Journal of Intellectual Property lughts Vol 4 November 1999 pp 360-374

.PR NEWS

International patent applications desig­nating India

There has been a sharp rise in the number of applicants who have designated India as one of the countries for registering their respective patents. This follows India be­coming a signatory to the Patent Coopera­tion Treaty on 7 December 1998.

As per the treaty, anyone filing his patent application anywhere in the world can desig­nate India as one of the country to be cov­ered by it. However, he has to file a formal patent application within 18 months in India after designating the country as one of'bene­ficiaries' of it.

Thus, between 7 December 1998 and 31 July 1999 nearly 13,000 applicants have desig­nated India and their formal applications will have to be filed before June 2000.

The current backlog of patent applications in India exceeded 30,000 and another 13,000 will join the queue. It takes anywhere be­tween five to six years to grant a patent and the designated offices to peJiorm this func­tion are simply not equipped to take on such a huge rush. Besides, there is also a normal queue of 10,000 applicants annually outside the patent offices in the country with head­quarters in Calcutta (Hindustan Times, 28 August 1999) .

Patent rights on kart/a, jamWl and brin­jal

Cromak Research Inc, aNew Jersey-based company was recently granted a US patent (number 5,900,240). The team comprises two non- resident Indian scientists, Onkar S Tomer and Kripanath Borah, and their col­league Peter Glomski. The patent was on edible herbal compositions comprising mix­tures of at least two Indian herbs selected from a group consisting of Syzygium cumini, popularly known as 'jamttn' Momordica charantia (bitter gourd or karela); Solanum melongena (brinjal or eggplant) and Gym­nema sylvestre (gurmar) for tl1eir use in re­ducing sugar levels [Down to Earth, 8 (6) 1999,131.

CSIR plans to have electronic database on Indian herbs

Dr R A Mashelkar, Director General, CSIR, said that every year around 30,000 - 40,000 patent applications are submitted in the US, it is very difficult to confirm whether the patented herbal products already exist in the market. Thus, it is important to create aware­ness about such plants through an elec­tronic database. CSIR now plans to translate ancient literature and provide this informa­tion in English to spread awarness about Indian herbs [Down to Earth, 8 (6) 1999, 131.

IPRNEWS 361

WIPO launches cyber-leaming course

The World Intellectual Property Organiza­tion (WIPO) launched its ftrst distance learn­ing course over the Intern et on 1 June 1999. This innovative on-line teaching technique would bring teachers specializing in intellec­tual property issues closer to students and other interested parties in all corn ers of the world through virtual means. Th is method will allow anyone seeking more information about intellectual property to fo llow a range of educational programmes in intellectual property at their own pace, in th eir space.

Using a web site designed especia lly for teaching and training pu rposes, th e pro­gramme will provide essential knowledge in various aspects of intellectual property. The six-part course, entitled "In troduction to In­tellectual Propeliy", will cover copyright, re­lat e d ri ghts, patents, trad emarks , geographical indications, and intern ational registration systems.

The distance learning in itiative takes full ad­vantage of information tech nology and the In ternet as an alternative to traditional train­ing programmes. It otfers new teaching methodologies, especially designed course materials, evaluation tools, tai lored means of delivery, and expanded au diences. Every phase of the learning process has been re­structured and modernized. The course, which will take about 40 hours of study Lime that can be spaced over a peri od of six weeks, includes self-assessment qu estions, tests, a glossary with links to the 21 b'eaties that WIPO admin isters and oth er sources of intell ectual properly informatio i , as well as mechanisms for student-teacher interaction.

Teaching will take place in th e virtual envi­ronment of th e WlPO Worldwide Academy (WWA) web site (http://academy.wipo.int). A network of tutors has been established in

various regions of the world to support stu­dents during their work. Students and teach­ers can interact as often as necessary during the course. Communication takes place through electronic mail after the tutor sets up a fIxed day to respond to queries. Replies that ar~ of general interest are copied to all students. At the end of the programme, stu­dents will rece ive a certificate ackn ow­ledging the tudent's completion of th e course.

In implementing this programme, WW A is working in partnership with several institu­tions, includ ing the University of Sou th Af­rica, th e Open Un iversity, UK; Cornell Un iversity, USA; and other leading universi­ties in Asia, Latin America an d in the Arab count ries.

Univers ity sued over rights to trans­genic technology

Anthony Perry, a molecular embryologist fo rmerly at the Babraham Institute in Britain who has been working with Ryuzo Yanagi­machi 's renowned mouse-cloning team at Hawaii , has sued th e un iversity over exploi­tation of the novel transgenic techniqu e. The technology could have broad applica­tions in genetically engineering mam mals to produce human substances.

In a lawsuit fi led in state court in Honolulu, Peny alleges that the university improperly licensed the technology to a small biotech­nology fI rm without his permission.

According to Walter Kirimi tsu , Hawaii's gen­eral counsel, the un iversity holds exclusive patent rights and title to the transgenic tech­nology, and licensed it appropriately. In court record s, Perry claims that it was he who illvented the transgenic technology, along with other novel methods employed by th e team. The technology can be used to genetically engin eer an imals-~uch as pigs.

3(i2 J !NTELLEC PRO P RIGHTS, NOVEM Bl ': I ~ 1999

cattle or sheep - to producc humaJl hor­mones or proteins, or drugs.

Typica lly, a US university owns th e rights to any tcchnology developcd by it~ scientists, whi le th e patent bears the Jlaille of the scien­ti.fic inventor once th e lC:lgtity filing proccss is completed. The university can negotiMc with a company or organization for develop­mcnt of a tec hnology. Tb e university an d scientific invenlondhcn shJre the royalties from any commercial prod uct.

In tb e current dispute, however, Peny- who was not cmployed by the university at the time - says in cOllli records that the univer­sity licensed the transgenic technology with­out his consent. He also questions the university's title to the techn ology, for devel­opment through a company with which he is associated.

