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Contents
Record US Applications US Patent System Anticipation An Interesting Alternative for Patents China's Drug Industry China and India: Projected GDP Support for Working Mothers Channel Stuffing Pepcid Complete Formulation Patent Invalid $1b to Biotech in MA Ban on Drugs and Seafood Record US Applications A record number of patent filings were lodged with the European Patent Office last year, with U.S. firms proving once again to be the most prolific applicants, according to figures released in June. US Patent System Our patent system is grounded in the Constitution. Among the specifically enumerated powers of Congress in Article I, Section 8, commands to “promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive right to their respective discoveries.” Those discoveries have, since the founding of our Nation, made us the envy of the world. Our inventors, our research institutions, and the many companies that commercialize those discoveries have brought a wealth of new products and processes to the world. We have all been the beneficiaries of that creativity and hard work. However, it is becoming very vulnerable and not reliable nowadays. A study by the FTC shows that, between 1992 and 2000, "generics prevailed in cases involving 73% of challenged drug products." Let us say you are a generic company. You could wait until the patent of a particular blockbuster drug expires to market a generic version of it. You know that some patents are vulnerable and may not be valid. You could market the generic version claiming that you have a right to market because the patent is invalid or unenforceable or isn't broad enough. The track record of such challenges in court is surprisingly good for generics as shown by the FTC study. Anticipation AstraZeneca sells Omeprazole under brand name Prilosec®. Omeprazole is a drug that inhibits the production of gastric acid. AstraZeneca’s Patent No. 6,013,281 (the ’281 patent) claims a process of forming the pharmaceutical formulation that is composed of a core containing an active alkaline reacting compound (ARC), a water-soluble separating layer and an enteric coating layer. A Korean patent application was published two years before AstraZeneca’s earliest priority date. The patent issuing from that application had been the basis for a lawsuit in Korea between AstraZeneca and the Korean applicant, Chong Kun Dan Corp. The Korean patent publications described compositions with no enteric coating processes. Andrx sought to market a generic version of AstraZeneca’s drug. It argued that its product did not infringe the ’281 patent because the separating layer in Andrx’s generic version contained talc and was not water soluble. After a lengthy trial, the district court entered a final judgment finding that Andrx literally infringed the asserted claims of the ’281 patent, but also found the claims anticipated or obvious. The trial record showed that the ingredients and protocols Chong Kun Dan Corp provided in the Korean action necessarily resulted in in situ formation of a separating layer. Accordingly, the Federal Court concluded that the trial court correctly found inherent anticipation. Judge Newman dissented that the majority contravened a vast body of precedent and pointed to the undisputed fact that no reference explicitly or inherently teaches AstraZeneca’s claimed process. In re Omeprazole Patent Litigation, Case Nos. 04-1562, -1563, -1589 (Fed. Cir., Apr. 23, 2007) (Rader J.; Newman, J., dissenting). An Interesting Alternative for Patents Democratic presidential candidate John Edwards on June 14th proposed cutting health care costs by overhauling the patent process for breakthrough drugs and requiring health insurance companies to spend at least 85 percent of their premiums on patient care. Edwards' plan would offer cash payments in place of long-term patents for companies that develop certain breakthrough drugs and then reap large profits because of the monopolies those patents provide. He said offering cash incentives instead would allow multiple companies to produce generic and other versions of those drugs to drive down prices. Campaign officials said the payments could be voluntary for drug companies and would be aimed at spurring the development of drugs that cure diseases. China's Drug Industry With its reputation on the ropes after a string of dangerous food and drug scandals, Chinese officials say they're overhauling the country's safety regulations and adopting an inspections system to stop drug counterfeiting. While much of the international attention recently has been centered on unsafe pet food, the country's drug industry has been tainted by widespread reports of dangerous or counterfeit drugs that have killed people inside and outside of the country. New controls are expected to be in place by 2010. China and India: Projected GDP Robert Fogel, director of the Center for Population Economics at the University of Chicago Graduate School of Business, makes some projections in a research paper: By 2040, India’s GDP (in PPP terms) will be $36,528 