to simultaneously grasp both truths.

If history is any indication, one minute before the proverbial tomorrow a comprise will be reached, and each side will proclaim victory to their respective constituents, who have often scratched their heads wondering why and how they entrusted their overall well being to such individuals.

If they can’t reach a compromise by the fast approaching deadline, then, tomorrow will really be a bad day.

 Proposed Tax Bill: Middle class to be squeezed BAD!

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The NY Times (failing, according to the ONE with the BIGGEST megaphone in the land) published “What’s in the Final Republican Tax Bill”. 

Here is a look (caution: It’s scary) at the issue of deductions and personal exemptions, important to middle class taxpayers:

 

Standard deduction and exemptions
Standard deduction Current

$6,500 / $13,000
(singles/couples)

  

Proposed 

$12,000 / $24,000

(singles/couples)
Personal exemptions $4,150 per taxpayer and dependent Eliminates

So, a family of 4 would be a big LOSER (a word loathed by the ONE with the megaphone) under the so-called middle class tax cut.  Here is  my math based on the numbers in the table above.  Under current law, deductions and exemptions (D&E) add up to $29,600:  $13,000 (couple standard deduction) + $16,600 (4*4150) for the 4 exemptions. Under the proposed tax cut, the D&E add up only to $24,000 for this family. That is a 18.9 %  ($29,600-$24,000)/(29,600)) tax increase.

Somebody tell me my math is WRONG.  If not, we are headed for some serious problems in the years to come.  I know first hand (Indian experience)  what happens when a country lacks a robust  middle class.

 

Inventions You Can Patent

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After a long silence, the Supreme Court has recently (2012-2013) re-opened its thoughts on a threshold question: what kind of inventions are patentable?

By way of background, scientific principles/laws are not patentable (in legalese, “non-patentable subject matter”); what is patentable are the applications of this knowledge.  For example, law books are fond of quoting the famous equation E = mC2 as a something that cannot be patented. The policy basis behind this prohibition is that, if such fundamental knowledge is patented by someone, others cannot explore/develop the practical applications of this equation, and thus limit the “progress of useful arts”, a constitutional requirement for granting a patent in the United States.

Similarly, naturally occurring things substances and life forms cannot be patented.

Applying these legal principles,, the Supreme Court invalidated two patents, which I discuss  in this short publication.  The first patent (The Prometheus Case) deals with a method for individualization of the dose of a drug based on its (and metabolites)  blood concentrations form  from previous doses. In other words, this invention is an application of the principles of therapeutic drug monitoring.  The second patent (The AMP Case)  deals with the patenting of certain genes, and after several years of litigation in the lower courts, the Court finally concluded in 2013 that certain genes indicative of a women’s risk for breast cancer are not patentable because they are naturally occurring substances.

I welcome your thoughts and comments, especially from scientists, my major target audience.

Biosimilars Litigation in the United States: Amgen v. Sandoz

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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).