The circumstances have been complicated by th e fac t that Perry's work in Hawaii was carricd out wh ile he was a European Mo­lecular Biology organizatio n fe llow.

After leaving the post al' the Babraham Insti­tute in Cambridge, Perry sought to join th e university as well. But hi s hiring has been suspended pending the outcome of the dis­pute. Funding for Yanagimachi's laboratory comes from the US Nation(ll Institutes of Health.

The University of Hawaii licensed tech no­logical inventions from Yanagimachi's lab to ProBio, a company headed by Australian businessman, Laith Reynolds oi Perth. Ironi­cally, it was Perry who first proposed a uni­versity deal with Reynolds. But Reynolds and Perry have since fallen out, reportedly after Pen), became upset that th e role of the scientists involved in the early experiments was being minimized.

Perry and Wakayama have since form ed their own company, BiogeneSys Interna-

tional LLC, with funding from John Henry FelLx, a member of the bOJ rd of tru stees of the Salk In sLitute in L, Jolla, California.

As the civil lawsu iL began , Pen)"s attorncy asked a Hawaii ad ministrative court: Lo de­clare vo id th e univeL i y's deal wiLh PI'OBio, argu ing LhaL it viobted sLaLe procuremenL law. An admi ni strative judge is expected to rul e soo n on that request [Nature, 400 (6745) 1999,601J.

Carofit patented

Ajanta Phanna Ltd (APL) , Mumbai , hus been awarded a South Africall paten t for product and process on carotenoids and mi­cronutrienLs. Carofit is an anLioxidant wi th natural carotenoids and microl1utrienls.

APL had conducted clinical trials and safety trials [or the product (Economic Times, 8 September 1999).

lJN meet on patents

In dia has urged th e international commu­nity and thc United NaLions to pay attention to biopiracy which is defrauding the devel­opin g countri es of finan cial resources.

Prof M G K Menon while addressi ng a UN committee said if just 2% of royalty were charged on genetic resources that had been developed in the South Asia in terms of in­digenolls knowledge, developed countries would owe more than $ 300 bill ion in unpa id royalties for farmers' crop seeds and more than $5 billion for medicinal plants.

Companies have agreed to 10% royalty rates for the right to bio- prospect yellow stone national park in the United States.

Expressing concern over new technology regimes being established unilaterally or plurilaterally, Prof Menon stated that the developing countries increasingly fac e ob­stacles in accessing state-of-the-art technolo­gies with expo rt restrictions on hi.gh

IPRNEWS 363

technolob'Y being put in place by exclusive c1u bs .of technology own ers on the ground of possible dual use.

Since in a knowledge in tensive global econ­omy, access to technology on reasonable terms determines whether countries can take advantage of technolog ical globaliza­tion, he told the delegates.

A levy of S 100 per patent could have gener­ated an income of S 300 million during 1998. The money could be ploughed back in to developing countries and facilitate creation of necessary infrastrtlcture and access to some vital techn ologies in areas such as health o n reasonable terms, said Prof Menon .

T echnological globalization is undoubtedly revolutionizing a range of economic activi­ties from food production and pharmaceuti­cals to communication.

If globalization is to be meaningful, the chal­lenge in the UN is "not to stand by as th e market sets off race to lay a claim on these technologies and scientific developm ent but to fashion a viable international technologi­cal architecture that rewards and encour­ages innovation but not at the cost of marginalizing the poorest, he further added (Financial Express, 13 October 1999).

Hessian patented by UK finn

After basrnati , turmeric, neem and bitter gourd (karela) now it is the turn of hessian to get patented by a foreign company. UK­based Geohess (UK Ltd) has recently re­ceived an European Pat 728048 claiming as an invention, th e use of hessian cloth on landfill sites, to cover rubbish. Th e above firm is now claiming that anyone covering rubbish with hessian cloth would have to pay it a royalty of the cost of hessian in the UK.

An UK firm, operating as a landfill site (re­fuse tip) and making use of hessian c1f)th to cover th e ru bb ish on th e site at the en d of each day was the latest in line which was billed by Geohess.

Though a numb er of fi rm s, who have not attempted to investigate the validity of the patent were payi ng the above charge. Th e above firm (name not disclosed) has chal­lenged its valid ity after being billed by Geo­hess for payment of royalty.

The fi rm challenged the entire claim of Geo­hess in a cou rt of law in the UK. Through its attorn eys, Dummett Copp, Patent Attor­neys, the affected firm has been able to es­tablish that other people were using variou s synth etic fabric covers for landfill sites be­fore the date of the patent, but the patent­holders are claiming that the idea of using hessian for this purpose is inventive and therefore patentable. The matter came to light in India recently when Dummett Copp, on behalf of the affected firm, approached Hastings Jute Mill after locating its name on website to get inputs to establish that the id ea of using hessian fo r landfill sites was not inventive and therefore was not patentable.

Stung by the development and anticipating depletion of demand of Indian Hessian prod­ucts, Shri Sanjay Kajaria, Hastings Jute Mill director and also chairman' of Indian Jute Mills Association (UMA) contacted other jute promotion bod ies such as Jute and Min­eral Development Corporation OMDC) and Indian Jute Mill Re~arch Associ atio n (URA) in this connection. He said that it was wrong that hessian was used for covering various things, including dumps since a long period. It is nothing new.

Jute is approximately 100 years old industry and as it is a natural fibre and comes cheap,

J INTELLFC PImp ]{ ]G]-ITS, NOVEMJ3E ]~ 1999

its fa brics are being used for various pu r­[loses over the period (Financial Express, 13 OctoiJer 1999) .

