Mr. Patrick Joseph Igoe

GLG News by Mr. Patrick Joseph Igoe, Life Sciences Patent Attorney

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

April 2, 2009

Analysis of: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

Analysis of: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

Analysis of: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

Analysis of: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

Analysis of: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.

TARCEVA Patent Infingement Battle Begins As OSI Pharmaceuticals Sues Teva And Mylan

March 20, 2009

Analysis of:OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva Pharmaceuticals USA and Mylan Pharmaceuticals | phx.corporate-ir.net

As stated in a Thu 19 Mar 2009 press release, OSI Pharmaceuticals (OSIP), in protection of its TARCEVA cancer drug, has filed separate lawsuits against each of Teva and Mylan.  As the innovator company for TARCEVA [a FDA Orange Book Prescription (Rx) Referencle Listed Drug (RLD) Product with 3 listed patents - 5747498 6900221 7087613 - and with New Chemical Entity (NCE) exclusivity 5-year expiration date of 18 Nov 2009] OSIP has now started its formal Hatch-Waxman patent offense against the Paragraph (iv) ANDA Filers, Teva and Mylan.  At the commercial level, TARCEVA is manufactured for OSIP by Schwarz Pharma and it is distributed by Genentech.  TARCEVA is an extremely important revenue source for OSIP; in a recent SEC filing (Form 10K Annual Report filed 27 Feb 2009) OSIP indicates that approximately 88% of its total 2008 revenues are TARCEVA-related.

VANCOCIN - ViroPharma Fights FDA's Possible Decision Allowing ANDA Filers To Establish Bioequivalence With In-Vitro Dissolution Testing

March 19, 2009

Analysis of:ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance | phx.corporate-ir.net

In reaction to the December 2008 FDA release of its Draft Guidance on Vancomycin Hydrochloride, ViroPharma announced Wed 18 Mar 2009 its submission of comments to the FDA.  As the innovator company for VANCOCIN, a FDA Orange Book Rx Reference Listed Drug without any listed patents nor any listed exclusivities, ViroPharma's point of view directly against the FDA's Draft Guidance is expected.  Analysis of the merits of these opposing viewpoints [FDA: in the Draft Guidance versus ViroPharma: in its comments] requires in-depth understanding of the underlying technical details within the context of the controlling laws and regulations.

SOLODYN/FDA Denies Medicis Citizen Petition Seeking 30-Month Stay Against ANDA Filers

March 19, 2009

Analysis of:SOLODYN/Medicis SEC Filing, 18 Mar 2009, Form 8-K Current Report | idea.sec.gov

The FDA, acting with surprising speed, recently denied a Citizen Petition (CP) filed 13 Feb 2009 by Medicis (NYSE: MRX) in support of SOLODYN.  If FDA's denial of this CP is not reversed, then the current 3 ANDA filers [Mylan (NasdaqGS: MYL);  Barr/Teva (NasdaqGS: TEVA); and Sandoz/Novartis (NYSE: NVS)] will not be subject to a 30-month stay of FDA final approval of each of their respective ANDAs.

Patent Win Protects Eisai's Aricept Against Teva's Potential Generic Product Launch Via Preliminary Injunction

March 31, 2008

Analysis of:WSJ/Aricept Maker Wins Injunction In Patent Case | online.wsj.com

* As noted in the Wall Street Journal article, Aricept® is a blockbuster drug for the treatment of Alzheimer's disease.  And, as noted in Judge Ackerman's ruling, Aricept sales are a huge source of Eisai's revenue - "sales of Aricept® in the United States constitute 70% of Eisai’s U.S. subsidiary’s profits, and 25% of Eisai’s revenues worldwide". * In patent infringement litigation at a Federal trial court, a preliminary injunction in favor of Eisai and against Teva has just been granted which orders Teva not to sell generic Aricept® as claimed in US Patent 4895841. * The Fri 28 Mar 2008 26-page Opinion & Order (Doc #191) by Judge Harold A. Ackerman of the United States District Court for the District of New Jersey grants Eisai's Motion for Preliminary Injunction (Doc #141).

Amgen's EPO Patent Win At The Federal Circuit

March 19, 2008

Analysis of:WSJ/Court Sends Mircera Case Back To Trade Commission | online.wsj.com

(1) The US Court of Appeals for the Federal Circuit - in a complicated 22-page split Opinion earlier today Wed 19 Mar 2008 - provided Amgen another victory in its long patent battle(s) with Hoffmann-LaRoche. (2) Amgen's Aranesp® and EPOGEN® (each a prescription only product that relates to EPO/erythropoietin) are protected by multiple US patents. (3) As indicated in the Wall Street Journal article, Aranesp® and EPOGEN® are each critical revenue-producers for Amgen with combined sales in excess of $6 billion. (4) Further ITC proceedings may ultimately transform the current intermediate patent victory into a more effective and more valuable ruling in favor of Amgen.

