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Study Group: Medical Device Patent Experts: Lawyers (US)

Council Members in this Study Group: 77

This study group may include professors, attorneys, former regulatory officers, and consultants knowledgeable on topics such as law and litigation issues, lobbying, policy and government, elections, antitrust, immigration, intellectual property, and legislation, among others.

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Leading Experts in this Study Group

Stephen Bent, Partner, FOLEY & LARDNER LLPStephen Bent

Partner
FOLEY & LARDNER LLP
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Stephen A. Bent is Partner and former co-leader of the Life Sciences Industry Team at Foley & Lardner in Washington, DC. He is also a member of the Biotechnology & Pharmaceutical Practice Group and the Health Care and Nanotechnology Industry Teams. Mr....

Patrick Joseph Igoe, Life Sciences Patent Attorney, Independent IP Litigation ConsultantPatrick Joseph Igoe

Life Sciences Patent Attorney
Independent IP Litigation Consultant
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Patrick Joseph Igoe is a consultant and registered patent attorney in New York. His focus is patent issues throughout Life Sciences - for example, diagnostic/therapeutic assays; medical devices/imaging technologies; Rx antibiotics, biologics, drugs, and...

Thomas Saunders, Of Counsel, RISSMAN HENDRICKS & OLIVERIO, LLPThomas Saunders

Of Counsel
RISSMAN HENDRICKS & OLIVERIO, LLP
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Thomas Saunders is an Of Counsel at Rissman Hendricks & Oliverio. He specializes in representing emerging medical technology, biotechnology/genetic engineering and pharmaceutical concerns, particularly as to patent prosecution, patent strategy, IP licensing...

Marc Scheineson, Partner & Chair, Food and Drug Practice, ALSTON & BIRD LLPMarc Scheineson

Partner & Chair, Food and Drug Practice
ALSTON & BIRD LLP
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Marc Scheineson is a Partner with Alston & Bird where he heads the firm's Food and Drug Law Practice. He has practiced food and drug law, health care law and administrative law for over 20 years in national law firms and at the FDA. His practice focuses...

Joel Bock

Partner
SONNENSCHEIN, NATH & ROSENTHAL, LLP
What is a GLG Educator?|GLG Educators have qualified for GLG Member Programs and are therefore eligible to participate in ongoing in-depth consulting projects with GLG clients.

Joel N. Bock is a Partner in the New Jersey office of Sonnenschein. Mr. Bock counsels companies regarding a wide range of intellectual property issues and structuring and negotiating transactions involving IP assets, including mergers and acquisitions,...

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GLG NewsSM Analyses by this Study Group's Leading Experts(?)

Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.

Generic ADDERALL XR Launched By Teva (NasdaqGS:TEVA) - VYVANASE Sales Of Shire PLC (NasdaqGS:SHPGY) Might Decrease

April 2, 2009

Teva Introduces First Generic Adderall XR® Capsules in the United States | www.tevapharm.com

(1) As stated in the 02 Apr 2009 Press Release, Teva Pharmaceutical Industries Ltd. (NasdaqGS:TEVA) has launched its generic versions corresponding to the FDA-approved Orange Book Reference Listed Drug (RLD) medical products of ADDERALL XR Capsules (mixed salts of a single-entity amphetamine product; strengths/mg: 5 10 15 20 25 30) of Shire PLC (NasdaqGS:SHPGY).  This event, although unfavorable to Shire, was clearly a known possibility.  Its anticipated impact will likely be a decrease in Shire's American sales of ADDERALL XR Capsules.  (2) Spillover damage for American sales of VYVANSE Capsules (lisdexamfetamine dimesylate; strengths/mg: 20 30 40 50 60 70) might be possible.  The nexus between ADDERALL and VYVANASE follows. VYVANASE's Active Product Ingredient (API) is lisdexamfetamine dimesylate; a prodrug of dextroamphetamine.  ADDERALL's APIs are a mixture of 4 related amphetamines.  Thus, ADDERAL and VYVANASE are related medical products.

