Happy 25th Anniversary Hatch-Waxman!! How Well do you Know the Law and its History?

By Kurt R. Karst –     

September 24, 2009 is the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act (Public Law No. 98-417) – commonly known as “Hatch-Waxman” or “Waxman-Hatch” depending on when you became familiar with the law.  To celebrate, we dredged Hatch-Waxman history to come up with some trivia questions (and also used some questions asked earlier this week at the Food and Drug Law Institute’s 25th anniversary reception).  Think you know Hatch-Waxman?  Then take our quiz below.  Anyone who is able to correctly answer all of the questions will receive an electronic copy of the first edition (1980) of the Orange Book.  We will update this post late on Thursday (Sept. 24th) with the answers.  (You can e-mail me your answers at kkarst@hpm.com)

Q1: Who said “So, when you add it all up, this bill will provide regulatory relief, increased competition, economy in government, and best of all, the American people will save money, and yet receive the best medicine that pharmaceutical science can provide”?

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Q2:   Why is the “Orange Book” cover Orange?

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Q3:   Who was the following exchange between? 

THE COURT:  The [Federal Food, Drug, and Cosmetic Act] itself uses the term “strength.”  It references the drug with respect to which the certification is made.  The certification will mention the listed drug which includes the strength; correct?

ATTORNEY:  That’s correct, Your Honor.

THE COURT:  All right.  There’s a special place in Hell where they torture people who write things like this.  For 14 years I was on the Rules Committee of Maryland’s Court of Appeals that didn’t have as many subsections as this, so I would flunk the person who gave me this as a draft rule.  I would say this is 50 rules.

Anyway, I wanted to wander into the right place of this endless section.  When I first went to Westlaw and said, just give me section 355, it had to tell me it was going to be 85 pages.  I said, no, no, no, no.  Let’s try (j), and I get this huge thing here.

ATTORNEY:  Well I hope that our brief lays out the precise subsections, Your Honor.  I believe it does.  But that is the sum of my argument, unless the court has any further questions.

THE COURT:  No.  You’ve been very helpful.  I’m glad to have somebody here who knows what they’re talking about.

ATTORNEY:  So am I, Your Honor.  It’s just not me.  Thank you.

THE COURT:  Thank you.   

A:

Q4: What is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product?  

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Q5: Both the 5th and 6th editions of the Orange Book carry a 1985 date on their covers.  The 7th edition of the Orange Book lists 1987 on its cover.  Why is there no edition with a 1986 date on its cover? 

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Q6: What is the difference between a New Chemical Entity and a New Molecular entity? 

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Q7: What was the period of stay of ANDA approval Congress contemplated (and stated in the House Report) after a timely filed lawsuit arising from a Paragraph IV certification notification?  (It was not 30 months.)

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Q8: How many Directors has the Office of Generic Drugs had since passage of Hatch-Waxman?

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Q9: What generic drug was at issue in Mova Pharm. Corp. v. Shalala?

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Q10: Who said about a provision of Hatch-Waxman that : “[O]ne must admit that while the provision more naturally means what respondent suggests, it is somewhat difficult to understand why anyone would want it to mean that.”

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Q11:   What drug was at issue in Roche v. Bolar?

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Q12: How many years of exclusivity was granted to an NCE approved between January 1, 1982 and September 24, 1984?

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Q13: What prescription NSAID drug got the benefit of this 10 year period?

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Q14: How many patent term extensions has PTO issued –  fewer than 500 or more than 500? 

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Q15: And for a total of how many years of extension – fewer than 1500 years or more  than 1500 years?

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Q16: What is the shortest patent term extension granted?

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Q17: What was the last provision of Hatch-Waxman to be negotiated?  And for whom was it a deal-breaker?

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Q18: What was the first drug approved in a “paper NDA?”

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Q19: Who have been FDA’s Chief Counsels since Hatch-Waxman was enacted?

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Q20: Who was Paul Parkman?  And what was his most famous letter?

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