I nnovati.o n in a cold climate

Accordin g- [0 th e allalysis clr"iecl fJl!t based Oil the Inn ovation Ilidex lTl'al<'d by .ichael Porter of Harvard j3l lsi ll css School, Scmdi­n:lvian cOli n ries ;).re hcacil'cil() Ih l' Lop of the list of ,glob;).1 high-tech inllovalors , wh ik the Uni ted St;).tcs is si l kil :g. The index (llso pre­dicls that th e US wIl l fall froll1 first to si};lh place by 2005 tlnlc::-.s tlIe government revises its R&D policies. It goes beyond efforls to measure compet itiveness, which have looked at market dominance, to a broader defin ition of in novation based, on such fac­tors as a country's per capita R&D spending, percentage of the population with advanced degrees, an d policies to protect intellc:clual properLy. These factors con'elate with the number of international pat ents, which Por­ter sees as a short-term measure of in nova­tion.

The most impressive peIiormer in Porter's top 10 is Finland, which he predicts will jump fro m six th to second place, thanks to a small,

Table - Changing of innovation guar~.

1995 200S

United States Japall

Switzerland Finland

Japan Switzerland

Sweden Denl11 i1rk

Germany Sweden

Finland United States

Denmark Germany

France France

Canada Norway

Norway Canada

technolog ically literate population (it has the hi ghest rate of Int ernet co nnec tions in Europe) and the success of such cOl11nlll ni· cations gia lis as Nokia.

I'orter <;:1ye; the US, ell-spite a boomi ng l'CO ll­

omy, is headed for a ~ lull1p i( it doesn 't boost '<,\if) spend i!lg, Iraill Illo re scieIlliq, ;llId (,1Ig-i IH'l' 's, I'CI1:ove regulatory road I)IIIC ks, " IHl pu,1l hankr fOI open markc1 s abroad . A prolong d recession lIa. lI 'l kllocked Japan frulll tlIe top rallks, bCCllIS(' of its cOlllilluing commi tm ent to innovation rSciclIC(', 283 (5409) 1999, 1841 J.

Growth in IT patenting

According to the report Th e New i nnovator: Global Pate1lting Trends ill Five Sectors, pat­enting in ,lreas relating to informalion tech­nology (IT) has und ergon e a dramatic pattern of growth since th e 1980s. It high­lights resea rch und ertaken by CHI Re­search Ill C, based on its Tech-line data-base of patent and citation indicators.

The IT sectors exhibiting strong growth in· c1ude software, hardware and semiconduc­tor manufacturing. Between 1982 and 1996, the number of paten ts in IT grew by over three times the overall (89%) growt~l in pat­enting. In 1906, IT accounted fo r 15% of US patents, co mpared with just 7% in 1982.

By 1996 Japanese compalli es were prod uc­ing more patents than European companies. The table below highlights this growth in East Asian firms: in 1989, the li st of top pat­enters in the US system conta ins five Japa­nese, two American and three European firms, but in 1998 th ere are seven Japanese, two American, one Korean and no European firms.

IPR NEWS 36~

Table -International top ten patenting companies in the patent system

1989

Rank Company

1 Hitach i

2 Toshiba

3 Canon

4 General Electric

5 Fuji Photo Film

6 Phillips Electronics N.V.

7 Mitsubishi Electric

8 Siemens

9 Bayer

10 IBM

All the East Asian companies share a heavy involvement in IT and Europe has missed out on the rise of IT. However, European firms do exhibit strengths in other areas. For example, half of the top ten (in terms of patenting activity) pharmaceutical firms are European (the other half are American); and half of the top ten chemical companies are European, whilstfour are American and only one is Japanese [Outlook on Science Policy, 21 (6) 1999, 68].

NDDS, the major breakthrough of Ran­baxy

Ranbaxy's mega deal to sell a novel drug delivery system (NDDS) for ciprofloxacin to Bayer brings into focus the Indian pharma's major R&D programme, and highlights the NDDS route as a provider of immense value for money.

The company spends 4-5% of turnover on R&D (target 6% by 2002), higher than the Indian average of about 2% but still modest

1998

Patents Compnay Patents

1234 IBM 2682

1090 Canon 1963

961 NEC 1725

930 Samsung 1553

898 Motorola 1426

859 Sony 1351

790 Hitachi 1322

776 Toshiba 1271

708 Fujitsll 1260

612 Matsushita 1239 Electric

compared to global majors who spend up to 15% of huge turnovers on new drugs.

Ranbaxy has filed patents in the US and India for 3-4 more NDDS products. The new NDDS products are in the areas of anti- in­fectives, cardiovascular and antihistamines. Two of the molecules which would be deliv­ered through the NDDS are currently under patent, like ciprofloxacin is. The company is planning to spend Rs 3-5 crore on each NDDS and has so far spent Rs 15 crore on NDDS research.

The new products have come through bio­availability studies. The NDDS will then go through a combined phase II and phase III before US FDA approvals are fil ed.

Ranbaxy is also working on an NDDS of omeprazole, a $3.7b antiulcerant drug for which Astra's patent expires in a few years.

The success of NDDS has temporarily put into the background the company's active novel .drug research programme. Its new molecule for benign prostatic hypertrophy

J INTELLEC PROP HIGHTS, NOVEMUE l ~ 1999

(BPy) is now entering the second part of phase J trials in Tndia. This product may be licensed out to a MNC after phi1se II oftri :lls. Ranbaxy has so far spent about Rs 10 crore on the molecule. Another new research rnok l"ttl c in the i1 ff: i1 of asthm a will go into phase one ( If cli!l ical tri;t! s in 2001) (Eco wIn ie Times, 9 September lQ99).

1 uhber recovery process patented

Goodyear Tyre :l1ld Hubber Co, Clevela nd, has been awarded a p:ttent for the process for recovering a high percentage of rubber from the existing S:',;lrc tyres. This process is different because if would give th e com­panya recovery rate of 80% or higher ohh e rubber compared wi th lhe cu rrent typical yield of Ito 2% (Economic Times, 10 Septem­ber 19~9) .