billion, which will account for 12% of global economic output. That figure represents a 1,400% increase over GDP in 2000. India’s per-capita income too will rise from $2,370 in 2000 to about $24,000 in 2040, according to Fogel’s projection. Over 40% of the population is still illiterate and gross secondary school enrolment rates in 2002 were less than half the numbers in China. And even the enrolment rate in higher education in India lags behind China’s, he points out. Agricultural labour productivity growth rates in India are half that of in China, and given that two-thirds of India’s labour force is still in agriculture, this hinders growth of the overall economy, says Fogel. By 2040, reckons Fogel, China’s per capita income will reach $85,000 - about twice the projected figure in respect of the European Union! That’s a 23-fold increase in 40 years (starting 2000 when the per capita income was about $3,616)! The European Union’s share of global GDP will decline from 21% in 2000 to about 5% in 2040, he prophesies. http://tinyurl.com/28lt77 Support for Working Mothers The United States and Australia are the only industrialized countries that don't provide paid leave for new mothers nationally, though there are exceptions in some U.S. states. Australian mothers have it better, however, with one year of job-protected leave. The U.S. Family and Medical Leave Act provides for 12 weeks of job-protected leave, but it only covers those who work for larger companies. To put it another way, out of 168 nations in a Harvard University study 2004, 163 had some form of paid maternity leave, leaving the United States in the company of Lesotho, Papua New Guinea and Swaziland. http://www.usatoday.com/news/health/2005-07-26-maternity-leave_x.htm Channel Stuffing Channel stuffing is the business practice where a company or a sales force within a company inflates its sales figures by forcing more products through a distribution channel than the channel is capable of selling to the world at large. This can be the result of a company attempting to inflate its sales figures. Alternatively, it can be a consequence of a poorly managed sales force attempting to meet short term objectives and quotas in a way that is detrimental to the company in the long term. Many managers will engage in channel stuffing to increase annual/quarterly sales. Even though this would hurt the company because the distributors would have to return any unsold goods back to the company, it would help the manager if his earnings was based on a sales quota. http://en.wikipedia.org/wiki/Channel_stuffing BMS won't face federal charges of channel stuffing as a two-year deferred prosecution agreement is set to end June 15, 2007. In a statement, New Jersey U.S. Attorney Christopher J. Christie said, "Bristol-Myers Squibb has made significant and transformational changes in its compliance practices as a result of the DPA [deferred prosecution agreement]." Pepcid Complete Formulation Patent Invalid A judge has dismissed a patent case brought by a unit of Johnson & Johnson and its partner Merck & Co. alleging that Perrigo Co. infringed a patent used in the formulation of Pepcid Complete. $1b to Biotech in MA Gov. Deval Patrick will soon begin the task of identifying which groups will be eligible to receive the $1 billion in biotech funding he proffered at the recent gathering of BIO in Boston. He proposed to funnel $100 million a year into biotechnology over the next 10 years. Ban on Drugs and Seafood China's capital banned ten types of drugs for exaggerated effectiveness, a newspaper reported on June 29th, amid rising concerns of fake and tainted products in China's food and drug supply chains. While the drugs were genuine, the results they claimed to produce in fighting high blood pressure, diabetes, and other ailments couldn't be supported in clinical testing, the Beijing News reported. Stores in the city have been told to stop selling them and media outlets that carried their advertising were told to print retractions, the paper said. The orders were the first application of a new law on drug advertising, it said. The announcement came a day after the United States banned farmed seafood from China, adding to a growing list of tainted and defective Chinese products that could pose health risks. Beyond the fish, US federal regulators have recently warned consumers about lead paint in toy trains, defective tires, and toothpaste made with diethylene glycol, a toxic ingredient more commonly found in antifreeze. All the products were imported from China. The safety scandals have put at risk surging Chinese agricultural exports to the United States, which reached $2.26 billion last year, led by poultry products, sausage casings, shellfish, spices and apple juice. They also raise the possibility of retaliation against U.S. food exports to China. At the end of June the Chinese government said it had seized shipments of U.S.-made orange pulp and dried apricots containing high levels of bacteria and preservatives. 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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