Basic Understanding of Generic Drugs and Brand Names

July 31st, 2008

Pharmaceutical research is one of the most valuable industry domain, as it is directly associated with human health. Pharmaceutical industries put lots of efforts in terms of cost, time and labor to develop a single blockbusting drug. This innovator companies, and then gets a patents protection and exclusive right to sell the drug as long as the patent is in effect. Basic understanding of the generic drugs and brand name is essential to know how the pharmaceutical business. Every drug has two given names:

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Nventa Wins European Patent Challenge Covering Lead Product Candidate …

July 30th, 2008

Nventa Biopharmaceuticals Corporation announced today that it has received a favorable decision from the Technical Board of Appeal of the European Patent Office for the company’s European Patent Number …

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Criminal Background Checks

July 29th, 2008

A criminal background check is a legal and inexpensive way of obtaining pertinent data about a person. Details of past convictions are stored in criminal records and other manuals of the court. Each state stores records and details of individuals with a criminal history in their respective courts. CBCs access these records to prepare a profile of the person concerned.

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Innovation in Patent Research Outsourcing

July 28th, 2008

During the last few years, the attention of people involved in competitive, market and technological intelligence has been focused on the patent research. It has been already well recognized that, patent research and intelligence is very essential for companies to sustain in the current highly competitive market. India has been the prime destination for many top level global firms, who are involved in outsourcing a larger set of their critical works of all levels to India. Success stories in software changed perceptions of India across the globe.

India is emerging as a patent research hub for technologies geared to the Third World. This progress has been evident in the emerging of lots of Research Process Outsourcing (RPO) and Knowledge Process Outsourcing (KPO) firms in India. Dolcera is one of the emerging firm, which has developed highly interactive and customize online dashboards for management of large set of patents. This dashboard is currently being used by several Fortune 500 companies in consumer electronics, medical devices and consumer packaged goods industries. Patent data is used extensively for competitive research and for innovation within companies. This data is shared between R&D, marketing, business development and executive teams for a variety of reasons. Online IP dashboard helps in better sharing of the patent analysis across the different division of the firms.

As the patent filing is increasing every day, there is always a need for more research and innovation in the patents domain. Automation of patent analysis, equivalent of human analysis is one of the white space, where a lot of new innovation is desirable.

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Family Lose Narnia Web Name Fight

July 27th, 2008

An Edinburgh couple have lost a battle with the estate of Chronicles of Narnia author CS Lewis over a web domain name.

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Get Patents & Reap Benefits

July 26th, 2008


Today, we are living in the age of information technology & spreading our wings to every aspect of the society. We exchange our information (ideas, techniques, process, and product) to a target group but we never come to know this thing that someone is also targeting our information. So we are much prone to unintentionally leakage of our precious ideas as our information passes through different portals.

It is the human tendency to share their innovative thoughts with their near & dear ones but that proves fatal, in most of the cases, in respect of the that original creation or your property i.e. intellectual property (IP).Most of the people acts indiscreetly & ignorantly which results in jeopardizing the chance of saving their intellectual property i.e. novelty of ideas as they comes under public domain & lose their chance to be protected by the INELLECTUAL PROPERTY RIGHTS.

Intellectual property literally means some academic or scholar work. Intellectual property (IP) pertains to any scholar or any original creation of the human intellect; that work can be artistic, literary, technical or scientific creation.

Intellectual property rights mean those rights which are given by the State to the inventor or creator to protect one’s invention or creation for a certain period of time.

Need for intellectual property rights:-

For individual: - IP helps to protect investment of time, money, effort & such other resources of the inventor or creator.

For public:-IP provides a pool of information to the general public since all forms of IP are published in journals & magazines except in case of trade secrets.

For country:-IP provides a mechanism of handling infringement, piracy and unauthorized use & it encourages industrial development & technological advancement which leads to overall economic development of the country.

Bundle of rights:-

IPR are bundle of rights i.e. it includes the various independent rights. Following are the various independent rights for which IPR collectively provides protection:

1. Patent Right(Patent Act,1971 & Patent Rules,2000)

2. Industrial Design(Design Act,)

3. Trademarks (Trademarks Act)

4. Copyright(Copyrights Act)

5. Geographical Indication(Geographical Indication Of Goods Act)

6. Trade secrets(Common Law)

7. Circuit Layout Design(Semiconductor Layout Design Act)

India at International level:-

• The fact that India is a member state of World Intellectual Property Organization (WIPO), an international organization, responsible for the promotion of the protection of intellectual property throughout the world proves that India has proved its potential & has been acknowledged at international level.

