(501 (c) (3) non-profit corporation)

The Foundation
The Andhra Journal of Industrial News
The Telangana Science Journal
Mana Sanskriti (Our Culture) Journal
Disclaimer Solicitation


The Andhra Journal of Industrial News
(An International Electronic Digest Published from the United States of America)
(Click here to subscribe to this free e-journal)

Chief Editor: Sreenivasarao Vepachedu, PhD, JD, LLM


Issue 15

5107 Kali Era , Paardhiva Year, Jyeshta month
2063 Vikramarka Era, Paardhiva Year, Jyeshta month
1927 Salivahana Era
Paardhiva Year, Jyeshta month
 2005 AD, June

Patent Search
Hatch-Waxman Safe Harbor Patent Case: Merck v. Integra
Inherent Anticipation Doctrine
Research For Third World Diseases
Animal Friendly Research in Britain

Patent Search
Where to Search
Scientific indexes like Chemical Abstracts can be used to find articles in specific subject areas. A variety of Internet-based search-engines that search documents from magazines, journals, databases and books exist. Searching of nucleotide and/or amino acid sequences can also be conducted on the Web.

Before the advent of electronic patent search technology, patents were searched by finding the relevant class and subclass, obtaining a list of patents in each appropriate class and subclass, reviewing the abstract of each patent on the list published in the Official Gazette (Patents) and then reviewing paper copies of each relevant patent. Relevant classes and subclasses were found by reference to three paper documents: the Index to the U.S. Patent Classification, the Manual of Classification and the Classification Definitions. Once class and subclass are identified, the references in those subclasses can be found organized in small drawers called "shoes" located in the Examiners' search room at the USPTO offices. Searchers can obtain permission from an Examiner or the Group Receptionist to view these patents. If only U.S. patents are being sought, they can be found in the Public Search Room. The USPTO also maintains a library of technical literature and foreign patent documents in its Scientific and Technical Information Center (STIC).

Electronic search technologies and services can be divided into three categories: desktop search software products, Web search engines and on-line services.   Inventors and entrepreneurs who are looking to cut costs may do some of the preliminary searching on their own using free databases such as the United States Patent Office patent search page. A lot of information can be found free.

Free Databases
On Delphion, the Quick/Number search lets you quickly find an issued US patent by number, word, or phrase, and is free of charge, but requires registration.

Produced by European Patent Office.

It covers 22 different databases, one for each member country of European Patent Convention: Worldwide 30 million patents including US, GB, CH, DE, FR, SE from 1920, EP, WO from 1978; European Patents 1997- date; PCT applications 1997-date; Japanese patent abstracts in English (PAJ); British patent applications 1996-date and other European countries.

It seems most of the users are located in Europe and come from the chemical, engineering, and pharmaceutical industry sectors and they are obviously researchers, engineers and scientists and many are patent attorneys or associated staff.

The home page offers you a simple search screen, which allows the search options that include Quick Search, Advanced Search, Number Search, and Classification Search. You can search in the worldwide database or choose from any other databases.

Produced by USPTO.

Two separate databases are available: the Patent full-text database and the patent bibliographic database, both covering United States patents including utility patents, design patents, plant patents, reissues, defensive publications and statutory invention registrations. These databases  cover the period from 1 January 1976 to the most recent weekly  issue date (usually each Tuesday).  The full-text database allows searching of the complete text of the patent specifications but the bibliographic database is faster to search. Images of the complete patent documents are available from 1976.  A subject search for U.S. patents requires a multi-step process:

The first series of steps are to discover the "field of search" which identifies the proper classifications to locate a particular patent. This consists of four steps:
1. Identify the parts of an invention. Its component parts classify an invention and not necessarily by what you may think is its intended use.
2. Search the Index to the U.S. Patent Classification. Look up the terms that most closely describe the invention or process's function, effect, end product, structure or use. Write down all relevant class and subclass numbers.
3. Use the Manual of Classification. Look up the classes and subclasses you retrieved in the previous step. Revise your strategy as needed by eliminating any false leads.
4. Consult the Patent Classification Definitions ( Read the definitions to establish the scope of classes and subclasses. Note: design patents do not have definitions.

