15 June, 2009

US Supreme Court to Review 'Business Method' Patents

The U.S. Supreme Court would take up a major issue in intellectual-property law: whether patents should be granted for business methods. Many financial, accounting, and e-commerce firms have rushed to obtain patent protection for such things as ways to structure financial products, manage organizations, or transact business on the Internet.

A claimed patent on this process, filed in 1997 by inventors Bernard Bilski and Rand Warsaw, was rejected by the USPTO on the basis that it simply involved a mental process and did not need any technology to implement. This rejection has been upheld though various appeals.

Critics of business-method patents say it was never the intent of the law to protect such things, which are often far closer to abstract concepts or mathematical algorithms rather than physical inventions. Whichever side the Supreme Court takes on the issue is likely to be of major significance and this will impact American innovation in the future. IBM, which has obtained many business-method patents, filed an amicus brief in what is known as the Bilski case, stating that the company is now opposed to them. IBM maintains that the patents are not needed to promote innovation; businesses would come up with the products even without patent s.
In the wake of that ruling, lower courts and patent examiners have increasingly been rejecting business-method patent claims. The Supreme Court won't hear arguments in Bilski until its next term, which begins in October. A ruling is likely during the first half of 2010.

Human gene patents can hinder research, suit says
The U.S. Patent and Trademark Office has granted patents to at least 4,382 human genes, including genes related to Alzheimer's, asthma, cancer, muscular dystrophy and other serious diseases. Rapid advances in biology and genetics are raising the number of patents on human genes.

A gene patent gives its owner the exclusive right, for up to 20 years, to control its use for medical research, diagnosis or treatment. Twenty percent of the human genes are currently patented. Many a scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents. Though gene patents are lawful, many scientists, health professionals and patients' organizations object that the patents are stifling research and interfering with patient care.

The ACLU suit was filed in federal district court in Manhattan on behalf of the American College of Medical Genetics, the College of American Pathologists, other research organizations and individual patients. The defendants are Myriad Genetics, a pharmaceutical firm in Salt Lake City, and the University of Utah Research Foundation, which sponsored the research on human genes.

The patents give Myriad Genetics the exclusive right to test women for mutations in two genes, known as BRCA-1 and BRCA-2, which may indicate a genetic susceptibility to breast or ovarian cancer. A woman who tests positive might decide to have her breasts or ovaries removed.

Japanese Govt set to allow patenting of drug dosing methods

The Japanese government is considering for the first time allowing dosing methods to be patentable as part of policies to be included in the Intellectual Property Strategic Program 2009. The move is based on the discovery in many cases that the side effects of drugs could be minimized by adjusting the dosages or the way drugs were taken. This new policy is aimed at encouraging the studies in this area.

The government plans to start revising the patent assessment criteria to enable early revision. Currently, drugs and their usage can be patented, but the patenting of dosing methods would be a new approach in Japan.

The pharmaceutical industry has for some time been calling for patents to be extended to dosing methods as it is extremely time consuming and costly to study and develop new dosing methods. The industry likens dosing research to the development of new drugs. Once dosing methods become patentable, any pharmaceutical company can apply for and obtain a patent on a dosing method of a drug even if its patent has expired and its generic drugs are already on sale, as long as the company has found a new dosing method or dosage for it.

In such cases, other pharmaceutical companies that have been selling drugs with the same active ingredients and with the old dosing method or dosage must pay royalties if they want to sell the drugs with the new dosing method or dosage.

Ranbaxy Inc.  to market a generic drug used to treat Alzheimer's patients
The U.S. Food and Drug Administration has approved Ranbaxy Inc to make and market a generic drug used to treat Alzheimer's patients.

Donepezil hydrochloride is used to treat mild to moderate dementia associated with Alzheimer's.  The sales of this drug are about $935 million annually in the US. The new drug is a generic alternative to the brand, but the brand is protected until 2010. This product will be introduced as soon as the patent expires.

As this is the first company to get approval for this particular generic, Ranbaxy will have a six-month period in which it is the only company allowed to market donepezil hydrochloride.

Ranbaxy Pharmaceuticals Inc. has bought patents, trademarks and equipment used for the self-administration of medicines.

Ranbaxy, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd., made a deal with Senetek PLC (OTCBB: SNTKY). Included in the deal is automated manufacturing equipment Senetek makes for the self-administration of drugs like epinephrine, which is used to treat anaphylactic shock caused by allergies to peanuts and other foods. Anaphylactic shock due to allergic reaction to peanut-based food additives is a health risk resulting in more than 30,000 emergency room trips, and 150 to 200 preventable deaths each year.

Ranbaxy will make a nonrefundable payment to Senetek and additional payments based on regulatory approvals and cumulative sales milestones. Terms also include a percentage of Ranbaxy's or its licensees' quarterly net sales of the products to be paid to Senetek.

Ranbaxy will focus initially on prefilling the autoinjector device with epinephrine, but will also evaluate other drugs, including Senetek's patented erectile dysfunction drug Invicorp.