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.

Controller Decisions Goes Public

Indian Patent Office (IPO) has lately made Controller’s Decisions public by making an online search provision to search any of his decisions. Visit Indian Patent Office Patent Decision Search link. The search page is not that of global standards but still good enough to search. The decision can be searched using search condition restricted by any of the six options, (1) Patent Number, (2) Section, (3) Opponent, (4) Controller, (5) Application Number, and (6) Applicant Name.

IPO also made search option available for patent applications published under section 11A (18 months publication). Check link. However, search results are restricted to patent bibliographic details (more or less similar to details published in Patent Gazette), not full-text patent applications.

Section 107A (b): As clear as mirror Part 2

Section 107A (b) of the Patents Act, 1970 allows provision for parallel importation. Parallel importation allow products produced genuinely under the protection of a “parallel” intellectual property right (such as patent, trademark or copyright), placed into circulation in one market, and then imported by an intermediary (parallel importer/trader) into a second market without the authorization of the local owner of the intellectual property right. Such imported products are called parallel imports and such cross border trade is called parallel trade. However, parallel imports do not include counterfeited or pirated (generic) products.

As illustration, consider an antidiabetic drug Sitagliptin patented by Merck in India and Argentina. A parallel importer can import antidiabetic Sitagliptin tablets in India, sold in Argentina by Merck (or with his consent), from authorized Argentine wholesalers/retailers without the authorization of the Indian patentee (Merck), but parallel importer cannot import Sitagliptin tablets manufactured by Argentine generic companies.

In 2005, the Patents Amendment Act 2005 amended section 107A (b) to bring in full advantage with the principle of parallel importation. Old provision, before amendment, stated –

“(b) importation of patented products by any person from a person who is duly authorized by the patentee to sell or distribute the product,”

The old provision though allowing parallel importation, but was restricting parallel importers to import patented products only from a person who is duly authorized by the patentee to sell or distribute the product. In other words, under old provision parallel importer was prevented from importing patented products from resellers such as wholesalers, retailers and pharmacies who brought the products from patentee distribution channel and are free to use and resell further without restriction from patentee.

New provision, after amendment, states –

“(b) importation of patented products by any person from a person who is authorized under the law to produce and sell or distribute the product,”

The new provision now removed the earlier restriction of importing the patented products only from a person who is duly authorized by the patentee to sell or distribute, but also include to cover resellers such as wholesalers, pharmacies and retailers. Wholesalers, retailers and pharmacies are licensed by the government and authorized under the law to sell and distribute the drug products. In other words, the new provision has broadened the scope of older provision and has amended to take full advantage of importation exemption.

According to new provision, importation of patented products by any person from a person who is duly authorized under the law to produce and sell or distribute the product will not be considered as an infringement of patent rights.

Here ‘patented product’ interprets a product protected by Indian patent (Indian Jurisdiction), not by a patent outside India (other jurisdiction). There is no confusion in this as section 107A (b) is exemption to infringement of Indian patent, not foreign patent as we can not regulate infringement in other jurisdiction.

Here ‘duly authorized under the law’ interprets authorized under the law of exporting country. There is also no confusion in this as section 107A (b) is exemption provided to a parallel importer against infringement of Indian patent, and if someone is already authorized under the Indian law to produce and sell or distribute the patented produce then what made him to seek immunity under section 107A (b).

After new provision, I do not see any confusion or loophole in section 107A (b) and would not be reluctant to say that section 107A (b) stands as clear as mirror.

Section 107A (b): As Clear as Mirror

Under Indian patent law, a patentee has exclusive right to prevent third parties, who do not have his consent, from the act of making, using, selling, offering to sale or importing patented product in India till patent is valid and enforceable. If third party indulges in any of these act that will constitute an act of infringement and the patentee (or its authorized licensee) has a right to trigger an infringement suit against the third party. But there are certain instances which though constitute infringement but will not be considered as infringement under the Patents Act, 1970 and referred as exemptions. Such instances can also be used as defences in suits for infringement. Section 47 and 107A relates to exemptions provided under the Indian patent law. Section 47 particularly covers (a) research (experimental use) exemption and (b) government use exemption whereas section 107A relates to (a) regulatory (bolar-type) exemption and (b) importation exemption. The exemptions provided in section 107A are result of flexibilities provided under TRIPS Agreement (Article 6 and Article 30). However, herein we are only going to discuss about importation exemption.

