Mumbai High Court Ask Cipla to Reply in 2 Weeks

Mint has further reported that Justice Abhay Oka of Mumbai High Court has asked Cipla to reply in two weeks to the patent infringement suit filed by Swiss-major F Hoffmann-La-Roche over anti-infection drug Valganciclovir. The case is expected to come up for hearing in the third week of October. In parallel, Roche is also facing post-grant oppositions from Ranbaxy, Cipla and the Delhi Network of Positive People in the Chennai Patent Office. Though we are not able to go through the complete specification of Valganciclovir patent but according to reliable sources Roche’s patent has broadly issued claims which may likely invalidated on the grounds of obviousness (and possibly be challengeable under section 3(d) on the grounds of obvious variation of known compound ganciclovir).

Natco Withdraws Application for ‘Export’ Compulsory Licenses

Mint has reported that Natco requested Controller of Patents to withdraw its applications for compulsory licenses for export of generic anti-cancer drugs Sunitinib and Erlotinib, both patented in India. Earlier, Natco filed application for compulsory licenses of Erlotinib and Sunitinib to be exported to Nepal under section 92A of the Indian patent law. Though Natco’s move was unprecedented and shocked many but legal equations were never favorable for Natco because there was no official notification made by Nepal Government to allow importation of anti-cancer drugs from India (a litmus test for Indian Patent Office to evaluate compulsory license for export). Whatever may be the reasons for Natco to withdraw its application for compulsory license but what can be concluded from the whole episode that it was a bad patent-legal strategy yet was a good business strategy to keep Natco's script rolling on Bombay Stock Exchange?

Cipla Mocks Roche’s Patent for Valganciclovir

Mumbai-generic major Cipla has yet again made a mockery of Indian patent law by launching a generic version of Roche patented anti-infection drug Valganciclovir. This is the second instance of Cipla mocking Indian patent after it deliberately launched generic copy of Roche patented anti-cancer drug Erlotinib. Though we are not sure how much impact this will make on availability of drugs to Indian patients but surely it will deteriorate India’s image in global IP scenario. What is more pathetic is India’s legal state-of-affairs which is slowly becoming hand-puppet and regularly been twisted by politicians and strong businesses for their self-business interest. Politicians often used language and regionalism for their political gain but continue to ignore national interest and security for better growth and war against terrorism. Cipla too have mastered targeting high-pricing of innovators’ for their business interests but continue to ignore building healthcare infrastructure. Even after 60 years of independence only margin section of society have access to medicines with most even struggling for food and shelter. Post 1970 Indian generic companies including Cipla made phenomenal growth (in absence of patent protection for pharmaceutical drug products) to thousand crore plus company but still Indian healthcare scenario is struggling for better infrastructure. Over the years, Cipla has proudly publicized to provide cheap AIDS medicines to African countries when back here in India their own people are dying of common disease like tuberculosis, cholera and malaria. What can be more shameful when home grown pharma companies are more concern in exporting AIDS and cancer drugs rather than reaching to rural areas of India to provide medicines for common diseases which make more horror news than AIDS?

Drug Patent Expirations: 2009 – 2015

Patent Circle has compiled a list of more than 100 active pharmaceutical ingredients (APIs) going off-patent in the US from the year 2009 – 2015. At least 24 APIs will go off-patent in the year 2009 including Levetiracetam (more than USD 700 million US sales in 2007), Lamotrigine (USD 2.2 billion US sales for twelve months that ended March 2008), Sumatriptan (nearly USD 1 billion US sales in 2007), Valacyclovir (USD 1.3 billion US sales in 2007), Topiramate (USD 2.2 billion US sales for twelve months that ended March 2008) and Tamsulosin (USD 1.3 billion US sales for twelve months that ended September 2007). Moreover, two of the biggest blockbuster drugs Atorvastatin Calcium (USD 6 billion US sales in 2007) and Clopidogrel Bisulphate (USD 3 billion US sales in 2007) will finally reaching end of their patent protection in 2010 and 2011.

Undoubtedly, there is a big opportunity coming up for generic players with many drug compounds going off-patent in next 6 years and our list will keep generic players stay tuned with drug expiries. Readers may buy our report by writing to us at varun@ipfeathers.com. We are confident that our report will help to seize business opportunity in growing competitive generic space.

