Monday, August 30, 2010
Saturday, August 21, 2010
- Prior publication
- Lack of inventiveness
- Not invention u/s 3(d)
- Lack of enablement
- Failure to disclose information u/s 8
Friday, August 20, 2010
Wednesday, June 02, 2010
Tuesday, April 20, 2010
Saturday, April 03, 2010
Lately Cipla sold its money-spinning contraceptive brand product “i-pill” to Piramal Healthcare for INR. 95 crores. I-pill is an emergency contraceptive pill containing 1.5mg of Levonorgestrel which was launched by Cipla in the Indian market, followed by another Indian pharma company Mankind under the brand name Unwanted 72. In past, the Government of India criticized and banned airing of i-pill advertisements on television due to irresponsible advertising.
In Europe, 1.5mg Levonorgestrel is marketed as Postinor-1 by Hungarian company Gedeon Richter which holds patent protection for 1.5mg dose of Levonorgestrel as claimed by EP-B1-1.448.207. Bayer and HRA Pharma are two other companies marketing 1.5mg Levonorgestrel in the
As far as my understanding of patent law is concerned, a patent right excludes third party including the Government from the act using, manufacturing or selling the patented product without the permission of patentee. However, the Government may still manufacture or use the patented product under the Government-use exemption. Ironically in India, the Government’s own agency is involved in issuing licenses to third party to manufacture and sell the patented drugs that clearly contravenes the spirit of patent right (obviously allowing third party to manufacture and sell patented drugs from commercial use do not fall within the Government-use exemption) but still Indian judiciary is finding hard to understand that such act of granting licenses to manufacture and sell patented drug constitute violation of patent right under section 47 of the Patents Act, 1970.
Monday, March 15, 2010
Diachii-owned Ranbaxy has lately entered into a settlement agreement with the Japanese drug manufacturer Takeda Pharmaceuticals to end patent lawsuit for anti-diabetic drug Actos, generically known as Pioglitazone Hydrochloride. Under the terms of the agreement, Ranbaxy received non-exclusive royalty free license to Takeda’s patents covering Actos and will be able to launch the generic version in the
Sunday, March 14, 2010
Teva has lately filed civil actions against the generic manufacturers Mylan and Mumbai-based Famy Care Limited for infringement of US Pat No. 7,320,969 and 7,615,545 listed with the
Friday, March 05, 2010
Often strategic business moves are played within the closed walls of the Management Boardroom that can even take market analysts with surprise. Lately, Ranbaxy failed to launch its generic version of Flomax which was expected to go on sales in the
Flomax is marketed by Boehringer Ingelhiem in the
Now the question is when Astellas/Boehringer already entered into a settlement deal to allow FTF generic company Ranbaxy to launch its generic Flomax on March 02, 2010 knowing that the Ranbaxy also entitled to 180-day market exclusivity then how Astellas/Boehringer made similar sort of agreement with Impax to allow its generic Flomax launch on March 02, 2010? Does Ranbaxy which received tentative approval for its generic Flomax more than two-and-half years back (June 2007) seriously failed to obtain regulatory clearance despite settling patent dispute back in November 2007 with clear idea of launch date? Or does Ranbaxy made some strategic deal to allow Impax to launch its generic version on March 02, 2010? If yes, then with whom --- Astellas/Boehringer or Impax? Interestingly, a news piece by Livemint.com is suggesting that Ranbaxy may likely to receive one-time payment for enabling the launch of generic version in the
Tuesday, February 09, 2010
Manish Rajan of livemint.com reported that the Delhi High Court on Monday dismissed the petition filed by Global Biopharma major UCB Frachim against the Indian generic major Cipla and the Indian Patent Office over rejection of its patent for a new anti-allergic drug. In its petition, UCB requested the Court to quash the order passed by the Controller General of Patents on July 24, 2009 rejecting its claims. The High Court directed UCB Farchim to file its appeal before the Intellectual Property Appellate Board instead of a High Court. However, still we are not sure which drug and patent application is subject of dispute. Even the Indian Patent Office does not have the Controller decision uploaded on the IPIRS database.
Thursday, January 21, 2010
Indian pharma companies started New Year with at least two patent infringement lawsuits filed against them in the
Second case was filed on January 13 by Takeda Pharmaceutical against Hyderabad-based generic manufacturer Aurobindo Pharma Limited (Takeda Pharmaceutical Company Limited et al v. Aurobindo Pharma Limited, New York Southern District Court, Case # 1:2010cv00247). However, we are not sure about the drug product for which patent infringement suit is filed. Readers any information on this.