The next series of steps search the "Prior Art" which identifies patents within the designated classifications:
5. Review the Subclass Listing. Retrieve a list of all patent numbers granted for every class and subclass to be searched.
6. Locate patents by number e.g., in the Official Gazette. Use the OG to look at a claim of a patent and eliminate those unrelated to the invention.
5. Obtain complete patent document. Complete patents are available, in print, microform, CD-ROM and online formats. It should be emphasized that currently not all years of all patents are available free of charge online. Complete patents are available from Patent and Trademark Depository Libraries (PTDLs) (

A tutorial on Patent Search is available here:

The Intellectual Property Digital Library Web site provides access to intellectual property data collections hosted by the World Intellectual Property Organization. These collections include PCT (Patents), Madrid (Trademarks), Hague (Industrial Designs), Article 6ter (State Emblems, Official Hallmarks, and Emblems of Intergovernmental Organizations) and others.

PATON (Patentinformationszentrum und Online-Dienste) Thüringer
Bibliographic data and abstracts in English of the following: European Patent applications (EP), Patent Co-operation Treaty (WO), Germany (DE), France (FR), United Kingdom (GB), Switzerland (CH) and USA (US) from 1971.   PATON also offers Patent Abstract of Japan (PAJ) from 1976 and Patent Abstracts of Russia which are English summaries of Russian patent applications and patents from 1994.

There are two search masks (English and German versions) allowing the following fields to searched: Patent Numbers, International Patent Classification (format e.g., H01H033-66), English title, Abstract, Patent applicant, Inventor, and "Words anywhere".  Truncation can be used and the symbol is $ for any number of characters. Boolean operators and comprehensive adjacency operators are available.  The "Words anywhere" field can be used for entering any data from the above fields or additionally from many other fields such as dates and classification.  Dates, e.g. priority, can be entered as @PRD=19870629.  Different components of the IPC including the index terms can be searched (e.g., the IPC assigned as the main class as (E01H005-04). ICM or the IPC as assigned by the European Patent Office as (E01H005-04).  A record is kept of the search history (back references) and earlier searches can be retraced and refined, if required.

DEPATISnet is a service provided by the German Patent and Trade Mark Office. You can conduct online searches in patent publications from around the world stored in the database of DEPATIS, the in-house patent information system of the GPTO. When a search has been performed, the result list will be displayed. Selecting retrieved documents from your result list leads to display of the bibliographic data (title, applicant, inventor etc.) of that document. The original document can also be displayed in PDF format. You can browse the displayed document backwards and forwards or you can jump directly to certain parts of documents (subdocuments) eg claims, drawing, description etc. Printing of the document page by page is also available. This service is free of charge.

Free Patent Searching from US 4000000. Updated as new patents are published by the USPTO.  FreePatentsOnline provides fast, easy-to-use access to millions of patents. Attorneys and inventors use this data for patent searching. Researchers use it to keep up on the latest developments in their field. now provides free PDF downloads. Many sites charge $2 - $5 each to compile individual image files into a PDF and let you download it. FreePatentsOnline does it for free!

IP Newsflash
This free service allows you to search for patent families complete with their legal status based on INPADOC data. The service was implemented using PHP, XSL and Open Patent Services.

This intellectual property portal is a special project of the Intellectual Property Office Of Singapore (IPOS). The portal aims to provide a comprehensive suite of services for both the layman and the business community. As a free SurfIP Associate Member, you can: search across multiple databases and web sources for information and facts for your business, research and project or to find innovative ideas, use our management tools like bookmarks, saved searches and scheduled searches as well as search for more patents using sophisticated search tools.

