In the June issue of Pharmaceutical Science &Technology Today, Richard Binns and Bryan

Driscoll highlighted some of the key elements

of intellectual property (IP) that companies,

particularly technology partners, should be

aware of1. For the scientist–manager in a small

enterprise or academic start-up, getting to

grips with IP can be an intimidating challenge,

particularly when these efforts are superim-

posed on the major workload of their core ac-

tivities. The new Head of Marketing at the UK

Patent Office has urged companies to realize

the benefits of adopting a fully informed IP

strategy. ‘Ownership of intellectual property

rights such as copyright, trade marks, designs or

patents, or the licence to use these rights, pre-

sents opportunities to make money,’ says Brian

Caswell. ‘We want firms to welcome these

opportunities.’

A report recently published by Derwent en-

titled Managing Patent Information: the GulfBetween Theory and Practice analysed feedback

from respondents to a European telephone sur-

vey of large corporations and small-to-medium

sized enterprises (SMEs). The respondents were

spread across a range of industrial sectors in-

cluding pharmaceuticals, chemicals, engineer-

ing and electronics.

National differencesThe findings highlighted some national trends.

For example, UK managers had a poorer under-

standing of the role of patents relative to their

European counterparts. Although most compa-

nies (85%) considered patents to be vital to

their future development (with 84% having an

active patent policy), only 42% performed

regular patent audits.

For most companies, the number of patents

filed had increased significantly in the past 10

years. It remains clear that in the pharmaceuti-

cal, chemical and electronics industries, patent

ownership is very important in the protection

of products in development and on the market.

Some 89% of respondents cited the primary

motivation to patent as the key reason for filing

a patent. Only 10% indicated that their major

reason would be to block the product develop-

ment of a competitor.

More than 90% of respondents consider

patent ownership to be very important to the

R&D process, although only 66% agreed that

patent volume reflects the degree of innovation

of a company. Some 54% indicated that, at

some stage in the company’s development, a

patent had been filed that significantly

changed its fortunes.

Competitive intelligenceSome 89% of respondents concurred that

monitoring of patents filed by competitors is an

effective way to obtain competitive intelli-

gence, and 82% of respondents do commit

time and resources to this activity.

Of those companies that did not own

patents, the primary reason was that patents

were not relevant to their particular business.

The second most significant reason was that

companies were deterred by the complicated

process involved in making an application for a

patent. In the light of recent discussions about

the cost of the patent process in Europe, it was

surprising that only one respondent indicated

this to be a factor in discouraging patent filing.

It seems likely that the increasing trend to

patent and to ensure awareness of competitor

patents is likely to continue. However, as the UK

Patent Office indicates, it is the small compa-

nies in particular that are reluctant to take ad-

vice on patents and registered designs. Perhaps,

as a result, small companies are the most likely

to become involved in litigation.

Reference01 Binns, R. and Driscoll, B. (1998) Pharm. Sci.

Technol. Today 1, 95–99

update news PSTT Vol. 1, No. 5 August 1998

Copyright ©1998 Elsevier Science Ltd. All rights reserved. 1461-5347/98/$19.00. 188

Intellectual property trendsDavid Hughes, Pharmaceutical Science & Technology Today, tel: 144 1223 315961, fax: 144 1223 464430, e-mail: pstt@elsevier.co.uk

Erectile dysfunction (ED) is estimated to affect

two million males in the UK alone, with preva-

lence thought to be approximately 5% in men

of 40 years of age and increasing to 15–25% in

males aged 65 years and over. The causes of ED

may be psychogenic through anxiety, fear or

depression, but there may also be organic rea-

sons such as defective arterial blood supply and

venous drainage, defects in erectile tissues and

neurological or hormonal abnormalities. The

condition may also be drug-related (whether

taken therapeutically or abused).

Some ED patients do not respond to Viagra

(sildenafil), a tablet-based product manufac-

tured by Pfizer for the management of ED. At

the 93rd Annual Meeting of the American

Urological Association (30 May–4 June 1998,

San Diego, CA, USA) speakers predicted that the

launch of Viagra would ultimately create

greater demand for alternative treatments for

the condition, such as injection therapy. In ad-

dition, the concurrent use of several other

medications preclude the use of Viagra. For ex-

ample, at the meeting Ridwan Shabsigh,

Options for Viagra failuresAdrian Smith, Pharmaceutical Science & Technology Today, tel: 144 1223 315961, fax: 144 1223 464430, e-mail: pstt@elsevier.co.uk

Director of the New York Center for Human

Sexuality, said: “Many patients have told me

they have ‘very infrequent chest pain’. They say,

‘I carry nitroglyercine only for safety reasons. I

only take it once every nine months’. The clear

message for these patients is: ‘If you take nitro-

glyercine once a year, you can’t have Viagra’.”

