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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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Michael Jackson experimented with an innovative “anti-gravity lean” in his performances, for which he was granted US Patent No. 5,255,452. The patent describes the anti-gravity lean used in the music video for “Smooth Criminal”.

The new design for shoes which will allow his or her performing artist, by engaging the shoes onto an upstanding post positioned to project upwardly from a stage at a predetermined time, to lean forwardly to put his or her center of gravity beyond the front or rear of his shoes, thereby creating the desired gravity defying interesting visual effect.

MJ claimed his innovative idea on anti gravity lean with USPTO on June 29, 1992 and the patent rights were granted to him on October 26, 1993 which gave him the sole right to use the technique during dancing.

To read the patent click here

- Ajay Kumar
Knowledge Scientist
Dolcera

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Ariad filed a claim of infringement against Amgen for its drug Ender.

Ariad’s ‘516 patent claims “A method for diminishing induced NF-kB mediated intracellular signaling comprising reducing NF-kb activity in cells such that NF-kB mediated intracellular signaling is diminished”.

NF-kB activity can be mitigated through two methods: (a) Inside the cells - by modifying the signaling pathway. This is specified in the Ariad patent as done by using decoy molecules and other methods and (b) Outside the cells - by modifying the inducing action of Tumor Necrosis Alpha (TNF-Alpha) that in turn effects the signaling pathway inside the cell which in turn affects the NF-kB activity.

The court in its judgment pronounced Ariad’s claims as invalid. It maintained that the Ariad’s ‘516 patent does not state in its specification any modification of NF-kB activity by preventing the ‘external influencing’ activity of TNF-Alpha. Citing the Philips v/s AWH Corp, the court argued that “a person with ordinary skill in the art, is deemed to read the claim not only in context of the particular claim, but in the context of the entire patent, including the specification”. The court further cited that the patent prosecution history informs ‘how the inventor understood the invention, and whether the inventor narrowed his/her claim during the course of prosecution”.

Going forward, it is going to be imperative for inventors to disclose as broadly as possible the scientific and technical ramifications of their inventions, and ensure that each ramification is well spelt out in the specification of the patent. Failing which, the legal validity of such patents in the court of law will be easily challenged.

Click here for source

- Lakshmikant Goenka
MD, Dolcera

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The US Patent 6,048,850 held by University of Rochester was found to be invalid for failing to comply with the written description requirement of 35 U.S.C. § 112.

University of Rochester sued G.D. Searle & Co. Inc., Monsanto Co., Pharmacia Corp. and Pfizer Inc. alleging that Pfizer’s sale of its COX-2 inhibitors Celebrex (R) and Bextra (R) infringed the ‘850 patent. The pharmaceutical companies counterclaimed that the patent is invalid.

Traditional non-steroidal anti-inflammatory drugs (“NSAIDs”) such as aspirin, ibuprofen, ketoprofen, and naproxen are believed to function by inhibiting the activity of enzymes called cyclooxygenases which are of two types COX-1/ PGHS-1 and COX-2/ PGHS-2. COX-1 is involved in the production of prostaglandins that serve a beneficial role while COX-2 is expressed in response to inflammatory stimuli, and is thought to be responsible for the inflammation. NSAIDs inhibit both COX-1 and COX-2 and hence are thought to result in undesirable side effects apart from reducing inflammation.

The ‘850 patent claims for the use of a “non-steroidal compound that selectively inhibits activity of the PGHS-2 gene.”

The ’850 patent however was not found to disclose any such compound nor provide any suggestion as to how such a compound could be made or otherwise obtained other than by trial-and-error research.

Three requirements referred to as the “written description requirement,” the “enablement requirement,” and the “best mode requirement” need to be satisfied to claim patentability of an invention disclosed in a patent.

Claims of the ’850 patent were thus found to be invalid as the specification did not describe in detail the method to manufacture or obtain the compound so that a person ordinarily skilled in the art could practice it.

The litigation case brings forward the concept of Reach-through claims seeks to protect things that have not yet been discovered by an inventor, but which might be discovered in the future by making use of their invention. When an invention is made in a widely applicable basic research technology (referred to herein as an “upstream” technology), it is often possible to envisage future technologies (referred to as “downstream” technology) which might be developed using the basic research technology. If the inventor of an upstream invention files a patent application for the upstream invention and attempts to claim downstream inventions which they have not as yet actually made, then the claims to those downstream inventions are referred to as “reach-through” claims.

Source 1 Source 2

- Priyanka Goyal
Knowledge Scientist
Dolcera

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AstraZeneca’s patent on Toprol-XL® was judged to be invalid by Court of Appeals for the Federal Circuit (CAFC). The seeding of the case way backs to 1971. The final judgment is in favor of opponents of Astra as Astra filled double patents for the same drug salts of Metoprolol. This is one amongst most talked about IP cases in world. Read on the complete article and understand how tides turned against Astra in this historic case.

