Plavix Patent Settlement Runs into Trouble

US State Regulatory made a knock-out punch to Bristol-Myers Squibb and Sanofi-Aventis, rejecting their patent litigation settlement with Apotex for blockbuster anti-clotting drug Plavix, generically known as Clopidogrel Bisulfate. This move came as federal investigators examine the revised terms of that patent settlement with Apotex in a criminal probe. Bristol and Sanofi filed revised terms last month to the state attorneys general and Federal Trade Commission, who were revising the settlement deal. Earlier, Bristol and Sanofi proposed an agreement in which they would pay Apotex US $ 40 million to drop a patent challenge relating to Plavix, the sixth best-selling drug in the U.S., with annual sales of US $ 3.5 billion. In return, Apotex would launch a generic in 2011, eight months before a key U.S. Patent No. 4,847,265 (the ‘265) covering dextro-enantiomer of clopidogrel actually expired.

35 USC 135(b) (1) Limits Post-Critical Date Claim

On July 17, 2006 the U.S. Circuit of Appeals for the Federal Circuit in the Regents of the University of California v. University of Iowa Research Foundation et al. has affirmed the Board of Patent Appeals and Interferences (the Board) decision that a claim filed more than one year after an issued patent would bar such a claim from the interference under 35 U.S.C. § 135 (b) (1). The appeal was filed by the Regents of the University of California against the Board’s decision to grant University of Iowa Research Foundation et al. motion for judgment under 35 U.S.C. § 135 (b) (1) barring California’s sole claim interfering with Iowa’s U.S. Patent No. 6,207,646 (the ‘646 patent). 35 U.S.C. § 135 (b) (1). A claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted. The ‘646 patent. The ‘646 patent assigned to University of Iowa Research Foundation, Coley Pharmaceutical Group and The United States of America as represented by the Department of Health and Human Services is directed to compositions and their use to minimize allergic reactions. Particularly, claim 3 of the ‘646 patent, the count in the interference, claims a method of desensitizing a subject against the occurrence of an allergic reaction by administering allergen together with an effective amount of an immunostimulatory nucleic acid. California’s Request for Interference The ‘646 patent was issued on March 27, 2001. However, at the time of issuance of the ‘646 patent, California’s Application No. 09/265,191 (the ‘191 application) was pending before the USPTO. California later, on October 31, 2001 (seven months after the ‘646 patent issued) added claims 202-204 to the ‘191 application, and subsequently requested an interference with the ‘646 patent. In that request, California proposed that the interference include two counts, one to the composition corresponding to claims 202 and 203, and the other to the method corresponding to claim 204. In response to California’s amendment, the USPTO rejected claims 202-204 but California continued to prosecute the ‘191 application even after rejection of claims 202-204. Interference by USPTO On May 09, 2002 more than one year after the ‘646 patent had issued, California added another method claim, claim 205, to the ‘191 application. Later, during prosecution California canceled claims 202-204 and subsequently the USPTO declared an interference between claim 205 of California’s ‘191 application and the ‘646 patent. Claim 3 of the ‘646 patent became the sole count in the interference. Iowa’s Motion for Judgment under 35 U.S.C. § 135 (b) (1) During preliminary motions phase of the interference, Iowa filed a motion that claim 205 was not patentable to California under 35 U.S.C. § 135 (b) (1), and as a result of that the Board opted to consider first the 35 U.S.C. § 135 (b) (1) threshold issue. In its decision, the Board found that California filed claim 205 more than on year after the ‘646 patent issued and unless California could link that claim to claims filed within a year of the ‘646 issue date, section 135 (b) (1) would bar claim 205 from the interference. Accordingly, the Board examined claim 205 for material difference from California’s earlier claims, particularly with claims 202-204 and found that California’s claim 205 contained material differences from claims 202-204. The Board concluded that claim 205 could not benefit from the earlier filing date of claims 202-204 and thereby barred under 35 U.S.C. § 135 (b) (1). Accordingly, the Board granted Iowa’s motion for judgment under 35 U.S.C. § 135 (b) (1). California Appealed to CAFC California subsequently made an appeal to the CAFC. However, California does not contest the Board’s finding of material differences between claim 205 and claims 202-204 but instead challenged the Board’s conclusion that the correct inquiry under 35 U.S.C. § 135 (b) (1) asks whether claims 202-204 contain material differences from claim 205 and not whether claims 202-204 are to the same invention as claims in the ‘646 patent. In its appeal, California argued that when it filed claims 202-204 within a year of the issuance of the ‘646 patent, it “discharged” its duty under section 135 (b) (1), and that section 135 (b) (1) no longer bars any subsequent claim filed in the ‘191 application. California asserted that the proper 135 (b)(1) test requires the Board to confine its analysis to pre-critical date claims, where the “critical date” is the date one year after the issuance of the patent relevant to the section 135(b)(1) analysis. Test to Determine Material Differences In re Berger, 279 F.3d 975, 980 (Fed. Cir. 2002), the court while applying section 135 (b) (1) ruled in the favor of the Board. In Berger, the appellant had copied a claim from the Muller patent more that one year after the patent has issued, and later amended his application to add the copied claim as new claim 7. The Board affirmed the examiner’s rejection of claim 7 under section 135 (b) and further explained that the rejected claim contained material differences from claims 1-6, which were on file before the critical date. On appeal, the court assessed the correctness of the Board’s test to determine whether the earlier claims 1-6 supported claim 7. In Corbett v. Chisholm, 568 F.2d 759 (CAFC 1977), the court explained that “to establish entitlement to the earlier effective date of existing claims for purposes of the one-year bar of U.S.C § 135 (b), a party must show that the later filed claim does not differ from an earlier claim in any ‘material limitation.’” In Cryns v. Musher, 161 F.2d 217 (CCPA 1947), the court permitted a party confronted with a section 135 (b)(1) bar to show that claims filed after the critical date find support in claims filed before the critical date. If a party can show such support, section 135 (b)(1) will not act as a bar. Relying on Berger, Corbett, and Cryns, the court maintained that California’s position that the relationship between the post- and pre-critical date claims is not relevant to section 135(b)(1) contravenes the weight of precedent. The Court affirmed that the Board has correctly construed section 135 (b)(1).

