J:lUrnal of Intellectual Property Rights Vol 3 March 1998 pp 109-114

IPR NEWS

Aggressive attitude to~ IPR

According to Shri N Vittal, Chainnan, Public Enterprises Selection Board, India should amend its Patents Act (1970) to bring it in line with the World Trade Organization (WTO) and Trade-Related Intellectual Prop­erty Rights (TRIPS) conditions . Developing countries like India should develop a "posi­tive, aggressive, and pro-active posture" with regard to intellectual property rights (IPR) instead of a 'defensive and reactionary nega­tive posture'. IPR and global competition are the key is­sues to be taken care of by developing coun­tries while enhancing technological capability, Shri Vittal told the Seminar on National Policies and Technological Capa­bility Building in Developing Countries, or­ganized by the Economic and Social Commission for Asia and the Pacific (ES­CAP) in New Delhi in November 1997. Referring to the 1970 Indian Patents Act which recognises process patents only, Shri Vittal said adopting a restrictive policy to­wards IPR has negative consequences though it may give a temporary advantage to Indian companies to change processes and come up with products similar to those de­veloped ehsewhere at a fraction of the cost. If developing countries bring their IPR re­gime in tune with global standards, they may be able to build up on their technological

manpower, he added. Developing countries such as India, China, Indonesia and Brazil provide exciting market opportunities for technologies which the developed countries would like to exploit by using the WTO mechanism to open up barriers. The global environment is conducive to the flow of tech­nology to developing countries to suit the interests of enterprises in developed coun­tries. With flow of technology becoming a key feature of globalization, "it will be diffi­cult for the Indian government, even if it wants, to go back to the era of economic isolationism," Shri Vittal said. Stressing that foreign direct investment (FDD will be one of the key instruments through which tech­nology flow will be promoted, India should adopt a policy which encourges FDI and liberally allows majority share , instead of restricting access to it as in the past An open-minded and free approach to FDI has the double advantage of attracting capi­tal investment and the benefit of technology [Chern Weekly, 43 (13) 1998, 104] .

Arbitration board for industrial property

For a quicker and more flexible form of pro­ceedings, the Japanese lawyers Union and Japanese Bar Association plan to erect a cen­tre for out of court settlement of industrial property disputes that will open its door in

llO J. INTELLEC. PROP. RIGIITS, MARCH 1998

March 1998. Apart from being available to the &ipanese and Japanese companies, the Alternative Dispute Resolution Centre will also be available to foreign enterprise. The arbitrator in each case will be chosen accord­ing to the particular legal and technical as­pects involved [WISTA Intell.ec Prop, 2 (8) 1997,3] .

Assent to copyright act amendments

The Bill C-32, an Act to amend the copyright, marks the first revision of Canada's Copy­right Act since 1988. The Bill receiving the royal assent by the Governor General of Canada on 25 April 1997 comes after a year ofintense scrutiny by the Parliament of Can­ada

All the provisions of the Bill have not come into force . Only three technical provisions have been proclaimed into force as of early June 1997. The remaining provisions of the Bill are expected to come into force some­time before the end of 1997 as they require drafung of regulations and definitions.

The Bill C-32 includes some other measures like, neighbouring rights entitling perfOlm­ers and producers to royalties when their works are performed or broadcast, provi­sions to benefit exclusive book distributors to restrain the parallel importation of books that infringe copyright, and the availability ofsummary courlprocedures and minimum. statutory damages for infringement of copy­right [WISTA Intell.ec Prop, 2(8) 1997,3].

Copyright amendment bill introduced

In Australia, the Federal Attorney General introduced the Copyright Amendment Bill 1997 into the House of Representatives on 10 June and into the Senate on 27 June. The Bill

seeking important amendments to the Copy­right Act of 1968 includes:

(a) Introduction of comprehensive moral rights which consist principally of a right of attribution and a right of integrity for crea­tors;

(b) Changes to ensure that copyright in packaging and labels on goods cannot be used to control the importation of goods that are not otherwise protected by copyright.

