An act to streamline, harmonize US patent law

On September 16, 2011, the US President Barack Obama signed the Leahy-Smith America Invents Act – enacting it into law that is widely perceived as a reform to foster innovation and stimulate US economic growth by streamlining, harmonizing the US patent process. The new law will speed up the patent process that will help applicants and entrepreneurs bringing their inventions to market sooner, creating jobs and new business avenues. This reform is proposed to give a boost to American companies and inventors who suffered costly delays and unnecessary litigation, and to focus instead on innovation and job creation.

The new law have several effective dates for various provisions, some changes coming in effect immediately whereas other changes will not be implemented until 2012 and 2013. Some of the key highlights of American Invents Act include:

Section 3

First Inventor to File

Amends 35 USC § 100 to reform the US patent system by adopting a first-to-file system instead of a first-to-invent system, bringing the US in conformity with the rest of the world in determining priority of invention based on the earliest date a patent application was filed with a patent office. There is a limited one-year grace period related to public disclosures made by the inventor. 

Derivative proceedings

Amends 35 USC § 135 to replace interference proceedings with “derivative proceedings” to determine whether an inventor of first-filed patent application derived the claimed subject matter without authorization from an invention named in a later filed application. This reform will eliminate long-standing interference proceedings. A petition for derivative proceeding will only be allowed if it is filed within a limited one-year period beginning on the date of the first publication of a claim in the earlier filed application. 

Conditions for patentability; novelty

Amends 35 USC § 102 to redefine the scope of prior art as anything patented, published, on sale, or in public use before filing, or any patent application filed by another before the effective filing date of the claimed invention. This reform will now broaden the scope of on-sale or public use outside the US, bringing the US in conformity with practice of other jurisdictions such as EU and India. This reform will now allow US examiners to take into account traditional/indigenous knowledge whether in written or oral form as prior art in determining novelty of the invention. 

Conditions for patentability; non-obvious subject matter

Amends 35 USC § 103 to consider obviousness as of the effective filing date of the claimed subject-matter rather than at the time invention was made. 

Amendments made to section 3 will come in effect 18 months after the date of enactment, i.e. March 16, 2013. 

Section 4

Inventor’s oath or declaration

Amends 35 USC § 115 to permit applicants to make a “substitute statement” instead of an inventor’s oath when an inventor is deceased, under legal incapacity, or cannot be found or reached after diligent effort. 

Filing by other than inventor

Amends 35 USC § 118 to allow applicants to file the application for patent when inventors has assigned or are under the obligation to assign the invention, bringing the US in conformity with the rest of the world in permitting applicants to directly file patent application on behalf of inventors. 

Amendments made to section 4 will come in effect 1 year after the date of enactment, i.e. September 16, 2012. 

Section 5

Defense to infringement based on prior commercial use

Amends 35 USC § 273 to expand “the prior user” defense to infringement to all patents rather than restricting only to business method patents. The prior user have the burden of showing a prior use of the claimed invention more than a year before the priority date of the claimed invention. Even if a prior use is kept confidential it will be a valid defense to infringement. The prior use defense is not available in case where the invention was owned by or under obligation of assignment to a university or technology transfer organization at the time invention was made.

Amendments made to section 5 are in effect immediately. 

Nexavar: Compulsory license will severely impact global pharma companies

In what can be described as a major concern for the global pharma companies, Hyderabad-based Natco Pharma has triggered statutory compulsory licensing provision under S. 84 of the Patents Act, 1970 to manufacture and sell a generic version of Bayer’s patented anti-cancer drug Nexavar, generically sorafenib tosylate. This development came after Bayer refused Natco’s plea to grant voluntary license in December 2010. In its application for compulsory license, Natco mainly relied upon on the issue of pricing. Natco is reported to have said that it can sell generic version at INR 8900 for a month dosage compared to INR 285000 charged by Bayer. The Controller will now review the application of its merit and proceed as per procedures laid down in the Act but a favourable decision for Natco will certainly open the floodgates for other drug manufacturers to apply for compulsory licenses for most of the patented drugs in India.

Nexavar Patent

Sorafenib, active ingredient of anticancer drug Nexavar belonging to the class of tyrosine kinase inhibitors and has been granted Indian Patent No. 215758. There had been no pre-grant oppositions filed against Nexavar patent application and grant of patent was published on March 28, 2008 whereas one year window period for post-grant opposition ended on March 28, 2009. Sorafenib received marketing approval in India on July 31, 2007 and for additional hepatocellular carenoma indication on January 01, 2008.