ANOTHER MILESTONE ACHEVIDED BY FICCI-DIPP CONSULTATIVE WORKING GROUP - PRE-GRANT OPPOSITION PROCESS SREAMLINED

This is further to the news item which appeared in the “The Hindu Business Line.” The non-uniformity in the practice being adopted by each patent office with regard to pre-grant opposition procedures is no more a worry for the opponents representing NGOs, Health care groups, industry, competitors, researchers and other stakeholders. As a result of the proposal made by FICCI-DIPP Consultative Working Group, the Controller General of Patents has issued administrative instructions to all patent offices in India to furnish a copy of the applicant’s reply to the opponent if he has made the request and has paid prescribed fee. This Order of the Controller General is timely and has come as a great sigh of relief for the stakeholders who were so far staggering under the weight of non-uniform practices. The problem underlying the procedural aspect are the uneven practices being followed by the officials at each patent office with regard to providing to the opponent an access to the patent applicant’s reply contesting pre-grant opposition. The reason behind this non-uniformity across and within the patent offices is that the Indian Patents Act is completely silent about this issue. FICCI and DIPP are working synergistically in bringing more consistency in the procedures being followed by the officials of patent office. For any further clarification on this matter you may contact Sheetal Chopra, Senior Assistant Director, FICCI-IPR Division at sheetal.chopra@ficci.com, 011-23766930.

UPCOMING FICCI-DIPP-WIPO Conference for Industry and Policy makers

Pls. note that Federation of Indian Chambers of Commerce and Industry (FICCI) in association with World Intellectual Property Organization (WIPO) and Department of Industrial Policy and Promotion (DIPP), Government of India is organizing a Conference on Development and Intellectual Property (IP): Building Synergies with Policy Makers and Industry at Taj Exotica, Goa from September 1 to 3, 2008. This conference is meant for Industry Leaders, IP professionals/Experts, Legal practitioner and Policy makers. It would be worth attending this conference in case you wish to know about the issues of concern to the Industry and about the steps Government is taking to address them; to get an international flavor of experiences with respect to IP laws and sectoral issues (such as pharmaceuticals, IT, etc.); to learn about the strategies and best practices being adopted by stakeholders in using IP as a business tool. This conference also aims to highlight the emerging issues in effective enforcement of IP issues & strategies/emerging technologies to combat the menace of counterfeiting and piracy. The details about the conference, participation fees, boarding & lodging in Goa have been provided in the attached Brochure. This is the tentative Programme copy and the registration form. For further information you can touch base with Sheetal Chopra (sheetal.chopra@ficci.com), Senior Assistant Director – FICCI IPR Division or P L Sharma (plsharma@ficci.com), Executive Assistant (Ph: 23738760-70 Extn. 212, Direct: 23736306).

Abbott Files Para IV Litigation Against Dr. Reddy's Labs

Abbot Laboratories has filed an infringement lawsuit against Hyderabad-based Dr. Reddy’s Laboratories for the infringement of US Patent Nos. 6,511,678, 6,528,090, 6,713,086 and 6,720,004 following DRL paragraph IV certification as part of an abbreviated new drug application (ANDA) to manufacture a generic version of Depakote ER (divalproex sodium extended release tablet). Depakote ER is anti-seizure drug with US sales of $1.48 billion in 2007. The lawsuit is filed in the United States District Court for the District of New Jersey. In 2005 and 2007, Abbott filed similar infringement lawsuits against Mylan, Impax Laboratories, Teva and Wockhardt Ltd. but earlier this year entered into agreement with Mylan to allow launching a generic version no later than January 1, 2009. Mylan believes to have 180-day exclusivity period for 500 mg strength and under terms of agreement also obtained a license for the 250mg strength tablets to be launched no later than January 1, 2009.

Will it be Raining Patent Litigations in India?

