CI & Patent News: 11/02/2011

Posted on 11/02/2011 by Guna

1) Panacea to launch PacliALL (Paclitaxel) – Novel drug delivery product for Breast Cancer. It seems The PCT application WO 2007069272 protects this novel drug delivery system (Panacea Press Release)

2) Lilly Asks High Court To Review Double Patenting (law360); CAFC rejected rejected en bac review for double patenting

3)  Baselia in talk to sell rights of ceftobiprole (Bloomberg)

4) Protect Pharma sells patent portfolio to Germanys Grunenthal (thepharmaletter); Grunenthal has various opioid pain drugs (Tramadol, tapentadol etc).

5) Anacor and Medicis Enter Into Research and Development Collaboration for the Treatment of Acne (Businesswire); boron-based small molecule compounds (Anacor has large number of patent filings on boron based small molecules; the earliest one is WO 2006/089067)

6) Medivir Announces Start of Phase 1a Trial of the Hepatitis C Polymerase Inhibitor TMC649128 (Businesswire)

7) Novartis Says Mylan Infringed Lescol Patent (law360)

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Perrigo announces settlement in Rogaine® foam

Posted on 10/02/2011 by Guna

Today perrigo announced settlement relating to Minoxidil foam brought by Stiefel Research Australia. Under this settlement, perrigo will launch generic Men’s Rogaine® Foam on March 1, 2012.

Stiefel sued perrigo on Oct 09, 2009 at Delaware District Court view on Patent doc.  For Men’s Rogaine, US 6,946,120 (expiry: Apr 20, 2019) is listed in Orange book.

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District court ruled in favor of Watson in Mucinex patent suit

Posted on 10/02/2011 by Guna

[Bloomberg]

Watson in press release announced that he United States District Court for the Southern District of Florida has ruled that Watson’s generic versions of Mucinex(R), Mucinex(R) D and Mucinex(R) DM (Guaifenesin, Dextromethorphan HBr/ Guaifenesin, and Pseudoephedrine/Guaifenesin) Extended-Release products, do not infringe U.S. Patent No. 6,372,252 (the “‘252 Patent”).

A U.S. appeals court in August overturned a ruling that generic-drug maker Perrigo Co. of Allegan, Michigan, didn’t infringe the same patent. That case was sent back to the court for further review.

[CAFC Order in perrigo case]

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Natco Gilead Tamiflu ANDA

Posted on 09/02/2011 by Guna

Today Natco confirmed the first to file status in press release and will have 180 days exclusivity if Natco ANDA approved by FDA. Natco ties up with Alvogen for marketing generic version in USA.

As of now, Gilead has not sued Natco yet and its has time to sue Natco (45 days time). Gilead announced the receipt of paragraph IV notice letter on Feb 07, 2011. Natco’s ANDA approval will be stayed till 30 months (date of submission is Nov 15, 2010), if Gilead sues within 45 days.

Three patents are listed in Orange Book which are 5763483; 5866601 & 5952375. As per Gilead announcement Natco challenged ‘483 patent which expires after other patents (‘601 & ‘375).

Update: 16/03/2011

Gilead sued Natco on Monday, March 14, 2011 @ Delaware District Court (RFC express)

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UCB cell tech PDL Biopharma Patent Disputes

Posted on 08/02/2011 by Guna

Today UCB announced that they resolve all patent dispute with protein design lab (PDL Biopharma) and UCB will pay PDL US$ 10 million

[UCB Press Release]

On Feb 2005, USPTO declared  interference proceeding between certain claims of Queen et al U.S. Patent No. 5,585,089 and certain pending claims of Adair et al., U.S. Application No. 08/846,658 under 35 U.S.C. 135(a). USPTO held this interference proceeding in favour of PDL biopharma. The ‘658 application’s european counter part was also revoked by Opposition filed by PDL biopharma.  One more interference proceeding pending at USPTO between 6180370 (PDL biopharma) and 10/938,117 published as US2006/0029593 (UCB).

This agreement resolves all such pending patent dispute between PDL biopharma’s queen et al patents and UCB patent applications. Also a covenant not to sue UCB for any royalties regarding UCB’s Cimzia® product under the Queen patent portfolio.

