Safe Harbor Patent Case: Merck v. Integra
Inherent Anticipation Doctrine
Research For Third World
Animal Friendly Research
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
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
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
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 (http://www.uspto.gov/web/offices/ac/ido/oeip/taf/def/index.htm).
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: http://www.libraries.psu.edu/instruction/business/Patents/mod1/index.html
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.
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. FreePatentsOnline.com 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!
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.
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
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."
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. (http://patentlaw.typepad.com/patent/2005/06/smithkline_beec.html
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
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
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.