FDI in proprietary or patented tech ar­eas allowed

The government has decided to perm it for­eign entities to set up wholiy-owned subsidi­ar ies involv ing proprie1ary or patented tech nol ogy. In effect, 100% Foreign Direct investment (fDD would be permitted i such G\Scs. The primary objec1:ve of this is to bring in lti-tech Il Qlog:,: and at the same time ~ lrotccllhe in tercs of foreign player.

Tecli llo logy is usuc:!'y '1 result of , esearch and dC"JcJopmcnt (R.\.'. D) . 2 e::i cleo. , effective­ness of (h e tcc: linc;Jogy is <lIso n Ul ial to the existencC' of th e develop~r . vVorltll)'.·lT, most player' work hard on protecting prr,p;'ietary k chn c:logy anti hence the: reC F: nt r)olicy in­iti ative.

Of late. th e Foreign Investmen t Promotion Board (rlPB) cleared an appl ication of Ciga­rette Components Ltd, a wholly owned su b­sidiary 'If Bunzl Pic, und er these new norms.

The battle for such a policy st.arted with E 1 Dupont's case where the co mpany was or-

dered to divest 26% equity in favour ot" an Indian entily or public.

Dupont had argued that the techn ology it used was patented and hence could let out a trade secret I)y bringing OIl-board oth er shareholders.

TIl(' company had said that the manufactu re of its products are b:lsc:d on licC'1lces of pro­prIetary and patented information of thei r pa r:.;]] t E T Dupont de 'e I1101l L., and com­pany. All in iormation and t.rad e secret need 10 b(' prolect,'d.

After <l rejection, the FIPB reviewed ti l mal­ter ,1 1ld b ter permitted E I Dupolll to lwld Oil

to its equ ity. The policy move was only for Clses wh ere companies were expected to divest their holding as per the c1eara1lce IeUers given to them rtl the time th ey set up shop in India. Now, th e norms are broad­bCl ed and are to cover jusl about any sector of in dustlY

This would be done 011 a case-to-case basis ami not through th e automatic route, gov­ern ment officiJls add ed. In the case oJ Cig;J· rettes Co mpo nent, th e sub s idi ary will manufacture and sale tear tapes fo r usc in th e packaging in the tubacco in du st.ry and other industries like confeclioJleri es, phar­macC'uticals and audiovisual products (Eco­nomic Times, 2:1 September 1999).

Research pays in new pat2nt regime

Bayer developed ciprofloxacil on which it has a patent till 2003, bu t the drug requires to be taken orally twice daily. R£l nbaxy's new formulation, for which it has applied for worldwide patent, reduces oral administra­lion to once da ily. Effectively, the advance extends the patent fo r ciprofloxacin which grossed sales of DM 2.5 billion worldwid e in 1998. Bayer has been quick to seize the product differentiation by taking it up for developmen t and marketin g worldwide,

I PI~ NEWS 367

leaving Ranbaxy exclusive marketing righ ts for India (wh ich offers a market for Rs 300 crore plus a year) . Bayer wi ll pay Ran baxy S 50 mill ion in instalments owr iI 20- car period (including an illit ial of S 10 mil ion) and upto 10 % of worldwide sales in r )yaJt . The new fo rmulation vill be :1 cash CO\, for Ranbaxy. Knowledge pays. Defore ~;Jnh;L y, the point was undeL~cored by Dr A!lji Rt'c1dy (of Dr Reddy's Labs) who en tered into deCl ls with Cl multi national Lo develop and mClrkel his company's breakthrough s in medical re­search. I3efore that Reddy had stunned th e Americans by exporting hu lk-p roduced ibuprofen at a vastly reducec cost.

Rcddy-RClnhaxy are pioneers, but it should not b e forg otten th Clt folic acid (and hetrazen) are prod ucts of an Indian mind which flowered in the Un ited States. At the present time Ind ians abroad are into re­search in life sciences in a big way . In diClns at home lack organized backup and an envi­ronment that lets them grow. In medicine, Ranbaxy and Reddy have shown that it pays to let organized ta lent reach for the stars . This may ye t happen in Indian software which has, in a manner of speaking, re­versed th e brain drain. Will medical re­search back not on ly domestic talent but attract brains that have emigrated. The drug industry thrived (under the Indian pat­ent regime) on formulations, and diversiJied into bulk drugs production. It is now learn­in g that research CCln he pCly ing under th e international patent regim e (but fo r which straight deals with multinationals would not have been feasible).

On the fli p sid e, the Reddy-Rillbaxy experi· ences bring out a sad fact. Indian drug com­panies Clre weak in relCltion to giants like Bayer an d Pfizer. They cannot develop the fruits of th eir research in to commercial products. This involves expensive clinical

trials 111 t'he industrialized COllll tries. Be­sides, Indian companies lack the I11Cl ssive marketing network to penetrate Am erica, Europe anc! Japan. fruiti lIl research has, wi llY-lli lly, to he rOil ed :llJ"o<1d thrCiugl1 mlll-1;l laf:(J !1ab. Indian drug co mpCln ies sllo uld perll,"ps combine to bllild a !~1arkcling lI et­work ill the first world (Financial Express, 10 C;cptE'm b I' 1009).

Term of hiotech noIoro-- patents length­ened

Tn a boost to ill(' US biotechnology industry, the House of Representatives approved a bill. The bill, sponsored by Congressman Howard Coble (Republican, Nor th Caro­lina), aims to mitiga te the effects of a GATT provision that changed palent terms to 20 years from th e date a patent <1pplicaLion is fil ed. Pa ten t pro tectio n was previousl y gran ted fo r 17 years from the date Cl patent was issued.