Bristol Sends Ripples in Indian Generic Market

Bristol-Myers Squibb India Pvt. Ltd. has send a stunning wave in the Indian Generic Market launching its oral antiviral drug --- Baraclude, generically known as entecavir for a whopping price of Rs. 208 per 0.5 mg tablet. However, in India Bristol has priced the drug lower as compared to other markets. Baraclude is an oral anti-viral therapy specifically designed to block the replication of hepatitis B virus (HBV) in the liver and recently approved by the Drug Controller General of India. Last year, in March 2005 Bristol got USFDA approval for Baraclude and subsequently protected by U.S. Patent # 5,206,244 (the ‘244) which will run through October 18, 2010. Price factor further followed an unprecedented move by Bristol stating that Baraclude will not be available at local chemist stores instead patients would have to fax the prescription to a specific Bristol distribution centre for authentication, and will subsequently delivered at the patient’s doorstep. Baraclude is pre-1995 compound disclosed in the ‘244 patent.

U.S. District Court upheld Ramipril Patent, Lupin loses Para IV Litigation

The U.S. District Court for the Eastern District of Virginia has upheld the validity of U.S. Patent No. 5,061, 722 covering King’s top-selling hypertension drug --- Altace, generically known as Ramipiril. Earlier on June 05, 2006, same court granted summary judgment in favor of King Pharmaceutical finding that Lupin’s proposed generic Altace product infringed the ‘722 patent. Later, on June 14, 2006, during trial period, the Court found that the ‘722 patent is enforceable and thereby dismissed Lupin’s unenforceability claims as a matter of law. This litigation was result of Lupin’s Para IV certification challenging the validity and enforceability of the ‘722 patent, and seeking marketing approval for generic Altace before expiration for the ‘722 patent. In July 2005, King jointly with Aventis filed a patent infringement lawsuits in the U.S. District Court for the District of Maryland and the Eastern District of Virginia against Lupin for infringement of the ‘722 patent. Later on February 01, 2006, the Maryland and Virginia cases consolidated into a single action in the Eastern District of Virginia and scheduled for trail on June 06, 2006. Pertinent Case --- Aventis Pharma Deutschland GmbH and King Pharmaceuticals v. Lupin Pharmaceuticals USA, Inc. (D. Md. 2005)

Patent Gurukul to launch next session in September 2006

Mumbai-based Patent Academy --- GNA Patent Gurukul will be launching their next session from September 23, 2006. Headed by Dr. Gopakumar G. Nair, Patent Gurukul delivers one of the finest and exhaustive patent lectures and course modules currently available across the country with well supported case studies and practical mock-assignments. Course will be 6-months Diploma in Patent Law & Practice with emphasis on patentability assessment, patentability criteria, patent prosecution from filing to post-grant opposition, and office actions. In addition, course module also deals with infringement analysis and other litigation issues. Dr. Nair is registered Patent and Trademark Agent with well-established name in Indian IP/Patent industry and unparallel grasp over Indian patent law. He is also visiting and guest faculty to various universities and colleges. The Director of Patent Gurukul --- Dr. Kaushalya Santhanam is a biotechnologist and US Patent Agent who has now established herself as a Patent Consultant and Practitioner in India. Patent Gurukul has various faculties which include dignitaries of IP field, leading attorneys and international visiting faculties. For further information and registration inquires: http://www.patentgurukul.com

Toshiba Sign Patent Licensing Deal with Rambus

Recently Rambus and Toshiba has signed a new patent license agreement granting Toshiba a license to Rambus patents for SDRAM and DDRRAM memory controllers. Toshiba already holds licenses for the use of Rambus’ XDR memory solution, DDR2 interface cells and FlexIO processor bus interface. Additionally, Toshiba has licensed various Rambus serial link interface designs, including those for Advanced Backplane, Fibre Channel and PCI Express applications. Earlier, in April 2006 a Jury of the U.S. District Court for the Northern California awarded $ 307 million as damages to Rambus in patent infringement lawsuit against rival Hynix Semiconductor for infringing Rambus’ U.S. Patents. However, Hynix later appealed the district court ruling. Rambus patent litigation fire starts back in January 2000 when it sued Hitachi for infringing its patents for standard memory chips but later agreed to grant Hitachi a license to Rambus patents under a licensing agreement and thereby terminating all pending litigations. Relevant Cases --- Hynix Semiconductor et al. vs. Rambus, Inc. (Judge Ronald M. Whyte, United States District Court for the Northern District of California, filed on August 29, 2000)