Possession to Market

Technically, patent is a legal document (certificate) issued by the government to an applicant for an invention that gives the applicant: (1) a right to prevent unauthorized third party from making the patented invention, (2) a right to prevent unauthorized third party from using the patented invention, (3) a right to prevent unauthorized third party from selling the patented invention, (4) a right to prevent unauthorized third party from offering to sale the patented invention, (5) a right to prevent unauthorized third party from importing the patented invention, and (6) importantly a right to file an infringement suit against the unauthorized third party infringing any of the above right (1) to (5).

In other words, a patent gives an applicant bundle of exclusive rights to control the commercial activity of patented invention. Till the patentee is having patented products in his possession (not placed on the market) all of these rights are intact with the patentee, that is, patentee has sole discretion to commercialize the patented products whenever he want, whosoever he want, wherever he want and whatever price he want. However, when the patented product is first sold or marketed by the patentee (or with his consent) it ceases patentee’s certain exclusive rights on the patented product. In other words, once the patentee has been able to obtain a commercial return from the first sale or placing on the market, the purchaser of patented product is free to use and resell it without further restriction from patentee.

As illustration, consider an anticancer drug Tarceva protected by an Indian patent. Because Roche holds patent rights on that drug, it may prevent others from first-selling the anticancer Tarceva without his consent. If you buy 25 strips of Tarceva tablets from an authorized first-seller, Roche’s right in its patent is ceased, and it cannot prevent you from using the sold tablets, or from giving or re-selling to others. The patentee has lost its right to control further movement of the sold tablets. Your purchase of the Tarceva tablets does not authorize you to begin making your own generic version of Tarceva, or licensing the patent to others. In other words, the first sale does not grant you rights in the patent, but rather extinguishes Roche’s exclusive right to prevent further movement of those particular sold tablets. This phenomenon is referred as doctrine of exhaustion which can further be attributed as international and national exhaustion.

If a country recognizes doctrine of national exhaustion, a patentee’s right to prevent movement of a patented product is only extinguished by the first sale or marketing of a patented product within the territory of that country. In other words, national exhaustion does not allow the patentee to prevent third party from using and reselling patented products already sold or put on the domestic market by the patentee or with his consent. If a country recognizes a doctrine of international exhaustion, a patentee’s right to prevent movement of patented product is extinguished when a patented product is first sold or marketed anywhere in the world. Notably, the WTO member countries are free to incorporate doctrine of exhaustion under Article 6 of the TRIPS Agreement. The policy of exhaustion significantly affects the flow of patented products across borders. Under doctrine of international exhaustion, patented products flow across borders after have been first sold or placed on the market by the patentee or with his consent anywhere in the world. Under doctrine of national exhaustion, the movement of patented products across borders may be blocked by patentees.

As illustration, United States adopted doctrine of national exhaustion whereas Canada and India adopted international exhaustion. Consider an antiretroviral drug Selzentry protected by patent in US, Canada as well as India. Because Pfizer holds patent rights on that drug, it may prevent others from first-selling and importing the antiretroviral Selzentry without his consent. Pfizer sells Selzentry tablets to an Indian pharmacy and this exhausts Pfizer’s right to prevent use or resell of sold tablets. Under international exhaustion, a Canadian company Apotex may import Selzentry tablets from that Indian pharmacy without the consent of Pfizer having Canadian patent and resell in Canada at lower price. But under national exhaustion, a US company Barr cannot import Selzentry tablets from Indian pharmacy and resell in US at lower price because Pfizer’s patent rights within the US are not exhausted by virtue of sales outside the US. This phenomenon of importing patented drugs from across the borders after have been first sold or placed on the market by the patentee is referred as parallel importation.

If an importing country agrees to international exhaustion, a third party may import a product patented in importing country from anywhere in the world where the product is first sold or marketed by a patentee or with his consent. Thus, the concept of exhaustion is critical in the context of parallel importation and possibility of importation can only be there when a (importing) country agrees to doctrine of international exhaustion.

