BRITISH MEDICAL JOURNAL

28 JUNE 1975

759

NEWS AND NOTES MEDICOLEGAL Patents, Injunctions, and Sutures FROM OUR LEGAL CORRESPONDENT

In deciding to restrain Ethicon from infringing American Gyanamid's patent rights in absorbable surgical sutures made of polyhydroxyacetic ester (PHAE) filaments, the House of Lords' has revolutionized the basis for the grant of interlocutory injunctions pending trial. Formerly judges invariably investigated the merits of the plaintiff's action and the likelihood of his succeeding at the trial in deciding whether to grant an interlocutory injunction. Now Lord Diplock has said that provided the plaintiff reveals a serious question to be tried, an interlocutory injunction will be granted if the "balance of convenience" between the parties demands it. Incomplete Evidence At interlocutory hearings the evidence is, naturally, always incomplete. It is only put before the court in writing on affidavit and has not been tested by oral cross-examination. Lord Diplock considered that the point of giving the court a discretion to grant an injunction or not would be stultified if there were a technical rule forbidding the exercise of the discretion if the court evaluated the chances of the plaintiff's ultimate success in the action at 50% or less, but permitting it if the chances seemed better than 50%,' . Cyanamid's United Kingdom patent in PHAE dates from 2 October 1964. The company did not claim that either PHAE or its manufacture in filaments2 was new but merely that a new use for a known substance had been invented. PHAE sutures were first sold by Cyanamid in 1970, and three years later the firm had captured 15% of the British market for absorbable sutures. The competition confronting Ethicon (who had previously supplied 80% of the market with catgut) was so great that that company decided to introduce its own artificial suture, known as XLG. But while PHAE is a homopolymer XLG is a copolymer. It was this distinction that Ethicon emphasized in its defence when Cyanamid moved to stop the sale of XLG on the grounds that it infringed the patent in PHAE. Ethicon also claimed that the invention was too obvious to form the subject-matter of a valid patent. Cyanamid argued, on the other hand, that at the date of the publication of its patent the words "a polyhydroxyacetic ester" were a term of art in chemistry meaning not just homopolymers (of which the units in the chain, apart from the end stabilizers, consisted solely of glycolide radicals) but also copolymers (of which up to 15% of the units in the chains would be lactide radicals).

the injunction for which it had asked. But Ethicon's appeal was to prove successful: after eight days spent examining voluminous affidavits and exhibits, Lord Justice Russell discharged the injunction. When the matter came before the House of Lords leave was sought to file fresh evidence and the appeal was estimated to last at least 12 days. Lord Denning has recently commented3 that the House was clearly appalled by this prospect. By refusing to investigate the plaintiffs' merits and examine the evidence the House in fact disposed of the appeal in less than two days. Lord Diplock said emphatically that the courts were not justified in embarking on anything resembling a trial of the action of conflicting affidavits in order to evaluate the strength of each party's case. The House of Lords restored the patent judge's injunction as it was convinced that Ethicon could be adequately protected by Cyanamid's cross-undertaking in damages (that is, to compensate Ethicon should it turn out at the trial that the injunction should not have been granted). Examining the balance of convenience Lord Diplock took into account that Ethicon's XLG sutures were not yet on the market. No jobs were therefore going to be lost if the injunction was granted; and, in any event, the company held a dominant position in the market in the United Kingdom for absorbable sutures, he said. Appreciating that the case might take over three years before a final decision was reached, Lord Diplock was afraid that if Ethicon could establish itself in the market for synthetic absorbable sutures Cyanamid (if it succeeded at the trial) would have lost its chance of the share in tht market which otherwise it would have gained in the years of uninterrupted monopoly until 1980 when the patent expired. Lord Diplock added that it was notorious that new pharmaceutical products took a long time to become established, but that once established with the benefit of the monopoly the benefit continued to be reaped after the expiry of the patent. The patent judge had been impressed by an additional reason for the grant of an injunction. Mr. Justice Graham thought that if doctors and patients got accustomed to Ethicon's XLG in the period before the trial Cyanamid might not be willing to insist at the trial on a permanent injunction. Such a course could have a damaging effect on the firm's good-will in the pharmaceutical market and on the sale of its other products.