USA Video Technology sued Cable Companies over Video-on-demand patent

USA Video Technology Corporation has recently filed a patent infringement lawsuit in the U.S. District Court for the Eastern District of Texas against several large cable companies including Time Warner, Cox Communications, Charter Communications and Comcast for infringing its U.S. Patent No. 5,130,792 (the ‘792 patent) and seeking fair compensation and a court injunction against further infringement. The ‘792 patent titled “Store and Forward Video System” covers a pioneering breakthrough system and method for providing video-on-demand (VOD) service. Earlier, in April 2003 USA Video Technology sued Movielink for patent infringement in the U.S. District Court for the District of Delaware alleging that Movielink was willfully infringing the ‘792 patent and sought declaratory judgment for both infringement and willful infringement, permanent injunctive relief, compensatory and treble damages. However, on January 28, 2005 District court ruled in the favor of Movielink stating that Movielink is not willfully infringing the ‘729 patent and thereby granting Movielink’s motion for summary judgment of non-infringement. Following unfavorable verdict, USA Video Technology further filed an appeal with the Federal Circuit of Appeals which later in June 2006 upheld the district court ruling that Movielink is not infringing the ‘729 patent. The ‘729 patent is directed to a system and method for transferring a video program for display at a remote location. The application for the ‘729 patent was filed in February 1990 assigned to USA Video Inc. Since, issuance of the ‘729 patent in July 1992, the ‘729 patent seems to be pioneering with about 200 forward US patent citations. Relevant Cases --- USA Video Technology Corporation v. Movielink LLC (Judge Kent A. Jordan, District Court for the District of Delaware, decided on January 2005) USA Video Technology Corporation v. Movielink LLC (Judge Paul Michel, S. Jay Plager and William Curtis Bryson, U.S. Court of Appeals for the Federal Circuit, decided on June 2006)

Watson files Para IV for Loestrin 24 FE

Watson has recently filed a Para IV certification for oral contraceptive Loestrin 24 FE marketed by Warner Chilcott. Watson moved ANDA with US FDA seeking marketing approval for generic Loestrin 24 FE prior to expiration of orange book listed U.S. Patent No. 5,552,394 which run through Jul 2014 contending that the ‘394 is invalid and unenforceable or its generic product do not infringe the ‘394 patent. Subsequently, Watson notified Warner of Para IV certification on June 23, 2006 triggering Warner’s 45 days time limit to launch patent litigation against Watson. As of date, Warner has not commenced patent litigation against Watson. Loestrin 24 FE (a combination of ethinyl estradiol and norethindrone acetate tablets, and ferrous fumarate tablets), is an oral contraceptive drug which is recently approved by US FDA for the prevention of pregnancy.

Alcon Settles Pending Patent Litigations with Advance Medical Opitcs

Under a settlement agreement, Alcon and Advanced Medical Optics Inc. (AMO) resolved all their four pending patent infringement lawsuits in Delaware and Texas covering equipments and methods for performing cataract surgeries and Alcon agreeing to pay a lump sum $ 121 million to Advance Medical Optics. The parties also agreed not to sue each other regarding the patents at issue in pending cases, and cross-licensed patents covering existing features of commercially available phacoemulsification products. Also as a part of the settlement, the parties agreed to a dispute resolution process for future claims before litigation is commenced. Earlier, on December 03, 2003 AMO filed patent infringement lawsuit in the U.S. District Court for the District of Delaware against Alcon for infringement of U.S. Patents Nos. 5,700,240 (the ‘240 patent) relating to Occlusion Mode and 6,059,795 (the ‘795 patent) relating to a fluidics management system. AMO alleged that Alcon’s Infiniti infringed the ‘765 patent and the infinity and the Series 20000 AdvanTec and Everest Legacy phacoemusification machines infringe the ‘240 patent. Subsequently, on January 28, 2004 Alcon filed a patent infringement lawsuit in the U.S. District Court for the Northern District of Texas against AMO and Allergan for infringing of U.S. patents No. 4,832,685 (the ‘685 patent) and 4,935,005 (the ‘005 patent). Alcon alleged AMO’s Prestige and Sovereign phacoemusilification systems and replacement cassettes infringe Alcon’s patents. On December 16, 2005 Judge Jordan of District Court for the District of Delaware found that AMO’s patents related to surgical removal of cataracts were valid and willfully infringed by Alcon and awarded damages ($ 94.8 million) based on lost profits and a reasonable royalty. However, Alcon subsequently moved for JMOL (Judgment as a Matter of Law) and a new trial, and AMO moved for attorneys’ fees, enhanced damages, and a permanent injunction. In denying Alcon’s motions, Judge Jordan in his Memorandum Opinion found that Alcon had waived its right to challenge the verdict on obviousness by failing to make a JMOL motion at the close of evidence, and also held that AMO’s expert on infringement of means-plus-function claims was not required to provide “particularized testimony and linking argument” to show structural equivalence under § 1126. Judge Jordan while awarding treble damages ($ 213.9 million) and attorneys’ fees found evidence of copying and that the Alcon did not conduct an appropriate investigation of AMO’s patents. He also granted AMO’s motion for permanent injunction and Alcon’s motion for a stay pending appeal. Now as a result of agreement AMO and Alcon will request the District Court for the District of Delaware that the judgment and injunction previously entered against Alcon be vacated, and corresponding appeals will be dismissed.

