He average particle a diameter of the included granules must be about 400 μm or less, preferably about 350 μm. Preferably, the average particle diameter of the fine granules is 300 to 400 μm. In the present invention, “fine granules having an average particle diameter of 400 μm or less … have an average particle diameter of about400 μm or less, in order that roughness is not felt in the mouth. Takeda pointed to passages in the specification that refer to a particle size of “about 400 μm or less,” but the Federal Circuit found that those same passages indicate that a smaller particle size is desired. Thus, there can be little doubt that the narrower construction “most naturally aligns with the patent’s description of the invention.” That clear dividing line between the “fine” granules of 400 μm or less (which avoid a feeling of roughness in the mouth) and “conventional” granules of 400 μm or more (which do not) disappears if the “fine granules” are construed as incorporating a 10% deviation. The specification explains that conventional granules of that size “produce a feeling of roughness in the mouth”-one of the very problems the claimed invention purports to solve. Turning to the specification, the Federal Circuit noted: The Federal Circuit first noted that “the claim language is not qualified by the word ‘about’ or any other indicator of imprecision,” even though the hardness strength is recited as “about 1 to about 20 kg.” The Federal Circuit determined that the claim language, specification and prosecution history supported Zydus’s position on claim construction. The Federal Circuit decision was authored by Judge Prost and joined by Judge Plager and Judge Chen. While Zydus argued that the highlighted phrase should be construed precisely, the district court construed the highlighted phrase as including a 10% deviation, based on Takeda’s arguments that it was “‘universally accepted’ that there is a 10% standard of error for particle size measurements.” An orally disintegrable tablet which comprises (i) fine granules having an average particle diameter of 400 μm or less, which fine granules comprise a composition coated by an enteric coating layer comprising a first component which is an enteric coating agent and a second component which is a sustained-release agent, said composition having 10 weight % or more of an acid-labile physiologically active substrate that is lansoprazole and (ii) an additive wherein said tablet having a hardness strength of about 1 to about 20 kg, is orally disintegrable. As noted in the Federal Circuit opinion, “the stated objective of the ’994 patent is that the formulation contains granules small enough to avoid a feeling of roughness in the patient’s mouth upon disintegration.”Ĭlaim 1 was the only claim at issue on appeal:ġ. Patent 6,328,994, which is listed in the Orange Book for Prevacid® SoluTab™, an orally disintegrating dosage form of lansoprazole used to treat acid reflux that can be taken without water. While this decision is not particularly remarkable, it highlights the scrutiny that the Federal Circuit will apply to claim construction and the risks of arguing for a broad claim construction. However, the Federal Circuit also explained that it would have held the claim at issue invalid if Takeda had prevailed on all of its claim construction // infringement arguments. Zydus Pharmaceuticals USA, Inc., the Federal Circuit reversed the district court’s finding that Zydus’s proposed generic product infringed Takeda’s Prevacid® SoluTab™ patent, but agreed with the district court that Zydus had failed to prove that the patent is invalid.
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