Biotechnol ogy inventions usu ally lake longer to win <1pproval at the Patent and Trademark OfJice (PTO) than other inven­tions, which take less than two years OIl average.

Under the bill- Ule American I11ventors Pro­tection Act - inventors would be COlllpen­sated by haviIlg a day added to the patent term for each day over three years that it takes lhe PTO to grant a patent (providing that the delay is not the applicant's fault). This would effectively gUClrantee a 17-year patent term from the date a patent is issued.

The bill also requires th e PTO to pu blish after 18 months any p<1 tent applications that are already published in other cou ntries. In­dustlY had lobbied for publication of all ap­plications, not just those published abroCld. It says tha t publication helps compan i s to avoid pursuing research and development in areas already staked out by others. Bu t in-

3GB J INTELLEe I'IWI' I~IGHTS. NOVEMBEH 1999

dependent inventors are opposed to th is pro­vision, arguing that companies might intimi­date them or steal their inventions if they are published before patents are g ranted.

Although the bill has not been introduced in the Senate, Jeanne Lopatto, a spokes-woman for the judiciary committee, says that th e committee's chairman, Senator Orrin Hatch (Republican, Utah), "is committed to patent reform" and will address the issue in Con­gress.

The bill does not address the issue of 'first to file' vs 'first to invent', which divides the countries ofthe European Commission from the United States. Some European countries were seeking a US shift on this in exchange for accepting a period of grace on patent applications in Europe [Nature, 400 (6745) 1999,604].

Why quasi-persons are not patentable?

The US patent office rejected a bid by Stuart Newman and Jeremy Rifkin to patent tech­niques for creating a human-animal hybrid. In rejecting their claim, the examiner in­formed the would be inventors that the US Patent Act does not cover the patenting of humans. Although the examiner is correct that propeliy rights in a human cannot be granted under US law, the Newman-Rifkin invention raises a different question, as only a part of it is human . But even something that is only part human-a quasi-person-can­not be patented, according to constitutional law.

To be granted a patent in the United States, an invention must be new, useful and not obvious to a person skilled in the pertinent scientific discipline. In 1976, Chakrabarty tried to patent a bacterium genetically engi­neered to digest oil but, although the bug satisfied all three criteria, the patent office refused to grant a patent on the ground that

living organisms cou ld not be patented . The Supreme Cou rt overturn ed this decision, concluding that "anything man-made und er the sun can be patented".

That opened the door for patents on engi­neered, living organisms. Did it make hu­m ans pa te n tab le? A human bein g is 'man··made' (woman-mad e, too, of course) so it satisfies the first level of inquiry set out by the Supreme Court. A human is also new (the <combination of genes is novel), usefu l, and not obvious (no one could predict what maternal and paternal genes would come together nor the resulting phenotype). All the criteria to earn a patent are met.

But the matter is not settled so simply. Pat­ented inventions become the personal prop­erty ofthe inventors to dispose of as they see fit. However, under US law, a human cannot be held as property. The thirteenth amend­ment to the constitution, which ended a slav­ery, prohibits taking property rights in human beings. A human, therefore, cannot be patented.

What about the patentability of hybrids? Rifkin suggests that the answer requires the patent office to define the maximum quantity of humanness that can be present in an or­ganism for it to be considered patentable. But this analysis has already been done. Not only does the thirteenth amendment pro­hibit the ownership of a person, but it also forb ids property rights in a quasi-person. When the constitution was framed in l'7S7, it contained a provision that slaves were to be counted as three-fifths of a person for the purpose of apportioning representatives to the Congress. The goal of the amendment was to outlaw slavery-to bar the ownership of Black people. But it did not change the legal status of Black people. They remained part·people (quasi -people) who were not entitled to vote, citizenship, or other r ights.

IPI~ NEWS 3G9

It was not until th e fourteenth amendment was passed that Blac! people were made ci tizens and granted full pcr"onh ooduIldl'1 lh e constilUlion.

The thirteenth amendment stood 1(., ill(' proposition that a CiU<lsi- person was no property to be helel by dno llll'r. So tlte !};It­ellt office is COlT ct in rc lu :--ing to .t!ran l ;1

patellt on <In organism that is only part hu­man [Nature, 400 (r17l.1) l~)CJ~). () 0].

PPL'lberapeutics fi kd pnlem for new technology

PPL Therapeutics, UK has ril ed patenl fo r its new technology of gene targeting. The new technique involves introduci ng <I gene at a specific pbce in the chromosomes of livestock cells in culture. Offspring carryin g th e desired changes are th en produced fr0111 these cell s using nuclear transfer (the tech­nique used by PPL and th e Roslin Insti tute to prod uce Dolly). Previously, it was only possibl e to add new genes, but not replace or inactivate ("switch off') existing ones. Also , th e site of addition of a gene was pre­viously entirely random and in a di£feren t place for every new transgenic animal.

The benefits of this new technology are nu­merou s. It will allow a chosen gene for a th erapeutic protein to be in serted at a spe­cifi c chromosomal site selected for its abili ty to facilitate high expression from any in­serted gene. The ability to enh ance expres­sion will greatly accelerate PPL's capacity to produce th erapeutic and nutritional protein s in the milk of transgenic livestock.

PPL now in tend s to apply th e new techn ol­ogy to th e replacement of speciiic genes with th eir human equivalent. for exampl e, re­placing th e bovin e vers ion of serum albumin wi th the human form (an und ertaking which was previously impossible) wi ll enab le th e cost effective production of human serUl11

albumin in the milk of cows. PPL will incor­porate the new techn ology into its existing hl1111 a11 ~enll1' ;t1bI11l1i n progr<llllme which is used in ~h .. trea tmellt (If hum" anel nth(·r tral l lll.lt:c i".itTY cll rr( ' I1! I ~' prIH Ilccd from human pb~!1l:t. PPL lw1it'vl';; th,if cost dkc­ti\ l' prO( ucliol] in tr;lnsge lic cuw') will (lnl ~ be po~~ibk if Ihl' hUIll,1 1l <l lbllll1in gelll' is sClb ... tilllkc1lo)" the 110\ illl' albl1l,lill ~l'nt'.