Wednesday, January 20, 2010
Press Trust of India (PTI) reported that Global Biopharma major UCB Farchim yesterday approached the Delhi High Court against the Indian generic manufacturer Cipla and the Indian Patent office over rejection of its patent for a new anti-allergic drug. In its petition, UCB requested the court to quash the order passed by the Controller General of Patents on July 24, 2009, rejecting its claims. Admitting the petition, Justice S Murlidhar posted the matter for hearing on January 28, 2010. Indian Patent Office rejected UCB’s claim on the grounds of lack of inventive steps. In the process of rejection, Cipla filed a pre-grant opposition on December 04, 2008. However, news report does not mentioned information about drug name or the patent application number. Even a quick search at the official website of Indian Patent Office does not reveal any Controller’s decision for any UCB patent application. We will appreciate if any of our reader can bring more clarity over the drug and patent number in issue.
Pfizer Inc. has filed a civil suit against the generic drug manufacturer Teva Pharmaceutical Industries Ltd. for infringement of US patent for antibiotic drug Zyvox. The lawsuit was filed on January 15 in the US District Court, District of Delaware in response to Teva’s submission of an abbreviated new drug application (ANDA) with the US Food and Drug Administration seeking approval to market a generic version of Zyvox before the expiration of
Last month, Pfizer Inc. sued Hyderabad-based Dr. Reddy’s Laboratories Ltd. for infringement of US Patent No. 5,969,156 (protecting crystalline form of atorvastatin calcium) for anti-cholesterol drug Lipitor. The lawsuit was filed on December 08 in the same district court following Dr. Reddy’s filing of an abbreviated new drug application (ANDA), seeking approval to market a generic version of Lipitor before the expiration of OB listed patents for Lipitor (Pfizer Inc. et al v. Dr. Reddy's Laboratories Ltd. et al, US District Court, District of Delaware, Case No. 1:2009cv00943).
Friday, January 15, 2010
Last year, the Indian Patent Office (IPO) reported filing of eight (8) post-grant opposition applications under section 25 (2) of the Patents Act, 1970. The post-grant opposition can be filed against any granted Indian patent within twelve (12) months from the date of publication of grant. List of patents that are opposed under section 25 (2) in 2009 are:
(1) IN214103: Torrent Pharmaceuticals Limited filed opposition on January 30, 2009 against Sankyo/UBE Industries Limited’s Indian Patent No. 214103 protecting pharmaceutical compositions containing Prasugrel and Aspirin for prevention of diseases caused by thrombus or embolus. Prasugrel, marketed as Efient by Eli Lilly is a novel platelet inhibitor approved for use with acetylsalicylic acid (aspirin) for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS).
(2) IN221171: Cipla Limited filed opposition on February 16, 2009 against Glaxo’s Indian Patent No. 221171 covering Ditosylate salt of anti-cancer drug compound Lapatinib. Lapatinib Ditosylate is active ingredient of Tykerb approved for the combination therapy for breast cancer patients already using capecitabine.
(3) IN220257: Enercon (
(4) IN216080: Cipla Limited filed opposition on March 06, 2009 against Ivax’s Indian Patent No. 216080 protecting Budesonide and Formoterol combination HFA aerosol formulation.
(5) IN217464: Emcure Pharmaceuticals limited filed opposition on March 27, 2009 against Eli Lilly’s Indian Patent No. 217464 protecting Olanzapine lyophilized product for parenteral administration.
(6) IN221113: Enercon (
(7) IN221017: Cipla Limited filed opposition on April 08, 2009 against Glaxo’s Indian Patent No. 221017 protecting anti-cancer drug molecule Lapatinib. This is the second opposition filed against Glaxo’s Lapatinib product by Cipla.
(8) IN220287: Ranbaxy Laboratories Limited filed opposition on May 21, 2009 against Eli Lilly’s Indian Patent No. 220287 protecting Olanzapine pamoate salts and formulations thereof.