Hatch-Waxman Safe Harbor Patent Case: Merck v. Integra

There are two competing policy interests in patent law: an inventor's interest to have exclusive rights to his or her invention, and the interest of the public to benefit from the progress of knowledge and technology. The US Congress enacted the Hatch-Waxman Act of 1984 to balance these competing interests in the pharmaceutical area, and to encourage development and expedite introduction of pharmaceuticals. Three principal components of the Act are: patent term extension, Abbreviated New Drug Application (ANDA) filing and a research exemption.

First, the Act provides potential five-year patent term extension for new drugs approved by the US Food and Drug Administration (FDA, Washington, DC, USA) to compensate for time lost in the FDA-approval process. The second provision, ANDA filing, permits generic drug manufacturers to incorporate the safety and efficacy data from an approved product, saving generic manufacturers from the extensive clinical trial period required for new drugs.

The research exemption from infringement is provided in Section 271(e)(1) of Title 35 of the United States Code, which states, in part, that "[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products". This was intended to allow potential competitors to enter the market immediately upon expiration of the patent, protecting against an artificial extension of patent monopolies beyond the expiration of the patent, for activities related to obtaining FDA approval and to insulate drug research from charges of infringement so long as the research is "reasonably related to the development and submission of information" to the Food and Drug Administration. All necessary FDA-approval procedures could be completed before the patent expires, allowing the product to be launched as soon as possible after the expiration of the patent.

Further, the Hatch-Waxman Act sought to ensure that a patent did not de facto extend past the expiration of the patent term because a generic competitor also could not enter the market without regulatory approval (See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669-70, 110 S.Ct. 2683, 110 L.Ed.2d 605, 58 USLW 4838, 15 USPQ2d 1121 (1990)). Thus, the Hatch-Waxman Act permitted competitors to conduct experiments in advance of patent expiration, as long as those activities were reasonably related to securing regulatory approval. In addition, without the provisions of the Act, not only would the competitor need to wait until expiration of the patent to conduct experiments for regulatory approval, but also the ANDA filing would not be available. The potential experiments needed to obtain regulatory approval would be more extensive, time consuming and expensive than an ANDA filing, further extending the patent monopoly and raising the barrier to market entry.

On June 6, 2003, in a 2-1 decision, the Federal Circuit in Integra Lifesciences I, Ltd. v. Merck kGaA, 2003 WL21299492 (Fed. Cir. June 6, 2003), in an opinion by Judge Rader with Judge Newman dissenting, significantly limited the scope of § 271(e)(1) to exempt from infringement only those activities “reasonably related” to generating information that would be submitted to the FDA. The court held that the use of research tools to identify drug candidates that might later require FDA approval was not exempt from infringement. The court acknowledged that the Hatch-Waxman Act had two key purposes: (1) to restore to pharmaceutical patents a portion of the expired patent term to compensate for delays in regulatory approval; and (2) to overrule the Bolar decision, so that competitors could conduct experiments in advance of patent expiration such that introduction of generic drugs would not be unnecessarily delayed. Despite its emphasis on generic drugs, the court noted that all clinical trials were exempt under § 271(e)(1).

In analyzing the specific facts in Integra, the court noted that the experiments-at-issue did not generate information for submission to the FDA, but were screening activities conducted to identify drug candidates for further testing. In refusing to hold those activities exempt, the court emphasized that the “safe harbor” exemption applies “solely” to activities which generate information for submission to the FDA. In this case, the work sponsored by Merck was considered by the court to be “only general biomedical research to identify new pharmaceutical compounds” and that “the FDA has no interest in the hunt for drugs that may or may not later undergo clinical testing for FDA approval.” Thus, the court held that the experimental work sponsored by Merck in this case was not “solely for uses reasonably related” to testing for submission to the FDA.

Merck appealed to Supreme Court to review Hatch-Waxman Safe Harbor Patent Case. In January 2005, the Supreme Court granted certiorari in the case and will hear the appeal on April 20. This decision would have allowed, if upheld, the pharmaceutical and biotech companies the possibility of being pursued for infringement of patented research tools used in the early stages of drug discovery, presenting several significant risks. Perhaps most troubling is the danger that an injunction could shut down certain research activities. On the positive side, the Federal Circuit's decision provided discovery companies with new competitive ammunition. The research tool patents could be asserted to block competitors from using their innovative research methods. Additionally, companies that have developed their own portfolios of patented research tools could further leverage them as a revenue-generating asset.

