The Andhra Journal of Industrial News, June 2006, Issue 27, Vepachedu Educational Foundation

Contents
Time to Rethink Obviousness
New Accelerated Examination Procedures at USPTO
Watch What You Write in Your Patent
Changes in Timelines India
Monopoly for New Drugs in India

Generic Drugs from Reddy's Labs
Drug Companies Compete, Patients Win
ACE Inhibitors
New HIV Drug - Prezista
Buffett and Gates

Time to Rethink Obviousness

New Accelerated Examination Procedures at USPTO
The United States Patent and Trademark Office (USPTO) has established procedures under which the examination of a patent application may be accelerated. Under one of these procedures, the USPTO will advance an application out of turn for examination if the
applicant files a grantable petition to make special under the accelerated examination program. The USPTO is revising its procedures for applications made special under the accelerated examination program with the goal of completing examination within twelve months of the
filing date of the application. The USPTO is similarly revising the procedures for other petitions to make special, except those based on applicant's health or age or the recently announced Patent Prosecution Highway (PPH) pilot program between the USPTO and the Japan Patent
Office. http://www.uspto.gov/web/offices/com/sol/notices/71fr36323.htm

Watch What You Write in Your Patent
The CAFC considered the meaning of the claim term “fuel injection system component,” in Honeywell v. ITT Industries (Fed. Cir. 2006). The specification refers to the phrase “this invention” to mean the “fuel filter.” The specification did not indicate that a fuel filter is an embodiment or a preferred embodiment. Accordingly, it was concluded that the scope of the patent claims was limited to a fuel filter.

Changes in Timelines India
The following timelines apply for all patent applications pending as on May 5, 2006:
 Request for Examination time line is changed. It is now 48 months from the date of priority or the date of filing the application whichever is earlier.
-Examination is now time-bound. An application to be referred to an Examiner, by the Controller, within 1 month from the date of publication, or the date of RFE, whichever is later. The Controller has to dispose off an examination report of the Examiner within 1 month of its receipt from the Examiner. The First Examination Report to be issued within 6 months from the date of RFE or the date of publication, whichever is later.
-Timeline to put application in order for Grant is now 12 months from the date of issue of the FER. No extension available.
-Opposition to Grant of Patent. No application to be granted before the expiry of 6 months period from the date of publication of the application. Specific description of timeline to file Representation for opposition is omitted. However, at least 6 months period is provided from the publication to file a Representation for Opposition. Period to respond to Notice of Representation increased from 1 to 3 months.
-Foreign Filing Permission. Foreign Filing Permission to be issued within 21 days of making such request.
-Information under Section 8. Details of corresponding applications to be submitted within 6 months of Indian Filing Date. Subsequent details to be submitted within 6 months of such corresponding filing date. Search and Examination reports to be submitted within 6 months of receiving any notification in this regard.
-Proof of Right. Proof of Right to be submitted within 6 months of the Indian Filing Date.
-Publication of Application. Applications to be published in the Patent Office Journal within 1 month of the expiry of 18 months period or within 1 month of making a request for early publication.

Monopoly for New Drugs
Indian government is considering a law that could effectively grant a monopoly to the developer of a new drug for several years even without a patent. Making generic copies of a new, unpatented drug is a hugely lucrative business in India. Once a new drug is approved for sale, other drug companies only need to point to the clinical safety data already filed with India's drug controller by the drug's original developer, and prove that their generic drug is identical to the original. But this is unfair to innovating drug companies who invest millions of dollars collecting the necessary data they need for marketing approval through clinical trials. This system allows innovative drug developers to recover little of their investment and reduces the incentive to research and develop new drugs. Opponents of the new law argue that the law would particularly affect poor people with HIV who had developed immunity to first-line anti-retroviral drugs and were waiting for the expensive second-line drugs to become affordable and can't wait until the innovative drug developer recovers its costs.

