The Dolcera Blog

Ranking makes life easier. Be it top 10 companies, top 10 universities to study technology or to choose amongst top 10 sci-fi movies you want to watch on the weekends; ranking allow us to choose the best amongst the available. Time saver, decision influencer and extremely helpful are the ranked material.

At Dolcera, we thought of applying the ranking methodology to patents. We have ranked patents based on a variety of parameters. First factor amongst all remains the client focus, second, sufficiency of disclosed information in patents and third credibility of a patent to perform the same process/art with higher efficiency than any other patent with similar focus.

Let us consider an example, the first table in the image below show patents with similar focus of decreasing tumor volume using RNA interference (RNAi). The patent one has disclosed maximum information in this area and in addition to the desired data, it has also published a lot more supporting information derived from other experiments. Further, as the rank goes down the percentage decrease in tumor volume decreases. Some may argue that patent 2 has disclosed more decrease in tumor volume than patent 1 but then patent 1 has disclosed more supporting data, taking its overall weighted score higher. Of course, if the client is still interested only in comparing tumor volume, patent at rank 2 will come at rank 1. Hence the ranking is customized to suit the client requirements.

The ranking of patents is not that simple as it may sound. The analysis team has to encounter challenges and figure out the ways to overcome them. Graphs, charts, instrumental outputs etc. will not give you data in percentages which can be just copy-pasted to compare. They have to be calculated first using mathematical tools which may vary from calculating areas under the graphs or applying differentiation & integration on instrumental outputs, to allow the reader to compare results before making the final decision. It’s considered an absolute value add to the decision making process by the clients who have sought such a service from us.

Not all experimental data will be quantitative. For people familiar with biotechnology would know that there are experiments (such as gel electrophoresis, staining etc.) that give qualitative or quasi-quantitative results. I am sure, the same will hold true with other technology fields too. Second part of the figure above summarizes few patents which can not be ranked as there is no data yield from such experiments and hence comparison is not possible. But then why miss them? We provide a Dolcera summary table which will give reader an idea as these experiments were atleast conducted and disclosed in patents. This comparison will thus strengthen the decision to be taken from ranking matrices discussed above.

This systemic approach of collecting, sorting, analyzing, and finally ranking the data has the following advantages:

1. Saves time!
2. Easy comparative analysis.
3. Helps in competitive watch
4. Decision on in-and-out licensing can be made.
5. Strong baseline for future scientific investigations.

Who will be benefited?

Scientific community: Extensive experimental data, comparison matrix of data from different patents with same focus is a feast to researchers and scientists as it helps them to choose best technologies.

Patent attorneys: Allows competitor watch, supports their decision on in and out licensing.

Venture capitalists / investors: Patent ranking based on disclosed information helps investors to decide patents to further invest upon.

Which technology fields are covered?

Patents in all the technological fields can be ranked. You just need to tell us the focus area and we will rank the patents for you. The ranking and weighing scores can be customized to suit user’s requirements.

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The discovery of RNA interference (RNAi) is one of the transforming events in biology. Gene silencing agents such as small interfering RNA (siRNA), micro RNA (miRNA) and small synthetic oligo-nucleotides (DNA, RNA or DNA-RNA complex) lead to target specific RNAi. We aim at building a one-stop comprehensive database of RNAi agents patented or described in scientific literature.Dolcera has provision to customize the database against the target gene suiting client’s requirement. Till now, RNAi agents against some of the important cancer target genes are updated to the database and the trial access is available on request. These genes include bcl2, myc (c-myc, n-myc), ras (k-ras, h-ras, n-ras), VEGF, STAT3 etc. RNAi agents can be extracted and added to the database based on client’s interest.

Dolcera RNAi database can prove helpful:

• For scientific community: RNAi agent sequences aligned to target genes, extensive experimental data and comparison matrix of data from different patents with same focus.  
• For patent attorneys: Competitor watch, assignee vs. number of publications graphs, timeline based on application and publication dates.
• For venture capitalists/ Investors: Patent ranking based on disclosed information, data useful for decision making.

Salient features of the database:

1. Interactive maps of taxonomy: 4 levels of in depth classification of patents and scientific literature allow both “bird’s-eye view” and “in-depth views” of technologies.
2. Patent and non patent dashboard: Grouping specific elements into more general categories is conceptually easier and cleaner than entertaining hundreds of specific elements separately. Dolcera dashboard has a friendly user interface. It groups the patents according to the taxonomy, patent numbers, publications and application dates at the click of a button.
3. Sequence Dashboard: The tool not only aligns all patented/ non patented siRNA/ miRNA sequences to the target gene but allow user to see the sequence related information on a simple click of the mouse.
4. Experimental matrix: Experimental data be it quantitative (eg. % inhibition of target mRNA expression) or qualitative (eg. gel blots) are compared amongst patent document with similar focuses. This allows users to compare literature with same focus. The ranking of documents can also be done based on scoring matrices, which allows user to read the most relevant patent first.