Compulsory License

In India, a third party can apply for compulsory license with respect to a patented invention on either of the grounds:

1. reasonable requirements of public remain unmet/unsatisfied
2. not available at reasonable price
3. not worked within the territory of India

However, compulsory license can only be triggered after the expiration of three (3) years from the date of grant of patent. Natco’s application mainly relied upon on the issue of reasonable pricing.

Ongoing Litigation/Opposition

In 2008, Bayer filed an appeal in the Delhi High Court to restrain Drug Controller General of India (DCGI) from marketing approval to Cipla’s generic version of Nexavar. Cipla subsequently filed a post-grant opposition against the grant of Nexavar patent which is currently pending. The appeal was rejected by the High Court¹ which allowed Cipla to receive marketing approval and launch its generic version at risk. In March 2010, Bayer filed another lawsuit in the Delhi High Court for infringement of Nexavar patent against Cipla² which is currently pending. In May 2011, Bayer also filed an infringement lawsuit against Natco³ though Natco has not yet launched its generic version in market and has instead triggered compulsory license option.

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¹ Bayer Corporation & Anr vs. Union of India & Ors, LPA-443/2009 (link)

² Bayer Corporation & Anr. Vs. Cipla Ltd., CS (OS) 523/2010 (link)

³ Bayer Corporation & Anr vs. Natco Pharma Limited, CS (OS) 1090/2011 (link)

Writ petition questioning competence of IPAB

Economic Times lately reported that a group of patent lawyers under the aegis of a newly formed public interest group, Promoting Public Interest Lawyering (P-PIL) have filed a writ petition challenging the legality of the Intellectual Property Appellate Broad (IPAB) saying the members are incompetent to hear IP cases. The patent lawyers have requested the Madras High Court to prevent IPAB from adjudicating any cases pending the disposal of the petition. Shamnad Basheer prompted P-PIL for the purpose of using the law and legal instruments for public interest causes. It is indeed a welcome move and must congratulate Shamnad for making such much-needed initiative.

In fact, it is not only IPAB whose competence is questionable but also many patent examiners (mostly promoted to Assistant Controller level) lack technical expertise and common sense to examine the applications. Particularly examiners handling pharma applications not only lacking technical nuances of pharmaceutical science but at the same time applying inventive-step in such a manner that they themselves worked in R&D for at least 20-30 years. In the patent law, non-obviousness is judged by considering working knowledge of a person ordinarily skilled in the art. Such ordinary skilled person is usually considered to have average technical level in the field of the invention but in India, the level of a person ordinarily skilled in the art has exceed average and is not less than a scientific genius/veteran with considerably strong experience in drug discovery and pharmaceutical development. In most of the orders (u/s 15) and opposition decisions related to pharmaceutical, new drug compounds and formulations are made look so easy and obvious that it seems to be that drug discovery is nothing complex and obvious to even first year pharmacy student or day-to-day practiced by scientists/pharmacists working in India. But in reality the situation is so miserable that it is impossible for our so-called person ordinary skilled in the art to develop anything until and unless the source of copying is not provided. Corruption and incompetence has become pretty common in the government agencies.

Patent Office continue refusing pharmaceutical formulations under S.3 (d) and (e)

The Delhi Patent Office lately refused the Application Number 4015/DELNP/2006 filed by Warner Lambert claiming topical formulation of Pfizer’s potential potassium channel opener UK-157147 for the treatment of alopecia, which got discontinued in phase II trials. The Application got refused on the grounds of lack of inventive step and not patentable under S.3 (d) and (e). During the prosecution, Warner tried to substantiate the inventive step in terms of selection of UK-157147 from thousands of potassium channel openers disclosed in the closest prior art document. Warner also argued that the closest prior art document generically suggested that potassium channel openers can be delivered orally, by inhalation, rectally, or topically, and also list twenty different diseases that may be treated which included male pattern baldness. The Controller found Warner’s argument unconvincing and held that the prior art document disclose all elements of the claims at issue and hence lack inventive step under S.2 (1) (j). It is bit harsh that a broad, presumptive generic disclosure will make the claims obvious. 

Over S.3 (d) and (e) objections, Warner argued that the claims relate to pharmaceutical formulation and is neither a mere new form of a known substance under S.3 (d) nor a mere admixture under S.3 (e). The independent claim at issue, as amended during the prosecution, recites topical formulation containing UK-157147 with inactive ingredients propylene glycol and ethanol. In his order, the Controller held that formulation is merely a new form of the known substance which is not patentable under S.3 (d). He further equated using inactive excipients with active agent with mere combination that needs efficacy data under S.3 (d). It is unfair to equate use of excipients in formulations and compositions with mere combination. 

