The Dolcera Blog

Claims 1,4,15 & 18-21 of US Patent Application No. 10/346,493(”Appln. 493″) filed by “Gleave”(Martin Gleave and Maxim Signaevsky)  were rejected by the examiner as anticipated or obvious under 35 U.S.C 102/103. Gleave appealed against the decision but the Federal circit affirmed the rejection.

Appln. 493(titled “Bispecific Antisense Oligonucleotides that inhibit  IGFBP-2 and IGFBP-5 and Methods of Using the same”) claims antisense oligodeoxynucleotides, pharmaceutical compositions containing them and method of treating cancer by using them.

The claims rejected by the examiner included Composition claims consisting of these antisense oligodeoxynucleotides, which were claimed to be complementary to a portion of a gene encoding human IGFBP-2/ IGFBP-5, “wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5″.

The examiner rejected the present claims over anticipation by prior art PCT Publication of Wraight et al. (WO 00/78341).This publication disclosed every fifteen-base long sense oligodeoxynucleotide in the IGFBP-2 gene and further also disclosed that these oligodeoxynucleotides may be bispecific(capable of acting as a inhibitor of IGFBP such as IGFBP-2 and/or IGFBP-3).

For a reference/document to be anticipatory, the following requirements should be satisfied:

1.     The reference should disclose each and every element of the claimed invention, explicitly or inherently. Those elements must be combined or arranged in the same way as in the claim.

2.     The reference must enable “one of ordinary skill in the art to make the invention without undue experimentation”.

Gleave claims that Wraight does not describe any particular individual antisense species, there are no particular selections and no understanding of what targets would be useful. Thus Gleave primarily argues that although a large and exhaustive list was disclosed to the public, no basis was provided for selecting some individual members over the others. In effect, he argues that what is actually disclosed is not more than a generic concept underlying the list.

However, the court held that Gleave’s argument failed for two reasons. The list disclosed in Wraight’s  application anticipates Gleave’s claims. Secondly, Gleave’s argument that Wraight’s application is a generic concept stating that one could make antisense constructs that target IGBFP, was also nullified as court held that a person of ordinary skill in the art having the IGFBP sequence is capable of envisioning how to make antisense sequences. Thus, Gleave does not hold right to patentability over Wraight.

In conclusion, the discovery of a new property/use of known composition even when the use/property are non-obvious over prior art cannot impart patentability to claims of the known composition. If a new use is  discovered, patentability can only be claimed for that method of use.

-Priyanka Goyal

Knowledge Scientist

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NOTE: Click on the graphs for enlarged view

1. The complete picture

In 2006 total number of application filled across the world were 1,764,633 which were 4.9% more than filled in 2005 (1,681,596).

There is 91% increase in patent filing from 1985 to 2006 and 67% increase from 1995 to 2006.

2. Top 10 patent filing countries

Japan remains the undisputed number 1 country filling maximum patents across the world. Number of filling has increased by 5.1% from 2000 (489,187) to 2006 (514,047).

USA is the top second country with an astonishing increase of 42.5% increase in patent filling from 2000 (274,317) to 2006 (390,815).

3. Top 11 patent filing offices

USPTO displaced Japan patent office from its number 1 position in 2000 to number 2 in 2006. While US showed a gigantic leap of 44% Japan came down by 2.6% during the same period.

China patent office was at number 3 and showed enormous increase in patent filing of 305% from 2000 to 2006. The neighbor country India (global number 11) also showed 188% increase in 1 year from 2005 to 2006.

4. Patent filing trend: Rise and Fall

Countries on RISE: China, USA, Netherlands, Switzerland and Republic of Korea
Countries on FALL: Japan, Russian Federation, Germany, France and United Kingdom

Compiled from World Patent Report: A Statistical Review (2008)

- Harit Mohan

Knowledge Scientist, Dolcera

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Summary: Use of both wikis and iPhones is growing within enterprises. Using wikis from iPhones is not very easy yet, though there are some promising applications/approaches in the works. A notable application is Mini Confluence for the iPhone.

Wiki usage is growing rapidly in enterprises, and the success of Wikipedia has encouraged information technology (IT) and business units to try and set up something similar to a Wikipedia within their organizations as well.

A concurrent trend is the growth of smartphone use by business users. The Blackberry devices, currently the favorites of enterprise users, have always had top-notch email capabilities, but have not focused on the web browsing experience, though that’s changing rapidly.