which demanded that the plaintiff should make out a prima facie case before he was granted an injunction. In a recent Court of Appeal case3, Lord Denning (never noted for his willingness to bend to the authority of the House) criticized the basis of the decision, though not the decision itself. He pointed out' that as recently as 1965 (in a precedent4 not cited to the Lords at the Cyanamid hearing) Lord Upjohn had spoken5 of the "clear principle" that the seekers of an interlocutory injunction should establish a prima facie case. Lord Denning said that he found the pronouncements of Lord Upjohn and of Lord Diplock quite impossible to reconcile. Lord Justice Browne, though, emphasized that the lower courts should follow the Cyanamid ruling because that had been a direct decision, whereas in 1965 the House had merely adopted without argument what was common ground between counsel. In all the uncertainty Lord Justice Browne wondered if the House could provide further clarification soon of a decision whose effect will be felt daily by both surgeons and lawyers. American Cyanamid Co. v. Ethicon Ltd. (1975) 1 A.E.R. 504,2 W.L.R. 316. 2 In the United States Lowe (in 1953) and Higgins

(in 1954) both patented methods of making PHAE filaments. Fellows and Son v. Fisher: The Times; 6 May 1975. 4 Stratford v. Lindley: (1965) A.C. 269. 5 Stratford v. Lindley: (1965) A.C. 269, p. 338. 3

PARLIAMENT Questions in the Commons

Advertising The Minister of State at the Department of Health and Social Security, Dr. David Owen, said, in a written answer on 18 June, that the Secretary of State would not reconsider her decision to reduce promotion advertising. The questioner claimed that the decision would mean that several publications of reference value to the medical profession would cease publication. Dr. Owen's full reply was: "The overall proposal for a substantial reduction in promotional expenditure allows for considerable flexibility within the voluntary price regulation scheme system and is mainly directed at Departure from Practice medical representatives, free samples, hosThe House of Lords' decision is a complete pitality and lavish and unnecessary promoLengthy Action Possible departure from the old practice in both the tional activity. The detailed proposals which In July 1973 the patent judge gave Cyanamid Chancery and the Queen's Bench Divisions, my Department will be discussing with the

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BRITISH MEDICAL JOURNAL

Association of the British Pharmaceutical Industry and the professions are specifically designed to try to shield publications of undoubted reference value to the medical profession."

of the control of the content of advertising and of information to doctors. In the light of the Commission's advice, Dr. Owen said that he had put a series of detailed proposals to the industry which were currently being discussed.

Pharmaceutical Industry On 13 June the Minister of State, Dr. David Owen, was asked if he would implement the recommendations of the Sainsbury Report on the Drug Industry. Dr. Owen said that action on some of the recommendations had been taken when the report was published in 1967. "In relation to those recommendations which referred to prices and profits in the industry a revised voluntary price regulation scheme based on annual financial returns was renegotiated in 1969. Discussions on many of these matters are now taking place in the industry," Dr. Owen explained, "and reflect the Government's wish to make a substantial cut in the current cost of sales promotion." He went on to say that "the committee's recommendations about the content of advertising have in part been implemented by the enactment of the Medicines Act and in particular by the introduction of the system of data sheets." Dr. Owen reminded the House of what he had told them on 21 November 1974 that the Medicines Commission was asked to report on the question

Emigration of Doctors Dr. Gerard Vaughan (Cons., Reading) asked Dr. David Owen, Minister of State, for the most recent figures for emigrating doctors. In a written answer on 10 June he was told that the provisional estimate for the year ending September 1974 was 800 British or Irish doctors emigrating, partially offset by 500 returning.

28 JUNE 1975

the N.H.S. we publish below the text of a letter dated 19 February 1975 from the Chief Medical Officer to all regional medical officers, to which the press statements apparently refer. The content of the letter was agreed with the Joint Consultants Committee at its meeting on 21 January.