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CI & Patent News: 08/02/2011

Posted on 08/02/2011 by Guna

1) Salix licenses RELISTOR from Progenics Pharmaceuticals (Press release); RELISTOR® (methylnaltrexone bromide) is opioid antagonist, indicated for treatment of opioid-induced constipation. “The methylnaltrexone license includes intellectual property from the University of Chicago, Progenics Pharmaceuticals, and Wyeth Pharmaceuticals, including patents and applications with expiration dates that will range from 2017 through 2031”

2) Gilead Sciences Announces Notification of ANDA Filing for Tamiflu (oseltamivir phosphate) (Businesswire). “In the Notice Letter, Natco alleges that a patent associated with Tamiflu – U.S. Patent Number 5,763,483 – owned by Gilead Sciences is invalid, unenforceable and/or will not be infringed by Natco’s manufacture, use or sale of the product described in its ANDA submission”

3) Valeant Pharmaceuticals to Acquire U.S. and Canadian Rights to Zovirax (Aciclovir) from GlaxoSmithKline for $300 million (Pharmalive)

4) Glenmark achieves positive results for anti-diarrhoea molecule (ET report); “…Crofelemer is licenced to the company from US-based Napo Pharmaceuticals. In November 2010, Glenmark along with Napo and Salix Pharmaceuticals, had announced the successful completion of phase III trials with Crofelemer for the treatment of diarrhoea inpatients with HIV in the US…”

5) FDA Approves Makena (hydroxyprogesterone caproate injection), the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth (Yahoo finance)

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Bayer-Anti-TNF antibodies patent- J&J and Abbott drugs (US & Europe)

Posted on 06/02/2011 by Guna

Bayer had sued Abbott and J&J for their Anti-TNF antibody drugs Adalimumab (Humira) and Golimumab (Simponi) respectively on Dec 2008 and Aug 2009. The patent involved in these suit, was US5654407 covers Human monoclonal antibodies composition.

According to Bloomberg article, Bayer has terminated both the suits as district court judge constructed the claimed term “Human monoclonal antibodies” specifically as “low affinity, referring to the strength of the antibody’s attachment to TNF, and that don’t neutralize the protein” . Bayer may appeal this claim construction.

Interestingly, the same patent’s equivalent (EP0614984) was involved in post grant opposition proceedings at EPO (Opposed by J&J and Abbott). The ‘984 patent was initially revoked by EPO and the Technical board of appeal had reversed this decision. J&J’s Golimumab (Simponi) was issued marketing authorization on 01/10/2009.

Another interesting thing is Bayer has filed SPC for Golimumab (Simponi) on 07/12/2009 at UK IPO (Link) and this SPC for Golimumab is now granted on ‘984 patent and expires on 20/02/2019.

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Novartis-Imatinib-India case

Posted on 05/02/2011 by Guna

[Business Standard]

The Supreme Court will start final hearing next month on a plea by Swiss pharma firm Novartis AG challenging the order of an appellate board, which upheld the government’s denial of patent to its blood cancer drug Glivec.

A Bench, comprising Justices Dalveer Bhandari and Deepak Verma, directed today to list the matter for final hearing in March.

Listed for hearing on 09/08/2011 (update: Moneycontrol news)

Background: Novartis’ imatinib crystalline form application [1602/MAS/1998] rejected in pre grant opposition and also in appeal at IPAB . This case is precedential for the term “efficacy” of section 3(d) (efficacy=therapeutic efficacy). Now the appeal of IPAB order lies with supreme court.

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Australia: Docetaxel case

Posted on 02/02/2011 by Guna

[Bloomberg]

The interlocutory petition for restraining generic launch of Docetaxel in Australia is denied by federal judge.

Docetaxel product per se is protected by patent no AU591309 (expiry: Feb 06, 2011) and composition is protected by patent no AU666859 (expiry: July 2012). The generic companies (Hospira & interpharma) intends to launch generic version after the product patent expiry ie after Feb 06, 2011.

Injunction against generic companies is not granted

[Order]

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Patent & CI News: 02/02/2011

Posted on 02/02/2011 by Guna

1) Allergan and MAP Pharmaceuticals Announce Collaboration on LEVADEX™ Investigational Therapy for Acute Migraine (Yahoo finance); LEVADEX™ contains a proprietary formulation of dihydroergotamine (DHE).

2) Judge granted motion filed by Medeva Pharma Suisse AG and Warner Chilcott in Asacol lawsuit and awarded roxane to pay attorney/expert fee (law360). In discovery phase of trial, Roxane found to have concealed batch of its generic version.

3) Data exclusivity in India (SpicyIP)

4) English translated version of Advair duch court decision (The SPC blog)

5) US litigation: Lupin Holding SA & Ethypharm Vs Paddcock (product: Antara capsulse); complaint filed at Southern District of New York on Jan. 31, 2011; View on PriorSmart

6) New study published by EPO: Patent Litigation in Europe (Link)

7) Eisai receives complete response letter from FDA for Rabeprazole ER for treating erosive gastroesophageal reflux disease (GERD) (Businesswire)

8) FDA Issues Complete Response to New Drug Application for Contrave®(naltrexone HCl/bupropion HCl) extended-release for the treatment of obesity (Takeda press release)

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