The Apple iPhone is the real game-changer when it comes to mobility. Now comes the news that it is making big strides in enterprise adoption. Via GigaOm, we have the following quote from the Apple COO, Tim Cook:

The phone is particularly doing well with small business and with large organizations that allow people to purchase the phones for individual use, and this is both in corporate and government settings. Specifically, to give you some numbers, almost 20% of the Fortune 100 have purchased at least 10,000 units or more and there’s now multiple corporations and government agencies who have purchased in excess of 25,000 each.

Business users will soon want to access their wikis from their iPhones. In most cases, they will want read-only access and for that, a variety of options are already available. For example, there is an iPhone app out for the the popular Confluence wiki. The app’s called Mini Confluence

and it allows for browsing, searching and commenting. Editing does not seem to be supported.

Other wikis are taking a different approach. SocialText made an announcement in 2006 for something called the Miki, which, for all practical purposes, seems like a ’skin’ or a stylesheet that makes the wiki content readable on a mobile device. Many other wikis (including Twiki) follow the same model.

Yet a third approach is that of dumping the entire wiki on to the phone, since these phones have plenty of memory. Wikipedia-iPhone, for example, lets you take the whole encyclopedia with you on your device.

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http://www.cafc.uscourts.gov/opinions/09-1001.pdf

It is our contention that in the globalized world of manufacturing, where most of the manufacturing activity happens outside the developed world, having legally valid patents in the manufacturing hubs of China, Mexico or India can pay off handsomely. A legal right in those countries can ease gathering of evidence as can be seen in the case below where video shots of manufacturing process used in Mexico is used as admissible evidence.

This case pertains to an infringement claim won by Gemtron Corp. against Saint Gobain for refrigerator shelf manufacturing method and design.

Background:
Saint Gobain manufactures refrigerator components in Mexico and sells them in the United Sates. Gemtron Corp. has a patent for manufacture of refrigerator shelves where by a glass portion of the shelf is held to a polymeric base using ‘fingers’ and not ‘adhesive’ ( a traditional method) filed in both USA and Mexico.

Gemtron Corp. alleged that Saint Gobain was infringing on its patents since it was using a similar method for manufacturing its shelves - in which a glass portion is held to its polymeric base using ‘fingers’. Saint Gobain was countering Gemtron Corp. allegation saying that the claim 23 of the ‘673 Gemtron patent was only a ‘process’ patent and hence the end result from the process (the end design or the structural component) was not claimed. The CAFC rejected Saint Gobain’s plea on the grounds that the result of a claimed process which lead to a unique structural change were also by default patentable subject matter.

In order to refute Saint Gobain’s claims that its manufacturing process was significantly different than claimed in the patent, Gemtron Corp. showed videos of the manufacturing process used at Saint Gobain’s manufacturing site in Mexico. The video clearly proved similarity in the process used at Saint Gobain manufacturing site.

In the overall case argument, while the moot point was the ’structural component’ or the design of the shelf, it can be argued that the video showing Saint Gobain’s manufacturing process was also helpful in winning a non-technical jury’s verdict to prove wilful infringement at the district court level.

- Lakshmikant Goenka

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Continuing from the previosuly published study on India Close Second to China in Clinical trial registered to be conducted in Asia: A Dolcera Study, we analysed 4 other important Asian countries and the trend of clinical trials there, these were: Philippenes, Russian Federation, Korea and Japan. The numbers of trials, as registered with clinicaltrials.gov by companies all across the world were considered in both of these studies. 

1. Clinical trials in Asia on a rise (Part-II) 

As in the case of India and China (discussed in part-I of this study) Philippenes, Russian Federation, Korea and Japan also showed whopping growth in number of clinical trials registered to be taking place in these countries.

2. Growth curve for clinical trials in Asian countires (Part-II) 

As can be seen, number of clinical trials registered to be in Japan took a dip down in year 2005 which was  recovered in subsequent years. Also, number of clinical trials registered was found to be plateatued for the period between 2005 to 2007 for Russian Federation. Republic of Korea on the other hand has aggresively accelerated on this front keeping it at the top in this four nation clinical trials study.

- Harit Mohan, Dolcera

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Last week, we’d reported the results from the success of Rapamycin in increasing mice longevity.

