The Andhra Journal of Industrial News
(An International Electronic Digest Published from the United States of America)
(dedicated to Andhra, My Mother's Homeland)

Chief Editor: Prof. Sreenivasarao Vepachedu
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Issue 51

5110 Kali Era, Sarvadhari Year, Jyestha month
2066 Vikramarka Era, Sarvadhari Year, Jyestha month
1930 Salivahana Era
Sarvadhari Year, Jyestha month
 2008 AD, June





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Patent Exhaustion
In a unanimous decision rendered on June 9, 2008, the U.S. Supreme Court confirmed the continued vitality of the patent exhaustion doctrine — the principle that limits the patent rights that survive an initial authorized sale of a patented item — and expanded the doctrine in two key respects. First, the Supreme Court reversed the Federal Circuit and held that the doctrine of patent exhaustion applies not only to patented products, but also patented methods. Second, the Supreme Court addressed the issue of the extent to which the components sold must embody a patent in order to trigger exhaustion and held that provided the components substantially embody the patent, the initial authorized sale of the components exhausts the patent. The Court was also careful to parse out and disclaim any holding with respect to potential contractual rights of the patent owner, suggesting that while the patent owner could not seek patent damages after the patent is exhausted with the first sale, contractual remedies may be available.

USPTO's Obviousness Guidelines
The PTO's Obviousness Guidelines have the following rules for making an obviousness rejection based on the obvious to try reasoning:
(1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.

Invitrogen has agreed to acquire all of the shares of Applera's Applied Biosystems in a $6.7 billion cash and stock deal.  The Invitrogen/Applera combo, to be called Applied Biosystems, will have $3.5 billion in annual sales and will be based in Carlsbad, CA.  The companies say they'll be able to shave $125 million in costs following the merger. In a release, the company said it would hold a major presence in key areas like genetic analysis, proteomics, cell biology and cell systems.

South Korea Invalidates Pfizer’s Patent
A patent court in South Korea on June 26 ruled in favor of five local pharmaceutical companies involved in a dispute with multinational Pfizer, company officials said.  The court upheld a lower court ruling, which dismissed claims by the global drugmaker that the five firms breached its patent for the cholesterol-lowering drug Lipitor.

The Korean Intellectual Property Tribunal in July last year ruled in favor of the local companies, which include Dong-A Pharmaceutical and Boryung Pharmaceutical. The tribunal invalidated the patent related to Lipitor.  Although the original Korean patent for the drug expired in May last year, Pfizer extended it to 2013 by modifying the patent.

It marked the second victory this month for South Korean drugmakers in patent disputes with multinationals.  On June 9 French drugmaker Sanofi-Aventis lost a lawsuit against Boryung Pharmaceutical over its treatment for colorectal cancer.

An Australian court passed a favorable order for Ranbaxy Laboratories in its patent proceedings against Pfizer with regard to 'Atorvastatin'. The Federal court had ruled that one of Pfizer's patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of Australian patent. However, the court at the same instant delivered the verdict that a proposed Ranbaxy generic product under a different patent infringed Pfizer's basic 'Lipitor' patent.

Pfizer has announced in June an agreement to head off generic competition for its flagship drug until November 2011. The drug maker said that it had settled patent litigation with Ranbaxy Laboratories, an Indian maker of generic drugs that had threatened to market its own version of Lipitor, the world's best-selling medicine. 

As the first company to file with federal regulators to market a generic version of Lipitor, Ranbaxy has rights under the Hatch-Waxman Act to 180 days of generic market exclusivity. During that six-month period, the maker can price generic drugs fairly close to the brand-name version. Prices generally decline sharply when other generic competitors can enter the market.

The settlement agreement does not prevent other generic companies from challenging the Lipitor patent, but Ranbaxy's "first filer" rights in the United States eliminate much of the incentive to do so.  Pfizer currently faces a generic-Lipitor challenge in Canada from Apotex, a drug company in Toronto known for aggressively litigating patent cases. Lipitor is the world's best-selling drug, generating nearly $12.7 billion in 2007 sales and representing a quarter of Pfizer's total $48.61 billion revenue.

Indian Patent Applications
Global and Indian generic companies are in a hurry to seek patents for drug in India, filing applications for process and composition patents. Teva, an Israel based generic company, tops the list, beating Indian and American companies.  Ranbaxy, India's largest drug maker, and Eli-Lily, a US based research company, are next in line filing 225 and 86 drugs respectively. A total of 10,000 applications were received by the Indian patent office recently.

China’s Eyes on GSK
According to China Intellectual Property Office's website, the patients in the country are demanding for compulsory licensing for allowing the domestic companies to manufacture the medicine 'Lamivudine' and market it at a lower price.  The alleged reason behind such demand is supply of Lamivudine during the second half of 2007.  GlaxoSmithKline (GSK) owns the Patent and marketing rights for Lamivudine in China.

Crystalline Form Circumvented
Ranbaxy Labs got the tentative approval from the USFDA to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Ranbaxy is First Para IV filer generic company and is entitled for 180 days exclusivity. Ranbaxy and innovator Roche are in litigation on US6083953 (Expiry: Mar 29, 2015) which covers 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinate hydrochloride (Valganciclovir) in crystalline form as product.  Ranbaxy has designed around the '953 patent by preparing their formulation by amorphous form of Valganciclovir (as patent covers crystalline form). Roche in its complaint has alleged that on stability Ranbaxy product will convert to crystalline form.  Innovator Roche got approval on this product on Mar 29, 2001 for the treatment of Cytomegalovirus and is mainly used for eye infection, on absorption this drug is converted into the body into Ganciclovir by esterase enzymes present in intestine and liver.