(c) The remedies of delivery up and conver­sion damages will be awarded at the discre­tion of the courlratherthan automatically as is the case under the current law, and

(d) Changes to the ownership of employed print journalists copyright which will give print media proprietors the right to control electronic delivery of news and the right to restrain the copying of more than 15%of a publication.

It is expected that the Bill will become law by the end of 1997 [WISTA Intell.ec Prop, 2(8) 1997,3] .

New legislation on unfair competition

A new Act on protection against unfair com­petition has been passed by the Supreme Soviet of the Ukraine. The legislation en­tered into force on 1 &in 1997. The new Act regulates unfair competition, previously cov­ered only by Art 7 of the Act on Restraint of Monopoly, more comprehensively in inde­pendent legislation. Pursuant to the defini­tion contained in Art. 1 of the Act, unfair competition is deemed to be any competitive conduct which is contrary to decent behav­iour in commerce and trade [WISTA Intell.ec Prop, 2(8) 1997,4] .

IPRNEWS 111

Setback on intellectual property rights

The decision of the World Trade Organiza­tion (wrO) appellate body to uphold the US complaint against India on the intellectual property rights issue ignores the ground re­ality in this country on the controversial pat­ents and equally reflects the policy of the US administration to browbeat India on such a vital issue . The wro body has found that India is violating its international IPR com­mitments by failing to establish a mecha­nism to comply with obligations for product patents in pharmaceuticals and agricultural chemicals. Earlier also the wro upheld the US complaint that India had failed to set up the 'mailbox' mechanism to receive patents through changes in legislation. So the latest wro verdict is just a vindication o fits earlier stand.

India, however, has no cause for alarm. As per procedure now, the appellate body's re­port has to be adopted within 30 days by the wro's dispute settlement body (DSE) un­less there is a consensus against adoption. India can seek time from the DSB in view of the elections since only a new Parliament could decide on fresh legislation (H.T., 22 Dec 1997) .

Record patent filing by NCL

After earning the title of the largest money spinning research laboratory of the Council ofScienijfic and Industrial Research (CSIR), the National Chemical Lilioratory (NCL) in Pune is now heading for yet another path­breaking record in terms of highest number of patents filed by any scientific lab in the country. During the current year, the labo­ratory has already filed a total of 94 patents which is nearly one-third of around 300 pat­ents filed by all the forty laboratories ofCSIR collectively.

The record achievement is also expected to open the floodgates for the premier labora­tory in terms of "pure business' as most of the patent filed by NCL have commercial applications in industrial and agricultural sector throughout the world.

This is evident by the fact that during 1997 80 %of the total lab budget was generated indigenously through business activities with major companies all over the world. Going by the performance of 1997 in which NCL filed 64 patents, this year it has re­corded an overwhelming increase of around 35 %in the number of patents filed .

But what has come as a greater surprise is the fact that the biotechnology discipline has put up an exemplary performance at NCL this year. As compared to only four patents filed last year, this year a total number of 11 patents have been filed in the discipline, many of which also have tremendous com­mercial viability value.

The fact that the laboratory has taken a quantum leap in business-oriented research is evident by the fact that the polymers dis­cipline, which caters to a major portion of NCL's business purse, has filed 28 patents as compared to 11 last year [Chem Weekly, 43( 19) 1998,801.

US patent for dehydro~nation catalySt

Indian Petrochemical Corporation limited (IPCL) has received a US patentfor develop­ing a catalystfor dehydrogenation of normal paraffins. The dehydrogenation catalyst (DHC), developed by a team of IPCL scien­tists and engineers, is a critical item in the dehydrogenation process to manufacture linear alkyl benzene (LAB). DHC is nor­mally proprietary item of technology licens­ers and needs to be imported for commercial charge from time to time .

112 J. INTElLEC. PROP. RIGHTS, MARCH 1998

IPCL had achieved a breakthrough in .. mlU­ary 1994 when the first commercial charge of the dehydrogenation catalyst manufac­tured at IPCL's Catad Division was success­fully commercialized by a team of IPCL engineers in the lAB plant at Vadodara.