Assuming the life expectancy improvements continue at the rate of three months per year, here are some estimates of how long one can expect to live given the year of birth. The expected life expectancy in the US today, for example, is somewhere of the order of 78 years. But by the time the person born today is 78, the life expectancy would have gone well past 110. Here is some math on expected life expectancy at birth and the actual life expectancy:

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This is a report prepared on the basis of the Annual Report 07-08 provided by the Indian Patent office. This report provides us with an analysis of the patenting trends in the last five years (I.e From 2003-2008). The data for the analysis is taken from the Annual Report - 2007-08 provided by the Indian patent Office. This reports provides graphical representation of the trends followed in Indian patent office which gives us a better perspective of the progress made by the Indian Patent Office(IPO), the rise of patenting in various fields of inventions and major contributors to the patent filing trend in India.

Introduction

Indian Patent Office is functioning from its four branches located at Kolkata, Chennai, Mumbai & Delhi. Kolkata Office is the Head Office. The Patent Office administers the law concerning protection of inventions in the country by way of grant of limited monopoly to the inventors or their assignees or legal successors. The Patents Act, 1970(as amended) governs the grant of patents.

Dolcera Analysis

1.1 Trends of patents in India:

The above trend was prepared based on the Annual report provided by the IPO. Go to IPO site to download the Annual report 2007-08

A.Patents Filed:

From the above graph one can easily find that there has been significant increase in the filing trend in the last five years. The number of applications for patents filed in 2007-2008 was 35,218 compared to 28,940 applications in 2006-2007 representing an increase of about 22 % in the filing. When one looks at the patents filing distribution in the year 2007-08, It’s a rather disappointing figure.

The above graph was taken from the IPO Annual Report 07-08.The number of applications for patents which originated in India were 6,040 contributing approximately 17% of the total number of applications filed during the year. The Major contribution comes from Maharashtra followed by Delhi, Tamilnadu and other states. Number of convention applications filed in 07-08 was 4453, Increased by about 41% over the 06-07 year’s total of 3165.

Majority of the foreign applications were filed through the PCT National Phase route. The number of such applications filed during the year 07-08 was 23,891 which was about 21% higher as compared with the previous year total of 19,768.The major contributor is USA followed by Germany, UK and other countries.

The Number of PCT applications have grown considerably in the last five years, the legal entity showing greater interest than the individuals.During the year 07-08 total filing was 707 as compared with 534 in the previous year, an increase of approximately 33%.Major contributors for the PCT international applications during the year were CSIR, Cadila Healthcare Ltd, Matrix Laboratories Ltd. Alembic Ltd., Jubilant Organizes, Starlight Optical echnologies Ltd. Pricol Ltd., Onmobile Global Ltd., Panacea Biotech Ltd., Reliance Life ciences Pvt. Ltd., Natco Pharma, hetero drugs Ltd., Ind- Swift Laboratories Ltd.

From all the above data it is eviden that the number of foreign patent applications is nearly 4 times that of the domestic patents filed in India. It also reflects that developed countries continue their interest in R&D activities and they ensure that their invention is protected in developing and a great consumer market like India.

B. Patents Examined:

The number of patents examined each year is not steady and has its ups and downs each year. One can easily observe that the number of patents examined fell in the years 05-06 and 07-08 as compared to the previous years.

This raises doubts on the conditions of the patent examinations in India. Its well known fact that there is a crunch of patent examiners in the IPO to examine the patents. Hence there is a need to recruit qualified patent examiners which will help remove the backlogs of the pending patent applications in India.

C. Patents Granted:

The number of patents granted has increased significantly in the last five years. The year 07-08 saw nearly double the patents granted as compared to the previous years.

1.2 Patents application and grant in various technology fields:

The above chart depicts which categories of patents are most sorted for application in India. As far as patent application is concerned Chemical, Mechanical and drugs patents have gained significantly in terms of their application in India while there is decline in patent applications related to Food, Electrical, Computer/Electronics and Biotechnology patents in the year 07-08. The major reason could be the recent recession period which had hit many sectors or it could be as a result of the Bilski case. The Others category which contains specialised field has seen a considerable rise in 07-08 ahead of other patent applications.

As far as grant of the patents goes the grant of the patents have increased considerably due to the efforts put by the IPO and due to amendments in Indian Patent ACT in 2002 and 2005 respectively which could be the reason for the increase in the grant of the patents in recent years.

