By Kurt R. Karst –
It’s difficult to believe that almost 30 years have passed since President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 on September 24, 1984. So much in Hatch-Waxman law (or Waxman-Hatch law if you are a food and drug attorney “of a certain age”) – and the world – has changed since that signing in the Rose Garden. President Reagan is no longer with us; Representative Henry Waxman (D-CA), now 74 years old, is retiring after the conclusion of the 113th Congress; Senator Orrin Hatch (R-UT), now 80 years old, is still going strong, but announced that he plans to retire in 2018.
If you’re a regular reader of this blog, then you know that we have more than a passing interest in the Hatch-Waxman Amendments. It’s a bit of an obsession. And we also have a thing for anniversaries. Over the past couple of years we’ve celebrated the 30th Anniversary of the Orphan Drug Act (see our post here), and the 75th Anniversary of the enactment of the FDC Act (see our post here). This blogger also authored an article for the William Mitchell Law Review’s Hatch-Waxman 30th Anniversary issue providing the first ever analysis of FDA’s nearly 30-year track record of responding to ANDA suitability petitions (see our post here).
Five years ago we celebrated the 25th Anniversary of the Hatch-Waxman Amendments with a trivia contest (see our post here). We came up with a mere 20 questions for FDA Law Blog readers to answer. It’s five years later and once again we’ve decided to challenge FDA Law Blog readers with Hatch-Waxman trivia. This time we’re going “30 for 30.” We had to dig deep . . . real deep . . . to come up with new trivia. We hope you enjoy it! We’ll reveal the answers in a separate post later this week.
Q1: What U.S. Senator is a musician, songwriter and producer, a member of ASCAP, and whose works have been recorded by Gladys Knight, Donny Osmond and Brooks and Dunn, among others?
Q2: When standing at the base of the U.S. Capitol, this dome (pictured below) stands at 93.5 feet above sea level. To whom does this dome belong?
Q4: Who has a lower “Bacon Number”: President Ronald Reagan, Sen. Orrin Hatch, or Rep. Henry Waxman?
Q5: Were rain umbrellas needed in the Rose Garden on September 24, 1984?
Q6: What is the typographical error in the text of FDC Act § 505(j) that was never corrected? (Hint: The affected section was replaced by the 2003 Medicare Modernization Act (“MMA”).)
Q7: What is the significance of January 1, 1982 to the Orange Book?
Q8: What is the significant difference between ANDA No. 076933 and ANDA No. 076934? (The answer is neither “1,” nor the drug name.)
Q9: What pharmaceutical industry trade organization executive referred to the pre-Hatch-Waxman hurdles to generic competition of post-1962 drugs as an “iron curtain”?
Q10: What almost-U.S. President opposed efforts to pass legislation that would have extended brand-name drug patents without creating a generic drug approval process?
Q11: Donald Hare, R.Ph., who has since retired from FDA, is sometimes referred to as the Father of the Orange Book. To whom does the distinction of Mother of the Orange Book – or at least Mother-in-Law – belong?
Q12: As of today, what is the longest, unexpired period of non-patent exclusivity listed in the Orange Book?
Q13: When were Reference Listed Drug (“RLD”) designations added to the Orange Book?
Q14: When was an electronic Orange Book search function added to FDA’s website?
Q15: What is the “Blue Book”?
Q16: Prior to FDA’s formal creation of Orange Book patent listing forms (Form FDA 3542a and Form FDA 3542) in 2003, did FDA offer any informal guidance to NDA sponsors on patent listing?
Q17: Can you identify 10 types of non-patent marketing exclusivities (or non-patent exclusivity extensions) recognized by the FDC Act?
Q18: How long did it take after the December 8, 2003 enactment of the MMA for a member of Congress to propose a revision to the law (and specifically to the 180-day exclusivity forfeiture provisions)?
Q19: What U.S. law is modeled after the Hatch-Waxman Amendments, and how long has it taken FDA to issue implementing regulations?
Q20: How many times has FDA used its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) (“[I]f FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”) to effectively take away a first applicant’s 180-day exclusivity eligibility?
Q21: What case (and involving what drug) was the first judicial test of the 3-year exclusivity provisions of the Hatch-Waxman Amendments?
Q22: Who is Gary P. Jordan?
Q23: Who is Marion J. Finkel?
Q24: What is the only instance in which a court has ordered FDA to approve an ANDA during another sponsor’s period of 180-day exclusivity?
Q25: What is the only instance in whch FDA was faced with a leap year NCE NDA approval?
Q26: FDA’s regulation at 21 C.F.R. § 314.94(a)(12)(viii) states, in relevant part, “an applicant who has submitted a paragraph IV patent certification may not change it to a paragraph III certification if a patent infringement suit has been filed against another paragraph IV applicant unless the agency has determined that no applicant is entitled to 180-day exclusivity or the patent expires before the lawsuit is resolved or expires after the suit is resolved but before the end of the 180-day exclusivity period.” What is the status of this regulation?
Q27: Can a single patent use code serve as the basis for a split Paragraph IV certification and “section viii” statement? (This question is a nod to recent controversies involving patent use codes.)
Q28: In what case was the U.S. Patent and Trademark Office’s (“PTO”) longstanding interpretation of 35 U.S.C. § 156(a)(5)(A) concerning Patent Term Extensions (“PTE”) struck down?
Q29: What is the connection between the drugs INDOCIN (indomethacin) and CAPOZIDE (captopril and hydrochlorothiazide), U.S. Patent Nos. 3,849,549 (INDOCIN) and 4,217,347 (CAPOZIDE), and Title II of the Hatch-Waxman Amendments?
Q30: What patent concerning what drug led to a change in the PTE statute at 35 U.S.C. § 156 involving the deadline for submitting a PTE application to PTO?