IPCLhad filed application in June 1995 with the Commissioner of Patents and Trade­marks of the US. Granting of the US patent is significant in order to protect the IPR of this product and was clinched amidst stiff competition from a large number of patents filed in this area. It also signifies the capabili­ties of Indians in mastering high-tech chemi- ' ical process such as dehydrogenation.

The development of indigenous catalyst for dehydrogenation process to manufacture lAB will not only help IPCL and other manu­facturers of this detergent intermediate product but will also assist in reducing their import bill in the scenario of devalued cur­rency [Chern Weekly, 43(19) 1998,81).

Compound of Reddy's lab patented and licensed

A compound discovered and patented by Dr Reddy's Research Foundation (DRF) has been licensed by the group of Denmark based NOVO Nordisk - an international pharmaceutical company. This is for1he first time an Indian company has licensed its home made discovery to an international phamaceutical company.

The Rs 350 crore Hyderabad based DRF receives in return upfrontand milestone pay­ments and royalties. This marks a reversal in 1he usual flow of the tide of ideas and products from overseas to our country.

By this agreement, NOVO Nordisk has an exclusive world wide licence to develop and market pharmaceutical drugs based on com­pounds discovered and patented by DRF

with potential for treatment of diabetes, obe­sity and dyslipidemia[W1STA Intellec Prop, 2(8) 1997, 3) .

US patent on fungicidal properties of neem challenged

The European Patent Office (EPO) has de­livered an interim judgement in whic h it has recognized 1hataparticularpatentowned by 1he. US-based WRGrace & Co. on 1he fungi­cidal properties of neem was part of 'prior art'.

Recognition as prior art meant 1hat it would be difficult for 1he company to prove that its discovery was novel. Novelty, toge1her with non-obviousness and utility were 1he three conditions required for a patent to be ac­cepted.

The petition challenging WR Grace's patent (No. 436257 B1) was filed by a group of NGOs from many parts of1he globe, under the coalition called Neem Campaign. Also active in the campaign was the leader of the green MPs in 1he European Parliament, Ms Magda Alvoet

The EPO, after delivering this interim judge­ment, asked 1he members of the Neem Cam­paign and the officials ofWR Grace & Co to come up wi1h further evidence at 1he next hearings. The EPO has asked 1he applicants for more detailed information concerning the extraction process in order to proceed to the next stage [Chern Ind News, 42(12) 1997,1650) .

Patent for epidennal gene promoter

A US patent no 5,643,746 for epidermal gene promoter issued to Research Corporation Technologies, Tucson; has been lincensed to Avigen Inc, Alameda, CA

IPRNEWS 113

The patent covers specific gene promoter elements that enable tissue~pecific expres­sion of genes in human epidermis (the outer layer of skin and lining of the gastrointesti­nal tract). Such promoter elements may be useful for human gene therapy aimed at treating diseases of the epidermis or deliver­ing drugs to specific genes. Epidermal gene promoters may also be employed to produce artificial skin and to test pharmaceuticals and cosmetics.

Tissue~pecific promoters would be impor­tant for a number of gene therapy applica­tions because they allow fine control over gene expression and! or provide the ability to tum genes on or off depending on the medical application ofinterest. According to Avigen tissue~pecific promoters would be uniquely potent with adeno-associated virus vectors, as such vectors allow the tissue­specific promoters to behave as predicted. In contrast, non- adeno-associated virus ap­proaches to gene therapy based on retroviruses can be self-<lefeating since retroviral vectors contain remnants of viral genetic information that typically override the controls provided by tissue~pecific pro­moters [Biotech Pat News, 11 (9) 1997,2J.

Patent for treating thrombosis issued to Integra Life Sciences

The US patent no 5,648,330, exclusively li­censed to Integra through its affiliate Telios Pharmaceuticals, was issued to The Burn­ham Institute (La.blla, CA) (formerly the La .blla Cancer Research Foundation) . The pat­ent is one in a series of patent exclusively licensed to Integra for the use of RGD-<:on­taining peptides to treat thrombosis or blood clots, a common hallmark of cardiovascular diseases such as heart attack and stroke.

