CI & Patent News: 08/12/2010

1) Paragraph IV Litigations

Novartis  v. Aurobindo Pharma (Amlodipine + benazapril)

Complaint filed at District of New Jersey on Dec. 3, 2010

Patents in suit: 6162802 (Expires on Dec 19, 2017) View on PriorSmart

2) GSK signs agreement to acquire Nanjing MeiRui Pharmaceuticals in China (press release)

… MeiRui is a leading Chinese pharmaceutical business with a strong portfolio of urology and allergy products, including Prostat for benign prostatic hyperplasia and Sheniting for overactive bladder syndrome. GSK will gain access to this portfolio of products, as well as MeiRui’s established sales and marketing platform and a manufacturing facility in Nanjing City, Jiangsu Province, China ….

3) Forest Laboratories and Gruenenthal Enter Into Licensing Agreement for the Development and Commercialization of Novel Analgesic Compound (Business Wire)

…GRT 6005 and 6006 are novel first in class compounds with potent agonist activity on ORL-1 (opioid receptor like -1) and the well established mu opioid receptor… The compounds are covered by a composition of matter patent that will expire in November 2023. Additional patent term extension is expected.

4) Watson Confirms Development Agreement with Natco for Generic Revlimid(R) (Press release)

CI & Patent News: 06/12/2010

1) Paragraph IV litigation

Hoffmann-LaRoche Inc. v. Apotex Inc (ibandronate sodium)

Complaint filed at District of New Jersey on Dec. 2, 2010 View on PriorSmart

Shire LLC, Supernus Pharmaceuticals, Incl et. al. v. IMPAX Laboratories, Inc & Watson (Guanfacine HCl)

Complaint filed at District Court of Northern District of California on Dec. 2, 2010 View on PriorSmart

Medicis Vs Aurobindo (Minocycline HCl)

Complaint filed at district court of Delaware on ???? (Boolmberg)

2) Advinus announces tie-up with Corning India; Advinus is an indian company (TATA group) involved in drug discovery & development and Corning’s Epic® System is a high-throughput label-free screening platform based on optical biosensor technology. The system performs both biochemical and cell-based drug discovery applications and offers drug developers the ability to evaluate promising new drug targets. (Press release)

3) Imatinib Indian case:  Supreme court, on friday, asked defendants (Cipla, Ranbaxy Lab, Hetero Drugs, Natco) to complete formalities on Imatinib appeal case by Novartis. This is an appeal filed on IPAB’s order on rejecting imatinib’s beta crystalline form application (1602/MAS/1998).

4) Pfizer Plans Regulatory Submissions of Bosutinib in Chronic Myeloid Leukemia (Link)

5) Marketing Collaboration on Protopic® Ointment for Treatment of Atopic Dermatitis in Japan (Astellas press release)

6) Patent landscape on Anti-aging skin care by Patent insight pro (india invents)

7) RG1678: Phase II study with first-in-class investigational drug demonstrates improvement in negative symptoms in patients with schizophrenia (Roche Press Release)

Teva-Enoxaparin-Momenta & Sandoz

On december 02, 2010, Momenta and Sandoz sued Teva for patent infringement of its US FDA pending enoxaparin ANDA. Sanofi Aventis is innovator for enoxaparin and Sandoz has recently received approval of its ANDA. Sandoz has developed enoxaparin ANDA product in alliance with Momenta pharma

Momenta has sued Teva on 7,575,886 (the “‘886 patent”) and 7,790,466 (the “‘466 patent”). Teva in press release, said its ANDA product is manufactured and tested outside US and ANDA is not yet approved by US FDA for marketing and Teva will not infringe these patent before approval.

View on RFC and Teva Press Release [Complaint copy]

CI & Patents News: 2/12/2010

1) Para IV:

Ibandronate tablets: Hoffmann La Roche Vs Watson (View on PriorSmart)

Filed at District of New Jersey on Nov. 29, 2010

7,410,957: html | pdf	Method of treatment using bisphosphonic acid by Bauss et. al.; USPC #514/108; prosecuted by Johnston; George W. Rocha-Tramaloni; Patricia S. Wildman; David E.;
4,927,814: html | pdf	Diphosphonate derivatives, pharmaceutical compositions and methods of use by Gall et. al.; USPC #514/108; prosecuted by Felfe & Lynch;
7,718,634: html | pdf	Method of treatment using bisphosphonic acid by Bauss et. al.; USPC #514/108; prosecuted by Johnston; George W. Rocha-Tramaloni; Patricia S. Wildman; David E.;
6,143,326: html | pdf	Oral pharmaceutical preparation containing ibandronat by Mockel et. al.; USPC #424/482; prosecuted by Arent Fox Kintner Plotkin Kahn;

and 6,294,196; 7,192,938

2) Sorefenib Infringement case (Bayer Vs Cipla)

Judge framed the issues for trail without  hearing interim injunction application by Bayer and in addition to this, SC rejected SLP filed by Bayer on Patent linkage system and asked Delhi high court to decide this issue along with infringement case