We are here concerned with Patent Law; A patent is an exclusive right granted to inventor or creator of a useful or improved article or a new process of making an article for a specified period of time. After the expiry of the duration the invention becomes part of public domain i.e. everyone can use it. So Patent means monopoly rights of inventor in respect of an invention.

Geographical limits of the patent:-

Patent is granted for a specific invention in a particular country in which an application is made for the same cause. There is no international patent as such though it has acquired an international character. For e.g. a patent granted in India is valid only for India and not in the USA. However, a patent granted in the EPO is valid in all the contracting states recognized by European Patent Organization. The protection so granted in a country / region not only identifies the rights of the creator/ inventor or his assignees, but also enables the right holder to enforce his rights against infringers.

Moreover, several international agreements, treaties & conventions exist to monitor that the inventor/creator are not denied of his/her rights like European Economic Community Treaty(EEC),Patent co-operation Treaty(PCT),European Patent Conventions and Protocols(EPC),Community Patent Convention and Protocols(CPC) resulting in a common patent office for granting common patents applicable to the member countries.

What can be patented?

Only inventions can be patented.Sec.2 (1) (j) defines invention as an invention means a new product or a new process involving an inventive step & capable of industrial application. Invention includes within its scope any new & useful improvements of any manner of manufacture, article or substance whether patented or not but such improvement must qualify independently to satisfy the pre-requisites of the patent i.e. novelty, inventive step & capable of industrial application.

Who may apply for patent?

An application for a patent may be made by inventor, either alone or jointly with another, or his/their assignee, legal representative of deceased inventor or assignee are entitled to apply. For e.g. If a person invents a new product or process & unfortunately soon after that he dies then his legal heirs can or any person authorized by him before his death can apply for patent.

Term & date of patent:-

Term of every patent will be from 20 years from the date of filling of patent application & date of patent is the date on which the application for patent is filed, irrespective of the fact whether it is filed with provisional or complete application. To keep the patent in force renewal fee is to be paid every year. The first renewal fee is payable for the third year of the patent’s life & must be paid before the patent’s second anniversary. Term of patent can’t be extended beyond the specified term of patent.

Where a patent application should be filed?

The Indian Patent Office has its head office at Kolkata, which has three branch offices located at Mumbai, Chennai and Delhi. The Controller General heads the Patent Office and each branch has a Controller as its head. In case of an Indian applicant, the patent application must be filed at the patent office under whose jurisdiction the applicant’s has his place of work, or place of residence or place where he conduct business from.

For e.g. if an applicant provides a Chandigarh based address, the application must be filed at the Delhi Patent Office. In case of foreign applicant/s, the jurisdiction in which the patent application is filed would be based on the address for services of the applicant’s agent. For e.g. if the address for services for foreign applicant is based at Bangalore, the patent application must be filed at the Chennai Patent Office.

What are the rights given to the patentee?

The patentee (i.e. an applicant who has been granted a patent) has the exclusive right to prevent unauthorized third parties from making, using, offering for sale, selling or importing the patented product or process in India.

Patent information centre:-

Patent Information Centre (PIC) has been set up in 20 states & is further expanding in other states. Patent information centre provides information regarding the techniqulities & procedure laid down by the government to get a patent. One can get all the information regarding the filing of the patent application & further procedure up till the patent is not granted. The centre provides general precaution for the applicant before & after applying for a patent. The most common mistake which an applicant often does is to publish their invention in newspaper or scientific & technical journals, before applying for patents. Publication of an invention, even by the inventor himself, would (except under certain rare circumstances) constitute a bar for the subsequent patenting of it. Similarly, the use of the invention in public, or the commercial use of the invention in public or even in secrecy, prior to the date of the patent would be a fatal objection to the grant of the patent. However the secret working of the invention by way of reasonable trial or experiment, or the disclosure of the invention to other confidentially may not result into loss of novelty.

Another mistake, which is frequently made by the inventors, is to wait until their inventions are fully developed for commercial working, before applying for the patents. Delay in making application for a patent involves certain risks. so it is advisable to apply for the patent as soon as one’s invention get a physical appearance with 3-D drawings sheets depicting the whole model.