Generic Drugs from Reddy's Labs
Dr. Reddy's Laboratories has launched the authorized generic version of Merck's Proscar® tablets 5mg (finasteride) on June 19, 2006. The Company has also launched the authorized generic version of Merck's Zocor® tablets (simvastatin) 5mg, 10mg, 20mg, 40mg and 80mg on June 23, 2006.

Drug Companies Compete, Patients Win
Generic companies make most of their profits when awarded six months of market exclusivity because a lack of competition means they don't have to sell their product at an enormous discount to the brand. If the brand chops its price, the generic may be forced to follow suit.

Merck & Co. is slashing the price of its cholesterol drug Zocor so low for one insurance plan that members will actually pay less for the original pills than for the generic. Under the deal, members of UnitedHealth Group Inc. will pay around $10 for a month's supply of brand name Zocor and $40 for a generic after the drug loses patent protection on Friday. Both Merck and UnitedHealth say the arrangement demonstrates how market competition drives down costs, and that's good for patients. Pfizer is going to follow the suit with its Zoloft.

Zocor from Merck and Zoloft from Pfizer - are among the most recognizable names in Big Pharma. Merck's patent for Zocor, a cholesterol-cutting drug that totaled $4.4 billion in 2005 sales, expired on June 23rd. Pfizer's antidepressant Zoloft, with $3.3 billion in 2005 sales, loses patent protection on June 30.

Simvastatin, the generic form of Zocor, will be produced by Teva Pharmaceuticals (up $0.82 to $32.07, Charts), the Israel-based market leader in generic drugs, and Ranbaxy Labs of India. The Food and Drug Administration approved generic versions of Zocor from these two companies. As determined in patent litigation, they will be permitted to produce the drug for six months before the market opens up to other manufacturers. Teva will produce the generic through its subsidiary Ivax.

ACE Inhibitors
A commonly used type of blood pressure drug could be risky for pregnant women. A study published in the New England Journal of Medicine finds that taking ACE inhibitors in the first trimester of pregnancy could more than double the baby's risk of being born with serious birth defects. The study looked at Medicaid records on more than 29,000 babies born in Tennessee between 1985 and 2000. Researchers found that about 7% of the babies who were exposed to ACE inhibitors developed major birth defects affecting the heart, brain and kidney, while 2% of the babies whose mothers took a different drug or no medication developed these types of problems. ACE inhibitors already carry a "black box warning" about the risks they pose if used late in pregnancy, but the researchers say their findings suggest that the drugs should be avoided altogether during pregnancy, The Associated Press reports. The AP quotes other doctors who say pregnant women taking ACE inhibitors should immediately switch to another type of blood pressure medication, but should not stop treatment altogether, as uncontrolled hypertension poses its own set of risks for mother and baby.

New HIV Drug - Prezista
A new drug to treat HIV won federal approval Friday. The Food and Drug Administration said it approved Prezista for the treatment of the human immunodeficiency virus. The drug is the first approved HIV medication for its maker, Johnson & Johnson. It's also the first new HIV drug approved since June 22, 2005. The drug, also known as darunavir, is a member of the protease inhibitor class of drugs. They work by blocking protease, a protein the virus needs to make more copies of itself. Since 1995, FDA has approved 10 other protease inhibitors. The major side effects of this class of drugs are high cholesterol and blood-sugar levels, as well as lipodystrophy, or the redistribution of body fat. Protease inhibitors typically are taken as part of a cocktail of drugs. Prezista is meant for use in patients who don't respond to treatment with other antiretroviral drugs, the FDA said. Prezista -- taken as two pills, twice daily -- will cost $25 a day, according to J&J unit Tibotec Therapeutics.

Buffett and Gates
Warren Buffett made the world's biggest-ever philanthropic donation by pledging to give away $37 billion, the bulk of which will go to the Bill & Melinda Gates Foundation. The investor said he hoped his generosity would spur other wealthy people to donate more to foundations.

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 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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