Happy Diwali 2008

Patent Circle wishes all its readers a very happy, prosperous and peaceful diwali.

Novartis to Defend Mylan’s Paragraph IV for Fluvastatin

Swiss-drug major Novartis has filed a lawsuit in the US District Court for the District of New Jersey against Mylan Pharmaceuticals Inc. for infringement of Orange Book listed US Patent No. 5,354,772 (the ‘772 patent) for Lescol capsules, generically known as Fluvastatin Sodium. The infringement suit is result of Mylan’s submission of an abbreviated new drug application (ANDA) with paragraph IV certification for the Lescol capsules earlier in June 2008. Mylan believes that it is first to file ANDA for the product. Fluvastatin is indicated for the treatment of high cholesterol and had US market sales of approximately USD 60 million for the twelve months ending June 20, 2008 according to IMS Health.

Absent Innovation Culture, Disowning and Other Dangerous Things

If you remember Prof. George Lakoff, by reading this title, you are right. This renowned linguist wrote a book entitled “Women, Fire and other dangerous things” where he addressed interesting aspects of categorisation. I wouldn’t elaborate on it here. The book must be read in original though. This I mentioned since I borrowed Prof. Lakoff’s style.

Present text is about the attendant hue & cry about so called corruption in Indian patent office. This tempest was set in by a small butterfly article fluttering its wings in the Mint.

What is on record is that about 130 patent examiners in Indian Patent office helped grant about 15000 patents in one year (2007-08). This has been compared to EPO statistics where 4000 examiners helped grant 54000 patents in a year. An inference is drawn without any evidence on record that the system is greased with money which makes so many applications go through smoothly.

One wonders if this is fair to so many serious examiners who might be doing their jobs right without ‘extra cash’ as a carrot. I am not saying that all is well in Indian patent offices. In fact a couple of months back, I almost fainted after receiving an answer from a guy in Patent office’s library whom I asked if Dr. Mashelkar visited there in recent past. He coolly told me to leaf through the visitor’s register there kept in a corner in which all library visitors wrote their names. He just didn’t know who Dr. Mashelkar was. But by quoting this example I wouldn’t generalise that whole office staff is absolutely ignorant.

Likewise for a few examiners who might be part of dangerous liaisons during some part of grant process, I would not condemn the whole system. It ain’t cricket!

India might be having patent protection mechanism since 1911 but patent awareness is of recent times. If Britons are to be credited for installing this system, they may not shrug off the dire failure in teaching technocrats patentese and for failure in sowing the seeds of innovation culture.

The innovation culture is just absent here. Indians traditionally are just not into observing, documenting and using the surroundings for their material well being. If I write that science culture itself is absent, I might invite an avalanche of criticism. But I will tell you something. Although I have used the word ‘canary yellow precipitate’ several times while describing an outcome of certain chemical test, I have not seen Canary till now. I even didn’t know for quite long that this was name of a bird found in western countries and not sighted at all in India. Indians get science educated in a setting where the teachings are not internalised. Above example can be contrasted with my own experience when I was TA'ing in North America. There I came across a stunning visual description of a chemical reaction product which ‘looked like a rotten beer” to an undergrad in my lab. The product really looked like a rotten beer. The pragmatic thinking of west didn’t grow overnight. West has had a long tradition since renaissance period. Indian renaissance may be dated to 1947 the year of freedom.

Now the inventors and patent examiners are also product of this culture where ‘innovation is not intrinsically respected’. Property is hated, owning something is just a matter of following grand design. ‘Disowning’ is great. “Obedience” has to be inculcated. These are the memes we in India have grown-up with.

Corruption if any (and it could be there) would be just a symptom of several dangerous & deep seated issues. Now Indians can’t claim monopoly on corruption. It will be very naïve to eliminate incidences of corrupt practices in patent offices of other countries.