Incentives for obtaining patents:-

An innovative industry can gain competitive advantage in the market if it develops the necessary expertise and skills in developing and manufacturing new products, which are patented. For example, the advantage of a three year excise duty exemption or exemption from Drugs Price Control Order may translate into reserves / income which may offset the cost towards R&D. In order to promote R&D and innovation in Indian industries, Government of India provides a number of fiscal incentives and support measures to industries. Some of them are following:-

• Excise duty waiver on the patented article for a period of 3 years from the date of commencement of commercial production provided that such products be designed &developed by wholly owned Indian companies.

• Exemption from drug price control for a period of 5 years from the date of commencement of commercial production provided that they are produced from the basic stage by a process of manufacture developed by the unit through its own R&D efforts.

• Weighted tax deduction @ 150% on R&D expenditure is available to companies engaged in the business of biotechnology, or the business of manufacture or production of drugs, pharmaceuticals, electronic equipment, computers, telecommunication equipment, chemicals and manufacture of aircraft and helicopters. The expenditure on scientific research in relation to drugs and pharmaceuticals shall include expenditure incurred on clinical trials of drugs, obtaining approval from the regulatory authority under any Central, State or provincial Act and the filing of a patent application in India.

• Depreciation allowance at a higher rate is available in respect of plant and machinery installed for manufacturing goods based on indigenous technology developed in recognized in-house R&D units, Government R&D institutions, national laboratories and Scientific and Industrial Organizations (SIRO). The present rate of depreciation for plant and machinery is 40% as against 25% for other plants and machinery.

• Income tax exemption:-Under Section 35(1)(i) of the Income Tax Act 1961, the revenue expenditure on scientific research, by recognized R&D units, on activities related to the business of the company is allowed full deduction. Under Section 35(1)(iv) expenses of capital nature could be deducted totally from the income of the year in which the expenses have been incurred. Section 35(2AA) of the IT Act 1961 provides for a weighted tax deduction of 125% for expenses on sponsoring research programmes at National laboratories functioning under ICAR, CSIR, ICMR, DRDO, Department of Biotechnology, Department of Atomic Energy, Department of Electronics; IIT and universities.

For more information locate at:-http:/Ipindia.nic.in. Or e-mail at: pisnag@nag.mah.nic.in/pisnagpur@satyam.net.in

For further inquiries e-mail writer at: - kamal_417@yahoo.com, kamdahiya@gmail.com

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Commercialization Of Inventions Made Simple

July 25th, 2008

Lets assume you have an idea for the next great thing. Where do you go from here? Based upon extensive experience in developing products for both large and small companies, I offer a road map of the major steps and important choices faced by inventors
Inventors benefit most from their inventions when they have commercialized and patented them. Inventors should seek a patent to protect their invention.

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Boy’s domain name birthday present handed to C S Lewis estate

July 24th, 2008

Website of the Telegraph Media Group with breaking news, sport, business, latest UK and world news.

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Get Patents & Reap Benefits

July 23rd, 2008


Today, we are living in the age of information technology & spreading our wings to every aspect of the society. We exchange our information (ideas, techniques, process, and product) to a target group but we never come to know this thing that someone is also targeting our information. So we are much prone to unintentionally leakage of our precious ideas as our information passes through different portals.

It is the human tendency to share their innovative thoughts with their near & dear ones but that proves fatal, in most of the cases, in respect of the that original creation or your property i.e. intellectual property (IP).Most of the people acts indiscreetly & ignorantly which results in jeopardizing the chance of saving their intellectual property i.e. novelty of ideas as they comes under public domain & lose their chance to be protected by the INELLECTUAL PROPERTY RIGHTS.

Intellectual property literally means some academic or scholar work. Intellectual property (IP) pertains to any scholar or any original creation of the human intellect; that work can be artistic, literary, technical or scientific creation.

Intellectual property rights mean those rights which are given by the State to the inventor or creator to protect one’s invention or creation for a certain period of time.

Need for intellectual property rights:-

For individual: - IP helps to protect investment of time, money, effort & such other resources of the inventor or creator.

For public:-IP provides a pool of information to the general public since all forms of IP are published in journals & magazines except in case of trade secrets.

For country:-IP provides a mechanism of handling infringement, piracy and unauthorized use & it encourages industrial development & technological advancement which leads to overall economic development of the country.

