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17-04-2012 21:04:00

2nd UPDATE:Top Court Sides With Generic Drug Makers In Tactics Case

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--Justices give generics new legal tool against brand rivals

--Sun unit wins case, calls ruling important for generic drug makers

--Case involved Novo Nordisk patent for diabetes drug Prandin

(Updates with comment from Novo in 12th paragraph, additional background.)

By Brent Kendall

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The U.S. Supreme Court handed a victory to generic drug companies Tuesday, ruling they can file certain legal counterclaims against brand-drug companies in an effort to get their cheaper copycat medicines on the market.

The court, in an opinion written by Justice Elena Kagan, ruled unanimously that generic drug makers should be allowed to challenge the way brand-name manufacturers describe their patents to the Food and Drug Administration.

The decision overturned an appeals court ruling that said generic makers can't bring those legal claims against brand rivals.

The generics argued that their brand rivals, if left unchecked, can describe their patents broadly in FDA submissions as a way to shut out possible generic competition, even for unpatented uses of a drug. The Obama administration supported those arguments.

Brand drug companies said allowing the counterclaims could lead to costly litigation and undermine patent protection for innovative drugs that are costly to develop.

The controversy arises when the FDA considers a drug maker's application to market a generic drug. As part of that process, the agency considers whether the proposed generic will infringe a branded drug's patents. To determine infringement, the FDA relies on use codes submitted by brand companies that describe the scope of their patents. The agency does not independently verify the accuracy of companies' patent submissions.

As Kagan noted, "the breadth of the use code may make the difference between approval and denial of a generic company's application."

At issue was an appeal by Caraco Pharmaceutical Laboratories, a unit of Sun Pharmaceutical Industries Ltd. (524715.BY), which is seeking to introduce a generic version of Novo Nordisk A/S's (NVO, NOVO-B.KO) diabetes drug Prandin.

One Novo Nordisk patent on the drug compound has expired, but the company holds a second patent, which doesn't expire until 2018, that involves the use of the drug in combination with another medicine.

The FDA has approved three uses for the drug. Caraco wants to introduce a generic version for the uses that aren't patented. The company said it couldn't do so because Novo Nordisk's description of its patent to the FDA was so broad that it foreclosed the agency from approving a generic version of the drug.

A Sun representative called Tuesday's ruling "a very important victory" for the company and the generic industry as a whole.

Novo said its FDA submission is correct. "We are confident that further proceedings will show Caraco's challenge to the use code narrative is meritless," James Shehan, general counsel of Novo's U.S. subsidiary, said in a statement.

In a related dispute, the two companies are fighting over the validity of the Novo patent, which a Michigan federal judge invalidated last year. That case is on appeal.

The case is Caraco Pharmaceutical Laboratories v. Novo Nordisk, 10-844.

-By Brent Kendall, Dow Jones Newswires; 202-862-9222; brent.kendall@dowjones.com

(END) Dow Jones Newswires

April 17, 2012 15:04 ET (19:04 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

Opret kommentar

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20 jun
NOVO-B
Nu supplerede jeg f.eks. i fredag i 339,50 - dem solgte jeg i 347 idag og købte dem tilbage i 342 id..
6
24 jun
NOVO-B
Maaske, men kun paa kort sigt.   Dollaren styrket, og EUR vil snart gaa i par med USD, saa Novo faar..
5
21 jun
NOVO-B
Godt punktum, for en alligevel fin faglig diskussion. Sætter mine penge på Novo (og Team Alpehue-Goo..
5
21 jun
NOVO-B
Kære kommentarer, Ævl var det vist mig der kom med, sorry! Det jeg mener er at Novo har eksekveret o..
4
24 jun
NOVO-B
Hold nu kæft, thch. Du er så bundutroværdig at høre på. For 7 timer siden skrev du at du aldrig var ..
3
22 jun
NOVO-B
"har du et link til præsis følgende udsagn? "350+ for Zeal i 2016""   Det er da nemt, det er jo ikk..
3
22 jun
NOVO-B
Har købt novo i fredags og mener stadig folk bør kåbe inden bremain!! Uanset udfaldet vil novo på ko..
3
22 jun
NOVO-B
efter at have været i kort nedtrend siden midt marts er vi nu i gang med test af vigtig vandret mods..
3
24 jun
NOVO-B
Tak Tdt , har stadig Novo i porten disse var 500 stk jeg købte ved åbning . Det var sgu en heldig mo..
2
24 jun
NOVO-B
Fin dag først 23 k på APM og 12 k på Novo , , venter så lige på at sælge mine Vale ,
2

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