Lundbeck sued Caraco for Lexapro Patent Infringement

H. Lundbeck and Forest laboratories has jointly filed a patent lawsuit in the U.S. District Court for the Eastern District of Michigan against Caraco for infringement of U.S. Reissued Patent RE34, 712 (the ‘712 patent) covering escitalopram oxalate, the active ingredient of antidepressant Lexapro. This lawsuit is result of ANDA Para IV certification made by Caraco with USFDA seeking marketing approval for generic Lexapro product in U.S. prior to expiration of the ‘712 patent which runs through March 2012. Earlier, Lundbeck and Forest sued generic manufactures --- Ivax, Alphapharm and Cipla for infringing the ‘712 patent. However, later in October 2005 Lundbeck and Forest entered into settlement agreement with Alphapharm authorizing Alphapharm as authorized generic. And recently on July 13, 2006 U.S. District Court for the District of Delaware ruled in the favor of Lundbeck and Forest ruling that the ‘712 patent is valid and enforceable and infringed by Ivax proposed generic Lexapro product.

Pune-based drug discovery Co. files US patents for treating diabetes mellitus

Indus Biotech, a Pune-based drug discovery company, has filed a series of U.S. patent applications for a synergistic composition obtained from fenugreek seeds (methi) for treating diabetes. According to the disclosure made in patent applications, composition comprises trigonelline, amino acids, and soluble fiber which are said to be derived from fenugreek seeds which act at the pancreas through potassium channel mediated insulin secretion. Patent application disclosure further cites that the claimed composition leads to increase in the pancreas beta cell mass in a diabetic mellitus, namely diabetic type II, patients and thereby saves patients from a daily dose of insulin injections. Indus has filed three U.S. patent applications published as US20050008716, US20060134242, and US20060153937 covering compositions, process for preparation compositions, and method for treating diabetics. Indus has also filed PCT application having publication WO2004100968 to target large number of countries. However, application of fenugreek seeds in the treatment of diabetic has been traditional known in India.

Black Tuesday: Yet Again Mumbai!

7/11 strikes Mumbai, the financial capital of India, sending a wave of panic among high-spirit Mumbaikers. Within few minutes Mumbai’s core transportation, or better to say Mumbai’s lifeline, came to dead end witnessing a series of bomb blast within a short span of 11 minutes. Like other Mumbaikers I was too on my way to get back home and took 5:55 pm overloaded local train from Elphinstone Road for Kandivali. I think it was around 6:26 pm when my local train was crossing Jogeshwari I heard a loud sound blast and next moment I found myself lying on adjacent railway track. For 4-5 minutes I couldn’t understand what really happened, people were panic and running here and there. It was after few minutes I realized that there was bomb blast in adjacent compartment and impact was that high it scattered whole compartment into parts. Getting back to consciousness I climbed into bombed compartment to help others, at least who are alive at that moment. But it doesn’t take too long for me to lose control over me and I started vomiting and left that place leaving behind one of the worst phase I ever witnessed. Today I am back to work with same spirit and determination but with something stamped in my mind which I would never ever forget in my entire life. Before Tuesday it was always Patent which runs in my mind but post-Tuesday there is something else which I realized that life is very precious which is uncertain. Death can anytime infringe your precious life. May be it was a narrow escape for me but that escape will change my perception for life forever.

Finally, a 'Drug' that Stimulates Discovery!

India has found that amazing drug! Nobody would have expected this. India thrived on “process-patented” drugs since 1970 because of the Patents Act, which supported and legitimized re-engineered drugs. In a way, since 1970, most Indian pharma companies had out-sourced the research and development activity to other countries. It was a very different kind of out-sourcing arrangement: no contracts, no payments, no obligations, and no rights – not even Intellectual Property Rights (IPRs). Riding on someone else’s waves, and feeding on other’s kill, some of the Indian pharma companies had become complacent and laid-back. It was as if they had been inflicted with a disease. They needed a ‘drug’ that could change their thinking and mobilize their creative juices. India had always lagged behind in drug discovery and research. In the global analysts’ mind, India was not regarded as a country that can lead the pharma industry from the front. But, that was then, and this is now.