The Controller further held that the claims fail to prove the enhanced efficacy against the combined efficacy of the individual component of the formulation and hence claimed formulation is a mere admixture of UK-157147 and excipients which fall under S.3 (e). Firstly, this is absolute ridiculous that enhanced efficacy is quoted under S.3 (e) when there is no such requirement mandated by S.3 (e). Secondly, the pharmaceutical formulation is not a mere admixture where components used have additive effect, it is always the synergistic effect of components (active and inactive ingredients) which results in proper delivery and therapeutic effect of active agent. There is no doubt that in absence of proper guidelines, S.3 (d) and (e) are often and erroneously applied against pharmaceutical formulations, drug delivery systems and compositions.

Application for dabigatran polymorphic form II refused under S.15

The Delhi Patent Office lately refused the Application Number 924/DELNP/2006 filed by Boehringer Ingelheim claiming polymorphic form II of anticoagulant drug dabigatran etexilate mesylate, marketed under the brand name Pradaxa. The Application was refused on the grounds of lack of inventive step and not patentable under S.3 (d). During the prosecution, Boehringer tried to substantiate the inventive step in terms of better solubility resulting into higher bioavailability and argued that none of the cited prior art documents provide any hint that mesylate salt have better solubility and exists in different polymorphic modifications. The Patent Office was of opinion that Boehringer’s argument of higher bioavailability lack experimental and comparative data. In its post hearing reply, Boehringer argued to substantiate and validate that bioavailability translates in enhanced efficacy a clinical trial in human beings would be required and for which regulatory approval is needed. Boehringer argued that such a regulatory permission just for the sake of complying efficacy requirement under S.3 (d) would hardly be granted.

Patent for anti-hypertension combination drug Valturna revoked

The Indian Patent Office lately revoked the Patent Number IN212199 issued to Novartis claiming single-pill combination of aliskiren and valsartan marketed as Valturna. The patent was revoked after Novartis failed to overcome the post-grant opposition filed by Sun Pharmaceuticals Ltd. The decision is yet another case where combination claim was found lacking inventive step on the ground of ‘obvious-to-try’. Interestingly, one of the grounds of revocation was lack of enablement and best method requirements as none of the examples exemplified the combination of aliskiren and valsartan. More interestingly, another ground of revocation was lack of sufficiency of disclosure as one of the dependent claims used the generic name ‘aliskiren’ but the whole specification disclosure nowhere used the generic name. Complete review of the decision can be read here.

Application for telavancin hydrochloride refused under S.15

The Delhi Patent Office lately refused the Application Number 1770/DELNP/2006 filed by Theravnce, Inc. claiming hydrochloride salt of antibacterial drug Telavancin. The Application was refused on the grounds of lack of novelty and inventive step and not patentable under S.3 (d). Complete review of the order can be read here.

Application for contraceptive drug Yasmin refused in pre-grant opposition

The Chennai Patent Office lately refused the Application No. IN/PCT/2002/410/CHE filed by Bayer Schering Pharma, AG claiming contraceptive formulation of drospirenone and ethinylestradiol (EE) marketed as Yasmin and Yaz/Yasminelle in Europe and the US. The Application was refused after Bayer failed to overcome the pre-grant oppositions filed against the Application by generic manufacturers Cipla Ltd. and Natco Pharma Ltd. The decision was more or less influenced by the District Court and the CAFC decisions in Bayer Schering Pharma AG v. Barr Laboratories, Inc. which held US6787531 obvious and invalid. The Application is equivalent of the ’531 patent. The decision seems to be silent affirmation to KSR “obvious-to-try” test that may have far reaching impact on Indian patent practice. Complete review of the decision can be read here.

NCEs Outside the Scope of Sec. 3(d), Efficacy Data not Required - II

Continued from our last post where we briefly discussed about the rejection of pre-grant opposition filed by Cipla for the Application Number 3003/CHENP/2004 for anti-cancer drug Nilotinib which later matured into issued Patent Number 237430. The opposition proceedings was fought on the grounds of lack of (1) inventiveness u/s 25(1)(e) and (2) enablement u/s 25(1)(g).

Interestingly during the opposition proceedings Cipla argued against the narrowing of claims which the Controller clearly opined that narrowing of claims are well permissible within the patent law. Cipla also relied on two documents (one of which suggested that polymorphic form B of nilotinib was used for further drug development) published well after the filing date of the Application to contest the utility of the Nilotinib which the Controller rightly rejected from considering to decide the patentability of the Application.

