PATENT NEWS

Patent Service on Internet

Derwent would now provide the original American patent documents and not just the abstracts on the Internet. The instant avail­ability of such detailed information online could be protection for data down to the last detail. But it also brings such data in the open for competitors to see. The new infor­mation will become available by early 1997 following an agreement between Derwent and Microsoft.

ll1e University of Mississippi Medical Cen­tre patent for haldi is based on the argument that haldi was not used in India to treat external wounds. The new service would make. every detail of such claims instantly available on a computer online anywhere, not necessarily through the US patents of­fice.

Initially there will be patents only from the US on the Internet. But Derwent is negotiat­ing similar an-angements with other coun­tries.

The development is expected to be a strong influence on research and development within India as in other countries. The Indian patent market has grown rapidly within its tiny scope. From about 3,500 patent applica­tions in 1993-94, the number is expected to be about 10,000 to 12,000 during 1996, a more than three-fold increase.

But Indian confrontations with US patent holders, as in the haldi and earlier the neem case, could become trendsetting test cases that can make Indian patent laws and appli­cations significant though small. The new development not only protects more infor­mation but also makes more information

available. Ninety percent of patents are le­gally freely usable because they are past their 20-year date, said Mukesh Sharma of Derwent.

For American companies, this development amounts to a public declaration of every de­tail they have patented. The move seeks to cut out possibly grey areas in claims made by others. "But the precise information that will now be available can greatly benefit competitors. Competitors can now have a clear idea of what has gone before. Looking at the particulars of a process can also pro­vide a solution to technical problems. TIle legal jargon for various processes can also be instructive in suggesting ways to protect patents," said Mr Sharma.

The new information will have business as well as technological implications. Details of companies and the invention will be in­stantly available. Following the pattern of a company's patents can tell competitors which way that company is moving, he said and "survey the state-of-the-art." Apart from monitoring the activities of competitors the new online information could provide oppor­tunities to "spot the key players and head­hunt the experts to avoid enter ing a saturated market," said Mr Sharma.

The new information can also have an off­shoot in terms of licensing possibilities. Companies with similar or complementary processes can now begin to work out col­laborations for production through to mar­keting, said Mr Sharma (E.T., 19.11.96).

PATENT NEWS 107

Change in Patent law in USA

As a result of the General Agreement on Tariffs & Trade (GATf), there has been a major change in US Patent Law. The change would permit an applicant or patentee to establish a date of invention based on evi­dence of inventive activity occurring outside, as well as inside, the USA.

A furth er effect of this law change is to allow the applicant to "swear back" to this date of invention in order to show that it was earlier than the date of publication of a reference cited as prior art against a patent application.

This change becomes effective on I January 1996. Prior to 1 January 1996, the only date that a non-US patent applicant can rely on is the date of filing of a US patent application or, if any, a priority application, even though the invention was actually made before fil­ing.

Accordingly, after 1 January 1996, non-US inventors will be able to establish invention dates prior to 1 January 1996, although pre-1 January 1996 information is to be treated as showing a date of invention of 1 January 1996. That is to say, the earliest date which can be established is either the filing date or 1 Janu;:u-y 1996 for events occurring prior to 1 January 1996.

New Patent Law in Japan

There are changes in the patent granting procedure and publications of patent docu­ments because of the new patent law which was amended as of 1 July 1995 and 1 JanuaJ-Y 1996.

Changes in Patent Granting Procedure

(1) Maximum lifetime of a patent -The new patent law sets forth that the term of a patent shall be 20 years from th e application date.

(2) Patent applications in foreign language -The new patent law allows an applicant to make a patent application in foreign lan­guage, provided that the applicant files a Japanese translation of the application within two months from the application date. At present, only English is acceptable. The Japanese translation is regarded as authen­tic.

(3) Opposition after granting a patent -Un­der the old law, examined patent applica­tions have been published for opposition challenge before a patent is granted. The new law sets forth that a granted patent should be published, and that anyone can oppose it within six months from the publi­cation of the patent.

Changes in Publication of Patent Documents

(1) A-documents -A-documents continue to be published on CD-ROM apO CD-ROM A&U) 18 months after the publication date. They have the same style of publication number as under the old law, i.e. a two-digit emperor's year number followed by a six­digit serial number.

With respect to the patent applications in English, the Japanese translation of the claim, the specification, drawings and the abstracts are published on the CD-ROM to­gether with their English equivalents.

Japanese translations of unexamined PCT applications designating Japan have also been published on the CD-ROM with search reports as A-documents since January 1996. The publication number of these new docu­ments consists of a two-digit emperor's year number and a six-digit serial number begin­ning with 50000l.