Section 107A (b): In Compliance with Principle of Importation

To be continued …

Mint Reported Irresponsibly

Indian newspaper Mint has recently covered a lose story related to section 107A (b) of the Patents Act, 1970 and to utter surprise was a major irresponsible reporting seen in recent times. Mint reported that section 107A (b) allows local Indian companies to import patented drugs in India by manufacturing in least developing countries such as Bangladesh without any authorization of patent holder. Shocking interpretation! Mint also pointed out that Indian drug makers have rushed to take advantage of this, and several of them have even started working on building manufacturing plants in these countries and further adding that this provision may not be in complete compliance with the international trade rules of WTO and even may violate Indian patent law. But surprisingly what Mint completely missed pointing out is what this section (provision) is all about. It is always important that while reporting on critical issue such as section 107A (b) complete background research should be made. So let’s scrutinize what section 107A (b) really stands for and how wild is the interpretation made by Mint.

Rights & Exemptions

Section 48 of the Patents Act, 1970 gives patentee an exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing patented product in India. If third party indulges in any of these act, that will amount to infringement of patent right under the Indian patent law. But there are certain instances which though infringing are not considered infringement under the Act. Such instances are often termed as exemptions, which are derived from judiciary-created doctrines (usually US and European judiciary) and section 107A covers two of such exemptions. Both these exemptions are result of flexibilities provided under TRIPS agreement (Article 6 and Article 30). Clause (a) of section 107A relates to regulatory exemption famously known as Bolar-type exemption whereas clause (b) relates to parallel importation. Now before discussing section 107A (b) in detailed, let’s discuss two important aspects: (1) Exhaustion of Rights, and (2) Parallel importation.

Exhaustion of Rights

As referred earlier that Patentee has exclusive right to prevent third party from making, selling, offering for sale, selling or importing patented product. According of doctrine of exhaustion, once a patented product has been marketed by the patentee or with his consent, the patentee will exhaust certain rights on the product. Particularly, patentee will exhaust right to prevent the resale, importation or exportation of the patented product that have been placed on the market. In simple words, once a patented product has been marketed by the patentee or with his consent, the patentee cannot prevent third party from resale, importation or exportation of the product. Importantly, exhaustion can further be attributed as international and national exhaustion.

National exhaustion does not allow the patentee to prevent third party from resale and importation of patented products put on the domestic market by the patentee or with his consent. In case of international exhaustion, the patentee rights are exhausted once the product has been sold by the patentee or with his consent in any part of the world. Article 6 of TRIPS Agreement leaves countries free to incorporate the principle of exhaustion of rights. Different countries regulate the applicability of the doctrine of exhaustion in different ways. The concept of exhaustion is critical in the context of parallel importation.

Parallel Importation

Parallel importation is a practice where patented products are imported from another country without the permission of the patentee (or his authorized licensee). The practice of parallel importing occurs because companies often set differential pricing for their products in different markets. Parallel importers usually purchase products in one country at a price which is cheaper than the price at which they are sold in a second country, import the product into the second country, and sell the product in that country at a lower price. This practice of parallel importation is legal if the country in which patented products is imported agree to international exhaustion. However, if the country in which patented products is imported do not agree to international exhaustion and instead follow national exhaustion then such importation of patented products by third party will constitute infringement of patent.

Section 107A (b)

Clause (b) of section 107A allows parallel importation of patented products from other country. According to the provision a person can import patented product from a person who is duly authorized under the law to produce and sell or distribute the product. Person who is duly authorized under the law to produce and sell or distribute include patentee or his authorized licensees and licensed pharmacists/licensed drug retailers. But what is important to remember is that the patented drugs which are imported in India should be manufactured by the patentee or by a person duly authorized by the patentee, not by any generic company manufacturing without the consent of patentee. If patented drug is imported from a generic company, who do not have consent of patentee, then that will constitute infringement under the Indian patent law. However, patentee may still prevent parallel importation by using contractual restriction in distribution channel (often referred as implied license).

Check list of countries having international exhaustion.