 For database related inquiries or free demo call us at, Phone: +1-650-269-7952 (US) and  +91-40-6451-0832 (India). You can also email us at info@dolcera.com

To read more about RNAi database click here

To visit Dolcera’s website and to explore more patent/ IP related services click here

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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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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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(Via In the Pipeline) A study reported in Nature magazine concludes that Rapamycin can increase the longevity of mice. The effect seems to be better than that of Resveratrol, which has also shown anti-aging effects in several organisms.

According to a 2002 paper in the journal Science, the longevity of women has been increasing linearly at the rate of 3 months per year. We may even see that rate accelerate within our lifetime. So get ready to live well past 100.

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Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. We did a comparative study for key Asian countries (India, China, Pakistan, Singapore and Sri Lanka) to better understand the trend of clinical trials in Asian countries. The numbers of trials, as registered with clinicaltrials.gov by companies all across the world were considered in this study.

1. India’s second largest pie share

India is close second to China (~41%) with 36% clinical trials being registered from 2002 to 2008, to be conducted in India. Singapore and Pakistan holds third and fourth position respectively in 5 nations comparison study. Sri Lanka has only 0.3% share in the pie.

2. Clinical trials in Asia on a rise

India has shown a whopping 463.33% growth from 2002 to 2008 in terms of clinical trials registered to be conducted in India. China follows close second with 365.56% rise in the same period. However, overall statistics showed that China remains number 1 for clinical trial destination amongst 5 countries.

3. Growth curve for clinical trials in top 3 Asian Countries

As apparent from our results India and China were head to head till the year 2006, following that China started getting lead from India. On the other hand, Singapore started losing to India and China following 2004.

Read Part-II of this study at : http://blogs.dolcera.com/blog/2009/07/21/clinical-tiral-in-asia-a-dolcera-study-part-ii/ 

- Harit Mohan
Knowledge Scientist
Dolcera

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The Dolcera Sequence Dashboard video demo is available on YouTube now. Here is the link.

The goal of this study was to find the patents published on Neem (Azadirachta indica) and its various compositions (utilizing Neem as an addivite with other chemicals or natural products) since January 2006 in India and the USA, and see if the Indian private and government sectors had woken up to the new age ‘land grab’ opportunities provided through patenting Neem. The second goal was then to drill down deep into the patents to find out the application areas covered.

Neem (Azadirachta indica) is a tree in the mahogany family Meliaceae. It is one of two species in the genus Azadirachta, and is native to India, Myanmar, Bangladesh, Sri Lanka and Pakistan growing in tropical and semi-tropical regions. In East Africa it is also known as Mwarobaini (Swahili), which means the tree of the 40, as it is said to treat 40 different diseases. Traditional uses of Neem 1. Neem acts as anti bacterial, anti parasitic, anti fungal, anti protozoal and anti viral thus helps in protection from all the microorganisms, which are always ready to invade in our body causing serious ailments. 2. Local application of neem powder or neem oil has miraculous results. As it is a famous anti microbial herb, it renders all the microorganisms inactive therefore helping in proper healing of wound without causing any infections and septic conditions. 3. Taking bath of neem leaves water is a very common sight in Indian homes that helps our body to counter mild infections, which our body might get in day-to-day activity. 4. Its tropical application makes us relieved from acne, eczema and even ringworms. 5. In skin related diseases, neem works as blessing of God on mankind. It has an action on almost every kind of skin disease thus making its indication in eradicating every kind of itch, rash, infection and allergy. 6. Neem water is extensively used in burn injuries, thus to protect them from any kind of infection and also promote healing. 7. Neem oil is extensively used in hair fall and early graying of hairs with very satisfying results. It also find its application in dandruff and in lice growth.. 8. Its local application on arthritic conditions like rheumatoid arthritis, gout, Osteoarthritis, lower back pain, and musculo skeletal pains is highly recommended with good results. Source

Dolcera Analysis

1. Top Assignees in India and US on Neem patents: We analyzed a total of 98 relevant patents published in India on Neem and 78 relevant patents published in US on Neem from 2006 to 27th June 2009.

Top Assignees Vs Number of Publications in India

Top Assignees Vs Number of Publications in US

A. One can observe from the above graph that CSIR is the leading assignee in both US and in India. It means that considerable research on Neem is being carried out by CSIR. B. In India, CSIR is being followed by Kalyani Chemicals, Indian council for agriculture result (ICAR), Godrej agrovet, Defense Research and Development Organisation (DRDO). C. In US, CSIR (India) remains the top filler followed by UOP LLC and Syngenta Corp protection Inc.