Media coverage generated by the launch of

Viagra is likely to lead to a larger overall patient

base through greater awareness of ED amongst

the male populace and an increase in the num-

bers of sufferers prepared to visit specialists and

ED clinics for diagnosis and therapy selection.

Options for Viagra failures andcontraindication casesSchwarz Pharma (Chesham, UK) – manufactur-

ers of Viridal Duo® [alprostadil alfadex

(prostaglandin E9-acd)], a prescribed, intracav-

ernous self-injection system for the manage-

ment of ED – has seen ‘a significant increase’ in

the number of prescriptions for the treatment,

even though administration requires self-

injection. The treatment is contained within a

dual chamber glass cartridge: one chamber

contains lyophilized Viridal® (10 or 20 mg) and

the other contains saline diluent. The self-

administration process begins by placing the

cartridge in the chamber of the applicator and

then, by twisting the plunger clockwise until it

goes no further, the saline solution is forced

into the second chamber and dissolves the

powder. Once the patient has ensured that the

liquid is free of trapped air, the solution may be

adjusted to the correct administrative dose and

injected. The treatment is delivered directly into

the penis via one of the corpora cavernosa, two

large cavernous bodies sited either side of the

penis and responsible for erection of the penis.

It is claimed that the method of injection repre-

sents the most effective form of medication be-

cause the drug is self-injected directly into the

relevant tissue to provide rapid drug delivery.

Results from injection therapySelf-injection performed with Viridal Duo® re-

sults in more than 85% of ED sufferers being

able to perform successful sexual intercourse.

The company claims that this level then

increases to 95% after 12 months of usage as

patients become familiar with both the treat-

ment and its result, and that its treatment en-

sures the development of erections, within a

matter of minutes, that usually last for between

30–60 min. The active ingredient in the therapy

is alprostadil, prostaglandin E1, a smooth muscle

relaxant that occurs naturally in the penis and is

involved in the normal erection. Therefore, the

company claims that its product is designed to

generate an erection by a mechanism that oc-

curs naturally in the normally functioning penis.

Other therapiesNexMed, an emerging international pharma-

ceutical and medical device company, has re-

cently announced that, in a clinical study con-

ducted in Argentina, its patented Alprox-TD

topical cream (alprostadil) for the treatment of

ED was proven to be as effective in the produc-

tion of targeted results as intracavernous injec-

tions. The formulation incorporates the NexACt

(acute transdermal drug delivery technology)

ingredients that are claimed to promote the

rapid penetration of the active ingredient

through the skin and to the site of action. The

company claims that in vitro and in vivo pen-

etration studies have shown that the NexACT

enhancers result in the rapid delivery of al-

prostadil through the stratum corneum (the

outer layer of the skin) as well as to the tissue

below the skin. The product currently awaits

regulatory approval.

An existing competitor in the alprostadil ED

treatment market is MUSE™ (VIVUS), a

transuretheral delivery system. In this treat-

ment, a small suppository is inserted into the

urethra which is then absorbed through the

urethra into the penis. At the correct dose, an

erection is reported to occur which will last for

30–60 min. Studies of this transuretheral deliv-

ery system for alprostadil versus intracavernosal

injection of vasodilating agents have been con-

ducted and reported1. The study concluded that

intracavernosal injections appear to be more ef-

fective than the transuretheral system studied.

The futureResearch is set to continue to explore the issues

of safety and efficacy that surround treatments

for ED. It is clear that, with Viagra being

launched in more countries, ED as a condition

will receive more recognition and more sufferers

will apply for treatment, whether it is to be de-

livered orally or by injection. However, because

more than 130 prescribed drugs have been iden-

tified as possible causes of disorders of erectile

function or which may produce ejaculation as

side-effects, pharmaceutical manufacturers face

a major challenge and opportunity in the devel-

opment of further ED therapies.

Reference01 Werthman, P. et al. (1997) Urology 50(5),

809–811

PSTT Vol. 1, No. 5 August 1998 update news

189

In 1997 the German cancer market was worth

$770 million. According to a new report by Datamonitor,

Generic Cancer Markets: Quantitative Analysis

and Forecasts, the generic cancer market and the

multisource market reached a value of $94 million and

$277 million respectively over the same period.

Generics accounted for approximately 34% of the cancer

multisource market, or 12% of the total cancer market.

The full report is available from Datamonitor

(tel: 144 171 316 0001, fax: 144 171 316 0002,

e-mail: krao@datamonitor.com). Price: $2995.

Report identifies value of German generic cancer market