If I were a Patent Examiner with a target of finishing at least 10 applications per month alongside attending several training sessions, I am better off going by what Assistant Controller allows. I won’t venture being a maverick. I wouldn’t see many mavericks upstairs too, so why set an example which will not benefit me? Moreover, why should I risk my career for the so called inventors who are busy in exploiting consumers? I am good in handling language, good in referring to the patent manual & have several applicants or their representatives eager to give me free ego trips. I wouldn’t do knit-picking what others afford to do sitting in easy-chairs ; I would just do my job because that’s my choice, last year when I visited Vaishnvi devi or Nasik an year before ; I thanked god for the bread & butter provided to me. I would rather carry on with this job, enjoy whatever ego gratification it provides without worrying about fancier pastures. I have done fairly well for my background. I am doing OK. Nothing earth shaking is happening around me. These big inventions and that entire publicised innovation news item are good as a read with a glass of fruit juice I have begun to afford these days. Nothing can be innovated, it is already with you; it is only resurrected. I cannot maintain few properties I have. Many times I think they are not mine, it is my luck that I am blessed with the material wealth I have. Things are fine the way they are. It is all pre decided.

I do not think quixotic expectations from Patent Examiners will lead to quality enhancements overnight. A person in the system is a part of the society he/she comes from. If managing more than one house, civil properties is difficult, one just can’t be expected to know the prowess of intellectual property & to know how wealth could be generated through it across the borders. It is not far stretched.

Where Innovation culture is absent & distributing something to everybody like ‘Prasad’ is commonplace, claiming ownership on the technological advances is difficult to digest. This again is not far stretched.

The persons who are not serious about respecting innovative activities, who do not respect ownership on intellectual property and who will not assert at right place on right time, will not be able to function properly as the facilitators of innovative culture.

One just can’t say - “I want these examiners to follow the Manual verbatim, if you can’t get the job done, clear the place”. The examiners are not robots.

One has to address this issue in holistic manner to attain desired goal of honest & transparent system. Smartly worded and ill founded criticism without deep analysis will only harm the system. There are better ways of catching attention than putting examiners/agents in a corner and squandering accusations.

Good structured training, adequate patience and empathy will help the examiners at various stages on the learning curve. It is surely understandable that we expect exquisitely drafted FER, a prudent application of law and overall a well home- worked boldness in performing on this extremely important position. But it is going to take time.

Patent examiner being part of the absent-innovation-culture will not feel the sanctity of patent law.

Dr. Uday Gokhale Joins Patent Circle Family

We’re happy to welcome Dr. Uday Gokhale to join Patent Circle family as a co-author. He is an organic chemistry with Ph.D. from University of Alberta. He has rich 20 years of professional experience in bioorganic and pharmaceutical field and has been involved in new product development activities with repute companies including Ciba-Giegy, Glaxo and Boots. He is presently been retained as an advisor by pharmaceutical companies for intellectual property issues, technology know-how and cGMP.

Roche Cuts Price of Tarceva in UK

After UK’s National Institute for Health and Clinical Excellence (NICE) agreed to pay for Roche’s anticancer drug Tarceva on the condition that Tarceva should matched the price of an older, less costly remedy Taxotere, Roche discounted Tarceva by about $ 1000 in order to bring the cost in line with Taxotere (Docetaxel) marketed by Sanofi-Aventis. Earlier, NICE ruled that four drugs used to treat kidney cancer – Roche’s Avastin, Bayer’s Nexavar, Pfizer’s Sutent and Wyeth’s Torisel – are not cost effective for treating advanced or metastatic kidney cancer and should not be prescribed to new patients. However, NICE decision caused outrage among charities and patients. Importantly, there are reports (link 1, link 2) that Tarceva is significantly improved medication in prolonging life and quality of life.

Tarceva UK’s development is an example of fair negotiation between Health Agency and Innovator. Access to life-saving drugs at reasonable price can only be possible if there is constructive platform for mutual discussions between drug agencies and innovators. Not only innovators have resources to improve quality of life but also a moral responsibility that their drugs should reach across the globe to the patients who are in need of them. Reciprocally, Government should also make policies to safeguard business interests and provide incentives to innovators in brining effective and life-saving drugs.