Last edition of IDMA Bulletin (Vol. XXXIX No. 25) has interesting piece of advertisement from Cipla announcing brand names of 20 generic drugs likely to be introduce shortly. Just for the information of overseas readers, in India (unlike the US) generic companies sell generic versions under their own brand names. Here also, the list advertised by Cipla is of brand names not generic names so there is always a possibility of error in identifying the exact drug substance from brand name but still few brand names seems to closely resemble the generic names. The list includes brand names like Soranib (resembling Bayer’s anti-cancer drug Sorafenib), Sunitib (resembling Pfizer’s anti-cancer drug Sunitinib), Sprydas (resembling Bristol-Myer’s anti-cancer drug Dasatinib marketed as Sprycel), Lapanib (resembling Glaxo’s anti-cancer drug Lapatinib) and Nilotib (resembling Novartis’s anti-cancer drug Nilotinib). All these anti-cancer drugs belong to the same class of Tyrosine Kinase Inhibitors and for which either patent applications are pending or patents are granted in India (see here). Bristol-Myer has already received the Indian Patent No. 203937 for Dasatinib and last year Delhi Patent Office granted Pfizer the Indian Patent No. 209251 for Sunitinib. If Patent Circle guess about brand names is proper then possibly it will be raining patent litigations in India? It seems to be like Erlotinib (Tarceva), Cipla will again go ahead disrespecting patents for other anti-cancer drugs. Watch out … Roche may have company to join.

Teva Tasting Own Medicine

The world’s largest generic manufacturer Teva Pharmaceutical Industries instead of challenging Innovators’ drug patents will now be defending its own patented drug Copaxone against the Para IV certification made by Momenta and its partner Sandoz. Generically referred as Glatiramer Acetate, Copaxone is an anti-sclerosis drug that had US sales of $ 1.1 billion last year. Glatiramer is a biotech drug and Teva firmly believes that it would be difficult product to replicate and will require full clinical trials to get approval for the generic Copaxone. Teva said it intended to sue Momenta and Sandoz for alleged patent infringement of Orange Book listed patents. There are seven OB listed patents (US 5,981,589, US 6,054,430, US 6,342,476, US 6,362,161, US 6,620,847, US 6,939,539 and US 7,199,098) covering active ingredient Glatiramer Acetate, pharmaceutical compositions containing it, and methods of using it.

Federal Circuit Ruled Against Apotex Reverse Doctrine of Equivalents

The Federal Circuit has disagreed with Apotex that a district court erred in failing to find non-infringement under the reverse doctrine of equivalents and upheld the district court decision granting summary judgment that Roche’s US Patent No. 5,110,493 is valid and infringed by Apotex’s ANDA for generic version of anti-inflammatory eye drug Acular LS. Acular LS is an ophthalmic solution containing ketorolac tromethamine marketed by Allergan for the treatment of inflammation associated with glaucoma, conjunctivitis and eye surgery.

The ‘493 patent claims an ophthalmic formulation comprising a non-steroidal inflammatory drug, a quaternary ammonium preservative, and the non-ionic surfactant, octoxynol 40 (O40). In its Appeal, Apotex did not dispute that its ANDA falls within the literal scope of claim 1 of the ‘493 patent but instead argued that the district court erred in failing to find non-infringement under the reverse doctrine of equivalents. The Federal Circuit explained that the reverse doctrine of equivalents (“RDOE”) “is an equitable doctrine designed to prevent unwarranted extension of the claims beyond a fair scope of the patentee’s invention.” The court referred to Supreme Court’s RDOE test, set forth in the Graver Tank case:

Where a device is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claims, the reverse doctrine of equivalents may be used to restrict the claim and defeat the patentee’s action for infringement.

Apotex argued that the ‘principle’ of the ‘493 patent is “the use of O40 in an amount sufficient to cause the formation of micelles and thereby provide robust stability to the formulation by preventing interactions between ketorolac tromethamine and benzalkonium chloride.” The Federal Circuit disagreed and found no support for this principle in the specification, prosecution history or prior art. According to the Federal Circuit, Apotex relied exclusively on the declaration of its expert and agreed that Apotex failed to make out a prima facie case of non-infringement under the reverse doctrine of equivalents, and therefore summary judgment of infringement was proper. The Federal Circuit also agreed with the district court that Apotex’s invalidity arguments were barred by claim preclusion (e.g., res judicata).

Playing Double Standards?