(2) B-documents -B-documents will con­tinue to be published on CD-ROM apo CD-

108 1. lNTELLEC. PROP. RIGHT'S. MAHCH 1997

ROM B&Y) after examination. However, the B-documents under the new law will repre­sent granted patents while the current B­documents (published exa min e d applications) are published before a patent is granted. Publication of the CUlTent B­documents (publication of applications ex­amined under the old law) terminated by the end of March 1996 and the new 8-docu­ments started publishing in Jun e 1996 [World Pat In/, 18(3) 1996,170].

US patent for extending core vaccine technology

Aquila Biopharmaceuticals Inc has been is­sued a patent which covers chemical modi­fications to the company's propri etary Stimulon adjuvants including QS-21. The patent also contains claims to an alternative method for producing products through chemically linking antigens to the Stimulon adjuvants.

Aquila's proprietary human vaccine pro­gram includes the Quilimmune-P vaccine for the prevention of pneumococcal infec­tions, which recently entered clinical trials, and products in development for malaria and the tick-borne diseases, Lyme disease and human granulocytic ehrlichiosis.

ll1e technology covered under the newly issued patent allows Aquila to chemically modify isolated saponin adjuvants and chemically link antigens to adjuvants.1l1ese modifications do not destroy the adjuvant activity conferred by critical portions of saponin adjuvant molecules and may enable alternate methods for formulating vaccine products.

ImaRx awarded contrast media patents

ImaRx Pharmaceutical Corporation has been issued four US patents covering major aspects of its ultrasound contrast agent tech­nology.

US Patent 5,542,935 covers a device for mak­ing specialized liposomal compositions for use in therapeutic applications of ultrasound imaging in addition to related aspects of the technology. The liposomes contain acousti­cally active gases or gaseous precursor sub­stances which substantially enhance the images produced when ultrasonic waves are used to scan body tissues.

US Patent 5,558,092 covers methods and apparatus for simultaneous diagnostic and therapeutic ultrasound imaging. Reception of ultrasonic emissions at harmonics of the frequ ency of the therapeutic ultrasound waves are noteworthy. The therapeutic ul­trasonic waves are continuous-wave or pulsed. ImaRx's patented contrast agent v s­ides can contain bioactive agents which are released when the ultrasound waves rupture the vesicles, thereby providing the therapeu­tics in a noninvasive fashion.

US patent 5,580,575 furthers ImaRx's posi­tion as a leader in research and development of drug delivery facilitated by liposomes. The compositions of acoustically-active gas in the liposomes allow ultrasound imaging to monitor the position of the therapeutics in specific regions of the body as well as the rupture of the liposomes and the release of the therapeutic at the site requiring the drug. Especially targeted are the lungs and left ventricle of tl1e heart.

US Patent 5,585,112 provides extended pat­ent coverage for a wide variety of perfluoro­carbon-based liposomal contrast agents, as well as other related chemical compositions.

PATENT NEWS 109

Antex Biologics receives allowance for patent on influenza protein

Antex Biologics have received an allowance from US Patent and Trademark Office for a patent claiming a H. in/luenzae (nontypable) purified protein , recombinant forms of the protein, methods of inducing an immune response, and compositions and vaccines for otitis media infections.

H. in/luenzae is a common worldwide bacte­rial pathogen of humans, particularly infants and children, causing otitis media or inner ear infection . Approximate ly 25 mill io n cases of ear infec tions are treated annually in the US alone, triple the number in 1975. This dramatic increase is expected to con­tinue because of the increasing, resistance of the bacteria to antibiotic th erapy. Pres­ently, there are no vaccin es on the market fo r this disease.

Medimmune obtains US patent for respiratory syncytial virus antibody

MedImmune Inc has been issued a US pat­ent fo r RespiGam (Respiratory Syncytial Vi­rus Immune Globulin (Human» . The pa tent covering the material composition of Respi­Gam is owned by Massachusetts Health Re­sea rch In s titu te, Inc and is exclusively licensed to Medimmune.

RespiGam, a polyclonal antibody prepara­tion , is currently being launched in the United States by Medimmull e and its part­ner, American Home Products Corporation to prevent serious illness caused by respira­tory syncytial virus (RSV) in certain high­ri sk infants. Medimmun e has established a col\aboratioll with Baxter International Illc fo r commercialization of RespiGam outside of North America. RSV is the leading cause

of pneumonia and bronchiolitis in infants and children.

US patent for xenotransplantation licensed to Alexion Pharmaceuticals

The United States patent, genetic engineer­ing of mammalian cells with a human com­plement inhibitor issued to the Oklahoma Medical Research Foundation and Yale Uni­versity (New Haven, C1) has been exclu­sively licensed to Alexion Pharmaceuticals Inc.