2. Applications of Neem on which Indian and US assignees filled patents: Next, we compared the Applications of neem for which the patents are sought in both US and India.

Indian assignees (Application area Vs. No. of patents)

US assignees (Application area Vs. No. of patents)

A. The major application of neem in most of the publication is on Pest control. B. Indian publication concentrates on the medicinal aspects of neem whereas US publications concentrates mostly on the insect repellant property of neem. C. Indian assignees have patented use of Neem for its medicinal benefits such as for wound healing, wound coating, diabetes, HIV/ Aids and skin care. D. US assignees looked more interested in the areas such as Biodesel production, fertilizers, dental formulations, food packaging, cosmetics and Pharmaceutical compositions.

3. Sector wise distribution for Indian patents on Neem We tried to find out the major contribution of various sectors in publishing patents on neem and found that individual Application of patents has major part in the distribution of publication on neem in India followed by the private sectors and then the government.

Sector wise distribution on Neem patenting in India

Neem patent in India are mostly held by individuals, 41.84% followed by private sectors, 31.63%. Government institutes lagged behind all and retain only 26.53% patents on India’s traditional asset, Neem.

4. Dolcera Conclusion Indians have always cherished their traditional knowledge, heritage and culture. Neem is one such heritage and an integral part of our socio-economical culture. From times immemorial Neem has found use as an intergradient in Indian culinary, as a medicine for cure of several allergies/diseases and in various religious ceremonies across the country. Time and again there has been a hue and cry to stop other countries from patenting this age old Indian knowledge of Neem. This study, is aimed to answer the key question Are Indians holding an upper hand, legally too, on Neem usage? Comparing the trend of patent filing in India and US between 2006 to June 2009, we can safely conclude that India as a whole has risen up to the expectations and has filled 98 patents on technology surrounding Neem. CSIR (India) played a key role here in India as well as in US to remain as top assignee in the terms of number of patent fillings on application of Neem. However, the complete picture can be alarming. Figure this, despite CSIR remaining as the top assignee, patents on Neem in India are mostly held by individuals (41.84%), followed by private sector, 31.63%. Government institutes (which included CSIR, DRDO, ICAR, IIHR etc) lagged behind all and retain only 26.53% of patents on India’s traditional asset. While Indians have used Neem for its medicinal benefits such as for wound healing, diabetes, HIV/ Aids and skin care; US assignees looked more interested in the areas such as Biodesel production, fertilizers, dental formulations, food packaging, pharmaceutical compositions etc. This study was aimed to gain in depth insight of patenting trends on Neem in India and US. Waking up to the cause, India has done well to broadly cover the Neem application areas but the efforts should increase exponentially to retain the legal rights on Neem, the gift of nature to India. - Lakshmikant Goenka MD, Dolcera AND -Anil Sharma Knowledge Scientist AND - Harit Mohan Knowledge Scientist DISCLAIMER: Above study was conducted using the Indian patent search database provided by the Indian patent office and Micropat. The study was a broad level search and we might have missed out on few patents. The analysis is prone to human errors and can have marginal errors. Dolcera holds all rights on this publication and it should not be used without the consent of authors and the company.

© Dolcera, All rights reserved, 2009

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An important issue in the field of patenting Biotech inventions is the patenting of Genes or seeds/plant material. Pharmaceutical and agri-bio industries favor and want gene patents for commercial returns and to invest the time and money needed to develop gene-based drugs or biotech crops. On the other hand, the patenting on genes and seeds might lead to costlier medicines/treatment of some diseases and the seeds/plant material might become inaccessible to the poor again due to the high expenses.

In July 2002, the Nuffield Council on Bioethics published its report, “The Ethics of Patenting DNA.” approving to patent of genes but subject to rigorous tests of patentability including novelty, inventiveness, and usefulness.

Further the council recommended that the claim for DNA sequences to be used as research tools should be hindered and that gene patents should not extend to gene therapy- Inserting a normal gene / correcting or replacing the faulty gene should be considered obvious and hence not patentable.

In September 2002, Commission on Intellectual Property Rights (CIPR), set up by the British government’s Department for International Development, published its report, “Integrating Intellectual Property Rights and Development Policy.” Concluding the regime of gene patenting and other expansions in practice of Intellectual property would not be beneficial to developing nations raising the price of medicine and other amenities and further accentuating poverty.

The importance of the matter however lies in the crucial understanding and practice of patent rights which are subject to monopoly rights and dissemination of knowledge at the same time.

Edited from Sue Mayer (Director of GeneWatch UK) opinion on Source

- Priyanka Goyal

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