PATENT NEWS

Argentina punished for patent piracy

The Clinton Administration is using trade sanctions as a way to force countries to im­plement strong patent protection laws. Its latest target is Argentina, which is being penalized for its continuing record of patent theft.

Argentina has long been a problem with respect to patent protection - especially of pharmaceutical products. It is reported that Argentine patent pirates cost US pharma­ceutical firms more than half a billion dollars annually in lost sales [Chem Eng News, 75 (4) 1997,10).

US patent law changes endorsed

After two years of rancorous debate, the House of Representatives has given its stamp of approval to legislation revamping the nations's 200-year-old patent system. If, as is likely, HR 400 becomes law, it will fundamentally change patent practice, bringing US law into step with international norms and changing the operations of the Patent & Trademark Office (PTO) .

To a great extent, the bill harmonizes US law with those of Europe and Japan. It requires publication of most patent applications 18 months after they are filed and provides a defense against infringement for prior do­mestic users of a patented technology. The bill also converts PTO into a freestanding government corporation and allows it to keep the users fees it collects. PTO is cur­rently part of the Department of Commerce.

In addition to the support of the Clinton Administration, the bill also garnered the

support of the 75 US companies that have required 90% of the US patents issued to American inventors.

With the introduction and acceptance of an amendment in the bill, small businesses, universities, and individual inventors are ex­empted from the requirement of publishing applications 18 months after they are filed.

The bill now moves to Senate [Chem Eng News, 75(17) 1997,11).

Robust intellectual property protection for databases

According to recently released National Re­search Council (NRC) report, "Bits of Power: Issues in Global Access to Scientific Data", European Union countries will be re­quired to provide new, more robust intellec­tual property protection for publishers of databases, including those consisting of noncopyrightable data from government­funded research. One result might be to make accessing such data much more ex­pensive.

These more stringent protections have the potential to enable database vendors to charge scientists and educators commercial rates for accessing. Such copyright protec­tion may even allow vendors to maintain a monopoly on publicly-funded research data.

Strong database protection is supported by organizations such as the Information Indus­try Association, as well as the US Patent & Trademark Office [Chem Eng News, 75(15) 1997,8) .

264 ]. INTELLEC. PROP. RIGHTS, SEPTEMBER 1997

DNA test to guard breeders' right

The system for the protection of new plant varieties may be by way of patents, by sui generis system or a combination thereof. Breeders' righlt (BR) is a sui generis protec­tion for plant varieties. It pemlits the use of a protected variety as a basis for the develop­ment of new varieties. However, a new vari­ety has to be DUS: distinct (D) from other varieties, uniform(U) and stable(S).

DUS relies upon a visual characteristics (phenotype) such as leaf shape and flower colour, between the new candidate and ex­isting varieties. This requires the candidate and existing varieties to be grown beside existing varieties in glasshouse trials that are time consuming, subjective and prone to variability.

The Molecular Biology and Diagnostics sec­tion at the National Institute of Agricultural Botany (NIAB), Cambridge, England, is de­veloping DNA-profiling methods for variety identification in chrysanthemums to help protect growers' right. The research pro­gramme will result in more efficient testing as varieties can be analysed while the plants are still very young. At present, plant breed­ers may protect their intellectual property in new varieties of chrysanthemums through statutory plant breeders' right schemes.

The DNA profile for each variety is likely to be unique, providing valuable means of vari­ety identification. The development of profil­ing for chrysanthemum identification will eventually result in a more efficient testing system.

The profiling wiII obviate the need to grow candidate varieties to full maturity, thereby hastening the conclusion of the testing and identification. It will also reduce the influ­ence of environmental effects, such as tem-

perature and disease (Spectrum, May-June 1997).

Preparing the country for new IPR regime

One of the biggest challenges the Indian science is facing is the disturbingly slow patenting of Indian inventions. This is evi­dent from the number of patents that scien­tists in other countries have acquired on plant-based products - neem and turmeric for example - based on traditional Indian know-how. Now, the 'newly-constituted Sci­ence Advisory Committee to the Cabinet (SAC C) promises things will be different. Headed by CNR Rao, President of the Jawa­harlal Nehru Centre for Advanced Research in Bangalore, the 36-member Committeee comprises all secretaries of science-related departments, top scientists and business­men like Ranbaxy chairman & managing director,Parvinder Singh and ICI Chairman, Ashok Ganguli. The Committee has been entrusted with the task of preparing the country for the new Intellectual Proper1y Rights (IPR) regime and improving the tech­nological base of Iridian industry.