Give or Take a Billion! Pharma companies globally are investing heavily in research and development (R&D) to develop new drugs that will cure deadly diseases. Though the cost of developing a new drug has soared over the years from $100 million in the 1980s to more than $800 million now, the investment in pharma-related R&D is now higher than ever. According to industry analysts at Goldman Sachs, the total global R&D spending in 2004 had reached $50 billion. Says Clifford C Kalb, Senior Director of Strategic Business at Merck, “The key to sustainable growth is innovation. If we develop breakthrough drugs and focus on the patient, the profits will follow.” US, which is the world’s largest spender on pharma R&D and a global leader in drug discovery, has steadily increased its pharma R&D budget from $2 billion in 1980 to more than $38 billion in 2004. For every dollar spent on health, US spends about 6 cents on research. According to a report by Pharmaceutical Research and Manufacturers of America (PhRMA), the US biotech and bio-pharma investment in R&D went up 12.6% from $34.5 billion in 2003 to $38.8 billion in 2004. This increase in pharma R&D investment in 2004 is about five times higher than that in 1990. Out of the $38.8 billion, PhRMA member organizations invested about $30.6 billion in R&D within the US, while about $8.2 billion was invested in R&D outside US. Moreover, PhRMA member organizations invested about 18.8% of their 2004 domestic sales on R&D within the US. The increased spending on pharma R&D has resulted in the US Food and Drug Administration (USFDA) approving more than 363 new drugs, bio-medicines and vaccines between 1993 and 2003 for the prevention and cure of about 150 various diseases. The bio-pharma has, of late, become the most research-intensive of all industries in the US. Europe is second in the world in pharma R&D spending. Between 1997 and 2002, about 787 foreign investment projects were undertaken in the European bioscience industry. Among European countries, UK and France received the highest number of foreign investment projects in life sciences, while countries like Ireland, Germany, Belgium, and Spain follow closely. The study by PhRMA also revealed that pharma is a highly R&D-intensive sector in the US and UK. Moreover, UK has 7% more ‘R&D rigorous’ organizations (i.e. organizations that spend 4% of their sales on R&D and more than ₤1 million) in 2005 (116) compared to 108 in 2004 and 88 in 2001. It is estimated that the global pharma sector spent about $1.25 billion on R&D for each New Molecular Entity (NME) application approved by the USFDA in 2004, which is four-fold the R&D spending of each NME submission in 1995 (i.e. $317 million). Also, the global pharma R&D spending per worldwide New Active Substance (NAS) launch touched a new high of $2.3 billion in 2004, an increase of 43% over the previous year. Among R&D investments in various sectors, investment in pharma R&D is the highest in the world now. According to CMR International, a research firm that monitors R&D performance of global pharma industry, worldwide R&D spending has soared to a record high of more than $50 billion in 2004. Out of 31 NMEs (chemical and biological) launched globally in 2003, 14 were by US-based organizations, 10 by European organizations, 3 by Japanese organizations, and 4 by organizations in other countries. The cost of drug development is high because the costs of ‘failed’ pursuits are added to the costs of the ‘successful’ marketable drug. According to industry estimates, out of every 10 drugs that enter the clinical trial phase, only one succeeds. Says Nigel Sheail, Global Head of Strategic Alliances and Acquisitions at Roche Pharmaceuticals, “Ninety-five percent of everything we do is going to fail. That’s the nature of pharmaceutical drug development. The really important aspect is how you deal with failures and try to extract the value that’s still there.” Innovation & Research – The Golden Goose of Drug Discovery With the advancement in science and technology, research has become less complex and is now capable of addressing serious challenges in the field of drug discovery. New technologies such as genomics, proteomics, high-throughput screening, and molecular diagnostics are providing the needed versatility for drug discovery research. The emergence of Microfluidics is one such example that has made drug discovery practical and appealing. Microfluidics is not just a research tool, but it is an enterprise discovery platform with the potential to alter the drug discovery process. Microfluidics can transform an organization’s information management, thereby leveraging the efficacy of experimentation process, leading to quicker and shorter innovation cycles. Microfluidics systems are highly powerful and volatile data engines that produce high efficiency and accurate results. Besides pharma companies such as Pfizer, Eli Lilly, Merck, Johnson & Johnson, Wyeth, Takeda, Taisho, Serono, Novartis, Amgen, Millennium, and Sanofi-Aventis, drug discovery technology providers, such as Agilent and Bio-Rad, are also fully exploring the potential of microfluidics in developing new innovations in drug discoveries. Microfluidics enables decentralization of information, which is a vital component of innovation. Microfluidics is a truly breakthrough development that can transform the drug discovery process if deployed properly. Says Kevin Hrusovsky, President and CEO of Caliper Life Sciences, a US-based company that provides unique research tools for drug discovery and development, “Companies that realize the power of this revolution have the ability to retool their discovery engines and experience enormous organizational and scientific advantages.” Industry experts feel that the companies that conduct R&D in innovative ways create new drugs faster. After Ciba-Geigy and Sandoz merged in 1996 to form Novartis, Daniel Vasella, the Chairman and CEO of Novartis, spun-off the company’s research division into a new entity named Novartis Institute for Biomedical Research Inc. (NIBRI), and relocated it from Basel, Switzerland, to Cambridge, Massachusetts. NIBRI focused on development of new drugs for diabetes, cardiovascular, and other infectious diseases. Novartis invested about $2.2 billion in R&D in 1997. Soon, Novartis introduced new drugs and its sales soared to $18.8 billion in 1997, an increase of 10% over the previous year. In a short span of just two years (1996 and 1997), Novartis launched 15 new drugs in the market, which was the highest in the pharma industry. Between 1994 and 1997, Novartis had the highest number of USFDA approved new drugs than any other company. In 2001, the company’s net income increased 8% to $4.1 billion. India Rising and Shining Indian pharma industry, worth about $10 billion, is growing at a robust pace of 8-9% annually and is leading among the Third World countries. The growth of the Indian pharma industry