Posts Tagged ‘Warren Woessner’

Apotex Petitions Supreme Court to Review Therasense Standards

Thursday, May 21st, 2015

Magnesium SaltIn Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court’s ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court found was a perfect storm of misrepresentations during the prosecution of U.S. Pat. No. 6,767,566 that claimed a method to make the magnesium (Mg) salt of Moexipril. The Fed. Cir. found that Dr. Sherman, the named inventor on the application withheld prior art, mischaracterized the cited art in arguments and via a Rule 132 Declaration, and included examples in the application that had not been performed. In fact, this was characterized as an attempt to patent a competitor’s drug.  The  competitor, UCB, had listed in the Orange Book, as the hydrochloride salt – although the court found that Dr. Sherman was aware that the process disclosed in the listed patent, U.S Patent No. 4,743,450, would yield the Mg salt of Moexipril, which imparted substantial stability. The Fed. Cir. agreed with Apotex that Dr. Sherman had no duty to disclose his own suspicions or beliefs regarding the prior art (that he suspected that the ‘450 process would in fact yield the stable Mg salt) but rested its holding on its opinion that Dr. Sherman “affirmatively and knowingly misrepresented material facts regarding the prior art.” Slip op. at 15.

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FDA Finalizes Biosimilar Guidance

Thursday, April 30th, 2015

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents.

You can find the article here.

“Isolated” Natural Products Still in Purgatory Post-PTO Guidance?

Tuesday, April 28th, 2015

BacteriaRecently, a new class of antibiotic, teixobactin, was discovered in the soil in a Boston researcher’s backyard via a high throughput in situ screening chip that detected individual bacteria capable of growing in an uncultured state. The resulting isolates were extracted and the extracts screened for antibacterial activity. One peptidyl compound, isolated from a new species of bacterium and named teixobactin (“TX”), was found to kill a wide variety of pathogens without detectable resistance. The Nature pre-print I have ends, “It is likely that additional natural compounds with similarly low susceptibility to resistance are present in nature and are waiting to be discovered.”

“Discovery” seems likely, but a close reading of the examples provided with the December “2014 Interim Guidance on Patent Subject Matter Eligibility” is not encouraging. Practitioners generally hailed the revised Guidance as releasing Examiners to allow claims on nature-based products that were structurally or functionally different from their closest counterparts in nature. However, Example 4, “Purified Proteins” indicates the PTO’s unwillingness to embrace (read “treat as precedent”) cases like Parke-Davis (Adrenaline) and Merck v. Olin-Mathieson (purified vitamin B-12).

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Genetic Engineering Makes the Blacklist

Thursday, April 16th, 2015

iStock_000003273676_LargeJames Spader was quirkily funny as Denny Crane’s partner on “Boston Legal,” but NBC’s “The Blacklist” has him operating totally outside of the law. He plays Raymond Reddington, an enigmatic figure who reveals to a black-ops FBI agent the evil doings of criminals that fly under the radar of normal law enforcement – and who make “The Blacklist.” A recent episode involved trying to catch a “mad scientist,” funded by a middle-aged tech billionaire to conduct research on human subjects for his “Longevity Initiative.” When the scientist is captured, oddly, one might think, his lab contains tanks of phosphorescent jelly fish and two bunnies that glow in the dark.

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