The very first meeting of SACC s~erns to have had an important fall-out - it was de­cided that the patent office would be imme­diately modernised. (Business World, 22 July 1997).

New car alarm invented

A new and silent car alarm has been invented by Leslie George of Swansea (UK patent application 23 02 977). A concealed switch connects a pump in the exhaust system to the engine's ignition. When the alarm is switched on, any attempt to start the vehicle causes the pump to inject coloured dye into the exhaust pipe. So if the thieves drive off

PATENT NEWS 265

with stolen car they leave behind them a cloud of telltale coloured smoke (New Sci, 154 (2079) 1997, 25).

Internet patent news service

The Internet Patent News Service is a daily news service dealing with information about the patenting world . Topics include an­nouncement from various patent offices around the world, stories about who is suing who, interesting new patents and styles of patent drafting, statistics on issued patent (with a focus on software patents), reviews of patent books and computer programs. Additionally, contributions are solicited from anyone with some patent issue they have an opinion on, as well as explanation from patent lawyers about some of the issues raised in the news items.

Contact: Gregory Aharonian, Source Trans­lation & Optimisation at pat­ents@world.st.com [In/Today & Tomorrow, 16(1) 1997,27].

CSIR plans foreign patent bank of 500 by 2001

The Council of Scientific & Industrial Re­search (CSIR) has planned to have a patent bank of 500 foreign patents by 2001 AD.

CSIR has already drawn up a 'CSIR-2001-Vi­sion & Strategy' programme with goals set up for 2001 and it is hoped that by then CSIR will become a 50% self-financing organiza­tion generating over 7 billion from external sources against Rs 1.35 billion in 1994-95. At least 50% of this amount would be from in­dustrial customers. It has so . far signed 40 agreements with different countries [Elec­tronics Today, 30(5) 1997,96].

BHEL R&D unit files 27 patents

The corporate research and development division of the public sector giant, Bharat Heavy Electricals Ud (BHEL) has filed 27 patents during 1996-97 endorsing the com­mitment of the organization to R&D. Out of the total turnover of Rs 5.74 crores and a profit after tax of Rs 430 crores for 1996-97, the corporate R&D has contributed Rs 602 crore as against Rs 458 crore last year(Elec­tronics Today, 30(5) 1997,96).

Multikine gets a patent

Multikine, an immune boosting drug of CEL-SCI Corporation, Alexandria, has been issued a patent by the Japanese Patent Of­fice. The patent covers the basic technology for the production of Multikine, a drug which is in testing for various cancers. Japan is one of the largest pharmaceutical markets in the world.

Multikine is a natural mixture of human im­mune system regulators called cytokines. It contains interleukine-2 and other cytokines, several of which are being investigated indi­viduaIIy as potential cancer treatments.

Multikine is currently being tested in head and neck cancer and prostate cancer. Mul­tikine is also scheduled to go into a clinical study with HIV infected patients in the frrst quarter of 1997.

CEL-SCI a pioneer in the field of natural immunotherapy is developing Multikine for the treatment of cancers and other immu­nodeficiency diseases. It is also developing the HGP-30 HIV vaccine/treatment and a tuberculosis vaccine/treatment (Biotech Pat News, 11(1) 1997,5).

266 J. INTELLEC. PROP. RIGHTS, SEPTEMBER 1997

Gene transplantation patent issued

Oncogene Science Inc, New York, has been issued United States patent 5,580,722 which claims methods of identifying chemicals that transcriptionally modulate the expression of genes associated with cardiovascular dis­eases.

In collaboration with Hoechst Marion Roussel Inc (HMRI), Kansas City, MO, On­cogene Science is involved in the discovery and development of gene transcription­based drugs that modulate the expression of target genes involved in cardiovascular dis­eases, particularly atherosclerosis. Lead compounds identified in the HMRI screen­ing programme are currently undergoing preclinical evaluation as possible candidates for clinical development (Biotech Pat News, 11 (1) 1997, 10)

Hemosol files patent application

X-Cell Biotech division of Hemosol Inc, Can­ada, has filed a patent application for a novel technology able to enlist the cells of the body's own immune system rather than drugs to treat disease. A method to produce large number of substantially pure popula­tions of two types of immune cells known as CD 4 and Cd 8 T cells from a small sample of blood is described in the patent. The se­quential expansion of both CD4 and CD8 T cells in the same culture offers the unique potential to modulate or control the immune response under laboratory conditions. No expensive cell selection step is required.