Here again Cipla tried to take the Chennai Patent Office for a ride the way it took the Delhi High Court in infamous Tarceva patent litigation where it convinced the learned Judge that Cipla’s generic Tarceva tablets contain polymorphic form of Erlotinib whereas the patent issued to Roche protects Erlotinib per se and hence non-infringing. Now here Cipla went the opposite way arguing that when the Nilotinib drug development contains polymorphic form B (disclosed in pending Application Number 9925/DELNP/2007 for which pre-grant opposition decision is pending) then patent should not be issued to Nilotinib per se. In other words, if the marketed drug contains polymorphic form of active ingredient then patent should not be granted to active ingredient per se. However, the Chennai Patent Office rightly applied its reasoning rather getting carried away by Cipla’s arguments. 

To be continued…

NCEs Outside the Scope of Sec. 3(d), Efficacy Data not Required - I

Patent Circle earlier posted the issuance of Indian Patent Number 237430 to Novartis against the Application Number 3003/CHENP/2004 for anticancer drug Nilotinib, globally marketed as Tasigna. Like Imatinib and Erlotinib, Nilotinib too belongs to the class of tyrosin kinase inhibitors which is extensively discussed on our blog (read here, here and here). Notably, the Application for Nilotinib before maturing into an issued patent overcame a pre-grant opposition brought by Cipla. The opposition filed at the Chennai Patent Office is one of the well-reasoned and matured decisions (till date) ruled by the Indian Patent Office which is worth discussing here.

The opposition was filed on February 16, 2009 and hearing was held on September 15, 2009. Cipla opposed the Application on the grounds of.

1. Prior publication
   
2. Lack of inventiveness
   
3. Not invention u/s 3(d)
   
4. Lack of enablement
   
5. Failure to disclose information u/s 8
   

However, during the opposition proceedings Cipla dropped most of the grounds and focused on (1) lack of inventiveness u/s 25 (1) (e) and (2) lack of enablement u/s 25 (1) (g). Cipla argued that the use of nilotinib to treat imatinib resistant patients was not disclosed in the specification and was suppressed by or not known to the Applicant at the time of filing the Application. In response, the Applicant argued that the Application is not directed to salts or polymorphs but is directed to New Chemical Entity (NCE) and further argued that the invention is not improving the efficacy of the known compounds but relates to new compounds. Responding to Cipla’s argument, the Asst. Controlled Dr. S.P. Subramaniyan opined that the technical details and use of present invention is clearly described in the specification in accordance with Sec. 10(4) of the Act. He further added that efficacy data is required where substance of any claimed invention falls within the scope of Sec. 3(d) but the present invention is related to New Chemical Entity (NCE) and therefore efficacy data are not required for NCEs.

Patent Circle unquestionably agrees with the reasoning of the Asst. Controller that the NCEs fall outside the scope of Sec. 3(d) and does not require efficacy data to qualify for patent protection within the Indian patent law but the problem lies in Sec. 3(d) itself. In absence of proper guidelines and technical explanation, Sec. 3(d) time and again is used against the NCEs in the shadow of ‘other derivatives of known substance’ used in explanation part of Sec. 3(d). Now can anybody explain that in hardcore synthetic chemistry are there any compounds which are not derivative of known substance (structure)? Even a chemistry graduate can acknowledge the fact that every synthetic compound, whether old or new, are derived from one or the other known substances. In fact, in the drug discovery process the selection of ‘lead’ substance also starts from known substances (not necessarily marketed drug substances). Does that mean identifying a potent drug substance (NCE) from thousands or millions of compounds make NCE a mere derivative and put it in Sec. 3(d) test?

If drug discovery and NCE identification would have been so easy (the way it is portrayed in pre-grant and post-grant oppositions) then one out of every fifth Indian pharma company would have already rolled out their own new drug candidates. Frankly, a country which is still waiting to witness its first indigenous drug candidate to hit the market should not make a patent law that makes drug discovery or NCE identification look like child's play for a person skilled in the art. I wonder does the case of ERLOTINIB and GEFITINIB similar to the case of AMLODIPINE and (Z)-4-[(2-{[4-(2-chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4-dihydro-2-pyridinyl]methoxy} ethyl)amino]-4-oxo-2-butenoic acid (AMLODIPINE AMIDE DERIVATIVE) as disclosed in US Patent Number 6,602,893? Are both these cases fall within the scope of derivative? If yes then what is the threshold limit to distinguish NCEs from the derivatives covered in Sec. 3(d)? Obviously one cannot expect the Indian Courts to distinguish NCEs from derivatives especially when they failed to understand even a simple concept that polymorph cannot circumvent compound patent. There is no doubt that the word ‘derivative’ is loosely used in Sec. 3(d) without giving a proper thought about its meaning and scope, which now need explanation about its scope and threshold limit. In fact, the MNCs lately met and asked PMO officials to review and clarify the scope of Sec. 3(d).