"(1) After consultation with representatives of the medical profession, I am writing to suggest the procedures that would be appropriate in appointment of doctors to hospital posts with duties involving termination of pregnancy or advice on termination. "(2) Where it can be established after consultation with the relevant specialist advisers that there is a demand which cannot be met and where patient care would suffer if a doctor appointed to a particular vacancy did not feel able, on grounds of conscience to be involved in, or advise on, the termination of pregnancy it may be stated that the post includes duty to advise on, undertake, or participate in termination of pregnancy. As you will appreciate, the question may arise not only for posts in obstetrics and gynaecology, but also in anaesthetics and psychiatry. Where such advice is included in the job description, Dr. Forbes (room Appointment of Consultants: 404, Eileen House) should be informed. Termination of Pregnancy "(3) No reference to such duties should be In view of statements in the national press included in the advertisement of such a post. The description (the further particulars) made availimplying that the Department of Health and job to all applicants should however make explicit Social Security has recently placed a "ban" able such commitments whenever they arise. on the appointment of doctors who are unwilling to perform abortions to certain posts in continued on page 761

MEDICAL NEWS

MEDICAL BIRTHDAY HONOURS Among the members of the medical profession whose names appeared in the Birthday Honours list were the following: Dr. H. Yellowlees, C.B., chief medical officer of the Department of Health and Social Security, as K.C.B. (Civil Division). Dr. J. H. Croom, chairman of the Scottish Council for Postgraduate Medical Education, president of the Royal College of Physicians of Edinburgh, as Knight Bachelor. Mr. R. G. Swiss, president of the General Dental Council, as Knight Bachelor. Dr. D. Thomson, C.B., civil service medical adviser, as Knight Bachelor. Miss Joyce M. Daws, West Heidelberg, Victoria, Australia, for services to medicine, as D.B.E. (Civil Division). Miss Frances V. Gardner (Mrs. Qvist), dean of the Royal Free Hospital School of Medicine, as D.B.E. (Civil Division). C.B. (Military Division).-Surgeon Rear Admiral G. A. Binns, Q.H.S. C.B.E. (Civil Division).-Mr. A. S. Aldis;

Dr. H. Yellowlees

Mr. E. A. Barker, for medical and welfare services to the community of Natal; Dr. F. S. W. Brimblecombe; Professor J. C. McC. Browne, Professor P. S. Byrne; Dr. W. G. Daynes, for medical and welfare services to the community in the Transkei; Dr. B. 0. L. Duke, for services to medicine and the community in Cameroon; Miss Jean Littlejohn, Hawthorn, Victoria, Australia, for services to medicine and the community; Dr. A. S. McLean; Professor R. S. F. Schilling. M.V.O. (Fourth Class).- Dr. J. P. Clayton. O.B.E. (Civil Division).-Dr. R. M. Crookston, New South Wales, Australia, for services to medicine and the community; Dr. H. G. Davies; Dr.- W. M. Jamieson; Dr. M. J. Linnett; Dr. Alice L. Musgrave, for medical and welfare services to the community in South India; Dr. G. L. Myles, J.P., Western Australia, for services to medicine and the community; Dr. Doreen Rothman (Mrs. Pegrum); Dr. R. Southby, North Melbourne, Victoria, Australia, for services to medicine;

Dr. J. H. Croom

Mr. R. G. Swiss

Dr. A. C. Stanley-Smith, M.C., for services to medicine and the community in East Africa; Dr. R. G. Vine; Professor E. Wilkes; Dr. V. A. A. Winston. O.B.E. (Military Division).-LieutenantColonel W. E. I. Forsythe-Jauch, R.A.M.C.

M.B.E. (Civil Division).-Mrs. Prudence Barron; Dr. I. H. Chenoweth, North Mackay, State of Queensland, for services to medicine and the community; Mr. D. G. Evans; Dr. T. Flood; Dr. Margaret A. Haigh; Dr. N. C. Sharp. Q.S.O.-Dr. D. G. McLachlan, J.P., Wellington, New Zealand, for services to medicine, in particular psychiatry; Dr. J. L. Newman, Auckland, New Zealand, for services to the care of geriatrics. The photograph of Dr. Henry Yellowlees was supplied by Universal Pictorial Press, that of Mr. R. G. Swiss by Alfred Saunders, Dr. Daniel Thomson by Bassano and Vandyke Studio, and that of Miss Frances V. Gardner by Mr. C. C. Gilson.