1. 1971: Astra Sweden employee, named Toivo Nitenberg synthesized metoprolol succinate as well as the tartrate and sulfate salts of metoprolol.

2. 1982: Another Astra Sweden employee Lars Lilljequist synthesized a number of metoprolol salts, including metoprolol succinate.

3. 1982: Same year, The parties submitted conflicting evidence as to whether two other Astra employees in Sweden, Curt Appelgren and Christina Eskilsson, had directed Lilljequist to synthesize metoprolol succinate.

4. 1983: Appelgren and Eskilsson left Astra to join another company, Lejus Medical AB (“Lejus”).

5. Jan 1984: Lejus Medical filed a patent application (SE 8400085) with the Swedish Patent Office, describing “delayed and extended release dosage forms of pharmaceutical compositions, including metoprolol succinate” and naming Appelgren and Eskilsson as the inventors.

6. Jan 1985: Lejus Medical filed U.S. application Ser. No. 690,197 (the ’197 Application), claiming priority from the Swedish application filled in Jan 1984.

7. Oct 1985: In the settlement agreement, Lejus agreed to divide claims to “metoprolol succinate” and to a “pharmaceutical composition, characterized in that the active substance is metoprolol succinate” from the ’197 Application and to assign the divided claims to Astra. The settlement agreement listed Appelgren and Eskilsson as the inventors of the divided metoprolol succinate claims. Astra agreed that Lejus retained the rights to the ’197 Application that did not include the divided claims.

8. Mar 1988: In accordance with the settlement agreement, Lejus filed U.S. application Ser. No. 172,897 (the ’897 Application), which was a continuation-in-part of the ’197 Application. Lejus filed the ’897 Application with Appelgren and Eskilsson as the named inventors and Astra as assignee.

9. Jan 1989: Astra’s in-house counsel asserted to Astra’s outside U.S. patent counsel that “there remains an open question who is the proper inventor.” The last mention of this issue in the record is a phone call between Astra’s in-house counsel and outside U.S. patent counsel

10. Mar 1991: The ’897 Application (filled in Mar 1988 by Lejus) get issued as U.S. Patent No. 5,001,161 (the ’161 Patent). The only claim of the ’161 Patent reads: “A pharmaceutical composition comprising metoprolol succinate together with a sustained release pharmaceutically acceptable carrier.”

11. Jan 1992: A continuation of the ’897 Application issued as U.S. Patent No. 5,081,154 (the ’154 Patent). The only claim of the ’154 Patent simply reads, “Metoprolol succinate.”

12. 1992: The ’161 (Mar, 1991) and ’154 (Jan 1992) Patents both list Appelgren and Eskilsson as the inventors, and Astra as the assignee. Astra never revealed the inventorship issue to the U.S. Patent & Trademark Office during the prosecution of the two patents.

13 1992: During the same time period, Lejus’s ’197 Application issued as U.S. Patent No. 4,780,318 (the ’318 Patent) in October 1988.

14. District court invalidated Astra’s ’161 and ’154 Patents as double patenting over Lejus’s ’318 Patent.

Click here for source

- Lakshmikant Goenka
MD, Dolcera

AND

- Harit Mohan
Knowledge Scientist,
Dolcera

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Pepsi as we all know is a big giant in soft drink industry was founded and marketed by a pharmacist as digestive syrup. The name Pepsi itself is derived from ‘pepsin’, the enzyme that helps in digestion. North Carolina pharmacist Caleb Bradhan had invented the drink in the 1890s and had marketed it as digestive syrup, but it was only much later that the cola became a ‘cool’ drink. Pepsi is revisiting its roots with an ultra-cheap soft drink that will aid fight against Anaemia in women in rural India.

The product expected to be launched as early as next year and may cost just Rs 1 or 2 for a drink, although a decision on the packaging is pending.

The aim of this project is to reduce incidence of Anaemia in Indian women residing in rural India by 20% by 2020.

Pepsico, formed after the merger of Pepsi-Cola and Frito-Lay in 1965, has been stepping up accent on health and wellness and expanding its product portfolio with healthier choices such as ‘Pepsi Raw’, the cola drink made from fully natural ingredients, launched in the UK.

But the premium pricing formula for the drink may not allow the company to bring it to India, where the market for aerated drink is minuscule compared to the West.

Source

- Biplab Dey
Knowledge Scientist
Dolcera

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The recent federal court's verdict on the long standing patent litigation (involving the US patent 6,233,389) between the Dish Network (erstwhile Echostar - WO2008027406A1) and the digital video solutions provider Tivo has consolidated the position of NDS, a Newscorp and Permira owned company. NDS is only the second player in the same field providing digital video solutions standing second to Tivo. NDS has patents (US20090080866A1, US20080285943A1) in the field of Video Substitution or the ability to rewind, fastforward etc options on the satellite tv. Already NDS has several clients across the globe. With this court order, the position of NDS would be bolstered or subtly proclaimed that its THE alternative for the satellite TV providers across the globe to seek video solutions inorder to showcase the video subsititution features.