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Latest From Apotex Inc.
Apotex has confirmed launch of a generic version of Bristol Myers Squibb’s Abraxane, with details thin on the ground.
Split appeals court denies en banc review of GSK v. Teva ruling, but suggests the district court could consider GSK’s patent declarations in determining whether Teva’s label is evidence of inducement to infringe. Teva plans to file petition for Supreme Court review.
Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.
Apotex has moved first on Allergan’s Combigan, introducing a US authorized generic as the clock ticks on the originator’s IP. Sandoz is among ANDA sponsors seemingly waiting for patent protection to lapse.
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