Taxol 2: Can Ivax to launch its generic Taxol?

September 18, 2000

On Thursday, the Ninth Circuit refused to grant BMY’s Request for stay: if granted it would have left American Bioscience’s ‘331 patent listed in the Orange Book despite the District Judge’s order de-listing.  On Friday:  The FDA granted  final approval to Ivax to market its generic version of Taxol.  But before these two Ivax victories:

1. American Bioscience filed an infringement action in Federal court in California.  The case was assigned to a different Federal judge than the one who heard the Taxol case in August.

2 Bristol Meyers filed a new declaratory judgment action in Federal court in New York.

3. Bristol Meyers filed another listing of the ‘331 patent in the Orange Book  but it is unclear what action the FDA has taken.

Normally, a drug listing in the Orange Book blocks the issuance of a final ANDA which is the last step in the generic drug approval process.

A) Can ABI  or BMY challenge the FDA’s grant of an ANDA?

a) Verdict researched all 160 cases where the FDA was challenged for granting an ANDA. Only once did a Federal judge intervene, but was reversed on appeal. Challenges to the FDA’s grants of ANDA look pretty  weak, but Verdict expects ABI to try.

b)Unless BMY has signed an exclusive license for ‘331 it cannot challenge the ANDA; and,  in all pleadings reviewed so far by Verdict, BMY has a non-exclusive license.

B)  Can ABI or Bristol sue the FDA for failing to list the ‘331 patent in the orange book? BMY’s  declaratory judgment action in New York or ABI’s  infringement action in California could be amended to sue the FDA. There are two theories available:

a) FDA abused its discretion in failing to list the 331 patent before the Ninth Circuit’s decision:  clearly this is a weak argument for BMY.

b) Ivax does not meet the bio-equivalent standards for generics but this claim has not been asserted.

Conclusion: Time is running out for BMY.  Its biggest hurdle is the ruling by the Federal Judge who ordered ‘331 de-listed which has now been upheld by the Ninth Circuit.  Ivax will raise this issue wherever the Taxol issue is litigated and it should prevail.  BMY will probably seek to remain in New York but Ivax should succeed in consolidating the actions in California and those courts will not be sympathetic to Bristol’s delaying tactics.