The others field distribution is shown below. The IPO has classified it since these are specialised branches. The below analysis is for the others field distribution for the year 07-08

One can see that applications in the field of Physics, Communication and Biomedical contribute to 50% of the applications in the other specialised fields.

One can see that Biochemistry and Physics contribute to 50% of the patents granted in Others field, thus showing that new inventions are being made in these fields.

1.3 Conclusion:

Though significant steps are being taken by the Indian Government and the IPO to encourage patent application in India and improvement in the working of the IPO, we still are much behind then our neighbor China where the patent applications are said to have crossed US and Japan patent applications Source. What IPO needs is a better database where people can access patents easily similar to those patent database as USPTO and EPO, where patents documents can be easily downloaded and legal status of these documents can be accessed. Though Indian patent PDFs for application number 1-80000 are available but the patents after that are not available in full texts. Patents signify the Research activity in a nation. The number of domestic filings are very less and major applications are from foreign nationals which is a cause of concern since it shows that domestic R&D activities are not given enough boost. Hence steps should be taken to encourage original research activities which will help develop India and mankind

-Anil Sharma

Knowledge Scientist

Dolcera

© Dolcera 2009, All Rights Reserved. No part of this publication should be copied without the permission from the authour or from Dolcera.

Disclaimer: The above report has been prepared from the data provided in the Annual Report 07-08 by the IPO. There can be manual errors and the author or the company(Dolcera) takes no responsibility for the damage caused due to the data provided.

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http://www.cafc.uscourts.gov/opinions/07-1583.pdf

In this classic case of Friskit v/s Real networks, Friskit alleged Real networks media players had infringed its patents that claimed as its inventive the following (a) a media player with integrated search and playback features and (b) wher the entire control of the media player rest with the server side with no software (OS) from the client side assisting in the operation of the media player.

Real cited the following product and website evidence to counter Friskit. It cited the features available at www.iuma.com and Winamp to counter Friskit’s claims. In both cases of iuma.com and Winamp offered a media player interface with a search box. When a search was conducted, a new mini-browser window would pop up that would get populated with the search results. These search results could be dragged and dropped into the media player interface for immediate play-back with minimal intervention from the client side. Friskit’s only difference was the same interface (with no special mini-browser) window poping up providing this functionality.

The court cited KSR v/s Teleflex and found Friskit’s claims as obvious stating that as per the KSR case ‘predictable use of known elements according to their cited function’ results in obviousness.

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Follow-on Biologics or Biosimilars are generic versions of Biopharmaceutical products. The vastly increased complexity of Biosimilars as compared to common traditional small-molecule drugs and the complex means for the production of Biologics (Molecular cloning, fermentation and purification processes etc.) makes it all the more difficult to ensure that an imitator product is biologically and functionally equivalent to the original. Though the generic version uses the same mechanism of action and performs essentially the same role as the original version, it is difficult to create an exactly similar copy of the original version due to complex manufacturing processes and hence the name “Follow-on Biologics”.

With many Biopharmaceutical product patents nearing expiry in the US, the government has realized the importance of regulation at the level of approval to ensure safety and efficacy of Biosimilar products.

The Hatch–Waxman Act, 1984 was the conception point for regulation of the use of follow-on biopharmaceuticals. It provided incentives to generic manufacturers by lowering the cost of approval of Biosimilars as they have to demonstrate bioequivalence but not repeat the human trials for proving efficacy and safety of the product. The act also established minimum periods of market exclusivity for brand-name products.

The European Union has established a special approval procedure which is more stringent than required for chemical generics and also requires much more comprehensive information.

Other issue involving Follow-on biologics is the period of market exclusivity for brand-name biopharmaceuticals. A period of market exclusivity would provide the incentive for investment in research and development for newer Biopharmaceuticals but also hinder the price competition from Biosimilars which lower the cost of medicine and make it affordable to the general public.

While the debate is still on, White House believes a 7-year data exclusivity period “strikes the appropriate balance between innovation and competition.” Previously, PO Board adopted a resolution in September 2008 supporting legislation that “promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population. We can hope that to ensure safety and efficacy of Biosimilar products US Govt. will come up with a solution appeasing both companies and consumers.

Source 1

Source 2

Priyanka Goyal
Knowledge Scientist
Dolcera

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