Bundle of rights:-

IPR are bundle of rights i.e. it includes the various independent rights. Following are the various independent rights for which IPR collectively provides protection:

1. Patent Right(Patent Act,1971 & Patent Rules,2000)

2. Industrial Design(Design Act,)

3. Trademarks (Trademarks Act)

4. Copyright(Copyrights Act)

5. Geographical Indication(Geographical Indication Of Goods Act)

6. Trade secrets(Common Law)

7. Circuit Layout Design(Semiconductor Layout Design Act)

India at International level:-

• The fact that India is a member state of World Intellectual Property Organization (WIPO), an international organization, responsible for the promotion of the protection of intellectual property throughout the world proves that India has proved its potential & has been acknowledged at international level.

We are here concerned with Patent Law; A patent is an exclusive right granted to inventor or creator of a useful or improved article or a new process of making an article for a specified period of time. After the expiry of the duration the invention becomes part of public domain i.e. everyone can use it. So Patent means monopoly rights of inventor in respect of an invention.

Geographical limits of the patent:-

Patent is granted for a specific invention in a particular country in which an application is made for the same cause. There is no international patent as such though it has acquired an international character. For e.g. a patent granted in India is valid only for India and not in the USA. However, a patent granted in the EPO is valid in all the contracting states recognized by European Patent Organization. The protection so granted in a country / region not only identifies the rights of the creator/ inventor or his assignees, but also enables the right holder to enforce his rights against infringers.

Moreover, several international agreements, treaties & conventions exist to monitor that the inventor/creator are not denied of his/her rights like European Economic Community Treaty(EEC),Patent co-operation Treaty(PCT),European Patent Conventions and Protocols(EPC),Community Patent Convention and Protocols(CPC) resulting in a common patent office for granting common patents applicable to the member countries.

What can be patented?

Only inventions can be patented.Sec.2 (1) (j) defines invention as an invention means a new product or a new process involving an inventive step & capable of industrial application. Invention includes within its scope any new & useful improvements of any manner of manufacture, article or substance whether patented or not but such improvement must qualify independently to satisfy the pre-requisites of the patent i.e. novelty, inventive step & capable of industrial application.

Who may apply for patent?

An application for a patent may be made by inventor, either alone or jointly with another, or his/their assignee, legal representative of deceased inventor or assignee are entitled to apply. For e.g. If a person invents a new product or process & unfortunately soon after that he dies then his legal heirs can or any person authorized by him before his death can apply for patent.

Term & date of patent:-

Term of every patent will be from 20 years from the date of filling of patent application & date of patent is the date on which the application for patent is filed, irrespective of the fact whether it is filed with provisional or complete application. To keep the patent in force renewal fee is to be paid every year. The first renewal fee is payable for the third year of the patent’s life & must be paid before the patent’s second anniversary. Term of patent can’t be extended beyond the specified term of patent.

Where a patent application should be filed?

The Indian Patent Office has its head office at Kolkata, which has three branch offices located at Mumbai, Chennai and Delhi. The Controller General heads the Patent Office and each branch has a Controller as its head. In case of an Indian applicant, the patent application must be filed at the patent office under whose jurisdiction the applicant’s has his place of work, or place of residence or place where he conduct business from.

For e.g. if an applicant provides a Chandigarh based address, the application must be filed at the Delhi Patent Office. In case of foreign applicant/s, the jurisdiction in which the patent application is filed would be based on the address for services of the applicant’s agent. For e.g. if the address for services for foreign applicant is based at Bangalore, the patent application must be filed at the Chennai Patent Office.

What are the rights given to the patentee?

The patentee (i.e. an applicant who has been granted a patent) has the exclusive right to prevent unauthorized third parties from making, using, offering for sale, selling or importing the patented product or process in India.

Patent information centre:-

Patent Information Centre (PIC) has been set up in 20 states & is further expanding in other states. Patent information centre provides information regarding the techniqulities & procedure laid down by the government to get a patent. One can get all the information regarding the filing of the patent application & further procedure up till the patent is not granted. The centre provides general precaution for the applicant before & after applying for a patent. The most common mistake which an applicant often does is to publish their invention in newspaper or scientific & technical journals, before applying for patents. Publication of an invention, even by the inventor himself, would (except under certain rare circumstances) constitute a bar for the subsequent patenting of it. Similarly, the use of the invention in public, or the commercial use of the invention in public or even in secrecy, prior to the date of the patent would be a fatal objection to the grant of the patent. However the secret working of the invention by way of reasonable trial or experiment, or the disclosure of the invention to other confidentially may not result into loss of novelty.