is primarily propelled by exports to more than 65 countries, which contribute about $3.2 billion out of an annual turnover of $5 billion. This is further poised to increase to about $25 billion by 2010. Indian companies’ share in the domestic market too has been steadily rising from about 20% in 1970 to about 70% in 2005. India has also realized the importance of allocating increased budgets to R&D in the wake of the product patent regime. Earlier, Indian companies invested only around 1% on R&D, but are now investing whopping amounts on R&D. In 2003-04, the top 10 Indian pharma companies spent about $400 million on R&D. In 2004, Ranbaxy invested 7% of its $ 1 billion sales on R&D, while Dr. Reddy’s Laboratories (DRL) spent 14% of its sales of $ 446 million on R&D. With the advent of the new product patents from January 2005, India is now facing the best of opportunities and the worst of threats. First, the threats: Foreign companies with huge technological muscle and deep hard currency pockets may develop better drugs faster and patent them in India, enabling them to occupy the shelf-space of medical shops/drug stores, and the mind-space of medical practitioners. There is also the threat of litigations and the costs and damages that can wipe out the smaller pharmaceutical companies. Then, there are the opportunities. Indian pharma industry is now poised to take full advantage of the size they have achieved with the help of process patents. Without doubt, India is a huge market (1.1 billion potential local patients) for a high intellectual capital and capable work-force, a full data-base on drug research till date, and a low cost of drug development and clinical trials. India can also seize the opportunity of out-sourced manufacturing and also out-sourced drug development and clinical trials. According to Syngene, India’s highly successful contract research firm for pharmaceuticals, the cost of doing R&D and introducing a new molecule in India is $100-200 million, which is five times lower than the cost involved in new drug discovery in a developed country ($500-900 million). Out of the global contract research that accounts for $30 billion, a significant share is expected to be captured by India. Moreover, pharma companies globally spend $8-10 billion on clinical trials. India, which accounts for $20 million of outsourced research, is expected to grab $2 billion over the next decade. Order! Order! The current state of patent offices in India may not be fully equipped to facilitate the needs of the Indian pharma industry. India has less than 1,000 registered Patent Agents as per the Indian Patent Office records. Out of this, an estimated 50-75% is directly enrolled from law background. The availability of Patent Attorneys in the pharma sector in India is very low due to the negligible number of experienced Patent Agents/Attorneys and law firms dealing with Intellectual Property. The numbers are very meager when compared to USA and UK. USA has more than 30,000 patent agents/attorneys, while UK has 3,000 members, including 1500 registered patent agents/attorneys in the list of Charted Institute of Patent Attorneys. Moreover, as compared to about 6,000-7,000 Patent Examiners in other countries, India has only about 750 Patent Examiners. Because of the mismatch between the demand and supply of good patent attorneys, patent agents and IP firms in India, many small pharma companies may not be fully aware about the IP issues and may face litigations in future. According to American Intellectual Property Law Association (AIPLA), the median patent litigation costs in the US (excluding the cost of obtaining a patent), with $1 million to $25 million risk, was $1.5 million in 2001, which increased to $2 million in 2003. With the increase in the risk amount, the litigation costs also increase proportionately. The patent litigation costs of risks more than $25 million went up from $3 million in 2001 to $4 million in 2003. In India, the patent litigation cost in 2003 in a lawsuit involving Ranbaxy and Pfizer for Pfizer’s anti-cholesterol drug Lipitor, was estimated to be $2 million. According to a study in 2005 by James Bessen and Michael Meurer of Boston University School of Law, patent litigation is the costliest of all lawsuits, and firms engaged in patent lawsuits lose about 3.1% of their stock market value, which on an average amounts to $20 million. This loss comprises the general cost of the lawsuit including the loss of business and related risks which the company confronts. In the US, the number of patent infringement litigation cases soared from 1100 in 1991 to 2600 in 2002. Given the trend, the increase in patent litigation cases is bound to increase further. In UK, the median cost of full scale patent infringement litigation is between ₤80,000 and ₤500,000, which may further go up depending on the complexity of the case. The cost of obtaining an emergency injunction against a patent infringer is about ₤30,000-₤60,000. Patent litigations may not necessarily bring down the R&D investments of pharma companies in India as seen by the trend of Ranbaxy. Though Ranbaxy incurred a loss of $20.2 million (Rs.10.77 crore) in the third quarter ended September 30, 2005, yet it increased its R&D spending by 79% compared to the previous year. Indian companies, however, are not shying away from litigations and are boldly fighting it. This demonstrates the fact that Indian companies are open to litigations and the R&D budgets will in no way be affected by the litigations. Says Raghu Cidambi, Head (Corporate IP), Dr. Reddy's Labs, "Patents are top of the mind for discovery-driven companies like ours and Ranbaxy.” Indian pharmaceutical companies face the risk of litigations only for those drugs, which are registered in India within the stipulated time, and have unexpired patents, and which do not have any existing process patents in India. If any of these criteria is not met, the question of litigation may not arise at all. But, it is essential to perform a patent analysis/mapping for a company’s newer drugs to ensure that infringement is ruled out, thus avoiding litigations. Patent litigations are very expensive, and the damages are exorbitant. Companies in the process of acquiring other companies should thoroughly investigate the drug offerings to avoid any potential litigation. IPR valuation becomes essential in assessing the right price of the acquisition. The Wonder Drug With the threat of litigations on one hand, and the opportunity of own patented drugs and resultant revenues on the other hand, India is making progress by leaps and bounds. What India needed to invoke the impetus, to ignite the fuel, and to spark the fire has finally arrived! The product patent regime (2005) has proven to be the ‘drug’ that has stimulated Indian pharma industry to rise and shine, to invent, innovate and discover, and to, once again, lead the action in the global arena.

