Replies to post #9409 on Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

<<Look at VVUS, for whom the FDA just approved Qnexa; or IDIX, the FDA approved their Hep-B drug 6 years ago. If an ANDA was filed tomorrow, could the FDA approve it, this year or next year?

These drugs have valid patents listed in the Orange Book. So, of course the FDA can't give final approval for an ANDA. >>

Of course it can. That is exactly what Hatch-Waxman is about. It all depends on the timing and litigation in the district court, if any.

Here are the few opening paragraphs of a case in which a preliminary injunction was granted to prevent TEVA from marketing a generic copy of Evista. However, the FDA issued final approval; had it not, there could be no launch to enjoin. Read the underlined sentence in the middle of the second to last paragraph below:

ELI LILLY AND CO. v. TEVA PHARMACEUTICALS USA

609 F.Supp.2d 786 (2009)

ELI LILLY AND COMPANY, Plaintiff,
v.
TEVA PHARMACEUTICALS USA, INC., Defendant.
No. 1:06-cv-1017-SEB-JMS.

United States District Court, S.D. Indiana, Indianapolis Division.


April 22, 2009.

ORDER GRANTING PLAINTIFF'S RENEWED MOTION FOR PRELIMINARY INJUNCTION

SARAH EVANS BARKER, District Judge.
This cause is before the Court on the Renewed Motion for Preliminary Injunction [Docket No. 404], filed by Plaintiff, Eli Lilly and Company ("Lilly"), on February 9, 2009. Lilly holds an approved New Drug Application ("NDA") No. 20-815 relating to the use of raloxifene hydrochloride 60 mg tablets for the prevention or treatment of osteoporosis in postmenopausal women. Lilly markets the product disclosed in NDA No. 20-815 under the tradename EVISTA® ("Evista"). In connection with this NDA, Lilly listed twelve patents in the Orange Book, including: U.S. Patent Nos. 5,393,763 ("the '763 patent"); RE 39,049 ("the '049 patent"); 5,457,117 ("the '117 patent"); RE 38,968 ("the '968 patent"); 5,478,847 ("the '847 patent"); RE 39,050 ("the '050 patent"); 6,458,811 ("the '811 patent"); 6,797,719 ("the '719 patent"); 6,894,064 ("the '064 patent"); 6,906,086 ("the '086 patent"); 5,811,120 ("the '120 patent"); and 5,972,383 ("the '383 patent") (collectively, "Lilly's raloxifene patents").
Defendant, Teva Pharmaceuticals USA, Inc. ("Teva"), has filed an Abbreviated New Drug Application ("ANDA") No. 78-193 with the FDA for raloxifene hydrochloride 60 mg tablets for the prevention of osteoporosis in postmenopausal women. Teva sought and has received FDA approval to market its generic raloxifene hydrochloride product before the expiration of the Lilly patents listed in the Orange Book. Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), Teva's ANDA includes a "paragraph IV certification" to Lilly's raloxifene patents in which Teva certifies that each of Lilly's raloxifene patents is invalid, unenforceable, or would not be infringed by Teva's manufacture, use, or sale of its generic raloxifene product.
After receiving notice of the ANDA filing and paragraph IV certification, Lilly brought this suit against Teva for infringement of the '086 patent, the '968 patent, and the '049 patent (collectively, "the bone loss patents"); the '050 patent ("the low dose patent"); and the '811 patent, the '719 patent, and the '064 patent (collectively,
[ 609 F.Supp.2d 791 ]

"the particle size patents"). The bone loss and low dose patents cover the oral administration of raloxifene hydrochloride for prevention or treatment of post-menopausal osteoporosis. The particle size patents cover pharmaceutical compositions containing raloxifene particles having a certain size distribution. Teva concedes infringement of the bone loss patents and the low dose patent if they are found valid and enforceable, but challenges their validity and enforceability on the following grounds: obviousness, lack of enablement, and inequitable conduct. With regard to the particle size patents, Teva contends that its generic raloxifene product does not infringe and that, even if its product did infringe, the particle size patents are invalid on the basis of obviousness and lack of enablement. On March 17, 2008, the Court held a Markman hearing at which the parties presented evidence, testimony, and oral argument as to the proper construction of disputed terms. On June 11, 2008, the Court issued a claim construction order construing claims of the particle size patents. Docket No. 181.

Lilly's suit triggered the 30-month statutory stay on the FDA's approval of Teva's generic raloxifene product, which was originally set to expire on November 16, 2008. However, on October 29, 2008, the Court granted Lilly's motion to extend the stay until the commencement of trial on March 9, 2009.1 The hearing on Lilly's motions for a temporary restraining order and preliminary injunction was consolidated with the bench trial conducted from March 9, 2009, to March 24, 2009. On the opening day of trial, Teva notified the Court that it had received notice of final approval from the FDA of its generic raloxifene product. On that same day, the Court entered a TRO prohibiting Teva from launching its generic raloxifene product in the United States for ten days, subject to extension based on Lilly's proof in support of its motion for preliminary injunctive relief.

On the second day of trial, Teva informed the Court that it would voluntarily withhold launch of its generic raloxifene product until April 23, 2009, in order to allow the Court sufficient opportunity to rule on the preliminary injunction issues. Having considered the documentary evidence and testimony, the Court now enters its findings of fact and conclusions of law, pursuant to Federal Rules of Civil Procedure 52(a) and 65, and GRANTS Lilly's renewed motion for preliminary injunction.

http://www.leagle.com/xmlResult.aspx?xmldoc=20091395609brfsupp2d786_11326.xml