Bf':-.idcs the :IPI,lic(ll ion llf g(· I II .. 1.lrgt'lil1g fo r proll' in procil lcti oll, Ihe nl'W 1('chl1()logy mighl 1)( ;I ppliecl to , illl ation s in which il is necessary to inadiH: (or "swi ell orr') gelle, . Within PPJ .'" product portfol io, xell oi.r<lil. ­planta tion i one such arl' a where th e inacti­va tion of <1 specific gene could lead to pig organs being 1110rc readily accepted by the human immun e system, allowi ng transplan­tatioll of ani111 <l 1 orga l1 s to take place where human organs are unav<l ilable. PPL has al­ready used its gene ta rgeti ng tech nology to inactinte th e relevant gene in cultured pig cells [Biotech Pat News, 13 (7) 1999,4].

Patent for BCL .. 2 antisense to treat can .. cer

Gent<l Inc, MA, h<ls received US p<ltent for th e use of antisense t<lrgeted to the BCL-2 gene wh ich includes Genta's lead drug G 3139 to sensitize or kill cancer cells.

Genta's G3139, either alone or in combin a­tion with a number of currently ava ilable chemoth erapeutic <lgents, h<ls shown th e ability to kill human cancer cell s in sever<l l anim <l l models incl uding lymph oma, pros­tate, melanoma and breast cancers. Cur­rently, Genta h<lS seven ongoing Phase 1/ 2a and Ph<lse 2 clinical stud ies of its G3139 drug. B<lsed on data obtain ed from th ese stud ies, Gent] is planning on expanding its Phase 2 programme by the end o[ 1999 [Biotech Pat News, 13 (7) 1999, 5].

370 J [NTELLEC PROP 1 ~ [ G rITS, NOVEMBE I~ 199Y

Liver disease linked virus discovered

DiaSorin Inc, NJ, has discovered a new viru s associated wi th acute an d chron ic h ep~titi s ,

probably accounting for a majori ty of cases of viral hepatitis of un known origin . Viral hepatitis is a serious health problem with as many as 5.2 mill ion people in the United States infect ed with acute or chronic viral hepatitis. Wh ile statist ical data on incidence varies from country to country, five viruses (A,B,C,D,E) are known to cali se 80-90% of the cases worldwide, but 10-20% are of un­known origin.

The newly discovered virus is blood-borne, placing tr~ll1s[used patiellts and in travenolls drug users at risk. While no blood screening system exists currently for the new virus, appropriate screen ing to blood and blood products in the fu ture may control its spread. In this regard, it is estimated that worldwide approxjmately 50 mill ion units of blood are drawn annually.

DiaSorin fil ed patent appl ications covering th is discovery in 199R [Biotech Pat News, 13 (7) 1999, G] .

Ritalin Patented

Celgene Corporation, NJ. has been award ed US Pat 5,922, 736 for the once daily admini­stration of d-methylphenidale, the chirally pure version of llitalin (dt-methylphenid ate) for th e treatment of attention deficit-hyper­activity disorder. Current Ri ta lin regimens require multiple da ily dosages, a major in­convenience fo r young atten tion deficit-hy­peractivity disord er pat ients; pendin g scientific and regulatory revi ews, the single dose administration of d-methylph enida te may help many attention deficit-hyperactiv­ity disorder patients better comply with their treatment. 'The patent covers both methods and formulations for the pharmaceutical, which is being evaluated in pivotal clinical

tr ials in the United States ;:111c1 Canada [Biotech Pat News, 13 (7) 1999,81.

P heromone technol ogy patented

Human Pheromone Sc iences Inc, CA. has been granted Canadi an patent fo r fragrance compositions and other compositions con­taini ng human pheromon es.

As a result of this grant, the company wou ld now begin to aggressively seek a retail mar­keti ng and sales partner in Canad:! for its Realm and inn er Realm fragra nce and toi­letIy products. At present, sales of these products to Canadian consumers are being made exclusively through th e company's Website, www.Realmf ragrances.com.

Previously, the co mpany received patents on its proprietalY human pheromone technol­ogy in the United States. th e major European co untr ies , Mex ico, Japan and Tai wa n [Biotech Pat News , 13 (5) 1999,4].

Polycystic kidney disease diagnostic tests patented

Mill enium Pharmaceuticals Inc, MA, and Brigham and Women's Hospital, MA, have been issued a pa tent for com positions and methods fo r the diagnosis of auto somal dominant polycystic kid ney disease. This disease is an inherited disease that is most often the result of a mutation in a gene known as PKDl. The patent relates to anti­bod ies that bi nd to PKD 1 polypeptides, methods of detecting PKD1 nucleic acid s and polypeptides, and diagnostic test kits [Biotech Pat News, 13 (5) 1999, 4].

Patent for gastrointestinal and esopha­geal pmtectant

KV Pharmaceuticals Company, MO, has re­ceived a patent from US fo r its gastrointesti­nal and esophageal drug delivelY system. The technology is trademarked as Trans-EP (trans-esophageal) .

lPR NEWS 371

Th e new technology would oUer long acting site specific action to th e esophagus. KV is now exploring Trans-EP's potential applica­tions for the oral administration of major drug candidates, including some peptides and proteins and other molecules which cur­rently have little, if any, gastrointestinal ab­sorption. Currently some of these molecules such as erythropoietin and human growth hormones, must be either injected or in­fused through intravenously [Biotech Pat News. 13 (5) 1999,51.