Virtual Humans in Drug Discovery
In the not too distant future drug development work will be revolutionized by new computer technology that will "test" experimental therapies on virtual humans, says a new report from PricewaterhouseCoopers. The new computer-based human model will be instantly adapted to represent every disease, says Steve Arlington. And the cost of drug discovery can be cut by as much as two thirds.  That sort of brave new world would engineer a profound change for drug developers, who take years and hundreds of millions of dollars to advance a drug--often finding out in late-stage trials that they don't work as expected. It's also the kind of model that better suits an approaching age of personalized medicine, when a new generation of therapies will be developed that are more narrowly designed to address disease. Another sensible way to change the approval process would be to allow regulators to approve a drug for use in small populations and then expand its use as more data becomes available.

Drug Review Process
On June 13, 2008, the Office of Inspector General for the U.S. Department of Health and Human Services (the "OIG") released its report entitled "The Food and Drug Administration's Generic Drug Review Process." The report outlined the evaluation process for Abbreviated New Drug Applications ("ANDAs") as well as how long the evaluations took from start to finish in 2006. Additionally, the OIG used the report to offer recommendations to the Food and Drug Administration's Office of Generic Drugs ("OGD") regarding how it could increase efficiency and expedite generic drug release. Manufacturers should be aware of procedural changes likely to affect FDA new drug approvals.  Federal law requires that submissions receive a status determination (i.e., approval or disapproval) within 180 days of filing. However, nearly all evaluations required substantially longer to reach completion. Prior to even entering the queue for the various Divisions to evaluate, the OGD spends nearly 60 days simply assessing the completeness of the ANDA. Of 535 ANDAs approved in 2006, the median approval time was 17 months, nearly three times longer than mandated by federal law.

Satyam’s Pharmacovigilence
Satyam Computer Services Ltd. , a leading global consulting and information technology services provider, announced that it has formed an alliance with Sciformix Corporation, a Westborough, Mass.-based, Life Science Knowledge Process Outsourcing (KPO) company, to deliver end-to-end data management services in "Pharmacovigilance."  The partnership addresses the worldwide increase in focus on drug safety, which is leading to increased volumes of adverse events being reported to the regulatory authorities.

Abbott opened its new Formulation Development Center at the company's headquarters in Abbott Park, Illinois. The new facility provides leading capabilities for the formulation of new investigational medicines that have the potential to treat cancer and other deadly diseases. The center's technology and equipment will help enable Abbott to expedite its development programs, potentially bringing innovative new pharmaceuticals to patients faster.  The Formulation Development Center supports programs for both potent (drugs with highly active ingredients that require special handling) and non-potent oral compounds. This includes state-of-the-art capabilities for the safe formulation of potent compounds, such as cancer therapies, that are increasingly becoming more effective at low-dose levels.

Abbott's new facility is focused on transforming complex molecules from the laboratory into tablets and capsules that can be used in pre-clinical and clinical studies to determine safety and efficacy. Formulation is an important step in the research and development process, providing a crucial link between the laboratory and commercial manufacturing. Formulation and process work begins shortly after a candidate molecule is identified. Initial formulations are then refined as more information is gathered through the development process.

The center was specifically designed with cutting-edge equipment and improvements to advance the R&D process, including automated technologies that reduce the time for preparing, producing and refining pilot drug formulations. In addition, all of the equipment in the facility is aligned with the production equipment in Abbott's commercial manufacturing sites, which will allow for rapid scale-up of production as drug compounds move toward late-stage clinical trials and market availability for patients.

Generic Escitalopram for Depression
Lupin Pharmaceuticals, Inc. (LPI) announced that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (USFDA).  Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008, based on IMS Health sales data.

Sanofi Donates Vaccine
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced its commitment to donate 60 million doses of H5N1 vaccine to the World Health Organization (WHO) over 3 years for the establishment of an H5N1 vaccine global stockpile.

Influenza is a disease caused by a highly infectious virus that spreads easily from person to person, primarily when an infected individual coughs or sneezes. An influenza pandemic is a global epidemic of an especially virulent virus, newly infectious for humans, and for which there is no preexisting immunity. This is why pandemic strains have such potential to cause severe morbidity and mortality. The H5N1 viral strain has been identified by global health authorities as being a potential cause of a pandemic. In an attempt to minimize the impact of a pandemic, many countries are developing national and transnational plans against a possible influenza pandemic situation. According to the World Health Organization (WHO), there have been 383 cases of avian influenza transmitted to humans since 2003, with 241 resulting in death.

Source: The primary sources cited above,  BBC News, New York Times (NYT), Washington Post (WP), Mercury News,, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP,  Biospace etc.

Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances.

Copyright ©1998-2007
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2007.  All rights reserved.  All information is intended for your general knowledge only and is not a substitute for medical advice or treatment for special medical conditions or any specific health issues or starting a new fitness regimen. Please read disclaimer.

Om! Asatoma Sadgamaya, Tamasoma Jyotirgamaya, Mrityorma Amritamgamaya, Om Shantih, Shantih, Shantih!
(Om! Lead the world from wrong path to the right path, from ignorance to knowledge, from mortality to immortality and peace!)
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