Another mistake, which is frequently made by the inventors, is to wait until their inventions are fully developed for commercial working, before applying for the patents. Delay in making application for a patent involves certain risks. so it is advisable to apply for the patent as soon as one’s invention get a physical appearance with 3-D drawings sheets depicting the whole model.

Incentives for obtaining patents:-

An innovative industry can gain competitive advantage in the market if it develops the necessary expertise and skills in developing and manufacturing new products, which are patented. For example, the advantage of a three year excise duty exemption or exemption from Drugs Price Control Order may translate into reserves / income which may offset the cost towards R&D. In order to promote R&D and innovation in Indian industries, Government of India provides a number of fiscal incentives and support measures to industries. Some of them are following:-

• Excise duty waiver on the patented article for a period of 3 years from the date of commencement of commercial production provided that such products be designed &developed by wholly owned Indian companies.

• Exemption from drug price control for a period of 5 years from the date of commencement of commercial production provided that they are produced from the basic stage by a process of manufacture developed by the unit through its own R&D efforts.

• Weighted tax deduction @ 150% on R&D expenditure is available to companies engaged in the business of biotechnology, or the business of manufacture or production of drugs, pharmaceuticals, electronic equipment, computers, telecommunication equipment, chemicals and manufacture of aircraft and helicopters. The expenditure on scientific research in relation to drugs and pharmaceuticals shall include expenditure incurred on clinical trials of drugs, obtaining approval from the regulatory authority under any Central, State or provincial Act and the filing of a patent application in India.

• Depreciation allowance at a higher rate is available in respect of plant and machinery installed for manufacturing goods based on indigenous technology developed in recognized in-house R&D units, Government R&D institutions, national laboratories and Scientific and Industrial Organizations (SIRO). The present rate of depreciation for plant and machinery is 40% as against 25% for other plants and machinery.

• Income tax exemption:-Under Section 35(1)(i) of the Income Tax Act 1961, the revenue expenditure on scientific research, by recognized R&D units, on activities related to the business of the company is allowed full deduction. Under Section 35(1)(iv) expenses of capital nature could be deducted totally from the income of the year in which the expenses have been incurred. Section 35(2AA) of the IT Act 1961 provides for a weighted tax deduction of 125% for expenses on sponsoring research programmes at National laboratories functioning under ICAR, CSIR, ICMR, DRDO, Department of Biotechnology, Department of Atomic Energy, Department of Electronics; IIT and universities.

For more information locate at:-http:/Ipindia.nic.in. Or e-mail at: pisnag@nag.mah.nic.in/pisnagpur@satyam.net.in

For further inquiries e-mail writer at: - kamal_417@yahoo.com, kamdahiya@gmail.com

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Changes In US Patent Practice

July 22nd, 2008

On August 21, 2007, the United States Patent and Trademark Office (USPTO) announced significant changes to the rules of practice in patent cases. The changes include the following:

• limiting the number of continuation (or continuation-in-part) applications that applicants may file per invention without justification to only two;

• tightening the definitions of continuation and divisional applications and restricting the kinds of claims that can be pursued in divisional applications;

• limiting requests for continued examination (RCEs) to one without justification;

• limiting the number of claims per application to 5 independent claims or more than 25 total claims (the “5/25” rule), unless an “examination support document” (ESD) is filed along with the application;

• redefining the relationship between individual applications in a patent application portfolio so that if one or more applications have at least one patentably indistinct claim, their claims are combined for purposes of the 5/25 rule; and increasing the duty of disclosure.

Changing Continuation Practice

The general right to claim priority to a nonprovisional application through an unlimited chain of copendencies by 35 U.S.C. § 120 appears to be abolished. The new rules limit the number of continuation (or continuation-in-part) applications that applicants may file per application without justification to only two. Additional continuation or continuation-in-part (CIP) applications require justification. The justification for additional continuation or CIP filings is made by showing why any amendment, argument, or evidence to accompany an application could not have been filed earlier.
Beyond the above mentioned two continuations, applications pending prior to August 21, 2007 in which two continuation or continuation-in-part applications have already been filed are allowed to have one additional continuation application filed without justification. This additional continuation application may be filed before or after November 1, 2007.