IP Feathers - Value Innovation IP Services

It had been a long gap since I posted my last post on Patent Circle. Although there was so much to write about, but was miserably falling short of time to put it in black and white. Last three months had been most challenging and memorable part of my professional career as I finally took a leap forward to shape my three years old dream of starting an intellectual property consultancy firm, IP Feathers. While working in industry, both in Corporations and Law Firms, at various levels I always felt there is an urgent need for quality intellectual property consultancy firm in India, which can bridge the demand for quality intellectual property practice and expertise and can leverage enterprises into IP driven, globally competitive companies. This is what prompted the birth of IP Feathers, where quality meets expertise.

IP Feathers is all operational now having an office in Mindspace, one of the major commercial hubs in Mumbai, providing value innovation intellectual property services in the area of patent research operations, patent filing and prosecution, IP consultancy, IP due diligence, IP Licensing and Competitive Intelligence. Our website is currently under construction and will be available shortly for complete experience.

If you have any questions, please feel free to contact at +91 99679 77571, or varun@ipfeathers.com. We will be very glad to reply any of your questions.

Record Grant of Patents

The Indian Patent Office has issued a record number of 15,262 patents during the financial year 2007-2008. Read Press Release from the Government of India.

Roche Builds Over EPO

Switzerland based Biotechnology Company; Roche Holding AG who developed pegylated version of Erythropoietin (MIRCERA®) said on Tuesday that they agreed to conditions set by the federal judge of the United States district court of Massachusetts, overseeing a patent case brought by Amgen Inc, which could clear the way for Roche to sell its anemia drug MIRCERA® in the United States. Last year the same court ruled that Roche infringed at least four Patents of Amgen in the United States which will only begin to expire in 2013. Amgen requested a permanent injunction to prevent Roche from importing, using and selling any pegylated Erythropoietin product in the United States for the term of the four patents Roche was held to infringe. Roche then proposed royalty payments of 20% to Amgen which they rejected. Earlier this year in February the court said that they would allow MIRCERA’s US Introduction if Roche agreed to pay Amgen a royalty of 22.5% of US sales, compared to 20% Roche has initially proposed. Roche agreed to this on Tuesday and in their statement also guarantee that they wouldn’t charge higher prices than those of Amgen’s anemia treatments (EPOGEN and ARANESP). In one of its first kind of the judgment, the court tries to overcome the monopoly of Amgen that they had over Erythropoietin for Anemia associated with Chronic Kidney diseases. Erythropoietins have a worldwide market of over $12 billion and accounts major part of Amgen’s revenue from United States. MIRCERA® however is already selling in Europe and has been approved by both European (EMEA) and US (FDA) regulatory bodies for the treatment of anemia associated with Chronic Kidney diseases. It will be interesting to see how this move of the district court in the US affects Indian companies who plan to launch Biosimilars in the United States. As many as four Indian companies, Wockhardt, Biocon, Shantha Biotech and Intas Pharma are manufacturing EPO indigenously and selling it by the names of Wepox, EryproSafe, Shanpoietin and EPOFIT respectively. In a further interesting development Chennai patent office granted one of Roche’s product patent for MIRCERA last month. The patent IN212429 covers the product claims of MIRCERA which is required at a dosing interval of only once per month as compared to the existing products which are required more frequently. This development Roche vs Amgen case is important and will be closely watched by the Indian companies who are planning to launch their Biogenerics in the developed markets.

Litmus Test: Natco's Applications for Compulsory License

Indian Patent Office has finally started proceedings over Natco’s applications for Compulsory License for anti-cancer drugs Tarceva and Sutent to be exported to Nepal under statutory provisions of section 92A of the Patents Act, 1970, also referred as “Doha-style provision.” Natco even reported to offer a five percent royalty to Roche for the generic Tarceva exported to Nepal. Interestingly, the Delhi Patent Office allowed hearing Roche and Pfizer over the issue, which prompted Natco to file an interlocutory petition saying that Roche/Pfizer should not be privy to the compulsory license hearing that takes place between the Patent Office and Natco. No idea which provision allowed Natco to make such an objection?