Japanese patent for protein production in transgenic animals

Genzyme Transgenics Corporation , MA, has been award ed Japanese patent for the production of transgenic an imals secreting desired proteins into milk.

The patent covers the basic DNA sequences which link a milk protein promoter wi th a gene encoding the protein of interest, as well as the fundamental method used to produce therapeutic proteins in the milk of tran s­g enic animals. In 1996, Genzyme Tran s­genies received a similarly broad patent in Europe for the production of proteins in tJl e milk of transgenic animals [ Biotech Pat News, 13 (5) 1999, 6].

Patent for treatment of bifurcated ves­sels of heart

Modular Stent Systems Inc, CA, has been issued a US patent fo r coronary stent and method of fabricatin g th e same. Th e Stent technology is useful in stenting coronary lesions that occur at bifurcating vessels ef­fectively expanding the range of treatable cases. The newly patented Stent technology has the same mechanistic action of currently marketed stents but does not eliminate ac­cess to main side branches.

This important patent addresses the need for treating coronary artery disease without

redu cing blood fl ow to th e major s ide branches. Prel iminary stu dies demonstrate the Stent tech nology's ab ili ty to provide state-of-the-art performance wh ile enal>ling interventional procedures in major side branches [Biotech Pat News, 13 (5) 1999, 8].

Growing living cartilage with stem cens patent

Advanced Tissue Sciences Inc, CA, has been issued a US patent entitled "Three-dimen­sional Cartilage Culture. II The patent covers three-dim ens io nal cartilage compositions and methods of growing living cartilage in vitro by inoculating cartiiage-producing cells on to biocompatib le, non-living scaffo lds. The cartilage producing cells claimed in­clude precursor cells such as mesenchymal stem cells, chondroprogenitor cells, and um­bilical cord cells as well as mature chondro­cytes and fibroblasts. 'This patent extends through March 2016 [Biotech Pat News, 13 (5) 1999, 10] .

Wound healing technology patented

Biospecifics Technol ogies Corporation, NY, and Tufts Univers ity, MA have received a US patent for developing a wou nd h ealing tech­nology which promi ses to accelerate the healing of normal and abnormal wound s.

Th e human body normally remod els the wound healing response to injury by using naturally-produced enzymes, includi ng hu­man collagenase. Wou nd healing takes the form of mig ration, when cells crawl to cover injured tissue areas, and proliferation, when the cells divide and grow to repair the wound bed. The work performed in a T ufts Univer­sity laboratory suggests that the new tech­nology will accelerate normal wound healing by cell stimulation, as well as prove benefi­cial to healing chronic wounds such as bed­sores, and diabetes-related lesions [Biotech pat News, 13 (6) 1999, 2].

372 J lNTELLEC PROP RIGHTS, NOVEI\1f3El~ J999

Research grant from NIH

Alphagene, MA, has received a Small Busi­ness Innovative Hesearch grant from the Na­liunal In stitute of Health (NIH). Th is award is to advance the development of patent pendi ng process for Single Libra ry Ampliii­caLion of Gcne Exprcssion (SLAGE) . This proLess ;1 11 0 vs AlphaGcne to t1 :e mi nute quantities of tissue repc;:)tcd ly in gene ex­pression experim ents. Al pl!aGene is moving frolll a service- based ge ne discovery C0 111-

pany towards a rllnct iomd gcnomics COIl1-pa ll Y based on ce llular pathway develorment and diseased in neurological ti ssues. The develop men t of SLAGE will al­low to li se sillall quant ities of Li ssue [1'0111

biopsies to determine wha t genes are being differentially expressed in th ese disease tis­sus [Biol ('ch Pal News , 1 ~-{ (G) 1999, 4] .

p .. tcnt for b-ansgenic plant recombinant protein technology

Phytomed ics Iilc, NJ. has received ;:) US pat­ent for methods for recovering polypeptides irom plants and portions th ereof.

Th e invenLion termed as l~epo st is a powerful technology for the genetic transformation of live greell pbnts to synth esize amI secrete large quantities of polypeptides from both their roots allclleavcs, as well as met hods fo r th eir coll ection . It is a Jrigh-yield and low-cost­recombinant protein production method with simpl ified downstream procl'%ing and large-scale !nanubcLuring potelltial. It pro­vid es a novel. cost-effective sol ution to in­creasing yields and simplifyin g proteill extrac ti on all d puri ficat ion [Biotech Pal News, 13 (G) 1999, 51.

fNVOS cerebral oximeter patented

Somalletics Corporation, MI, has received a pat ent for developing and marketing INVOS cerebral oximeter.The Oximeter is the only FDA-cleared and commercially-available Pi!-

tient monitorillg system that noninvasively and continuously mOil itors changes in the regiona l oxygen saturation of the bl ood in the adult brain during surgery an d other critical care periods.

Use of tll e p;:)lient monitoring system can help medical professio nals id entify low re­gioll ;:)1 brain biood oxygen saturaLiOll and Lake corrective action . Such adion ca ll po­ten tially prevel1 tor recillce II eu 1'0 logical ill ju­ri es reb ed to "ur.c:cr)' an d rC' d llc(' the associated cos! of care r Bio/ ('ch Pal N('ws , 13 (G) 1999, 6J.

Plant biotechnology patents

Agri tope Tn c, Porllan d, has bee n isslied th ree US patellts for p -Oll1ot ers ;:) nd th eir use ill regulatin g expressioll of genes in plants. Thethreepatellts,US r( l t5 ,7~';:), :N3,5,783,3!)4

and 5,859,:)30, cover si,' specific promoters as well as related DN A. S<'qll cll ces usee! to express genes in plan ts. Th ese technologies also cover methods for regulating gene ex­pression ill pla nts as well as transgenic plants and fru its [Biotech Pat News , 13 (G) 19!)9,61.