…On Wednesday, the Supreme Court rejected the special leave petition filed by Bayer. “The court said this matter should be decided in its patent infringement suit which is pending with the Delhi HC,” said Prathibha Siva, who represented Cancer Patients Association of India, a party to the Bayer-Cipla case…. (Original link)

3) Glaxo close to buying Chinese drugmaker: sources (Live Mint)

4) Indian API exports to more than double by 2013-14 (Link)

5) India, China among fastest developing pharma destinations (link)

6) Merck to Acquire SmartCells, Inc (Press Release)

7) Pfizer May Release New Alzheimer Drug in 2-3 Years (Link)

8) Emami frontrunner to bag Paras Pharma for about Rs 3,000 cr (Link)

9) Galapagos candidate cachexia drug, GLPG0492, shows good safety and profile suitable for once-daily oral dosing (Press Release)

10) Abbott Laboratories along with partner Sucampo Pharmaceuticals Inc recently reported positive top-line data from a late-stage trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC)

11) Daptomycin: Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of CUBICIN (Link)

12) India to become key player in biosimilars market by 2015: Experts (Pharma Biz)

13) Sunitinib: SUTENT® Receives European Approval for a New Indication in Progressive Pancreatic Neuroendocrine Tumors (NET) (Press Release)

14) Indian patent examinations hit due to ongoing battle (link)

15) Watson Launches ella® (ulipristal acetate) Emergency Contraceptive (Press Release) Watson is the exclusive marketer of ella(R) in the U.S. under terms of a distribution agreement announced earlier this year

16) Dabur enters the OTC healthcare segment (BS)

17) Google’s constructive initiative in Patent space: Google signs deal to translate European patents (Link)

Google announced an agreement Tuesday to use its technology to translate patents into 29 European languages, a deal officials hope will smooth the way toward a simplified European patent system after years of infighting. Note: Reecntly Google and the USPTO have entered into an agreement to make the USPTO products available to the public at no charge [Patents (grants, published applications, assignments, classification information, and maintenance fee events); Trademarks (registrations, applications, assignments, and TTAB proceedings)] Link for google USPTO’s data hosting page

18) EU trade commissioner assures solution for drug seizure issue (Live Mint)

19) Demand for changes in patent law rejected (ET) & Govt plans VC fund to promote new drug research (ET)

20) Strides arcolab announces US FDA approval of Midazolam HCl injection

CI & Patent News:30/11/2010

1) Paragraph IV litigation

Astrazeneca Vs Mylan (product: Quetiapine ER)

Patent in suit: 5948437 (Expiry: May 28, 2017); Complaint filed at Northern District of West Virginia on Nov. 29, 2010. View on PriorSmart

Alza Corporation  Vs Impax Laboratories Inc & teva (Product: Methylphenidate ER)

Patent in Suit: 6930129 (Expiry: Jan 31, 2018); Complaint filed at District of Delaware on Nov. 24, 2010. View on PriorSmart

Impax had originally filed ANDA on Aug 17, 2005 and Alza  had sued Impax on ‘129 and another patent 6919373 (This case was dismissed by ALZA due to some reasons).  Now Impax amended its ANDA for which it got sued by alza on ‘129. Teva is distributor for Impax’s ANDA product in USA. (Note: Alza Vs ANDRX,  ‘373 patent got invalidated due to lack of enablement and which in appeal affrimed by CAFC).

Abbott Vs Impax (Simavastatin/Nicotinic acid; SIMCOR)

Patents in suit: 6080428, 6676967, 6406715, 6469035; Complaint filed at District of Delaware on Nov 24, 2010.

Jazz Pharmaceuticals Inc. v. Roxane Laboratories, Inc (Sodium Oxybate/Xyrem)

On November 22, 2010, Jazz has sued roxane at New Jersey District Court; Patents in Suit: 6780889, 7262219, 7668730, 7765106, 7765107; View on RFC; Roxane is first to file for Xyrem; (Jazz Press release)

Merck & Co., Inc Vs Hetero (Product: PROSCAR/Finasteride)

Complaint filed on New Jersey District Court on November 19, 2010; Patents (will be updated); View in RFC

2) Sun Pharma receives USFDA nod for generic Alzheimer’s drug (donepazil)

3) Bafna Pharma to invest Rs 30 cr in Specialty drugs (niche therapeutic segment of immunosuppressants)

… the company is looking to enter the niche therapeutic segment of immunosuppressants business by launching four products by the first quarter of 2011-12. These products have already been developed in collaboration with an Indian biotech major, and a tie-up has been signed with a marketing firm to sell the products in the Middle East and North African (MENA) region. The product would also be marketed in Brazil, Colombia, Sri Lanka and Philippines. However, he refused to divulge the details of its collaborations at this stage….

