By Kurt R. Karst –
Many thanks to all of those who participated in our little Hatch-Waxman trivia contest. Although no single person was able to correctly answer all of the questions, just about all of them were correctly answered through your collective knowledge. The answers are provided below. As a reward, we are posting the first edition (1980) of the Orange Book. Enjoy!
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”?
A: President Ronald Reagan on September 24, 1984, in the Rose Garden upon signing Hatch-Waxman into law.
Q2: Why is the “Orange Book” cover Orange?
A: The festive color was chosen by the "father of the Orange Book," Don Hare, because it was first published around Halloween.
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: Judge Roger W. Titus, U.S. District Court for the District of Maryland, and Gerald C. Kell from the Department of Justice (December 21, 2006) in Biovail Corporation. v. FDA.
Q4: What is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product?
A: October 24, 2008, the Electronic Orange Book listed information on three patents covering MiddleBrook Pharmaceuticals’ MOXATAG (amoxicillin extended-release) Tablets – specifically, U.S. Patent Nos. 6,544,555, 6,669,948, and 6,723,341.
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?
A: Between the 6th and 7th editions of the Orange book, FDA transitioned from a Fiscal Year to a Calendar Year publication schedule. The 6th edition has 16 cumulative supplements rather than the usual 12 because of the transition.
Q6: What is the difference between a New Chemical Entity and a New Molecular entity?
A: An NCE is a drug that contains no active moiety that has been approved by FDA in any other application submitted under FDC Act § 505(b). An NME is a drug that contains an active moiety that has never been approved by FDA or marketed in the U.S.
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.)
A: 18 months
Q8: How many Directors has the Office of Generic Drugs had since passage of Hatch-Waxman?
A: Four. Marvin Seiff, Roger Williams, Doug Sporn, and Gary Buehler.
Q9: What generic drug was at issue in Mova Pharm. Corp. v. Shalala?
A: Micronized glyburide
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.”
A: Justice Scalia in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 679 (1990) (referring to the “Bolar Amendment” provision of the Patent Code enacted in Title II).
Q11: What drug was at issue in Roche v. Bolar?
A: DALMANE (flurazepam)
Q12: How many years of exclusivity was granted to an NCE approved between January 1, 1982 and September 24, 1984?
A: 10 years (Question 13 answered this question).
Q13: What prescription NSAID drug got the benefit of this 10 year period?
A: FELDANE (piroxicam)
Q14: How many patent term extensions has PTO issued – fewer than 500 or more than 500?
A: More than 500 (about 556)
Q15: And for a total of how many years of extension – fewer than 1500 years or more than 1500 years?
A: More than 1500 years (about 1,510 years)
Q16: What is the shortest patent term extension granted?
A: 20 days
Q17: What was the last provision of Hatch-Waxman to be negotiated? And for whom was it a deal-breaker?
A: Filing an ANDA containing a paragraph IV certification at the end of four years of the five year new chemical entity exclusivity period. Senator Howard Metzenbaum (D-OH).
Q18: What was the first drug approved in a “paper NDA?”
A: Furosemide injection
Q19: Who have been FDA’s Chief Counsels since Hatch-Waxman was enacted?
A: Tom Scarlett, Margaret Ann Porter, Dan Troy, Sheldon Bradshaw, Jerry Masoudi, Mike Landa (acting)
Q20: Who was Paul Parkman? And what was his most famous letter?
A: Deputy Director and then Acting Director of FDA’s Center for Drugs and Biologics. He is famous for his April 1987 letter discussing 505(b)(2) applications. The following additional information was provided by one of our readers:
Paul Parkman, who is still alive, had a very distinguished career prior to becoming Director of CBER. He was in the Bureau of Biologics (name of the center prior to CBER) Division of Virology, where he discovered a way to grow rubella virus in vitro for the first time, and developed the first rubella vaccine. During the 1950s, Weller, Enders, and Robbins had developed a way to grow viruses in cell culture for the first time, but for many years no one could succeed in growing rubella virus. Parkman figured out a way to detect growth of rubella virus in cell culture by showing it interfered with the growth of another marker virus. Based on this discovery, he worked with his boss, Harry Meyer (later a director of what still later became CBER) to create and test a rubella vaccine. For this work, he and Meyer received a major award and the two of them had their photograph on the cover of Time Magazine in the 1960s.