Did the Federal Circuit and The Court of Appeals for the Federal Circuit err in concluding that this drug-research safe harbor does not protect animal studies of the sort that are essential to the development of new drugs, where the research will be presented to the FDA, and where barring the research until expiration of the patent could mean years of delay in the availability of life-saving new drugs? Apparently so, as the High Court Reverses Infringement Findings. The Supreme Court of the United States (Court) in Merck KGaA v. Integra LifeSciences I, Ltd., U.S. (June 13, 2005), painted a broad "safe harbor" under 35 USC § 271(e)(1) for patent infringement-free use of pharmaceutical inventions.  On June 13, 2005, in the case of Merck KGaA v. Integra, the Supreme Court held that §271(e) (1) "provides a wide berth for the use of patented drugs in activities related to the federal regulatory process, including uses reasonably related to the development and submission of any information under the FDCA", and "exempts from infringement the use of patented compounds in preclinical research, even when the patented compounds do not themselves become the subject of an FDA submission."

Inherent Anticipation Doctrine
According to the Federal Circuit's holding in the latest SmithKline v. Apotex case, a patent claim to a compound is inherently anticipated by a reference that enables preparation of that compound, even without evidence that the compound existed before the patent application was filed. This seems to reinforce and broaden the inherent anticipation doctrine of the recent Schering v. Geneva decision, where a description of methods to use a drug inherently anticipated later claims to a metabolite formed in the bodies of patients treated with that drug. ( and

Research For Third World Diseases
As the communist, socialist and corrupt regimes in the third world ignore the health of their own peoples, it falls upon the conscientious capitalist world to rescue the poorest of the poor.
"It's shocking how little research is directed toward the diseases of the world's poorest countries," Microsoft Corp. founder Bill Gates said in a statement. "By harnessing the world's capacity for scientific innovation, I believe we can transform health in the developing world and save millions of lives."

The Gates Foundation has committed $450 million to the program, which it calls its "Grand Challenges in Global Health" initiative, and more grants are expected to be announced later. The Wellcome Trust, a British charity that funds medical research, has contributed $27.1 million, and the Canadian Institutes of Health have committed $4.5 million. The grants are administered by those organizations as well as the Foundation for the National Institutes of Health in the U.S.
The funding will help researchers prove the feasibility of several potentially brilliant projects such as, childhood vaccines that don't need refrigeration, a bacterial parasite to control mosquito population which infects up to 100 million people every year, fighting malnutrition by genetically altering the nutritional content of bananas, cassava, rice and sorghum, to develop an inexpensive handheld device that can test blood for a wide range of conditions, including bacterial infections, nutritional status and HIV-related illnesses and so on.
Animal Friendly Research in Britain
The National Center for the Replacement, Refinement and Reduction of Animals in Research said in May,  the extra money would fund its work over 2006-2008, enabling it to award more grants for animal-friendly research projects. The British government established the new center 12 months ago in a bid to bridge the divide by promoting the "3Rs."  Animal testing has stoked fierce passions in Britain in recent years, with opponents of laboratory testing engaging in sometimes violent protests which drug companies say threaten investment and jobs.  Replacement involves finding alternatives to animal experiments, for example by using cell-based studies, computer modeling or research on humans. Refinement means reducing animal suffering in tests, while reduction involves using fewer animals by redesigning experiments. The center is funded by government, charities and the pharmaceutical industry and this year has a budget of 1 million pounds.

Copyright ©1998-2005
Vepachedu Educational Foundation, Inc
Copyright Vepachedu Educational Foundation Inc., 2004.  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!)
One World One Family

Hosted by Dr. Ramesh Cherivirala

The Foundation
The Andhra Journal of Industrial News
The Telangana Science Journal
Mana Sanskriti (Our Culture) Journal
Disclaimer Solicitation