Posts Tagged ‘USPTO’

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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U.S. Patent Commissioner Focarino To Retire

Friday, May 1st, 2015

From IPO Daily News, Friday, May 1, 2015

Peggy Focarino_smallThis week U.S. Patent and Trademark Office’s Commissioner of Patents Margaret (Peggy) Focarino announced that she will retire on July 3 as U.S. Patent and Trademark Commissioner. Focarino has been with the USPTO for 38 years. Executive Director Herb Wamsley said “Focarino has consistently earned high marks for her management skills and her strong interest in working closely with user groups. We wish her well in retirement.” Focarino’s successor has not been named.

She was appointed Commissioner of Patents in January 2012; she was the first female to serve in that role. As Commissioner, Focarino is responsible for management and direction of all aspects of patent operations, examination policy, resources and planning, and budget administration. She previously served as Deputy Commissioner for Patents. Focarino also served as Acting Director and Deputy Director of the USPTO before Michelle Lee’s appointment in late 2013.

“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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USPTO Myriad-Mayo Guidance Still Not At An Alpha Standard

Tuesday, March 24th, 2015

This is a guest post from Paul Cole.

iStock_000029586246_SmallAs readers will be aware, the USPTO published revised Guidance on Section 101 eligibility in December 2014 together with Nature-Based Examples and Abstract ideas examples. These materials and the case-law on which they were based appear on a dedicated web-page.

A Forum on the revised Guidance was held on 21 January with contributions from Raul Tamyo on behalf of the USPTO and from eight members of our profession. Their slides are accessible on the web-page. It also promises a Forum Replay in three parts, but those wishing to hear in detail what was said will be disappointed because the three links are broken and play nothing. The comments period ended on 16 March, and the absence of a workable Forum Replay (which has been pointed out to the USPTO) would arguably in itself justify an extension of the comments period for our profession and for the public.

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