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Contents
Inventor
Sues USPTO
Lipitor Stents and Jobs India Update: The challenge to section 3(d) Knowledge Process Offshoring (KPO) GM Layoff
Galantamine Hydrobromide Famvir® (Famciclovir) Lanreotide Acetate Evithrom (human thrombin) Inventor Sues USPTO The USPTO has published amended, final patent rules that will take effect on November 1, 2007, limiting the use of continuing patent applications and requests for continued examination that can be filed during patent prosecution. The new rules limit the number to five independent claims and 25 total claims that may be presented in an application family that contains patentably indistinct claims. If these numbers are exceeded, applicants must file an Examination Support Document (ESD) prior to a first Office Action (OA). A restriction requirement is not considered to be a first office action although it may be included with a first OA. The 5/25 claim rule is not limited to applications filed on or after November 1, 2007. It is applicable to all pending applications that have not received a first OA by that date. The PTO has heightened the standard for a claim to be considered a dependent claim by requiring incorporation by reference of all the limitations of the claim to which it refers and requiring the claim to specify a further limitation of the subject matter of the previous claim. Claims that do not meet these standards will be considered independent claims and count against the limit of five. The rule changes were intended to cut down the backlog of applications in its queue, but which also has IP attorneys and inventors on edge. As a result, the Patent and Trademark Office was sued by an inventor. Dr. Tafas argues the changes suppress scientific progress and violate the Patent Act and the U.S. Constitution. Tafas invented a high throughput diagnostic microscope sold through his company, Ikonisys. He also has a patent pending on a method for improving automotive efficiency. Tafas protects these inventions through patents and has now sued the USPTO. Tafas asks the E.D. Virginia District Court for a declaration that the PTO’s newly finalized rules are in conflict with the Patent Act and are thus invalid. The proposed amendment to Section 284 may leave patent holders who wish to obtain enhanced damages for pre-litigation willful infringement open to the risk of being sued first by the accused infringer, say some attorneys. Changes to Continued Examination: http://www.patentlyo.com/patent/Continuation_20Changes_20Final_20Rule.pdf A new set of proposed Markush rules were published in the Federal Register on August 10, 2007. Highlights: An intra-claim restriction is proper unless all species share a feature that is substantial and essential for common unity. A claim may not incorporate part of the specification by reference unless absolutely necessary. Markush alternatives must be substitutable; may not encompass other alternatives; may not be a set of further alternatives; and must not make the claim difficult to construe. http://www.patentlyo.com/patent/2007/08/new-proposed-ru.html http://www.patentlyo.com/patent/Markush_20Rules.pdf Lipitor The U.S. Patent and Trademark Office dealt Pfizer Inc. another blow in the company's ongoing fight to hang onto its patents to the world's best-selling drug, cholesterol treatment Lipitor, when it rejected the drugmaker's bid to extend one of the patents. Stents and Jobs Drug-oozing heart stents became the fastest-selling medical device in modern history, and a cash cow for Johnson & Johnson and Boston Scientific Corp., because of the device's ability to prevent scar tissue from forming new blockages after artery-clearing surgery. The U.S. market peaked at $3.1 billion in 2005, when the global market hit $5.2 billion, according to Toronto-based Millennium, which surveys hospitals performing artery-opening surgery called angioplasty. In about four years, some six million people worldwide were implanted, a modern record for medical devices. But the market reversed course in mid-2006, after research indicated drug-coated stents slightly raise the risk of life-threatening blood clots months or years after they're implanted, unless people stay on an anti-clotting drug. The safety questions about the stents have triggered steep sales declines and job cuts for the makers, and are expected to shrink the U.S. market by one-third this year, a $1 billion drop just four years after the tiny gizmos were introduced. J&J is cutting nearly 5,000 jobs due in part to a stent decline after studies questioned the devices' safety and effectiveness in preventing heart attacks and bypass surgery. Boston Scientific is preparing its own cuts after its stock hit a five-year low and its credit rating sank below junk-bond status. India Update: The challenge to Section 3(d) On 6 August, the High Court in Chennai dismissed the writ petition challenging the constitutionality of Section 3(d), and deferred to the World Trade Organization (WTO) to resolve the TRIPS compliance question. It appears that the case has created a lot of publicity about this section of Indian patent law. However, Novartis has to go for the real battle before the WTO. Section 3(d) Explanation: 'For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.' Many people believe erroneously that Novartis' appeal is an attempt to restrict the availability of medicines to people who may not be able to afford them, conveniently forgetting the fundamental fact that new drugs need protection to encourage innovation which in turn creates much needed new drugs