Xenotransplantation is the transplantation of nonhuman organs and tissues into human patients. The genetic engineering of porcine cells, ti ssues and organs with a human com­plement inhibitor may present a highly effec­tive means of protecting such xenogenic cells, tissues and organs from destruction by the human immune system, thereby provid­ing xenotransplantation products.

Th e use o f non-human ti ssu es , o r xenografts, in transplantation has generally not been feasible due to the rejection of these non-human tissues by the human im­mune system. Since the rejection process is initially mediated by complement protein s, therefore, the application of human comple­ment inhibitors is necessary for successful xenotransplantation.

Tra ns plantation of non-human ti ssu e (xenografts) into patients is generally be­lieved to be limited by a severe and rapid form of transplant rejection called hyper­acute rejection. Hyperacute rejection is gen­erally believed to be mediated by naturally occurring antibodies in the patient, most of whi ch targe t a ca rbohydra te antige n uniquely present on the surface of non-hu­man ti ssue (but not on the patient's own tissue). After binding to the foreign tissue,

110 ]. INTELLEC. PROP. RIGHTS, MARCH 1997

these antibodies activate a cascade of enzy­matic reactions whereby normally inactive complement proteins are tran sformed into their activated disease-causing byproducts on the surface of the xenograft resulting in severe ti ssue destruction and organ fa ilure.

In collaboration with United States Surg ical Corporation , Alexion is developing geneti­cally eng in eered organs that express both a human blood group enzyme to eliminate the antibody-targ eted carbohydrate epitopes and a human complement inhibitor that will act as an additional protective shield against the human complement proteins.

Several thousand patients die each year in the United States as a result of inadequate organ supply. The demand for organ trans­plantation is lncreasing at an annual rate of 15-20%. However, the supply of human donor organs has not increased substanliaIIy. Pub­li shed articles estimate that approximately 100,00 patients yearly would medically bene­fit fro m organ transplantation if sufficient organs were ava ilable.

Patent for targeted drug delivery

Advanced Magnetics Inc. has received a pat­ent from the United States [or delivery of therapeutic agents to receptors using poly­saccharides.

One potential application und er develop­ment is the delivery of th erapeutics to the liver for the treatment of Hepatitis B. In ani­mal studies, AM I co mbin ed the antiviral agent Vidarabine with a poiysaccharide that targets the liver. This conjugate showed sub­stantial increase in viral replication and ex­hibited less toxicity than Vidarabine alo ne.

Patent Cell for herbal medicine

The Department ofIndian Systems for Medi­cine and Homeopathy (ISM and H) is going

to set up a patent cell with a view to protect­ing the knowledge available within the coun­try regarding the use of herbal plants. The urgent need for setting up this cell is scien­tists working in the fi eld of ISM and H are not well versed with the highly tech nical procedure for applying for patents. The State Health Ministers also stressed upon the need for a national policy for ISM and H drugs to serve as a reference source for the pharmaceuticals industry. The policy would cover issues like the role of ISM and H in the health care system, IPR and patents, matter relating to import and export of raw drugs and protocols for standardisation, quality control and research & development with provisions to include new drugs under ISM and H (Hindu, 20.2.97).

IBM Patents

IBM has won more patents in the US than any other company for the fourth year 1997. During 1996, the US Patent Office accepted 1867 of IBM's applications. Canon was sec­ond with 1538 patents and Motorola th ird with 1064 patents.

IBM patent (US 5 521650) on technology [or video-on-demand, which lets a cable TV sub­scriber control a remote server as If it were a home video player, complete with fast-fo r­ward and rewind is worth appreciating. US patent 5 530 759 describes a method of wa­termarking images to prove own ership, even after th ey have been copied fro m the internet.

IBM is now using the Internet to post an index of the 2 million US patents it has won over the last 26 years. Searching is free and by keyword. Searchers can view a full copy of each of the million patents issued since 1987.

PATENT NEWS 111

Proctor & Gamble files patent for herbicides

Proctor & Gamble of Cincinnati, Ohio, is filing patent applications around the world CWO 96/32103) which claim that some types of weed-killer can cure cancer. A mixture of systemic herbicides known as N-chlo­rophenyicarbamates and N-chlorophenyl-

thiocarbamates, with N-phosphonoglycine derivatives, will inhibit the growth of tu­mours in mammals, particularly humans. The same composition will also treat viral infections such as herpes, HIV and influ­enza. The patent claims that when taken orally, the concoction kills tumour cells much more quickly than healthy cells.