Refer to our earlier posts on blockbuster blood thinner medicine Enoxaparin litigation Here, the innovator Sanofi’s appeal against May, 2008 ruling of CAFC w.r.t key patent US5389618 (Expiry: Feb 14, 2012) which was later reissued as USRE38743 (Expiry: Feb 14, 2012) covering Enoxaparin, wherein, court declared patent invalid due to inequitable conduct. Subsequently, innovator appealed to US supreme against said decision.
As per latest decision, the appellate court has refused to hear innovator’s appeal without citing any specific comments.
Earlier, generic players like Amphastar and Teva has filed ANDA for this product and successfully challenged innovator’s key patents ‘743.
The inequitable conduct was alleged w.r.t EP40144, which was granted in Europe as patent in 1980 (Which got revoked in 1990). The said patent covers the same invention as disclosed in ‘723. Aventis got ‘618 patent after overcoming 3 rejections by USPTO.
Finally, Aventis demonstrated that pharmacokinetic profile with respect to t1/2 is better in ‘618 patent in comparison to ‘144 patent. The federal court affirmed the ruling by a district court in California that there was an intent to deceive by Sanofi-Aventis in its failing to disclose dosages of the drug in pharmacokinetic studies.
Enoxaparin (6-[5-acetylamino-4,6-dihydroxy-2- (sulfooxymethyl)tetrahydropyran-3-yl] oxy-3- [5-(6-carboxy-4,5-dihydroxy-3- sulfooxy-tetrahydropyran-2-yl)oxy-6-(hydroxymethyl)- 3-sulfoamino-4-sulfooxy-tetrahydropyran-2-yl] oxy-4-hydroxy-5-sulfooxy-tetrahydropyran-2- carboxylicacid ) is a low molecular weight heparin manufactured by Sanofi-Aventis.
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