Medical Data International has estimated that in 1998, more than 325,000 coronary artery bypass graftprocedures would be per­formed in the United States Thrombosis is the leading cause of vascular graft failures . Current prophylactic approaches to prevent this problem suffer from potential side effect of bleeding. Integra believes that this class of drugs would represent a significant ad­vance in this area TP-9201 and similar com­pounds may have particular applicability in the acute treatment of ischemic stroke where bleeding can be a life threatening complication associated with anti-throm­botic therapies.

RGD-based peptides and mimetic com­pounds have emerged as powerful media­tors of cellular function . Integra Life Sciences is a leader in the emerging field of in vivo tissue regeneration. In addition to its commercial product for skin regeneration - INTEGRA Artificial Skin - the company is moving to rapidly commercialize products for bone and cartilage repair, and dental and neurological applications. It is applying the RGD technology in these areas and is ac­tively seeking to license pharmaceutical products, such as TP-9201, for development with major pharmaceutical marketing part­ners [Biotech Pat News, 11 (9) 1997; 4J

AIDS dignostic kit patent

CELSCI Corporation, Alexandria, has been given a US patentfor diagnostic method and test kit for the serological detection of the AIDS virus. The test kit is based upon the measurement of antibodies against the HGP-30 region of the core of the AIDS virus.

As part of the same research program, CEL­SCI is also developing the HGP-30 AIDS vacccine . This vaccine has been tested in

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over sixty individuals and is expected to go into phase II studies soon.

CELSCI is a pioneer in the fielJ of natural immunotherapy. It is developing Multikine for the treatmentofcancers and otherimmu­no deficiency diseases. In addition, it is devel­oping the HGP-30 lllV vaccine! treatment and a tuberculosis vaccine/ treatment [Biotech Pat News, 11 (9) 1997, 41 .

Genelabs receives seven patent allowances fur DNA-binding technology

The company Genelabs Technologie Inc, Redwood City, CA; has recently received · notices of allowances for seven patents cov­ering its technology, significantly expanding the intellectual property protection for anew class of gene-regulating drugs.

Merlin, the platform technology on which Genelabs' DNA-binding drug program is based, has already been awarded broad pat­ents in the US, Canada, and Australia The new patents would claim technologies for: screening biological, chemical and combina­torial chemistry libraries to identify novel DNA-binding molecules; profiling these molecules to determine sequence binding preferences; methods for designing mole­cules to target sequences ofsufficientlength for functional specificity; and confirming se­quence binding preferences. Additionally, the company has also received a composi­tion of matter patent allowance broadly claiming small, organic molecules that bind to DNA in a sequence-sepcific manner to alter gene expression by displacing tran­scription factors from their binding sites. These allowances add to the strong intellec­tual property position Genelabs has built around its gene-regulating drug discovery program.

"The ability to selectively block the interac­tion of certain factors with their DNA-bind­ing sites using small molecules has the potential for opening up an entirely new class of pharmaceuticals," stated Dr Ed­wards. "The power of such an approach lies in the "universal" structure of DNA Once molecular building blocks have been identi­fied using Merlin, the drug discovery proc­ess could be markedly shortened for any therapeutic area in which gene expression plays a casual role."

Genelabs believes that gene-regulating drugs have the potential to bring significant value to the ongoing genomics efforts in academics and industry, which are provid­ing a wealth of information about the genes involved in disease increases, so do the po­tential targets for Genelabs' entirely new class of drugs, genespecific DNA-binding drugs.

At the end of 1996, gene labs received a US patent covering the therapeutic use of small -molecule drugs that act by binding to a se­quence -specific region of a gene and displacing a regulatory protein from its bind­ing site, potentially creating an entirely new field of drugs for the regulation of disease­associated genes. The patent specifically claims a method f~r altering the binding charaeteristics of a DNA-binding protein (e.g., a transcription factor) by adding a small-molecule drug' that binds to a target region in the DNA that is adjacent to or overlapping a regulatory protein binding site .

Genelabs is workillg with the DuPontMerck Pharmaceutical Company Wilmington, DE; to jointly develop small molecule gene-regu­lating drugs for certain target genes and Genelabs retains the' ability to establish other types of collaborations as well [Biotech Pat News, 11 (9) 1997,6).