Reading section 92A, there is nothing explicitly mentioned about hearing will be allowed to patentee or not, but that even does not mean to exclude the possibility for hearing. This can further be supported by the rule 97(1) of the Patents Rules, 2003 which reads as –

If, upon consideration of the evidence, the Controller is satisfied that a prima facie case has not been made out for the making of an order under any of the sections referred to in rule 96, he shall notify the applicant accordingly, and unless the applicant requests to be heard in the matter, within one month from the date of such notification, the Controller shall refuse the application.

The rule clearly allows the Controller to consider evidence to judge a prima case for making an order under section 92A. Now the question is, how the Controller will decide is there a prima case for compulsory license or not? Only by hearing Natco (and may be doing some additional search over Google)? Obviously that will be unfair enough to do that, particularly when Nepal, till date, has made no notification to WTO Council about the importation of Tarceva under Doha-style provision from India. Having an import license from Nepal Drug Authority is not sufficient enough to establish a prima case for making an order for compulsory license under section 92A. In fact, the Controller has made fair and just decision to allow hearing Pfizer/Roche, which will build a transparency and creditability in Indian Patent System.

It would be interesting to know, who approached whom? Whether Nepal Drug Authority approached Natco for supplying the generic Tarceva in Nepal or Natco suggested Nepal Drug Authority to trigger Doha-style provision?

Latest in News

· Tarceva Patent Re-issue Application: OSI Pharmaceuticals, Inc. filed an application to reissue US Patent No. 5,747,498 for Erlotinib, the active ingredient in anti-cancer drug Tarceva. Read.

· Genentech Patent for Cabilly rejected fourth time: United States Patent & Trademark Office has issued rejection action against Genentech’s Cabilly patent. Read.

· Sun Pharma Challenged J&J Drug patent: Sun Pharmaceuticals filed a post-grant opposition against Janssen’s Risperidone extended release version. Read.

· MNCs’ Diabetes Drug Patents Worry Experts: Business Standard reports exclusive story over diabetes drug patents in India. Read.

· Barr Challenge Glaxo’s Prostate Drug Avodart: Barr made paragraph IV certification for Glaxo prostate drug Avodart, generically known as dutasteride. Read.

Sun Pharmaceuticals Filed Post-Grant Opposition

Mumbai-based Sun Pharmaceuticals Ltd. has filed a post-grant opposition in respect to Indian Patent No. 208191 issued to Janssen Pharmaceutica N.V. against the mail-box Application No. 188/CAL/1995. The opposition was filed on January 02, 2008 with the Mumbai Patent Office, which last year in July (dated July 20, 2007) published the grant of the ‘191 patent under section 43(2) of the Patents Act, 1970. The ‘191 patent relates to sustained-release microparticle of risperidone.

Patent Circle Building Gravity

Brett Trout of BlawgIT lately posted his Patent Meme mentioning that “there are lots of blogrolls out there, but almost all include non-patent related blogs or patent blogs which have not been updated for months.” Stating, “if only I could have a link to all the important patent law blogs in one place”, Brett listed down his important patent law blogs which also include Patent Circle. This is obviously a great feeling and a sense of pride that fellow US patent attorney recognize Patent Circle as one of the important patent law blogs and includes in likes of Patent Baristas (my favourite), Patent Docs (top-class), Orange Book Blog (not to be missed), Patently-O (extraordinary) and Patent Prospector (best in the class). Thank you Brett for recognizing and including Patent Circle in your invaluable p-meme!

Not only fellow bloggers are recognizing the spirit of Patent Circle, but also India’s leading business newspapers are keeping track of our interesting posts. India’s premier business newspaper Economic Times has lately covered a story on antiretroviral drug Etravirine, which brought into notice by one of our earlier posts. Earlier, another leading business newspaper Business Standard covered a story on global pharma seeking cancer drug patents, which was also moved by one of our earlier post. Even, Business Standard covered an exclusive story on bloggers driving India’s IPR regime and recognized Patent Circle as one of the blog for separating the wheat from the chaff in the flood of intellectual property related information.