Dr. D. Thomson

MMiss Frances V. Gardner

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"(4) The Advisory Appointments Committee will wish to be satisfied that applicants are in all respects fitted and prepared to carry out the full range of duties which they might be required to form [sic] if appointed. In doing so, enquiries about duties that relate to termination of pregnancy should be confined to professional intention, and should not extend to questions about candidates' personal beliefs. "(5) I enclose extra copies of this letter for the A.M.O.s of A.H.S.s and A.H.A.s(T) to whose attention you will wish to bring it. It is also being copied to administrators, S.C.M.s (Medical Staffing), and regional personnel officers." It will be noted (para. 2) that the D.H.S.S. must be notified of each occasion on which the above procedure is adopted. We understand that this requirement was included at the instance of the J.C.C. and is intended to help to ensure that the procedure is not used too freely.

out the country. P.P.P. was established in 1940 as a non-profit organization and is the second largest private health insurance company in Britain, protecting half a million of the four million potential private patients in the country.

People in the News Professor Midhael Heidelberger has been elected a foreign member of the Royal Society for his pioneering studies of artigenantibody interactions and of the stucture of bacterial poly,saceharides.

COMING EVENTS

28 Sat.

Annual Conference of Central Committee for Community Medicine, 10 a.m. JULY

Scottish G.M.S. Committee (at 7 Drumsheugh Gardens, Edinburgh), 10.15 a.m. Anaesthetists Subcommittee (Central Committee for Hospital Medical Services), 2 p.m. 6 Sun. National Conference of Hospital Medical Staffs (Rupert Beckett Lecture Theatre, Universitv of Leeds), 2.30 p.m. 7 Mon. to Annual Representative Meeting (ReI1 Fri. fertory, University of Leeds). 9 Wed. and Annual Scientific Meeting (Rupert Beckett 10 Thurs. Lecture Theatre, University of Leeds). 22 Tues. Joint Consultants Committee (at Royal College of Obstetricians and Gynaecologists, London NW1). 3 Thurs.

3 Thurs.

UNIERSI IESAND COLLEGES ABERDEEN

Chemical Society.-Symposium "Heavy Metals The title of reader in community medicine has been as Environmental Hazards," 28-30 July, Bristol. conferred on Dr. George Innes in respect of his post. title of reader in medicine has been conferred Details from Education Officer, Burlington House, onThe Dr. Derek Ogston in respect of his post. OBN. London W1V (Tel. 01-734 9971). Unit Neurobiology Developmental M.R.C. Workshop on Prolactin.-24-25 August, 1975, CAMBRIDGE The Medical Research Council has set up Amsterdam, satellite symposium of Xth Acta At ceremony held on 5 June the titular degree of D.Sc. a new unit for developmental neurobiology Endocrinologica Congress. Details from H. G. wasa conferred on Mr. G. K. McKee, C.B.E., clinical research orthopaedic surgeon (joint replacement under the direction of Dr. Robert Balazs. Kwa, Netherlands Cancer Institute, Plesmanlaan surgery), East Anglian Regional Health Authority. The work of the unit will fall into two main 121, Amsterdam, Netherlands. areas: it will apply biochemical, morphological, 5th Australian General Practitioners' Con- LIVERPOOL and behavioural techniques to the study of vention and 2nd Joint Conference of the normal growth and maturation of the central Colleges of General Practitioners of Australia, Appointments.-Mr. A. Cuschieri (reader in surgery). nervous system in experimental animals and Singapore, Malaysia, and New Zealand.- LONDON man; and it will investigate the effect of 25-29 August, Sydney. Details from the convention metabolic factors, including hormones, nutri- manager, P.O. Box 45N, Grosvenor Street, Sydney, M.D.-R. S. Elkeles. tion, and drugs on the development of the N.S.W. 2000, Australia. ROYAL COLLEGE OF SURGEONS OF ENGLAND brain. Temporarily, the unit is housed in the European Dialysis and Transplant Associa- At the ordinary meeting of the council held in May, with M.R.C.'s laboratories at Carshalton, Surrey, tion.-Congress, 26-29 August, Copenhagen. Sir Rodney Smith, president, in the chair, Sir Stanley Clayton was elected to serve on council as the co-opted but by 1977 it will probably transfer to the Details from E.D.T.A. Congress, DIS-Congress representative of obstetrics and gynaecology. Institute of Neurology in London, where, it is Service, Knabrostraede 3, DK-1210 Copenhagen Mr. Jeffery Attale has been elected to the board of of dental faculty surgery. Denmark. K, hoped, close academic and clinical links will Dr. Victor Goodhill is Joseph Toynbee Memorial develop with that establishment and with the 10th Acta Endocrinologica Congress.-26-29 Lecturer for 1976. Mr. N. A. Olbourne been awarded a Sir Alexander Institute of Child Health. August, Amsterdam. Details from the secretariat MacCormick fellowship.has Hallett Prizes were awarded to Dr. S.H.H.A. Galal of the congress, Department of Pharmacology, Free University Medical Faculty, Van der and Dr. R. R. Morcos of Cairo and Dr. M. M. Hussein Boechorststraat 7, Amsterdam-1011, Netherlands. of Khartoum. British Migraine Association Essay