To be continued... 

Cipla knocks down key patent blocking i-pill

In another post-grant opposition decided earlier this month, the Mumbai Patent Office revoked Indian Patent Number 202297 issued to Richter Gedon protecting emergency contraceptive pill containing 1.5mg Levonorgestrel, the active ingredient of Cipla’s money spinner i-pill (recently sold to Piramal Healthcare) and Mankind’s Unwanted 72. The ‘297 patent was issued against the Indian Patent Application Number 1119/MUMNP/2003 filed on December 09, 2003. The post-grant opposition was filed by Cipla on February 05, 2008 and hearing was fixed on May 03, 2010. During the hearing, Cipla contested the novelty, prior public use, lack of inventive step, section 3(d), section 3 (e), enablement requirement and failure to disclosed information u/s section 8. The Controller found Cipla’s arguments regarding novelty, lack of inventive step, section 3(d) and section persuasive and subsequently ordered revocation of the ‘297 patent. The ‘297 patent is one of the two patents protecting 1.5mg Levonorgestrel, other is IN206098 issued against the Application Number 75/MUMNP/2004.

Novartis loses DULERA patent in India

Earlier this month, the Swiss Multinational Novartis lost DULERA post-grant opposition to Mumbai-based Cipla as the Chennai Patent Office revoked Indian Patent Number 202350 on the ground of obviousness/lack of inventive step. The ‘350 patent protecting FORMOTEROL FUMARATE and MOMETASONE FUROATE inhalation aerosol combination, the active ingredients of lately approved fixed-dose combination asthma drug DULERA (marketed by Merck) was issued against the Indian Patent Application Number IN/PCT/01/1168/CHE filed on August 20, 2001. The post-grant opposition was filed on February 04, 2008 and hearing was made on July 07, 2010. During the hearing, Cipla argued that the ‘350 patent lacked inventive step as the combination of bronchodilators and steroids for the treatment of an inflammatory or obstructive airways disease are well taught in the art and obvious to a person skilled in the art. Interestingly, the similar combination (having different dose quantity than that of DULERA) was approved in India on December 30, 2009.

APJ Abdul Kalam Speaks

One of the finest scientists India ever produced – APJ Abdul Kalam urges Indian scientists to become pioneers in innovation and technology in his recent speech at the Tata Institute of Fundamental Research. He categorically stressed that India’s present growth has been achieved based on patents generated elsewhere sometime ago as well as innovations and technology developed elsewhere. He also emphasized the need for green energy (read here). PatentCircle whole-heartedly welcomes and appreciates Dr. Kalam views, at least there are people in India who do understand the value of innovation and need to move on from copying to research. We are not sure for how long our country will afford to stay in shades of copying when other Asian countries (China, Taiwan and Korea) aggressively continue to foster in innovation and technology and back here in our country, we continue to discuss the same age old issues of religion, reservation, caste, poverty and corruption. In India, we have objections regarding patents in pharmaceuticals and software because of the vested business interests of Indian companies associated with blatant copying of drugs and software but when it comes to patents in green energy, nanotechnology and stem cell development we have no issues because we have no vested business interests (and possibly no expertise and know-how) as of now to copy them. It is quite unfortunate that despite we have so much potential and caliber to fuel innovation and technology development in India but because of our government ill policies and governance we are contributing far below to our par. India has tremendous potential to become IP and innovation capital of the world but thanks to our copying business industry that we are not able to match our own potential even after 60 years of independence.

Novartis Sues Macleods Over Famciclovir Patent

Novartis has lately filed a civil lawsuit against the Mumbai-based generic manufacturer Macleods Pharmaceuticals Limited for infringement of US Patent No. 5,866,581 listed with the Orange Book for Famvir tablets, generically Famciclovir. The lawsuit is filed in the US District Court for the District of Columbia in response of Macleods submission to the FDA an abbreviated new drug application (ANDA) seeking approval to market generic Famciclovir 125mg, 250mg and 500mg tablets before the expiration of the ‘581 patent. With this development, Macleods is another Indian company that joined the league of Paragraph IV challengers from India.