Often accusing foreign MNCs for ever-greening of patent protection, Cipla has filed fair number of patent applications for new forms of known drug substances such as Alfuzosin, Tolterodine, Perindopril, Citalopram, Fexofenadine, Levosulbutamol, Sibutramine, Topotecan, Clopidogrel, Duloxetine, Montelukast, Olanzapine. Over the years, Cipla has successfully pioneered reverse-engineering of innovator drugs with an ability to launch generic versions within shortest possible time. This business strategy not only made Cipla a preferred choice for cheap generic drugs but also transformed into Billion Dollar Company. Though Cipla lacked any expertise in drug discovery or research but went ahead challenging the validity of Tarceva patent under section 3(d) arguing that Erlotinib is a mere derivative of known drug (Gefitinib). I wonder do reverse-engineering expertise gives sufficient insight to complex drug discovery and make such statement (which essentially requires strong research experience and scientific evidence). It is almost like a chemistry department of third-tier University questioning research ability of premier National Chemical Laboratory (NCL) or Indian Institute of Technology (IIT). Interestingly, Cipla recently got patent for inclusion complex of esomeprazole with cyclodextrin, which technically is a case of frivolous patenting but instead they booked Roche for frivolous patenting of Erlotinib. In India, there seems to be case evolving for ‘differential non-obviousness’ and why not Cipla is not innovator and at their level of expertise any patent application filed by them (though how obvious that is) is non-obvious but when it comes to copying of innovator drugs everything under the sun is obvious.

AstraZeneca Wins Summary Judgment

AstraZeneca has been granted summary judgment for no inequitable conduct in Seroquel patent litigation and strategically avoided running into expensive and time-consuming expert discovery trial that was scheduled to begin on August 11 against the generic manufacturers Teva Pharmaceutical Industries and Sandoz. Teva and Sandoz had already conceded infringement and the validity of the ‘288 patent, leaving only inequitable conduct contentions. Teva said it plans to appeal the judgment by the US District Court for the District of New Jersey. AstraZeneca sued Teva in September 2005 for willful infringement of Orange book listed US 4,879,288 protecting Seroquel drug substance Quetiapine Fumarate. The lawsuit was in response to an Abbreviated New Drug Application filed by Teva with the United States Food & Drug Administration seeking marketing approval of generic Seroquel before the expiration of the ‘288 patent. Later in April 2007, AstraZeneca sued Sandoz following submission of an Abbreviated New Drug Application by Sandoz intended for marketing approval prior to the expiration of the ‘288 patent. In February 2008, AstraZeneca filed a motion for summary judgment that the ‘288 patent is not obvious and that there has been no inequitable conduct.

More Patents for New Forms Issued to Generics

There are some more patents issued by the Indian Patent Office to generic companies for new form of known drug substances.

1. Teva Pharmaceutical Industries received Indian Patent No. 210420 for novel hydrate forms of alendronate sodium having water content of 1.35% to 11.7%. Patent was issued last year in October by the Mumbai Patent Office against the application no. 497/MUMNP/2005 which is national phase application of WO 2000/012517. The WO disclosure do not made any data suggesting improved efficacy over the known substance.
2. Indian Patent No. 219014 issued to Torrent Pharmaceuticals Ltd. for Form T1 of nebivolol and its pharmaceutically acceptable salts against the mail-box application no. 811/MUM/2004. The patent issued earlier this year in April. Equivalent WO 2006025070 does not disclose any data suggesting improved efficacy over the known form.
3. Indian Patent No. 212951 for polymorph Form I and 2 of desloratadine hemifumarate issued to Sandoz against the application no. 139/CHENP/2005 which is national phase application of WO 2004012738. The WO disclosure gives no data suggesting improved efficacy over the known form.
4. Indian Patent No. 219489 for amorphous and crystalline forms of losartan potassium issued to Teva Pharmaceutical Industries against the mail-box application no. 1286/DELNP/2004 which is national phase application of WO 2003048135. The WO disclosure does not suggest any data relating to improved efficacy over the known form.

Note: Above information is based on title and abstract available on official website of Indian Patent Office not on issued claims.

Daiichi Filed Infringement Suit Against Indian Drug Company

Daiichi Sankyo which recently shocked Indian generic industry by announcing to buy out controlling stake in India’s largest drug company Ranbaxy has lately filed an infringement suit in the United States District Court for the District of New Jersey against Matrix Laboratories for alleged infringement of the US Patent No. 5,616,599 (the ‘599 patent) claiming active ingredient olmesartan medoxomil. The infringement suit is in response to Matrix’s submission of an abbreviated new drug application (ANDA) to the United States FDA, seeking approval to market generic version of anti-hypertension Azor tablets containing the active ingredients amlodipine besylate and olmesartan medoxomil before the expiration of the ‘599 patent. The suit was filed on June 03, 2008. Matrix is believed to be First-to-File Para IV applicant, which if succeed would give Matrix 180-day market exclusivity.