Tech nol ogy for o ral d e livery of osteoporosis product patented

Unig ene LaiJo ratories, NJ, ha s been award ed a US parent ior th e technology for oral delivery uf calcitonin for tir e treatment of osteoporosis an d other diseases [Biotech Pal News. 13 (G) ]999,7 ].

KP-102 patented

Killetek Pharmaceuticals Inc. Canada, has been granted a US patent for KP-I02, on organo-vanad ium compound that acts as an insul in scnsitizer and effective in th e treat­mcn t of type 2 diabetes.

Type 2 diabetes is ;:)n end ocrine disease caused by defective in sul in signaling and leads to seriolls complicaLion s includ ing

IPR NEWS 373

blindness, kidney failure ;lIld ci rculatory problems th at ca n cause non -h ea ling wounds and limb amputations. In addition, diabetes increases th e ri k of cardiovascular disease and other degenerative vascu lar conditions. I<P-I02's mechanism of action resets defective insulin sign aling, thereby addressing the underlying pa thology of type 2 diabetes [Biotech Pat News, 13 (8) 1999, 7].

Hybrid capture technology patented

Digene Corporat ion, MD, has been awarded a patent for discovety and development of hybrid capture technology. Hybrid capture is a platform that uses "signal amplification" to detect as few as 100 molecules of DNA or RNA in a rapid, easy-to-use test format. All of Digene's molecu lar diagnostic tests and research products are based on hybrid cap­ture. Nucleic-acid technologies such as hy­brid capture offer superior performance to tradi tional laboratory tests for detecting in­fect ious diseases and cancer [Biotech Pat News, 13 (8) 1999, 71.

Third patent for GeneSwitch technology

Valentis Inc, CA, has been issued a third US patent for GeneSwitch technology. Thi s tech nology provides precise control over th e level and duration of gene expression when introduce d via gene th e r apy. Using GeneSwitch, therapeutic genes may be ex­pressed by ad mini str ation of an orally bioavailable drug in a dose-dependent man­ner. Levels of a therapeutic protein can be conb-olled as needed by administration of the regulating drug in a pill form.

Applications of the GeneSwitch technology include viral and plasmid-based gene ther­apy; as well as functional genomic studies using transgenic animals [Biotech Pat News, 13 (8) 1999,5) .

XenoMouse technology

Abgenix Inc, CA, has been gran ted a US patentfo r the method fo r making transgenic mice lacking endogenous heavy chain s.

Such transgenic mice technology, referred to as XenoMouse technology makes use of the natural power of th e mouse immune system to respond to human disease targets by making mul tiple hig h affin ity antibodies. However, th e antibodies gen erated by these mice are composed of 100% human protein rather than mouse protein. Th e method cov­ered by th e new patent enables this by pre­venting the expression of mouse antibody genes, so that they can be functio nally re­placed with human an tibody genes, while leaving intact the rest of the mouse immune system [Biotech Pat News, 13 (8) 1999, 5].

New pectin granted patent

CalTington L1boratories Inc, TX, has been granted a patent fo r the discovery and isola­tion of a new pectin (complex carbohydrate) from natural Aloe vera L. or other Aloe spe­cies. The new patent covers th e composi­tion of uniqu e pec tin processed from the rind or pulp (in ner leaf gel) of Aloe vera L. which features unique chemical and func­tional properti es that distingu ish it from other co mmercial pectins. Pectins are com­plex carbohydrates associated with plant cell walls. Other commercial pectins have been traditionally w~ed as food additives and more recently for pharmaceutical applica­tions such as drug delively. 'Th e uniqueness of this new pecti n allows for development of novel products in the nub-aceutical area as well as possible therapeutic applications [Biotech Pat News , 13 (8) 1999,3] .

Bone graft substitute technology pat­ented

THM Biomedical Inc, Duluth, has been is­sued a US patent for a process and device for

374 ] INTELLEC PROP RIGHTS, NOVEMBEH 1999

treClting and heali ng tissue defic iencies by incorporating biologically active agents sllch as bone morphogenic protei ns into th e vo ids or pores of a porous hydrophobic biorcsorhable material. Th e proteins can be used to sti'l1 ulnte bone growth iu to the three­dimens iol1::l1 polymer scaffolding allowing for cr.'r1tion of bone within nnd extern al to norma! ~kek!~l bOLindari e::: [Bio!['c/z Pal News, 13 (1'1) 1.999, 2].

FSH patent

Vitro Diagnostics fl c, Lilt k ton, bas received a US patent for thc' method for the purifica­tion offollicJe stirlllti .tLing Ilo r'llone (FSH) , a pituitary gonadotrop!p. hormone importa nt in the regu lation of reprod uc tio n. FSH is an active ingredient in several dit1erent fertili ty drugs currently on the market (Biotech Pat News, 13 (8) 1999, 12 ].

Heterozygosity patent

Exact Laboratories Inc, Maynard, has re­ceived a US Patent for the method for the

detection of loss of heterozygosity. This pat­ent describes methods [o r detecting chro­mosome losses commonly seen in can ers and methods to detect genetic variations for pharmacogenomics and genetics research.

Loss of he terozygosity occurs wh e ll all or Dr}1-t of a chromusonw is lost d ,l riIlg Ihe ;le­

velopmen l of can cer . Thi s ph enomenon is virtu ally universal to all cancers. T bese Joss events often remove large genomic reg ions though t to harbour genes involved i l l GlllCer suppression. Current tech niques lack th e sen sitivity to detect loss of I elcrozygosit y in t lC majo rity of patien t samples. especially those patient samples commonly used in screening such as s tool, serUIll, urine, spu­tum samples and cervical sm ars. Exact's technology can detect loss of hete rozygosity indicative of cancer and may allow for the development of a general cancer screen (Biotech Pat News, 13 (8) 1999, 9],