for everybody. Generic manufacturers should not be able to cheaply produce copies of patented drugs to supply the large market in India or elsewhere. In this particular case, new polymorph of Glivec is one of the many drugs available for the same disease including Glivec generic version. Novartis patent for Glivec polymorph would not preclude local manufacturers from producing generic versions of the previous formulation. Now that the earlier version of Glivec has become generic, Novartis developed a polymorph, which has a better bioavailability that should be protected by a patent. Obviously, bioavailability increases efficacy required under section 3(d) of Indian Patent Law. However, if the Indian law doesn't recognize bioavailability and such polymorphs as new patentable entities, Novartis is out of luck. That, of course, sadly will end patenting in India of new polymorphs, salts, ethers etc, unless WTO decides otherwise. Whatever may be the outcome, hopefully, there will be some clarity in Indian law, thanks to Novartis. Knowledge Process Offshoring (KPO) Knowledge Process Offshoring (KPO) involves the offshore outsourcing of knowledge-driven or "high end" processes that require specialized domain expertise, such as R&D, insurance underwriting and risk assessment, financial analysis, data mining, investment research, statistical analysis, tax preparation, engineering and design, animation, graphics simulation, medical services, clinical trials, legal services and more. Unlike the ITO and BPO market sectors, which create cost savings solely through leveraging economies of scale and "rules based" process expertise, KPO accesses the global talent pool to carry out processes that demand specialized analytical and technical skills as well as the exercise of judgment and decision-making. The strategic driver for KPO is to add value by providing high quality business expertise and superior productivity through improved time to market in addition to realizing the traditional cost reductions through arbitrage of labor markets that have made ITO and BPO successful. KPO, a new wave of global outsourcing to India, is following on the heels of the remarkably successful Indian market for information technology outsourcing (ITO) and business process outsourcing (BPO). KPO offers significant potential benefits, but with possible greater reward comes risk, and KPO involves a number of key issues and risks that must be carefully evaluated when considering a KPO transaction in India. Read more here: http://www.mondaq.com/article.asp?articleid=51196&email_access=on Structuring any outsourcing transaction requires careful planning. In today’s environment, outsourcing customers would be well-advised to ensure that their outsourcing transactions are structured to preserve the ability to engage in multi-process outsourcing (MPO) transactions. To preserve such ability, customers should incorporate terms and conditions into their outsourcing contracts that enable ongoing flexibility in their relationships with their outsourcing suppliers. Read more here: http://www.mondaq.com/article.asp?articleid=51186&email_access=on GM Layoff General Motors of Canada Ltd. will cut 1,200 jobs at an Ontario truck plant in January 2008, a move the Canadian Auto Workers Union says shows the effect of slumping U.S. housing and credit markets on the already struggling auto industry. GM Canada spokesman Stew Low said the layoffs were part of the company's plan to keep its inventory in line with production and offset some of the value that was lost as a result of incentive plans. Consumers were in no mood to buy a car this month as they faced rising mortgage payments and roiling financial markets, and some analysts already predict 2007 will be the worst year for U.S. auto sales in nearly a decade. Galantamine Hydrobromide Ranbaxy Laboratories Limited (RLL), announced that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Galantamine Hydrobromide Tablets, 4mg (base), 8mg (base), and 12mg (base). Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Total annual market sales for Razadyne were $130.0 million. Famvir® (Famciclovir) Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis’ Famvir® (Famciclovir) Tablets, 125 mg, 250 mg and 500 mg. The brand product had annual sales of approximately $200 million in the United States for the twelve months ended June 30, 2007, based on IMS sales data. Lanreotide Acetate The U.S. Food and Drug Administration today approved Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly, a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain. FDA designated Somatuline Depot orphan status because the drug treats a rare disease and meets other criteria. Orphan products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product. Acromegaly affects approximately 15,000 people in the United States and Canada and is most commonly found in middle-aged adults. Patients with acromegaly have reduction in life expectancy of 5 to 10 years. The drug will be marketed by Beaufour Ipsen, Paris, France. Evithrom (human thrombin) The U.S. Food and Drug Administration approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery. Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases. Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal. Evithrom is manufactured by Omrix Biopharmaceuticals, Ltd., Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon, Inc., Somerville, N.J. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, womenfitness.net, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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