Lipitor Settlement: What Lies Beneath? Part II

Strategically Lipitor settlement seems to be more favorable for Ranbaxy as this provides certainty for Ranbaxy to launch generic product in the United States without any patent hurdle and may allow recouping the expenses made in Lipitor litigation worldwide but what benefits Pfizer from settlement? Pfizer too avoided legal cost that would be spend further in litigation and importantly put an end to nightmarish litigation which witnessed the ‘995 patent going down.

What about 180-day market exclusivity?

Technically the 180-day market exclusivity will trigger soon after the expiration (March 2010) of the genus patent but Ranbaxy, under the terms of the agreement, would delay the launch until November 2011 which would possibly lead to forfeiture of Ranbaxy’s right to 180-day market exclusivity. 21 USC 355 (j)(5)(D) states that if the first applicant fails to market the generic product within 75 days from the date of FDA final approval of ANDA that will lead to forfeiture of 180-day exclusivity period. And in case of forfeiture, any later ANDA applicant may market its generic product upon receiving FDA final approval. Interestingly, if Ranbaxy forfeits its 180-day market exclusivity then the Lipitor generic space will open much earlier than the expected (that is before July 2010). However, it would still not be easy for any generic player to cross hurdles of Pfizer’s polymorphs and amorphous patents and step into Lipitor generic fortune. Pfizer not only litigated its patents strategically but possibly put an end to prized 180-day market exclusivity.

Lipitor Settlement: What Lies Beneath?

Historical patent litigation between world’s largest drug manufacturer Pfizer and world’s most aggressive generic company Ranbaxy over biggest ever blockbuster drug Lipitor has finally ended in unexpected climax with both Pfizer and Ranbaxy settling all their patent litigations worldwide. Under the agreement, Pfizer voluntarily licensed Ranbaxy to sell generic versions of Lipitor in the United States effective November 30, 2011. In addition, the agreement provides a license for Ranbaxy to sell generic versions of Lipitor on varying dates in seven additional countries: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Thought the settlement is win-win for Ranbaxy and Pfizer but gives more strategic value to Ranbaxy. It would be really interesting to revisit and trace some of the facts and carefully look what lies beneath the historical settlement?

Pfizer’s Strategy was Ranbaxy’s Dilemma

It all triggered when Ranbaxy filed an abbreviated new drug application (ANDA) with the United States Food and Drug Administration seeking marketing approval for generic equivalent of Lipitor before the expiration of Orange Book listed patents. Pfizer sued Ranbaxy within statutory timelines (45 days) and filed civil action for alleged infringement in the District Court. During the course of litigation proceedings, Ranbaxy strongly challenged the validity of the US 5,273,995 patent and also questioned patent term extension awarded to the US 4,681,893 (genus patent). Alas Ranbaxy failed to convince the District Judge any of its arguments and lost to Pfizer. Ranbaxy appealed and this time CAFC partially reversed the district court judgment, invalidating the ‘995 patent. CAFC ruling gave Ranbaxy the grandest legal victory by any generic company in the United States and importantly entitlement to 180-days market exclusivity. This mean that Ranbaxy’s precious 180-days market exclusivity will be triggered soon after the expiration of the genus patent. Though most of the business and news analysts predicted that Ranbaxy will be able to bring generic equivalent soon after expiry of the genus patent but it was not that easy for Ranbaxy to breakthrough ‘Lipitor generic space’ even after knocking down the ‘995 patent. Till here, Pfizer strategically avoided Ranbaxy from suing for other orange book and non-orange book listed patents covering different polymorph and amorphous forms. Probably Pfizer (legal team) thought waiting till Ranbaxy launches its generic equivalent and then sue for infringement of polymorph and amorphous patents. This strategy not only would hinder Ranbaxy’s generic equivalent but also may give Pfizer an opportunity to claim treble damages against the willful infringement. Though Patent Circle is not sure whether Ranbaxy used different form other then patented by Pfizer and planned declaratory judgment for non-infringement prior to launch of its generic equivalent or was planning to challenge the validity of Pfizer’s patents for polymorph and amorphous form but what is sure that Pfizer would have hunted down Ranbaxy for polymorph and amorphous patents.

