GLG News by Medical Device Patent Experts: Lawyers (US)

Thomas SaundersOf CounselRISSMAN HENDRICKS & OLIVERIO, LLP

RIPENING INHIBITORS: ROSY FUTURE OR BRUISED FRUIT?

December 21, 2007

Analysis of:Current and Potential Commercial Applicationsof the Suppression of Ethylene Action by 1-MCP in Plants | www.rohmhaas.com

    Product shelf-life is a major economic concern for the agricultural industry.   The biological mechanism for regulating the ripening of fruits is mediated by ethylene.     Ethylene  management is addressed in three ways: 1) Ethylene absorption 2) Inhibition of ethylene biosynthesis and 3) Prevention of ethylene receptor signaling.     In the ripening control patent landscape novel cyclopropene compounds function as ethylene receptor blockers.  Of the 60 U.S. patents that have issued, approximately 15 are related to cyclopropenes, while the remaining 45 are more or less evenly distributed between about 20 different ethylene management technologies. AgroFresh Inc., a Rohm and Haas subsidiary, has staked out a significant position in ethylene receptor blocking technology by claiming a wide range of cyclopropene derivatives

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

 

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Thomas SaundersOf CounselRISSMAN HENDRICKS & OLIVERIO, LLP

Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing

March 1, 2007

Analysis of:Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing | www.iptoday.com

-Name Brands vs, Knock-Offs: Strategies and Counter-Strategies

-Vulnerabilities of Name Brand Copyrights

-Why the internet Knock-Off market will always exist

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