We would like to thank all our readers for their support, encouragement and involvement. We are committed to contribute to the area of patents, will continue to bring latest updates, critical analysis and unbiased stories from the world of patents and will keep building presence of India’s first patent law blog on the global platform. We surely appreciate your views, comments and suggestions on any of our posts. Your feedback not only helps identifying our low points but also encourage pushing the envelope to make Patent Circle a reliable and authentic source. If you feel Patent Circle has managed to build a niche and has contributed to add value to your knowledge and information base, please do let us know at chhonkar.varun@gmail.com or seemasingh.patentlawyer@gmail.com.

USD 20 billion going off-patent

About 11 leading drugs, including four blockbuster drugs worth USD 29 billion are going off-patent this year in the US reports Reghu Balakrishnan from Financial Express. For full story read A $20 billion American generic market awaits Indian players.

Merck Generic Promotion

Just came across an interesting article about Merck’s promotional strategy to consolidate generic space for Fosamax, before its key indication patent expired. Read The Wacky World of Generics: Fosamax Edition.

Ignoring not the solution

Just came across an interesting article by D Ravi Kanth ‘Drug Capitalism’ pointing out the concern for affordable drugs to poor consumers, but what really caught my attention is, what Kanth pointed to be moot issue, whether the gap between those who invest billions of dollars to develop new medicines and those who need them most, particularly, the poorest of the poor, is bridgeable.

Undeniably, this is the core issue that need utmost attention across the globe including India, but unfortunately the issue is made diluted by raging politics over ‘Patients or Patents’.

Watson Authorized Generic For Merck's Osteoporosis Drug

Merck’s blockbuster osteoporosis drug Fosamax will lose patent protection tomorrow with the expiration of Orange Book listed US Patent No. 4,621,077, losing significant $ 1.6 billion US market to generic competition. Earlier in January, Merck announced to sign a deal for an authorized generic but did not disclose the name of its partner. Finally, it is Watson Laboratories that will be selling the authorized version of Fosamax. Barr Pharmaceuticals and Teva Pharmaceutical Industries are also expected to launch generic versions Fosamax this week.

Wockhardt Received Patent For Antibacterial NCE

Mumbai-based biotech company Wockhardt has recently received an Indian Patent No. 213142 for antibacterial NCE against the mail-box application no. 3/MUMNP/2005 filed on July 10, 2003. The published abstract of the application (u/s 11A of the Patents Act, 1970) reads as –

The present invention provides agents having high antimicrobial activity for preventing and treating infectious diseases. Thus, the present invention provides novel cyano-(substituted)-methylenepiperidinophenyl oxazolidinone derivatives, processes for making the compounds, as well as antimicrobial compositions containing said derivatives as active ingredients and methods of treating bacterial infections with the said derivatives.

Referring corresponding PCT publication WO2004007489, the antibacterial compounds are cyano-(substituted)-methylenepiperidinophenyl oxazolidinones. Interestingly, Wockhardt is having a strong research pipeline for anti-bacterial drug targets, with few already in clinical trails which include phase II WCK 771 (arginine salt of S (-) nadifloxacin), phase I WCK 2349 (oral prodrug of WCK 771), phase I WCK 1152 (enantiomer of another drug target WCK 919). Wockhardt’s other antibacterial drug targets in preclinical trails include WCK 2370, WCK 2664, WCK 1734, WCK 919 and WCK 1153 (enantiomer of WCK 919).

Merck dropped Melogliptin

Yet another indigenously discovered and invented anti-diabetic clinical drug candidate lost strategic and financial backup from the research-based company with Merck backing out to support co-development and commercialization of Glenmark’s phase II drug candidate Melogliptin (GRC 8200). The decision came after Merck’s decision to re-focus its portfolio and not to invest further in diabetes research and development. Earlier in 2003 and 2004, Novo Nordisk backed out from Dr. Reddy’s phase III anti-diabetic drug Ragaglitazar (DRF-2725) due to risk assessment and phase II anti-diabetic drug Balaglitazone (DRF-2593) due to lack of competitive advantage. Also, in 2003 Novartis discontinued development of anti-diabetic drug (DRF-4158) which Dr. Reddy’s out-licensed to Novartis in 2001. Later Dr. Reddy’s entered into co-development and commercialization agreement with Rheoscience for Balaglitazone, which is currently in final phase of clinical trial. Schwarz Pharma, in 2004, discontinued development of Ranbaxy phase II prostate drug Pamirosin (RBx 2258) whereas last year Medicines of Malaria Venture (MMV) lost interest in Ranbaxy’s phase II anti-malaria drug Arterolane.