Monday, January 11, 2010
This year at least 20 odd drug molecules will be going off-patent in the United States including (1) Merck’s anti-hypertension molecule Losartan, active ingredient of Cozaar and Hyzaar franchise, (2) Eisai’s anti-dementia molecule Donepezil, active ingredient of Aricept and Aricept ODT (3) Sanofi-Aventis’s anti-cancer molecule Docetaxel, active ingredient of Taxotere franchise, (4) Pfizer’s Latanoprost, active ingredient of Xalatan franchise, (5) Glaxo’s anti-viral molecule Lamivudine, active ingredient of Trizivir, Epivir and Combivir franchise, (6) AstraZeneca’s anti-cancer molecule Anastrozole, active ingredient of Arimidex franchise, (7) Boehringer’s anti-depressant molecule Pramipexole, active ingredient of Mirapex franchise and (8) Eli Lilly’s anti-cancer molecule Gemcitabine, active ingredient of Gemzar franchise. Novartis and Roche too are losing patent protection for their anti-viral molecule Penciclovir and antiretroviral molecule Saquinavir respectively. Other molecules losing patent protection include Cidofovir (Gilead), Imiquimod (Graceway), Naratriptan (GlaxoSmithKline), Zafirlukast (AstraZeneca), Zileuton (Critical), Topotecan (GlaxoSmithKline), Butenafine (Mylan), Adapalene (Galderma), Eprosartan (Abbott) and Tiludronate (Sanofi-Aventis).
Friday, January 08, 2010
The Chennai Patent Office lately published Indian Patent No. 237430 issued to Novartis for anti-cancer drug Nilotinib, globally marketed as Tasigna. In October 2007, the United States FDA approved Nilotinib for chronic myelogenous leukaemia (CML) second-line therapy for patients who are resistant or tolerant to Imatinib Mesylate (marketed as Gleevac). The patent is granted against the mail-box Application No. 3003/CHENP/2004 claiming priority from British Application Nos. 0215676.8 and 0229893.3. We reported about Nilotinib pending patent application in early 2008 (read here). In July 2008, we also reported an advertisement by leading generic manufacturer Cipla announcing introduction of new drugs that likely included Nilotinib generic version (read here). Nilotinib belongs to the class of tyrosine kinase inhibitors. Other tyrosine kinase inhibitors that are granted patents in
Google added yet another patent in its advertising business method patent portfolio in
236879 Determining and/or using local location information in an ad system
236106 Method and apparatus for facilitating the serving of ads having different characteristics
235451 Improving advertisement approval
230673 A method of using concepts for ad targeting
227221 Serving advertisements using a search of advertiser web information
226617 A method of serving one or more ads to a user device and an apparatus thereof
225041 Method of determining relevant advertisements
224942 An apparatus for delivering advertising
223351 Serving advertisements using information associated with e-mail
222680 A method of serving advertisements based on content
220065 Methods and apparatus for serving relevant advertisement
219140 A method and apparatus for serving content relevant advertisement with client side device support
208446 A computerized advertisement distribution and delivery system
Following feedback from the United States FDA for additional clinical data, the French drug marker Sanofi-Aventis lately withdrawn both US and EU marketing authorization applications for insomnia drug Eplivanserin (protected by the US Patent No. 5166416). Sanofi, which over the years occupied a major share in the branded insomnia market by its Ambien Franchise, was counting high on Eplivanserin, the drug that was likely to be the first drug in the class of serotonin receptor to reach the market, particularly following Sanofi’s discontinuation of another insomnia drug Volinanserin (protected by European Patent Nos. 0.208.235 and 0.531.410) in early 2009. Other serotonin receptors that are still running under development in different clinical phases are Pruvanserin (disclosed in WO01007435) by Eli Lilly and Pimavanserin (disclosed in WO0166521) by Acadia Pharmaceuticals.
Thursday, January 07, 2010
Cephalon Inc. has filed a civil suit for patent infringement against the generic drugmaker Watson Pharmaceuticals Inc. for its analeptic drug Nuvigil, generically known as Armodafinil. The suit filed on Tuesday (January 05, 2009) in the US District Court for the District of Delaware is to prevent Watson from commercializing the generic Vuvigil product prior to the expiration of Orange-Book listed US Patent No. 7,132,570. Approved by the United States FDA in June 2007, Vuvigil total US sales is approximately USD 42 million for the twelve months ending September 30, 2009 according to IMS Health data. Watson is believed to be “First-to-File” applicant for the 100mg and 200mg strengths of a generic Nuvigil and may be entitled to 180 days of market exclusivity for those strengths. Notably, both 100mg and 200mg strengths got the United States FDA approval on March 26, 2009 almost 21 months later than 50mg, 150mg and 250mg strengths.
Nuvigil’s active ingredient, Armodafinil, is (-)-(R) enantiomer of the racemic drug modafinil also marketed by Cephalon under the brand name Provigil. Provigil is likely to face generics from 2012 and it is considered that Cephalon is looking to protect its sales by switching patients to Nuvigil. Already the generic competition for Nuvigil is getting intense. Earlier in December 2009, Cephalon filed similar suits in the US District for the District of Delaware against three generic manufactures, namely, Teva Pharmaceuticals Inc., Mylan, Inc. and Actavis Inc. for infringement of