Changing Divisional Practice

Divisional applications may only be filed to non-elected groups of claims created when an Examiner finally restricts claims of an application. A properly filed divisional may also have two additional continuation applications filed without a justification; however, CIP applications claiming priority to a divisional application are not permitted. Further, the new rules require that greater attention be given to the labels given to each application, that is, whether an application is a continuation or a divisional. An improper divisional (e.g., an application pursuing claims rejoined after restriction) will be considered as one of the two continuation applications that is allotted for each invention.

The new rules also state that any continuing application that contains claims previously examined in any prior-filed application is not a proper divisional application. This has implications in applications in which the USPTO makes an election of species requirement. In such applications, generic claims must be prosecuted in the initial application or its two continuation or continuation-in-part applications, including exhaustion of any available appeals, before even filing a divisional application to a non-elected species. If a divisional to a non-elected species is filed earlier, the USPTO, upon allowance of a generic claim, will regard the divisional as improper for being addressed to an invention examined in a prior-filed application.

Limiting the Number of RCEs

Under the previous rules, an unlimited number of RCEs were allowed to be filed. Under the new rules, only one RCE may be filed per application and its continuation applications without justification. A proper justification requires a showing that any amendments, arguments or evidence could not have been filed earlier. Each divisional application and its accompanying continuation applications, if any, are also entitled to one RCE without justification.

Limiting a Number of Claims per Invention without Justification.

The new rules require a filing of an “examination support document” whenever an application contains or is amended to contain more than 5 independent claims or more than 25 total claims. The count of claims includes all of the claims in any other copending application with common ownership having at least one patentably indistinct claim.

An examination support document requires the following:

• a listing of the reference or references deemed most closely related to the subject matter of each of the claims;

• an identification of all of the limitations of each of the claims (whether in independent or dependent form) that are disclosed by the reference;

• a detailed explanation particularly pointing out how each of the independent claims is patentable over the cited references; and

• a showing of where each limitation of each of the claims (whether in independent or dependent form) finds support under the first paragraph of 35 U.S.C. § 112 in the written description of the specification.

Complying with these requirements will likely be very expensive for applicants. It is also quite likely that statements made in an ESD will be extensively scrutinized by patent infringement defendants in any patent issuing with an ESD in its file history. Therefore, an ESD will not be recommended in most, if not all applications. The new rules thus effectively limit the number of claims for most applications. It is important to understand how the USPTO will calculate the number of independent and dependent claims per application. The USPTO will:

• count a claim depending on a claim of a different statutory type as independent;

• count all of the claims in copending applications containing patentably indistinct claims (including applications having a continuity relationship), but not in issued patents containing patentably indistinct claims, in determining whether each such application contains more than five independent claims or more than twenty-five total claims;

• not count claims withdrawn from consideration as drawn to a nonelected invention or inventions, unless they are later reinstated or rejoined; and

• count multiple dependent claims as the number of claims from which they depend.

Importantly, the presence of even one patentably indistinct claim in two applications sharing the same ownership will cause the two applications to be treated as one application under the 5/25 rule. Thus, the two applications will be limited to 5 independent claims and/or 25 total claims. Further, applications with the same ownership, at least one common inventor, the same effective filing date and overlapping disclosure (in a sense defined precisely in the rules) will be subject to a rebuttable presumption that their claims are patentably indistinct. The presumption must be overcome to prevent the multiple applications being treated as one under the 5/25 rule.

Requiring Disclosure of Certain Copending Applications

The rules require the USPTO to be informed of applications with effective filing dates within two months of each other that have the same ownership, and one inventor in common. The rules provide that one or more other nonprovisional applications meeting the above conditions must be disclosed to the USPTO within:

(1) Four months from the actual filing date of a nonprovisional application filed under 35 U.S.C. 111(a);

(2) Four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f) in a nonprovisional application entering the national stage from an international application under 35 U.S.C. 371; or

(3) Two months from the mailing date of the initial filing receipt in the other nonprovisional application that is required to be identified under § 1.78(f)(1)(i).

These deadlines cannot be extended. It is unclear what sanctions exist for failure to identify these other applications, other than it provides a basis for which the USPTO may make final a second office action that includes a new double patenting rejection.

Effective Date and Compliance Date

The effective date for these new rules is November 1, 2007. Most of the rules, however, have implications for currently pending applications and any new applications that may be filed before November 1, 2007.

