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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

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
23 okt
NOVO-B
Han ejer 101 % af Novo 👻
3
24 okt
NOVO-B
typisk jounalist bonde fangeri. Prøv engang at læse artiklen, EFTER du har læst overskriften. Læs så..
2
24 okt
NOVO-B
Jeg morer mig meget over at en debattør herinde udelukkende deltager i debatten ved at kommentere mi..
2
24 okt
NOVO-B
Twin, Har du helt ærligt ikke noget bedre at give dig til? Drop nu det personfnidder. Goodwrench har..
2
24 okt
NOVO-B
Spørgsmålet er om goodwrench laver en ny Vestas i Novo - lidt en ulykkesfugl så at sige 🐽
2
23 okt
NOVO-B
Han blev ramt af margin calls - længere er den ikke. Købte lystigt ind af Vestas på 292- fortalte ha..
2
23 okt
NOVO-B
Nååå, nu synes jeg da at de strammer det med spændingen...kom så med den godkendelse FDA :-)
2
21 okt
NOVO-B
Og du er sikkeer på at det er nordea der sælger ud og ikke deres kunder som handler gennem dem?
2
24 okt
NOVO-B
Om det er rigtigt eller ej, hvilken forskel gør det? Twin, det er et onlineforum det her. Hvis ikke ..
1
24 okt
NOVO-B
Lidt naivt at forestille sig at Novo har lavet fatale fejl i deres produktion.   Når sådan en sag he..
1

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