Competition The British Migraine Association is providing SOCIETIES AND LECTURES prizes of £100, £50, and £25 for the best essays on "Migraine in Childhood." All For attending lectures marked 0 a fee is charged or a ticker is required. Applications should be members of the medical profession including made first to the institution concerned. those in preregistration year are eligible to participate. Entries should be typed on one Monday, 30 June side of the paper only and two clear copies ROYAL COLLEGE OF SURGEONS OF ENGLAND.-5 p.m., meeting to commemorate tihe life and work of the late sent to Mr. Peter Wilson, Secretary, British Norman Capener. Migraine Association, Evergreen, Ottermead Lane, Ottershaw, Chertsey, Surrey KT16 Tuesday, 1 July OJH, to arrive not later than 1 September BIRMINGHAM MEDICAL INSTITUTE SESSION OF PSYCHIATRY.-7 p.m., Professor F. J. Gillingham: 1975. Psychiatric Education. Wednesday, 2 July ROYAL POSTGRADUATE MEDICAL SCHOOL.-2 p.m., B.M.A. Awards Professor I. Doniach: The Pancreas in Diabetes. The British Medical Association is inviting Thursday, 3 July applications from medical practitioners for ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE.the T.V. James Fellowship, the Edith Walsh 6 p.m., Dr. S. S. Hakimn: Argemo;ve mexicana toxicity in cooking oils. Research Award, and a number of prizes. For further details see p. xix, 14 June. Friday, 4 July

ROYAL FREE HosPITAL-12.30, Dr. H. L. Sharp (U.S.A.): Decreased Intrahepatic Bile Ducts in Paediatrics. 2 p.m., immunology seminar, Professor K. H. Meyer zum Buchenfelde (Germany).

Private Hospital Provision Private Patients Plan has agreed to provide substantial-sums to help the Nuffield Nursing B.M.A. NOTICES Homes Trust in its expansion programme. This will ensure the future of private treatment and reaffirm the confidence which both organ- Diary of Central Meetings izations have in the future growth of private JUNE practice in Great Britain. N.N.H.T., which is Diseases of the Chest Group, Wolfson a charity sponsored in 1957 by B.U.P.A., has 27 Fri. Hall, Churchill College, Cambridge, already built 24 independent hospitals through4.30 p.m.

Corrections Antituberculous Drugs and the Liver In the leading article on this subject (7 June, p. 522) reference 2 should read "Smith, J. P., and Sharer, L., Annals of Internal Medicine, 1969, 71, 1113." Tolamolol in Treatment of Angina Pectoris We regret that a typographical error occurred in the letter from Dr. S. Oram and others (28 June, p. 686). In the penultimate line the word "advisers" should read "adviser"-referring to Dr. Good and not to the authors of the letter. Notice to Authors When original articles and letters for publication are not submitted exclusively to the British Medical Journal this must be stated. Correspondence on editorial business should be addressed to the Editor, British Medical Jrournal, B.M.A. House, Tavistock Square, London WC1H 9JR. Telephone: 01-387 4499. Telegrams: Aitiology, London, W.C.1. Authors wanting reprints of their articles should notify the Publishing Manager, B.M.A. House, Tavistock Square, WC1H 9JR, on receipt of proofs. (C British Medical Journal 1975 All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the British Medical Journal.

Patents, injunctions, and sutures.

BRITISH MEDICAL JOURNAL 28 JUNE 1975 759 NEWS AND NOTES MEDICOLEGAL Patents, Injunctions, and Sutures FROM OUR LEGAL CORRESPONDENT In deciding to...
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