The USPTO has also set a compliance date of February 1, 2008 for its newly required disclosures of related applications for all pending applications. Furthermore, for applications that have not received a first office action on the merits by November 1, 2007, the USPTO is expected to notify the applicants of the need to supply an examination support document, propose a restriction requirement, or amend the claims so as to not exceed the 5/25 claim threshold.

Action Needed Prior to November 1, 2007

The rules changes create one instance in which an additional action must be taken prior to November 1, 2007. For pending applications in which an RCE has been filed previously, only one RCE may be filed for each application after November 1, 2007 without a justification. This one RCE, without justification, may only be used once in each application family. Thus, for an application family in which an RCE has been filed previously, and the claims are finally rejected and may not be allowed in after final practice, a second RCE should be filed prior to November 1, 2007. Failure to file a second RCE prior to November 1, 2007 will require the applicant to submit an RCE with justification, a continuation application, or an appeal.

Consequences for Patent Application Filing Strategies

The new rules change the number of claims that can be filed in a given patent application. Now, only 5 independent claims and/or 25 total claims may be filed unless an examination support document is filed along with the application. This rule cannot be circumvented by filing multiple patent applications claiming the same invention because, as discussed above, applications filed with the same ownership and patentably indistinct claims will be considered to be the same application for the purposes of this 5/25 rule.

While only five independent and twenty-five total claims will be examined in an application, there is one way to file more than 5/25 claims initially in an application without filing an examination support document. In order to file with more than the 5/25 limit, the application must be filed with a “suggested restriction requirement,” suggesting to the examiner how the claims may be divided so that only groups of claims that comply with the 5/25 limit are examined in any one application. The applicant also selects the group of claims to be examined first. If the examiner agrees with the suggested restriction requirement, the elected group is examined in the application and the applicant may file divisional applications to pursue the groups that are withdrawn from consideration. Other strategies are available depending on the specific subject matter and prosecution strategy for each case.

Consequences in Patent Prosecution

The changes to the patent rules will make it prudent to present all necessary evidence, declarations and argument in response to the first substantive office action. Under the previous rules, which provided unlimited RCE submissions, applicants could attempt to overcome claim rejections initially by using only argument, or claim amendment, and then relying on multiple RCEs if necessary if more extensive arguments and supporting evidence (e.g., declarations) were considered necessary. Currently, as only one RCE by right is permitted in each patent application family, each office action response, especially the first response, will need to be much more comprehensive. If evidence to overcome a rejection is not used as early on in prosecution as possible, the opportunity to use such evidence may be lost.

Appeal practice will likely become much more common under the new rules. Appeal allows the ruling of the examiner to be reviewed by the Board of Patent Appeals and Interferences (BPAI) at the USPTO. Previously, most practitioners avoided the appeal process because it could take several years for the BPAI to decide an appeal. The appeal process also entails risk in that an adverse decision at the BPAI can only be appealed to the Court of Appeals for the Federal Circuit, or by filing an action in a federal district court. For these reasons, most practitioners utilized unlimited RCEs and/or continuation submissions to amend claims and argue to acquire an earlier allowance.

The USPTO has received numerous complaints about the extensive delays in the appeal process. In response, they have reduced the appeal docket so that cases may proceed through appeal more quickly. Patent term adjustment is also available so that at least some of the time lost in appeal will be regained as additional patent term. Moreover, the USPTO has added a pre-appeal process in which three senior examiners quickly review the prosecution of an application prior to appeal in order to decide more obvious disputes between the applicants and examiner.

Rules Will Require Greater Monitoring of the Patent Portfolio

The new rules require that if two patent applications with the same ownership have patentably indistinct claims, the applications will be treated as one application under the 5/25 rule. Thus, both applications must have 5 independent and/or 25 total claims in this situation. Indeed, if the applications have the same effective filing date, overlapping disclosure, one identical inventor, and the same ownership, there is a rebuttable presumption that the claims of the two applications are indistinct. In order to prevent this from happening, and possibly compromising the validity of patent claims, patent owners will generally want to ensure that the claims of different applications are patentably distinct. This can be problematic when a patent portfolio is being prosecuted by multiple practitioners.

Pending applications should be reviewed in order to ensure that the claims of the applications are patentably distinct and to determine whether there are applications with the same ownership, a common inventor, and priority dates within two months of each other. These applications should be brought to the attention of the USPTO in both applications. The USPTO must be informed of the existence of such applications after November 1, 2007, but no later than February 1, 2008.

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