CI & Patent News: 29/11/2010

1)  Actavis launches Docetaxel single vial on patent expiry in major European markets (Press Release)

…. launched by Actavis under its own brand in Germany, the Netherlands, UK and Sweden, as well as by Medis ― the company’s sales division to third-party clients ― in the UK and Germany…. Actavis has also launched the Docetaxel single vial in Ireland, Finland, Portugal and Austria which were patent-free. The product will be launched across Europe – patents permitting – during 2010 and 2011….

2) Selcia and Gilead Sciences Extend Liver Disease Drug Discovery Collaboration (Link)

3) Merck announced Phase III study results of ISENTRESS® (raltegravir) Investigational Once-Daily Dosing in Treatment-Naïve Adult Patients Infected with HIV-1 (Press Release)

4) Venus Remedies Ltd received patent protection in South Africa and New zealand for its proprietary product Vancoplus (Ceftriaxone and Vancomycin). PCT Patent application Number is WO2006085337 (ET)

5) Sanofi-Aventis to launch reusable insulin pens in India (ET)

6) PhRMA signs cooperation agreement with Chinese pharma assn, SINO-PhIRDA (Pharma Biz)

….no such agreement was signed in India as similar incentives are not offered here. India’s new Patent law which was introduced in 2005 does not recognize incremental innovation as grounds for acquiring a patent ….

7) Ranbaxy Laboratories Ltd. plans to begin sales of generic Aricept (Donepezil) in the U.S. Nov. 29

8) Paragraph IV Litigation:

Alza Corp & Ortho McNeil Vs Impax & Teva at Delaware District Court filed on November 24, 2010; Case No: 1:10-cv-01024-UNA (product & Patent info will be updated)

9) Perrigo Announces Launch of Naproxen Sodium Soft Gels – Generic Equivalent to Aleve® Liquid Gels

Cladribine Merck Oral Multiple Sclerosis therapy

Merck has developed oral therapy for relapsing forms of multiple sclerosis (MS). Cladribine is earlier known for treatment of cancer (leukemia) in intravenous administration. Now Merck licensing from Ivax (Teva subsidiary) has developed oral therapy for MS.

This product is now at pre-registration stage in USA and approved in Russia and Australia. Europe’s CHMP has given negative opinion for Cladribine oral therapy (Press release).

Patent: Ivax has two patent application on oral formulation of Cladribine, which are WO2004087101 & WO2004087100. Probably these patent applications may cover marketed formulation of Cladribine.

CI & Patent News:26/11/2010

Pronova BioPharma receives Lovaza(TM) Paragraph IV Notice Letter from Apotex Inc (Press release)

Impax Laboratories Confirms Patent Challenge Relating to SIMCOR® Extended-Release Tablets, 1000/20 mg (link)

Paragraph IV litigation:

1) Merck & Co., Inc Vs Hetero Drugs & Invagen Pharmaceuticals (No patent/product traced); Filed on November 19, 2010

2) Ortho-McNeil Vs Mylan & Famycare (Product may be “Ortho Tri-Cyclen”) filed on November 12, 2010; Famycare and Mylan have tie up for USA contraceptive market;  As per thier agreement two companies will jointly file ANDA for approval of at least 22 new oral contraceptives with the US FDA (Link).

For these two litigation will be updated soon with patent details

CI & Patent News: 24/11/2010

1) GlaxoSmithKline and Dr. Reddy’s Agree to the Sale of US Penicillin Facility and Products (Link)

… Under the agreement, GSK will transfer ownership of its penicillin manufacturing site in Bristol, Tennessee, United States, and rights for the Augmentin® and Amoxil® brands in the United States to Dr. Reddy’s. GSK will retain the existing rights for these brands outside the United States …

2) Lilly’s Testosterone Lotion (Axiron) receive FDA Approval to treat certain conditions associated with a deficiency or absence of testosterone in men (Link). Axiron lotion (testosterone) is developed by an Australian company (Acrux).

… Acrux will receive a payment of $87 million from Lilly, which bought the rights to the drug in March. The Australian company will get royalties and further payments of as much as $195 million from Lilly…

3) Biocon to strengthen its market presence of Orlistat after ban on sibutramine (Pharma Biz)

4) SIRS-Lab and Pfizer to Collaborate in the Field of Sepsis (Business wire)

 

6) Abbott-Solvay merger plan gets board nod (Business Standard)

CRCT & Schering has sued Accord Healthcare Temodar

Cancer Research Technology Limited & Schering has sued Accord Healthcare on US Patent 5260291. Product: Temodar Capsule (Temozolomide).

Note: Teva is the first to file ANDA holder. In the Paragraph litigation district court had held ‘291 patent invalid due to prosecution latches and inequitable conduct. Schering appealed this decision and CAFC had reversed the district court finding on prosecution latches and inequitable conduct. Meanwhile , Teva entered settlement with Schering as Teva will not commence marketing generic version till Federal court decision and Teva will commence marketing generic version after expiry of ‘291 Aug 2013, but before expiry of Pediatric exclusivity.

Now after Federal court decision upholding ‘291 patent validity, Schering has sued Accord healthcare the subsequent ANDA filler for Temodar.