According to Alun Davies, Hemosol's presi­dent and chief executive officer, the technol­ogy has potentially significant and widespread application . Not only can these cells be replicated in the laboratory, but this technology is being tried in a new immuno-

therapeutic procedure where cells rather than drugs may be used to treat disease. He said that the capability to modulate and con­trol the CD 4 and CD 8 T cell responses is expected to permit powerful new biological treatments for cancers, autoimmune dis­eases and tissue and organ rejection.

CD 4 T cells, also known as helper cells. regulate both antibody and cell-mediated im­mune responses. It is these CD 4 T cells, also known as T helper cells, that are infected by HIV, reducing the numbers of CD 4 T cells and causing the known inability of AIDS patients to fight infection. CD 8 T cells, when stimulated by such T helper cells, destroy virally-infected and cancerous cells. How­ever, under certain conditions, the CD 8 re­sponse may be inadvertently directed against an individual's own tissue leading to autoimmune diseases such as type 1 diabe­tes or multiple sclerosis. The ability to modu­late and control CD4 and CD8 cells opens up the possibility of treatment using cellular immunotherapy.

Dr David Bell, Vice President and Chief Sci­entific Officer of X- Cell Biotech explained that the company is concentrating on the type of cell therapy known as adoptive immu­notherapy. "T cells derived from a patient are processed outside the body using X- Cel.l Biotech's technology and subsequently rein­troduced to the patient. Such processing could involve directing the cells to attack specific virally-infected or cancerous cells," said Dr Bell. Other applications under evalu­ation include suppressing a specific immune response which gives rise to conditions such as autoimmunity and organ rejection.

Initially, X-Cell Biotech is studying the appli­cation of its technology for the treatment of type 1 diabetes using adoptive immuno­therapies in collaboration with Dr Terry L Delovitch. Director of the Autoimm u-

PATENT NEWS 267

nity/Diabetes Group of the John P Robarts Research Institute (London, Canada) an authority on T cell activation, signal transduction and immunoregulation. X-Cell Biotech is also collaborating on a study on the treatment of AIDS with Dr Ken L Bosen­thaI of McMaster University (Hamilton, Canada), an expert in viral immunology and HIV/AIDS. Hemosol also announced the appointment of Dr Leonard Chess, Professor of medicine at Columbia University Collge of Physicians and Surgeons (New York,NY) to the X-cell Biotech's Scientific Advisory Board. Dr Chess is an authority on T cell surface inter­actions.

Hemosol initiated its stem cell research pro­gram in 1994 and established X-Cell Biotech as a division of Hemosol in March 1996. The original research programme aimed at util­izing the proliferative capacity of stem cells as a means to establish alternative or addi­tional supplies of hemoglobin for Hemosol's blood substitute programme. While mature blood cells have only a limited lifetime, they are constantly renewed from a small popula­tion of bone marrow stem cells. Stem cells are capable of enormous expansion during the process of forming mature functional blood cells, most of which do not replicate further.

X-Cell Biotech scientists recently reported on new research findings which demon­strated that Hemolink, the company's first human blood substitute now in clinical trials, substantially enhances the 'in vitro' growth of red cell precursors induced by erythro­poietin, a blood hormone used to treat ane­mia. The current T cell program is a direct consequence of this research initiative in the red cell propagation field (Biotech Pat News, 11(2) 1997,3) .

US cancels patent on bald

The United States Patent and Trademark Office has cancelled (on 13 August 1997) the patent it granted (in March 1995) for the use of turmeric (haldt) powder as a wound heal­ing agent, announced Dr R A Mashelkar, Director General, CSIR, at a press confer­ence on 23 August 1997.

The cancellation of the patent is a significant development for far reaching consequences for the protection of the traditionallndian knowledge-base not only in India but in other third world countries, said Dr Mashel­kar.

This is perhaps the first case where the use of traditional knowledge-base of a develop­ing country, patented through US patent, has been successfully challenged . This proves that if patent cases are fought on well argued and well supported techno-legal grounds nothing could stop us from pro­tecitng our traditional knowledge-base, Dr Mashelkar pointed out.

The case also demonstrates that CSIR and other Indian institutions are now acquiring capabilities to fight the complex techno-legal issues of IPR, both defensively and aggres­sively to meet the challenges under the wro regime.

It also emphazies the importance of appro­priate documentation and public availability of records of traditional knowledge-base in a systematic manner which can be provided as evidence of prior knowledge which is an important criterion for the grant of a patent.

This success, which had cost nearly Rs 5 lakh, the DG hoped would enhance the con­fidence and pride of the people of India and help remove unfounded fears about India's helplessness in preventing bio-piracy and appropriation of inventions based on tradi­tional Indian knowledge-base.