Patent Circle believes that Pfizer strategically litigated Lipitor against Ranbaxy and kept polymorph and amorphous patents out of Para IV litigation so that Pfizer may unfold them in separate litigations. Pfizer not only used patents against Ranbaxy but also in parallel strategically filed a citizen petition with the United States FDA regarding amorphous atorvastatin. In its petition, Pfizer concerned about higher levels of impurities and inferior stability of other polymorphs and amorphous forms that may be used by generic companies. Pfizer also stated that the pending application for a generic version is in an amorphous form (though not mentioned the name of company but was possibly referring to Ranbaxy ANDA). In March 2008, Pfizer extended its strategy by filing fresh infringement suit against Ranbaxy for infringement of two non-orange book listed patents – US 6,087,511 and US 6,274,740 both covering processes for the preparation of amorphous Atorvastatin which suggest that Ranbaxy possibly used amorphous atorvastatin calcium for their proposed ANDA. The process patents are due to expire in July 2016 and would mean that if Pfizer succeeds in wining the litigation that would delay Ranbaxy’s generic product till 2016. This litigation put Ranbaxy in dilemma whether to launch generic soon after the expiration of genus patent with a possible risk of treble damages or wait till litigation get over but that may possibly risk of running out 180-days market exclusivity without even launching the generic product for which Ranbaxy played such a risky game. Pfizer’s Strategy was Ranbaxy’s Dilemma.

To be continued …

Cipla Patents Salt and Complex of Blockbuster Drug Substances in India

Mumbai-based Cipla has lately obtained patents for new form of two blockbuster drug substances, namely, esomeprazole and alendronate. In past, Cipla has constantly accused foreign MNCs for ever-greening of patent monopoly and strongly opposed patenting of so-called trivial improvements but in general practicing the same in India. In April 2008, Mumbai Patent Office issued Patent no. 219034 to Cipla for inclusion complex of esomeprazole with cyclodextrins which technically should fall under section 3(d) of the Patents Act, 1970 (that is complexes of known substances). Surprisingly the search report (ISR) of equivalent WO02098423 cited one ‘X’ category reference and eleven ‘Y’ category references against the novelty and non-obviousness of the invention but still Cipla managed to get patent in India. Though Patent Circle went through the WO equivalent but couldn’t find any data suggesting and relating to enhanced or improved efficacy. Also in April 2008, Mumbai Patent Office issued Patent no. 219022 for alendronate monosodium salt which also falls under section 3(d) (that is salt of known substances). In this case also the search report (ISR) of equivalent WO03033508 cited five ‘Y’ category references against the non-obviousness of the invention. Patent Circle also scanned the disclosure of WO equivalent but yet again couldn’t find any data suggesting and relating to enhanced or improved efficacy. Surely it would be really interesting to know on what basis Cipla managed to overcome the efficacy barriers under section 3(d). Unfortunately, Indian Patent Office (IPO) has ill-practice of issuing patent in India if patent for same invention is granted in other country particularly Europe and US and that also without giving any considerable thought. Possibly Cipla too provided copy of granted European/US patent to have patents issued by the Mumbai Patent Office.

Often public health interest organizations criticized patenting of polymorphs or other forms of known substances (considering such improvements as trivial modifications) and keep targeting foreign MNCs of being patent freaks but why avoided same practice against the Indian companies. The only reason they may give that the foreign MNCs will charge excessive price for patented drugs whereas domestic companies will not. Interestingly last year Cipla received Government notice demanding Rs. 24.23 crore for alleged overcharging on antibiotic ciprofloxacin during the period April 2006 to March 2007. Earlier Cipla also received similar notices from the National Pharmaceutical Pricing Authority (NPPA) demanding as estimated Rs. 941.92 crore for alleged overcharging till March 2006 for five drugs, namely, Salbutamol, Theophylline, Ciprofloxacin, Norfloxacin and Cefadroxil. Just note this overcharging is for generic drugs what if Cipla start marketing and pricing patented drugs. Anyhow bottom line of any business is profit (not public health) and it seems difficult to predict whether NGOs are more confidants to Indian generic companies or to public.