OXYCONTIN Update: Ratiopharm And Sandoz Infringe 2 European Patents Controlled By Napp And Purdue

April 2, 2009

OXYCONTIN Update: England Patent Infringement Victory {Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH [2009] EWCA Civ 252 (01 April 2009)} | www.bailii.org

(1) In this article, the London 01 Apr 2009 html version of judgment of the England and Wales Court of Appeal (Civil Division), a recent appellate court decision provides Napp and Purdue, in protecting OXYCONTIN, with a definitive patent infringement victory over both Ratiopharm GmbH and Sandoz Ltd (winners at the prior lower court).  (2) Its conclusion at Paragraph No. 117 is clear and unambiguous.  "The patents are valid and infringed."  (3) This important decision reverses a prior 16 Dec 2008 decision.  From a financial point of view OXYCONTIN is vital - "Its importance is shown by its sales figures - of the order of £32 million per annum in the UK alone." (Paragraph No. 4)

COPAXONE Update: Teva (NasdaqGS:TEVA) Continues FDA And Patent Fights To Delay Or Prevent Launch Of Generic COPAXONE By Novartis (NYSE:NVS) In Collaboration With Momenta Pharmaceuticals (NasdaqGM:MNTA)

March 30, 2009

Teva (NasdaqGS:TEVA) Announces FDA Response to Citizen Petition (Re COPAXONE ANDA) | www.tevapharm.com

As stated in the 25 Mar 2009 press release by Teva (NasdaqGS:TEVA), the FDA recently denied Teva's Citizen Petition (CP) which was previously filed 26 Sep 2008.  Teva is now fully-engaged in its dual efforts to protect its American COPAXONE sales.  These dual efforts are (1) at the FDA: through petition practice, Teva seeks to have the FDA undertake specific action which in effect would either delay or prevent FDA review or approval of the now pending Novartis-Momenta Abbreviated New Drug Application No. 90-128 for generic COPAXONE; and (2) at the United States District Court for the Southern District of New York (USDC/SDNY): in Case No. 1:08-cv-07611-BSJ-JCF, Teva as Plaintiff has sued Novartis (NYSE:NVS) and Momenta (NasdaqGM:MNTA) for patent infringement of multiple FDA Orange Book patents [7 patents are listed in the FDA Orange Book 5981589 6054430 6342476 6362161 6620847 6939539 7199098].

CUBICIN (daptomycin for inection) Patent Litigation Starts As Cubist (NasdaqGS:CBST) Sues Teva (NasdaqGS:TEVA)

March 25, 2009

Cubist Pharmaceuticals Files Patent Infringement Lawsuit Against Teva Parenteral Medicines, Inc. | www.cubist.com

As noted in the Mon 23 Mar 2009 press release, Cubist has sued Teva in response to Teva's Abbreviated New Drug Application (ANDA) seeking FDA approval of a generic version of CUBICIN.  This patent dispute is critical because, as noted in recent SEC filings, CUBICIN sales account for substantially all of Cubist's revenues.  Within the 3 patents-in-suit, 2 patents (US Patent Nos. 6468967 6852689) contain only method claims while the remaining 1 patent (US Reissue Pat. No. 39071) contains compound, composition, formulation, and method claims.

MULTAQ (dronderone hydrochloride) NDA - Sanofi-Aventis Awaits FDA Final Decision

March 23, 2009

Heart-Drug Review Gives Sanofi Shot at $1.9 Billion (Update2) | www.bloomberg.com

As indicated in the Tue 17 Mar 2009 Bloomberg article, the FDA has provided Sanofi-Aventis SA (NYSE:SNY) with a positive viewpoint for current NDA No. 22-425 [submission date: 31 Jul 2008], the New Drug Application for MULTAQ (dronderone hydrochloride).  However, this positive viewpoint is not the same as FDA final approval for MULTAQ; rather, it is a nonbinding and nonfinal recommendation of a committee.  Analysis of the public FDA documents on this matter indicate that the positive recommendation is both complicated and nuanced.

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Members in this Study Group include these company types:

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  • Law Firm (Boutique / Specialized)

Members in this Study Group often have these job titles:

  • Partner
  • Attorney

GLG Live Meetings with this Study Group's Leading Experts (?)

November 1, 2007 | New York

GLGi: Big Pharma v. Generics - Science Patent Battles

GLG Webcasts & Teleconferences

Leading Experts in Medical Device Patent Experts: Lawyers (US) have not participated in any GLG webcasts.

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