Today's post comes from M. Qaiser & P. Mohan Chandran with iPrex Solutions, Hyderabad. Copyright © 2005, iPrex Solutions.

Google’s Patent Muscle! Why?

Even the world’s leading online search company --- Google aggressively protects its innovative features using unparallel patent muscle. Google which is almost twice as large as rival Yahoo! has strategically and timely patented their revolutionizing online search and advertising features such as PageRank (assigned to Stanford University) (U.S. Patent # 6,285,999), highlighting search results (U.S. Patent # 6,839,702), information extraction from databases (U.S. Patent # 6,678,681), and recently voice-based search (U.S. Patent # 7,027,987). Recently in March 2005, Google has filed a U.S. patent application based on organic search results (U.S. Publication No. 20050071741) which is expected to change Google’s future strategy for search engine ranking position (SERP) which, in fact, has became a matter of concern among Search Engine Optimizer (SEO) companies. From last couple of years whenever Google moves ahead with patent filing or obtains U.S. patent, its patent/patent application become matter of debate across the IT industry, particularly online-based. Why? Answer is straight and simple because Google’s Patent Muscle means business. Every single patent/patent application obtained or filed by Google reveals its future move to transform future online search and online advertising business and to maintain its market dominance and supremacy. In future, I will keep posting some interesting posts on patents obtained or patent applications filed by Google which exhibits their strategy to protect its intellectual creations which not only impact online culture but also helped Google to maintain its world wide excellence and to establish them as a Pioneer in online business.

Barr sued over Razadyne Patent infringement

Janssen Pharmaceutical N.V., Janssen L.P., Ortho-McNeil Neurologics Inc. and Synaptech has brought patent infringement lawsuit against generic drug maker Barr in the District Court for the District of New Jersey for infringing their Orange Book listed U.S. Patent No. 4,663,318 for Razadyne ER, generically known as Galanthamine hydrobromide extended release. This lawsuit is result of Para IV certificate made by Barr with FDA for Galanthamine extended release capsule in 8mg, 16mg and 24mg strengths. Earlier a year back, Barr was sued by same companies for Galanthamine immediate release which is still in progress.