Indian Generics & Health Activists Having Problem Over Patent Titles

Business Standard reported that domestic drug companies and public health activists have accused research-based multinational drug companies of not providing clear information about the type or use of the potential new medicines in patent applications. Also accusing the practice of using complex chemicals, or molecular formulae, in place of clear indicators as patent titles as an attempt to hide the identity of the actual molecule. A Mumbai-based patent expert said, “There are instances of patent title merely mentioning the invention as ‘a novel compound’ or a ‘new pharmaceutical substance’. By doing so, the companies are trying to avoid detection of the actual nature of their products. The Indian patent law has, in fact, considered this factor while saying (in section 10) that the title of the patent application and the patent abstract that follows should describe the product, its use and explain its contents.” Further adding, “However, these rules are often broken than followed.” Addressing the issue, the Indian Pharmaceutical Alliance (IPA) insists that all applications for pharmaceutical substances should indicate the INN of the substance as the title of the patent.

Every year, the list of problems by domestic drug companies and public health activists seems to be increasing. Earlier, they had problem with (1) introduction of patent protection for pharmaceutical and drug products, (2) (triggering) period for compulsory license, (3) patent office issuing patent for mail-box drug applications (without giving hearing during pre-grant opposition) and latest is patent titles. I too search and track Indian patents/published applications for drug compounds/pharmaceutical products but surprisingly never faced any confusion/difficulty in locating through patent titles. In most of the cases where patents are issued for salts and polymorphs, INN or chemical name of the drug substance is mentioned. As far as new drug compounds are concerned, how someone can expect to have INN placed in patent title, considering by the time patent application is filed for new drug compound the applicant has not applied/received the INN from WHO. I do agree that sometime it is difficult to locate the clear indication (therapeutic application) by reading title such as ‘a novel compound’ or ‘a new pharmaceutical substance’ but in such case, a searcher, may try to out international classification and/or locate equivalent foreign application (using priority application data).

There is no point in accusing MNCs for such issue. They provide whatever they feel appropriate but under section 10 (4)(d) of the Patents Act, 1970 the Controller of Patents also have an option to amend the abstract for providing better information to third parties. If MNCs fails in providing abstract in a manner to facilitate searching then it is duty of Controller to do so (or ask applicant to do so).

Controller Decisions Goes Public - Part 2

Online availability of Controller’s decision and availability of abstracts of patent applications published after 18 months, enhanced user-friendliness of E-filing gateway etc. reveals that the Consultative working group constituted by FICCI and DIPP has proved to be very effective platform in making the patent offices more responsive to industry needs. The Consultative working group set by FICCI’s IPR division brings to Government’s notice issues of concerns for Industry w.r.t Indian Patent System. Sheetal Chopra (sheetal.chopra@ficci.com), Senior Assistant Director – FICCI IPR Division, through a short interview, stated that DIPP is providing all its support to FICCI in bringing the working of Patent office at par with International Standards.

I am sure that we all will witness many more initiatives taken by the Consultative Group leading to enhanced effectiveness of Indian Patent Offices and in bringing more transparency in their working.

Let us all join hands with FICCI by providing/highlighting issues of concern to each one of us and make deliberations of Group meetings successful.

Press Release: National IPR Campaign Announced

The rapidly growing relevance of intellectual property in the present knowledge driven economic development has led the Government to take several initiatives both in the legislative domain as well as the administrative set-up to create a modern and efficient Intellectual Property infrastructure in the country. Recognizing the critical importance of IP systems for the growth of Indian Industry and to create larger public awareness and further enhance the capacities of Indian patent office and enforcement authorities, FICCI and Department of Industrial Policy and Promotion (DIPP), Government of India have launched “National IPR Campaign”. Under the Campaign, FICCI and DIPP will jointly conduct seminars, workshops and specialized training programmes over a period of one year from April ’08 to March ’09. The Campaign would include awareness programmes on Intellectual Property issues; capacity building Programmes for enforcement authorities and the staff of Controller General of Patents, Designs and Trade Marks (CGPDTM); specialized orientation programmes for patent office examiners; programmes on sensitizing judiciary on speedy and quality adjudication of Intellectual Property cases; continuos advertisements in electronic and print media on “protecting IP and the consequences of violating IP Rights”; establishment of “Knowledge and Education Centres” at all Patent Offices; targeted programmes for stakeholders with a view to shift the current practice of filing patent/trademark applications from paper to electronic mode etc. The campaign will not be limited to big cities alone but will also be taken to tier II and III cities including Baddi, Meerut and Jaipur by FICCI.

For any further information pls. contact sheetal chopra (sheetal.chopra@ficci.com), Senior Assistant Director, FICCI-IPR Division.