Deals Still in Progress

In 2004, Torrent out-licensed a cardiac drug molecule (TRC 4XXX) to Novartis and Glenmark out-licensed an asthma drug Oglemilast (GRC 3886) to Forest Labs.

Cytopia Received Patent for JAK Kinase Inhibitors

Australian-based biotech drug discovery company Cytopia Pty Ltd. has lately received an Indian Patent No. 214081 (the ‘081 patent) for disubstituted pyrazine compounds having protein kinase, particularly Janus kinase (JAK) inhibitory activity. The ‘081 patent is issued against the mail-box application no. 1743/KOLNP/2004 dated November 17, 2004, claiming earliest priority from an Australian provisional application dated May 23, 2002. The published abstract of the Indian application (u/s 11A, the Patents Act, 1970) reads as –

"A compound of the general formula (I) or pharmaceutically acceptable salts, hydrates, solvates, crystal forms or diastereomers thereof is described. A method of treating protein kinase-associated disease states using the compound of formula (I) is also described."

Referring corresponding US Patent No. 7,259,179, the disubstituted pyrazine compounds are used to treat protein kinase-associated disorders which result from aberrant protein kinase activity, in particular JAK activity and/or which are alleviated by inhibition of one or more of these enzymes. Further referring that the term ‘JAK’, ‘JAK kinase’ or ‘JAK family’ refers to protein tyrosine kinases which posses characterizing features of JAK1, JAK2, and JAK3.

Cytopia has few other pending applications with Indian Patent Office for drug targets in same class of JAK inhibitors to treat immune diseases and cancer.

1. 1748/KOLNP/2004 – Protein Kinase Inhibitors
2. 845/KOLNP/2006 – Selective Kinase Inhibitors
3. 616/KOLNP/2006 - Azole-based Kinase Inhibitors

In June 2006, Cytopia signed a licensing deal with Novartis to develop JAK3 inhibitor compounds for the prevention of transplant rejection and the treatment of multiple indications of autoimmune diseases. Under the deal Novartis will pay Cytopia approximately $ 9.5 million over three years including an up front payment and research funding. Over the life of deal Cytopia may also become eligible to receive development, regulatory and sales milestones which could total approximately US $ 205 million if an agreed number of multiple indications are successfully commercialized. Cytopia will also receive royalties on product sales.

Cytopia lately announced that its lead JAK2 inhibitor compound CYT387 demonstrated potent activity in cells isolated from patients with myeloproliferative disorders (MPDs). Till date, none of Cytopia’s JAK inhibitors is in any phase of clinical trials, but Cytopia’s anti-cancer lead drug CYT997 has already received IND status by the US FDA and likely to reach phase II trials. CYT997 belongs to class of cancer drugs known as Vascular Targeting Agents (VTAs) and is modified version of another compound CYT490. The application no. 847/KOLNP/2006 for CYT997 is pending with Kolkata Patent Office and was published in the Patent Office Journal in April last year.

Novartis Strategic Move

In a major development, the Thai Government has decided not to issue a compulsory license on anti-cancer drug Imatinib Mesylate after Novartis strategically agreed to provide free Imatinib to cancer patients’ having a household income less than 1.7 million baht (US $ 51,515) per year under the government-sponsored Universal Health Insurance Programme. The drug will be provided free through the Glivec International Patient Assistance Programme (GIPAP) managed by Max Foundation. Describing the agreement as “win-win situation” for patients and the company, Dr. Vichai Chokevivat, advisor to the public health minister and chairman of the Public Health Ministry’s committee on compulsory license, praised Novartis for its decision. According to Chokevivat, the Universal Health Insurance Programme covers 48 million people of Thailand’s 63 million people. He further pointed out two other healthcare schemes – the social security scheme for employees of private companies and the healthcare scheme for civil servants - could afford Imatinib at market price (3,600 baht per tablet) for their patients. This strategic decision will not only allow Novartis to avoid enforcement of compulsory license, but also continue selling patented Glivec to patients in