Piramal acquired i-pill from Cipla

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 Europe as Levonelle One Step and NorLevo under license from Richter. In the United States, Gedeon Richter developed and manufactured 1.5mg Levonorgestrel tablet in partnership with Teva Pharmaceutical Industries Ltd. and currently marketed by Duramed Pharmaceuticals under the brand name Plan B One-Step. Gedeon currently has two pending US Application Nos. 20050032755 and 20050288264 for 1.5mg Levonorgestrel.

In India, Gedeon Richter holds two Indian Patent Nos. 206098 and 202297 covering 1.5mg dose of Levonorgestrel. Interestingly, Gedeon that aggressively licensed 1.5mg Levonorgestrel in various developed and developing markets including Canada and the US never initiated any legal proceedings against Cipla and Mankind for launching 1.5mg dose of Levonorgestrel in India. May be Gedeon had no faith in Indian patent system particularly after witnessing big pharma giants like Bristol-Myers, Bayer and Roche miserably failing to stop Cipla from launching generic copies of their patented drugs and enforcing their patent rights in India. Already it is slowly becoming well-known fact that Indian patent has no value, not even worth a paper on which it is issued – thanks to Indian judiciary which went on creating one after one biased and flawed precedents with respect to pharma patents.

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.

Ranbaxy settles with Takeda, is Japanese connection coming into picture?

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 US market on August 17, 2012. Interestingly, Ranbaxy seems to be getting business friendly with Japanese pharma companies, earlier it was Astellas for Flomax and now it is Takeda. No wonder if Japanese connection is coming into picture. Coming back to Actos, Takeda also signed similar sort of agreement with Watson to end patent lawsuits for Actos, allowing Watson to launch the generic version on August 17, 2012.

New Sources (1) the pharmaletter (2) the Economic Times

Para IV lawsuit against Mylan and Famy Care for OC pills

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 OB for oral contraceptive (OC) pills Seasonique and LoSeasonique respectively. Both Seasonique and LoSeasonique are combination of Ethinylestradiol (estrogen) and Levonorgestrel differing only in dose amount, designed for 91 days regimen cycle with 84 consecutive combination pill days followed by 7 consecutive Ethinylestradiol pill days. In past, Teva sued Watson and Lupin for both Seasonique and LoSeasonique, with Watson having the First-to-File (FTF) state for Seasonique but not very clear which generic applicant is having FTF status for LoSeasonique. The lawsuits are filed in the US District Court District of New Jersey.

Does Ranbaxy intentionally forfeited 180-day exclusivity for monetary benefit?

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 US market on March 02 with 180-day market exclusivity. Ranbaxy in its statement reasoned regulatory delay in obtaining final approval for its failure to launch generic Flomax.

Flomax is marketed by Boehringer Ingelhiem in the US and its active ingredient, tamsulosin hydrochloride is protected by the US Patent No. 4,703,063 issued to Astellas Pharma Inc. Ranbaxy had “First-to-File” status for generic version of Flomax, with Impax Laboratories in paragraph IV race. Ranbaxy got sued by Boehringer and Astellas for patent infringement but in November 2007 announced out-of-the-court settlement that allowed Ranbaxy to launch its generic Flomax on March 02, 2010 i.e., eight weeks ahead of the expiration date of ‘063 patent. Similarly, Impax got sued for patent infringement and in October 2009 announced out-of-the-court settlement with Boehringer and Astellas interestingly having similar sort of arrangement (as that of Ranbaxy) that allowed Impax to launch its generic Flomax on March 02, 2010.

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 US market, and also that Ranbaxy itself allowed Boehringer to bring in Impax for launching generic Flomax.

Delhi High Court directs UCB to approach IPAB

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.

Indian pharma starts 2010 with infringement lawsuits in the United States

Indian pharma companies started New Year with at least two patent infringement lawsuits filed against them in the United States. First case was filed on 6^th day of the year 2010 by Teva Women’s Health (Duramed) against Pune-based generic manufacturer Lupin Limited (Teva Women’s Health, Inc. v. Lupin Ltd. et al., District Court of New Jersey, Case # 2:2010cv00080). The case was filed in the District Court of New Jersey for infringement of US Pat. No. 7,615,545 lately listed with the Orange Book for newly approved ethinylestradiol and levonorgestrel combination oral contraceptive drug LoSeasonique.

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.