Post-Approval Study Revealed Tarceva Causes Deaths

Last month the US Food and Drug Administration published a notification submitted by OSI and Genentech bringing in notice about severe cases of liver damage among patients who look cancer drug Tarceva, as part of a post-approval study designed for patients with moderate liver impairment and advanced tumors. According to the notification, one patient died from rapidly progressing liver failure and another died from a liver complication called hepatorenal syndrome. Genentech spokesperson said that the label information will now include a stronger warning about liver damage and fatalities. Erlotinib was approved by the US FDA, after priority review, in November 2004 and later received marketing approval in India on July 13, 2005.

In January, Cipla launched the generic copy of Tarceva and was sued by Roche for infringement of patent in the Delhi High Court. High Court is already done with the hearing and verdict will be announced in near future. However, the incident of deaths caused by Tarceva raises an important question about the generic approval of newly approved drugs for which post-approval study is still under progress. Do Indian drug regulators need to have strong guidelines for post-approval study for newly approved drugs, particularly life-threatening diseases before giving marketing approval for generic drugs? At least such initiative will minimize the risk of Vioxx-like debacle.

Invitation for Co-Authors

We are looking to expand Patent Circle family and in respect would like to invite people interested in joining Patent Circle as a co-author. We are particularly interested in people with keen and analytical understanding of patent and intellectual property issues and can blog on legal, technical or even business aspects of patents and intellectual property. We also invite co-author from other countries, particularly China, US, Australia, Europe, Germany and Brazil in contributing to make Patent Circle the first global patent law blog.

We are sincerely working to scale this blog to the global platform for reliable source of patent news and reporting. Patent Circle has a fairly wide readership in India and across the global and mostly read by patent practitioners, R&D scientists, students, in-house counsels and print media. So if you are interested to be part of Patent Circle family and contribute in building globally regarded patent law blog, please write to us @ chhonkar.varun@gmail.com.

FICCI to organize One Day Training Programme on Patent Litigation

FICCI-IPR division in association with Indian Patent Office (IPO) and European Patent Office (EPO) with a leading European Law firm Kilburn and Strode is organizing a one-day industry specific training program on “Prosecuting and Litigating Patents in Europe and India” at FICCI, New Delhi on 24th October 2008 with an aim to share with each other the best practices.

The focus of the workshop is to make Indian Industry aware about prosecuting/litigating patent applications in India/Europe and to learn about the best practices being adopted by each patent office. The programme will also help in understanding the legal landscape so as to learn the ways of enforcing one’s Intellectual Property against the infringer.

Patent Circle personally views that this programme would be of tremendous help to not only those who are IP professionals but also for those who intend to build their career in the IPR field. This is the right platform to get in touch with not only senior officials from Industry and Indian Patent Office but also with the officials from European Patent Office. We are particularly grateful to FICCI and Sheetal Chopra (Senior Assistant Director, FICCI) who has agreed to give 30% discount in fee for the readers of Patent Circle who would like to participate in this one day training programme. We request our readers interested for participation to mention “Patent Circle” as a source of programme information.

The invited speakers for the program are expert Patent Examiners, Controllers from Indian and European patent office; Patent Attorneys and Litigators from the leading Law Firms, who have extensive years of experience in their professional fields. This program will be attended by Legal practitioners, Industry professionals, academicians and IP outsourcing organizations.

The programme copy, brochure and response proforma can be downloaded from the following link. For further details you can get in touch with Ms. Harinder at harinder@ficci.com (Ph: 23738760 (ext: 368), 23766930, 9910734340, Fax No. 91-11-23765333, 23721504) or with Mr. P L Sharma (Ph: 23738760 (ext: 212), Fax No. 91-11-23765333, 23721504).

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.