35 USC § 102(b) Not Only Confined to Published Matter

In one of the major development, the United States Court of Appeals for the Federal Circuit (CAFC) held that unpublished patent documents “removed” during prosecution before Patent Office will also constitute prior art and subsequently upheld the District Court’s summary judgment of invalidating U.S. Patent Nos. 5,567,085 (the ‘085 patent) and 5,820,301 (the ‘301 patent) based on the same “removed” subject matter on the grounds of obviousness. CAFC revisited 35 USC § 102(b), enlarging the scope of prior art to include the contents of the file wrapper as to constitute a printed publication for the purposes of 35 USC § 102(b). In Mark Bruckelmyer v. Ground Heaters (CAFC 05-1412), the court decided that abandoned drawings of Canadian patent application were “publicly accessible,” because the file wrapper could be located from the published patent and sufficiently accessible for public inspection at the Canadian Patent Office. To recap, Mark Bruckelmyer obtained two US patents --- the ‘085 and ‘301 patent, for method of thawing frozen ground so that a layer of concrete can be laid on top of the ground and later on July 15, 2002 filed a patent infringement suit against one of his former licensees – Ground Heaters in the District Court for the District. In response Ground Heaters filed a counterclaim challenging the validity of the ‘085 and ‘301 patents and on December 19, 2002 filed a motion for summary judgment of invalidity based on figures 3 and 4 of the Canadian patent application (the Application) which were omitted during prosecution subsequently leading to Canadian Patent No. 1,158,119 (the ‘119 patent). The court denied Ground Heaters’ motion for summary judgment of invalidity upon finding a genuine issue of material fact regarding whether a person of ordinary skill in the art would have been enabled by figures 3 and 4 to practice the technology claimed by the ‘085 and ‘301 patents without undue experimentation. However, while denying summary judgment, the court determined that figures 3 and 4 omitted during prosecution but continue to exist in the file wrapper of the ‘119 patent was a “printed publication” under § 102(b) and concluded that “the contents of the file wrapper were sufficiently accessible to the relevant and interested public as to constitute a printed publication for the purposes of § 102(b).” In view of the court’s determination that omitted figures 3 and 4 of the Application constituted § 102(b), Bruckelmyer filed a stipulation in the court conceding that omitted figures rendered the claims of the ‘085 and ‘301 patents invalid. However, in doing so, Bruckelmyer removed from dispute any question of fact as to whether omitted figures were enabling to a person of ordinary skill in the pertinent art. Following Bruckelmyer move, Ground Heaters filed a renewed motion for summary judgment of invalidity and which was later granted by court on May 13, 2005. Bruckelmyer subsequently appealed to the CAFC. The single issue of Bruckelmyer’s appeal was whether the two omitted figures 3 and 4 of the Application were “printed publications” under § 102(b). Bruckelmyer’s Rationale – Not indexed or Catalogued Bruckelmyer asserted that a reference to be a “printed publication” it must be “publicly accessible” and contended that a patent application located in a foreign patent office is not “publicly accessible” just because it is laid open for inspection by the general public during the relevant prior art time frame. Bruckelymer further elaborated, relying on previously decided CAFC decisions, that for a prior art reference to be considered “publicly accessible,” it must either (1) be published to those interested in the art for a sufficient amount of time to allow them to “capture, process and retain the information conveyed by the reference, or (2) those interested must be able to locate the material in a meaningful way.” Bruckelmyer asserted that the Application did not meet the either criterion, and thus it was not “publicly accessible.” Bruckelmyer further stated that there are no evidence produce by defendants that the contents of the Canadian file wrapper had been disseminated and no copies were known to have been made and sent elsewhere during the prior art period. Bruckelmyer contended that because Canadian Patent Office did not index or catalogue the Application, and because no printed abstract of the Application classified and published, a person of ordinary skill in the art would not have been able to locate omitted figures 3 and 4 in a meaningful way. Further, Bruckelmyer argued that the ‘119 patent itself would not have guided a person of ordinary skill in the art to locate figures 3 and 4 because the figures were “removed” from the Application during prosecution. Ground Heaters Counter Attack Ground Heaters responded that even though the Application was not formally indexed, a person of ordinary skill in the art would have been able to locate the figures contained in the Application through the published ‘119 patent. Ground Heaters further argued that the statement made in the ‘119 patent that: “the claimed system is suitable for applying heat to other objects and is not necessarily confined to use in relation to concrete placement. Other typical uses are: … thawing frozen ground” would have led one skilled in the art to the Application, and hence to figures 3 and 4. Moreover, Ground Heaters contended that the ‘119 patent was indexed and catalogued according to its subject-matter, and the Application was in the file of the ‘119 patent in the Canadian Patent Office, and thereby, the Application was also, as a practical matter, indexed and catalogued. CAFC --- Expanding Scope of “Printed Publication” The CAFC affirmed the District Court’s ruling of patent invalidity, holding that the Canadian Patent Application was “publicly accessible”, and thus that it was a “printed publication” under 35 USC § 102 (b). The CAFC maintained that a given reference is a “printed publication” when it was “publicly accessible” during the prior period, quoting ICE Corp. v. Armco Steel Corp. 250 F. Supp. 738, 745 (S.D.N.Y. 1966) which hold that a reference is “publicly accessible” upon a satisfactory showing that such document has been disseminated or other wise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation. Relying on In re Wyer, 655 F.2d 221 (CCPA 1981) where the existence of a published abstract that would allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office were central to the Court’s decision, the CAFC concluded that the Application was “publicly accessible” and further found that the published ‘119 patent is even more of a roadmap to the application file than the abstract was in Wyer. The CAFC also contended that it does not matter whether the Application was catalogued or indexed “in a meaningful way” because the ‘119 patent was indexed and could serve as a “research aid.” Dissenting Opinion Judge Inn in his dissenting opinion finds that “it is not entirely sound to view the issued ‘119 patent as a roadmap to the underlying file history.” He further noted that an indexed abstract is a brief statement of the contents of the more comprehensive work, while an issued patent is not necessarily looked as a summary or index of the underlying file history. He also argued that the removed figures had not been “catalogued or indexed in a meaningful way” because there was nothing in the text of the issued ‘119 patent to suggest that a disclosure of structure for implementing the “thawing frozen ground” use will be found in the Canadian File Wrapper.

Zoloft goes off-patent, Greenstone to launch Authorized Generic

Ivax has launched its generic Zoloft as Sertraline hydrochloride, active ingredient of Zoloft, went off-patent on June 30, 2006. After Zocor (Simvastatin) and Proscar (Finasteride), Zoloft is another blockbuster drug which losses patent protection this year with Ivax to enjoy 180-day marketing exclusivity. However, in another development Pfizer’s subsidiary Greenstone Ltd. is all set to launch Authorized Generic of Zoloft to compete Ivax’s generic version during 180-days marketing exclusivity period. After Merck authorizing Dr. Reddy’s to launch authorized generics of Zocor and Proscar, Pfizer's move doesn’t come as a surprise to generic players. Amidst of these developments, its time for Indian Generic players to go Dr. Reddy’s way, that is, be an Authorized Generic. Don’t you think its better way to take away U.S. generic share?