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Capsule Specifications: Product recalled due to reports of breakage and leakage. Under the two-way test, an interference exists between two claims if each claim anticipates or renders obvious the other.
Hi-Tech argues that the district court misinterpreted Section 156 as overturning settled law on the irrevocable nature of terminal disclaimers. Somerset also filed a motion for preliminary injunction at the same time. L, 5 mL Vial, Rx only, sigma-tau Pharmaceuticals, Inc. Tablets, USP, 100 mg, 100 count bottles, Rx only, Distributed by G.
Degradation Specifications: Product sample stability testing results did not meet the specification for impurities. In reaching its decision today, the Federal Circuit properly recognized that “the language of Section 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of Section 253.
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Dianeal PD-2 Peritoneal Dialysis Solution with 1. Boehringer responded by filing suit against Barr and Mylan, and the cases were consolidated for trial. ANDA: this is an unapproved drug that was also found to have subpotent assay results. Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc.
400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only, NDC: 0310-0800-60. Superpotent Drug: above specification for the assay. Thus, after Photocure, we will likely see the PTO grant patent term extensions in cases where it would not have granted an extension before. Orange Book Blog is Aaron Barkoff’s personal website and it is intended for other attorneys.
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On April 25, 2006, the district court entered final judgment on the pleadings in Merck’s favor and enjoined Hi-Tech from selling generic dorzolamide products until the ‘413 patent expires. Label on the immediate bottle is missing. Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 6, 8, and 10 oz Bottles, OTC Only. L and 1 vial of 2. In 2000, Genetics Institute obtained a patent term extension under 35 U.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. Microbial contamination of non-sterile product: Out-of-specification microbial results were obtained at the initial stability interval for Lansoprazole Delayed Release Capsules. By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9. Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.
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FDA, Nu-Pharm’s ANDA for generic Depakote, in which the D. Rx only, Distributed by Wyeth Pharmaceuticals Inc. The Federal Circuit rejected Novartis’s argument that the expiration of the patent term extension had the same effect as a disclaimer, because statutory disclaimers are retroactively considered part of the original patent such that the disclaimed claims are treated as though they “never existed. According to Pharmalot, Teva’s CEO is not concerned.
Due to the lengthy review process, the FDA granted Merck a patent term extension under 35 USC 156, thereby extending the term of the ‘413 patent to April 28, 2008. The Federal Circuit decided an unusual case yesterday respecting Somerset Pharmaceuticals’ application for an interim patent term extension for U. Solution, 50 mL Vial, Rx Only, Not for Resale. On July 16, Impax and Wyeth announced a settlement of their litigation over Impax’s generic version of Effexor XR. Quality Choice, UPC 6 35515 96577 5, 4oz.
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Last week, following a bench trial held in March, the U. ANDAs with paragraph IV certifications to the patents. For IV Use Only, Sterile, 100 mL Multi-Dose Vial, Rx Only, NDC 53150-317-01.
A decision in favor of Hi-Tech would have far-reaching consequences. FDA is now able to accomplish the goal of expedited notification within the Enforcement Report. Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.
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N-Desmethylsibutramine and N-di-Desmethylsibutramine are analogues of sibutramine. All unexpired lots of the above attached link of products. The AP reported on June 5th that Abbott and Mylan settled their patent litigation over Mylan’s generic version of Depakote ER, with the parties agreeing that Mylan may launch its generic no later than Jan. Venlafaxine HCL Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Product has correct label on the syringe and the case but some units are incorrectly labeled on the light protective overwrap. Clark Law Review recently published a special issue devoted entirely to the patent law doctrine of obviousness. Presence of Particulate Matter:The product may contain particulates from iron embedded in the glass container coming in contact with product solution. The FDA announced on July 9 that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc.
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Lake Forest, IL 60045, NDC 0409-4699-30. Many of the most valuable patents owned by innovator drug companies would lose years off their terms, potentially costing billions of dollars in lost revenue. Sibutramine and phenolphthalein were previously available drug products but were removed from the U. 1 billion drug for the treatment of Neutropenia.
Lansoprazole Delayed Release Capsules, 15 mg 14 count. ANDA: The product has been found to contain the undeclared active pharmaceutical ingredients Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin, making it an unapproved new drug. In contrast, an expired patent may form the basis of an action for past damages, subject to a defense raising the six-year time limitation on damages. 267 patent illustrates, the pharmacological properties of MAL differ from those of ALA, supporting the separate patentability of the MAL product. Particulates consistent with glass delamination found in vials.
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The district court’s opinion explains that the “basic premise of double patenting is that the same invention cannot be patented twice. Hi-Tech will now have to wait until at least April 28, 2008, when Merck’s patent expires, before it can launch its generic version of Trusopt. 154, so that by virtue of this disclaimer, the ‘812 patent will expire on October 8, 2010.
ANDA: FDA and New York State Department of Health analysis found these products to contain steroids or steroid-like substances, making them unapproved new drugs. Degradation Specifications: Out of specification for impurities. Nystatin USP Powder 150 Million Units, Plastic, 19. In the appeal, Novartis first argued that the Federal Circuit lacked appellate jurisdiction because the ‘112 patent’s extended term expired in 2010. GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl.
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20 mL Single-dose vials, Hospira, Inc. Publication of Orange Book Blog does not create an attorney-client relationship. In May 2008, during the extended term of the ‘112 patent, Genetics Institute sued Novartis Vaccines and Diagnostics, Inc. Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7. The WSJ Health Blog had an interesting post recently about a report from the HHS Inspector General, finding that FDA typically takes longer than the 180 days allowed under law to review a generic drug application. Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage.
BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 3132593, 3132594, 3134420, 3134421, 3134422 Exp. Hydrocodone Bitartrate and Acetaminophen Tablets, 7. Restore Tears Lubricant Eye Drops, Carboxymethylcellulose Sodium 0. If a new post is added during the day, you’ll receive it by e-mail the next morning. Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
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Federal Circuit affirmed a district court decision sustaining the term extension of U. According to an investor note from Bernstein Research, the decision was surprising because the district court was not expected to “make a controversial opinion on what is likely to be a precedent-setting ruling by the appellate court on patent extensions and terminal disclaimers. Presence of Particulate Matter: various particulate matter found in the solution. Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording “Rx Only”. Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P. According to Hi-Tech, “his case arises solely because the PTO regulation implementing 35 USC 156 added words to the statute which are not there.
In addition, the note indicates that Bernstein expects Barr to “maximize the value of the challenge through settlement. Presence of Particulate Matter: A foreign particle found in a pre-filled syringe. However, the court noted that “a dual problem is presented in that the terminal disclaimer was not only filed at or near the conclusion of trial in this action, but it was also filed after the expiration of the earlier ‘086 patent. On Thursday, Judge Sleet of the U. Nystatin USP Powder 50 Million Units, Plastic, 6. Meanwhile, the WSJ Health Blog recently reported that the CEOs of GSK and Roche have no interest in getting into the generics business.