Replies to post #140130 on Biotech Values

[DewDiligence]

Both Viagra and Cialis have Orange-Book patents running to Apr 2020. (Viagra just received a 6-month pediatric extension from the testing of Revatio in infant pulmonary hypertension: #msg-72269824, #msg-72270186.)

[DewDiligence]

TEVA, PFE settle US Viagra-patent litigation:

http://www.sec.gov/Archives/edgar/data/818686/000130901413000841/exhibit1.htm

Under the terms of the agreement Teva will be able to launch its Abbreviated New Drug Application (ANDA) products pursuant to a royalty-bearing license on December 11, 2017, or earlier under certain circumstances. The terms of the settlement agreement are otherwise confidential.

The phrase, “earlier under certain circumstances” means that if a company other than Teva launches a generic version of Viagra in the US before 12/11/17 (either as a result of a settlement or a court judgment), then Teva can launch on the same date as the other company. This is a strandard provision in these kinds of patent settlements.

The agreed launch date for Teva (12/11/17) is 2.3 years before the expiration of patent #6,469,012, PFE’s last Orange Book patent on Viagra (http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6469012.PN.&OS=PN/6469012&RS=PN/6469012 ), a “use” patent that
held up in US District Court (#msg-66176474, #msg-66190222) but might not have withstood scrutiny at the appellate level.

[DewDiligence]

MYL, PFE settle Viagra-patent litigation in US:

http://finance.yahoo.com/news/mylan-settles-patent-litigation-related-191000617.html

Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential…

The settlements terms are essentially the same as the ones in the PFE-TEVA deal in 2013 (#msg-95062675).

The phrase, “earlier under certain circumstances” means that if another company launches a generic version of Viagra in the US before 12/11/17 (either as a result of a settlement or a court judgment), then MYL can launch on the same date as the other company. This is a strandard provision in these kinds of patent settlements.

The 12/11/17 launch date is 2.3 years before the expiration of patent #6,469,012, PFE’s last Orange Book patent on Viagra (http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6469012.PN.&OS=PN/6469012&RS=PN/6469012 ), a “use” patent that held up in US District Court (#msg-66176474, #msg-66190222) but might not have withstood scrutiny at the appellate level.