Neurontin® (Gabapentin) Patent Trials - Pfizer Victory Remains Possible

September 24, 2007

Analysis of:IN RE GABAPENTIN PATENT LITIGATION [2006-1572] - Federal Circuit Opinion | www.fedcir.gov

The at-risk product launch by [NasdaqGS:TEVA] Teva of generic equivalents to [NYSE:PFE] Pfizer's Neurontin® (gabapentin) might - and the emphasis is clearly on might - yet prove to be an expensive mistake by Teva. The recent Opinion by the United States Court of Appeals for the Federal Circuit [also known as Federal Circuit, Fed Cir, or CAFC] essentially provides Pfizer a new opportunity to proceed with an actual on-the-merits trial. Upon remand, Plaintiff Pfizer will seek to establish patent infringement by multiple Defendants, including Teva. Pfizer previously enjoyed blockbuster Neurontin® sales of at least $2 Billion/year. As reviewed in-depth later, the CAFC Opinion - (a) reverses-in-part; (b) affirms-in-part; and (c) remands for further proceedings - the prior trial court judgment which had granted summary judgment of no patent infringement in favor of multiple Defendants.

Appellate Court Invalidates 2nd-Generation Altace ® (ramipril) Patent 5061722

September 12, 2007

Analysis of:Tue 11 Sep 2007 Federal Circuit Reverses Trial Court And Invalidates King Pharmaceuticals' Patent for Altace® (ramipril) | www.fedcir.gov

In my prior Tue 31 Jul 2007 Analysis available here http://news.glgroup.com/CM/Analysis/PostDetail.aspx?pid=14722 I stated: The upcoming Altace ® Opinion will most likely fall in line with this noted trend. In other words, King Pharmaceutical [NYSE:KG]'s patent protection for Altace ® (ramipril) appears to be a prime candidate for invalidation due to § 103 obviousness.  In today's 19-page Opinion by the United States Court of Appeals for the Federal Circuit [2006-1530, 2006-1555], this exact scenario has now occurred.  Sweeping generalizations about the fate of 2nd-generation, single-isomer active product ingredient patents are not helpful.  Only an individualized assessment of the particular marketed drug product in question is likely to be meaningful.

Federal Court Affirms Forest Labs' Lexapro® Patent Win Over Ivax & Cipla

September 6, 2007

Analysis of:Forest Lab's Wed 05 Sep 2007 Lexapro® Patent Victory At Appellate Court | www.fedcir.gov

With respect to the blockbuster antidepressant drug Lexapro®, the US Court of Appeals for the Federal Circuit, CAFC or Fed Cir, affirmed the prior November, 2006 Opinion of the Delaware District Court with respect to Plaintiff Forest Labs (NYSE:FRX) Paragraph (IV) patent infringement litigation against Ivax and Cipla. More specifically, the CAFC (a) affirmed that Reissue Patent 34712 [an Orange Book patent which protects Lexapro®] is valid; (b) affirmed the trial court's injunction order against both Ivax and Cipla; and (c) modified the scope of the injunction to apply only to escitalopram oxalate (the active product ingredient in Lexapro® - the single-isomer). This Fed Cir ruling is a definitive, solid win for Forest Labs; however, it does not mean that other currently marketed optically-pure drugs are all safe from generic manufacturers' assertions of patent invalidity.

The Federal Circuit's application of KSR within Life Sciences is bad news for Branded Pharmaceuticals.

July 31, 2007

Analysis of:In Re Metoprolol Succinate Patent Litigation | www.fedcir.gov

KSR involved mechanical technologies, but its rulings apply to all different arts, including biotechnology, medical devices, and pharmaceuticals.  The applications of KSR analysis by the Federal Circuit are multiplying and the results are not in favor of patent owners, including those patent owners within Life Sciences.  The upcoming Altace ® Opinion will most likely fall in line with this noted trend.  In other words, King Pharmaceutical [NYSE:KG]'s patent protection for Altace ® (ramipril) appears to be a prime candidate for invalidation due to § 103 obviousness.

JNJ's Definitive TOPAMAX(R) Win Over Mylan Labs

April 16, 2007

Analysis of:U.S. District Court Grants Permanent Injunction Prohibiting Mylan Laboratories Inc. (MYL) from Marketing Generic Version of TOPAMAX(R) | www.biospace.com

If the March 20, 2007 rulings of US District Judge Stanley R. Chester withstand further challenges, then JNJ's TOPAMAX(R) sales will not suffer - at least with respect to Mylan Labs.

 

The NORVASC® Battles Continue (Even After Federal Circuit Opinion)

April 9, 2007

Analysis of:Federal Circuit Opinion: Pfizer v Apotex | www.fedcir.gov

The March 22, 2007 CAFC Opinion invalidates claims 1-3 of US Patent 4879303, which is listed in the FDA Orange Book for Pfizer's blockbuster blood pressure drug NORVASC® (amylodipine besylate).  For companies other than Pfizer, this is great news - but it is not the end of the story.  Numerous recent filings at the FDA and other courts plainly show that the NORVASC® disputes continue and that multiple parties with differing views are willing to fight to the end.

Court Limits Piecemeal Infringement Assertions By Innovator Rx Company Against Generic Rx Company

April 2, 2007

Analysis of:Teva v Novartis: Federal Circuit Opinion | fedcir.gov

From among 5 patents listed in the FDA Orange Book, Novartis sued Teva for patent infringement of only 1 patent.  Teva filed a corresponding declaratory judgement action against Novartis seeking adjudication of the remaining 4 patents.  In its recent ruling, the Federal Circuit agrees with Teva and sends this ongoing litigation back down to the District Court for litigation concerning all 5 Orange Book patents.

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