The drug sold under this patent called Cipralex is boasted as being the top selling antidepressant in terms of volume in the world. Citalopram is sold in the United Kingdom under the brand name Cipramil; other serotonin inhibitors are fluoxetine sold as Prozac and paroxetine Seroxat. Since the expiry of the Citalopram patent, the drug has been sold by a number of manufacturers in its generic form. Citalopram is a racemate, consisting of equal numbers of two molecules called enantiomers. In brief, an enantiomer is a molecule that cannot be mapped to its mirror image by rotations and translations alone.
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See more information Biogen Inc v. Medeva Plc 1. I have had the advantage of reading in draft the speech prepared by my noble and learned friend Lord Hoffmann. For the reasons he gives I would dismiss the appeal.
I wish to express the gratitude of the Appellate Committee to our two expert advisers, Professor D. Glover of the University of Dundee and Professor J. Neil of the University of Glasgow, who provided the Committee with invaluable assistance both before and during the hearing.
For the reasons given in the speech prepared by my noble and learned friend Lord Hoffmann I too would dismiss the appeal. I have had the opportunity to read in draft the speech of my noble and learned friend Lord Hoffmann, and agree both with the conclusion that the appeal should be dismissed and with the reasons for that conclusion.
In particular I am glad to adopt the proposed reconciliation of sections 14 5 and 72 1 of the Patents Act , which eliminates a difficulty expressed by the Court of Appeal in Genentech Inc. There is however one matter which I should mention: namely, the necessity or otherwise for a valid patent to concern an invention, as well as satisfying the conditions expressed in paragraphs a to b of Section 1 1 of the Act.
This question was not contested before the House, although some reference was made to it in debate, for it was agreed rightly in my opinion that it has no bearing on the present appeal. My reason for referring to it is simply to make clear that in concurring with all your Lordships in the reasons for dismissing the appeal I should not be taken to accept, without full argument, that the need for an invention would always be academic, or that no such need is expressed by the words of section 1 1 : nor indeed do I understand my noble and learned friend as advancing any conclusion to that effect.
Certainly, in the great majority of cases, there will be no need to complicate the enquiry by looking outside the four conditions. The traditional law of patents is, however, in the course of adapting itself to new technologies, beyond contemplation when the foundations of that law were established.
This process is not without strain, and I believe that in some instances a close conceptual analysis of the nature of patentability will not be a waste of time. Such a case was Genentech Inc. There may well be others in the future. My Lords, my purpose in adding this footnote to the speech of my noble and learned friend is not of course to express any opinion, one way or the other, on the correctness of the reasoning outlined at pp.
The intention is only to emphasise that when a dispute does arise on which this question may have a bearing it will merit study leading to a definitive answer. For the reasons he gives I too would dismiss the appeal. Genetic Engineering. This is a technology which has developed only during the last 25 years, in consequence of the great advances which have been made in our knowledge of the genetic code contained in every living cell.
The code is embodied in a molecule of deoxyribonucleic acid "DNA" which directs the cell to make the proteins which the organism requires. Genetic engineering or "recombinant DNA technology" consists of altering the DNA of a suitable cell so that it produces a protein which in nature occurs in another organism. In this way it has been possible to manufacture products of great medical importance which could not have been made by orthodox chemical synthesis.
The patent in suit. The principal claim of the patent in suit is for an artificially constructed molecule of DNA carrying a genetic code which, when introduced into a suitable host cell, will cause that cell to make antigens of the virus hepatitis B "HBV".
I shall have to describe in much greater detail what antigens are and how the invention enables them to be made. Suffice it for the moment to say that HBV is a widespread human virus, often causing fatal diseases of the liver, and that its antigens can be used both to test for whether someone has the virus and to make a vaccine which can give immunity against infection.
Biogen and Professor Murray. Recombinant DNA technology was then in its promising infancy. In February Professor Murray and a number of other molecular biologists of international repute, together with financial backers, met in Geneva and decided to found Biogen Inc, the patentee company "Biogen" , for the purpose of exploiting the technology for commercial purposes.
One of the first projects upon which they agreed was to try to make the antigens of HBV. Professor Murray began work in the spring of that year and in November reported that he had produced two of the known HBV antigens in colonies of cultured bacteria. History of the proceedings and legal issues. On 22 December Biogen filed a U. This application, known in the proceedings as "Biogen 1" forms the basis of a claim to priority in respect of a later application filed with the European Patent Office "EPO" in Munich on 21 December Meanwhile, in Biogen began infringement proceedings against the respondent, Medeva plc, which was proposing to market what it described as a third-generation hepatitis B vaccine made by recombinant DNA technology in colonies of mammalian cells.
Medeva counterclaimed for revocation. It alleged that the patent was invalid on a number of grounds. I shall briefly mention those which are still relied upon without at this stage making any comment or doing more than to refer to the sections of the Patents Act on which the objections are based.
They are, first, that the claimed invention was obvious sections l l b and 3 , both at the date of application for the patent in suit and at the date of Biogen 1. Secondly, that Biogen was not entitled to the priority date of Biogen 1 because it did not "support" the invention claimed in the patent section 5 2 a. Thirdly, that the claimed invention was not an invention section 1 1 , and fourthly, that the description in the specification was insufficient section 72 l c.
Biogen concedes that the claimed invention was obvious at the date when the application for the European patent was filed but not that it was on the date of Biogen 1. Aldous J. He dismissed all the objections and held the patent valid and infringed. Hobhouse L. He held that Biogen 1 did not support the claimed invention and that in any case it was obvious at the earlier date.
He also held the description in the specification to be insufficient. The state of the art in In this appeal much turns upon identifying the inventive step, if any, in what Professor Murray did. It does not however follow that he was inventive.
The technology was developing very fast and recent developments might have made its use for that purpose obvious. Even if it was not, it does not follow that "making HBV antigens by recombinant DNA technology" would be the right way to describe his inventive step.
Whenever anything inventive is done for the first time it is the result of the addition of a new idea to the existing stock of knowledge. Sometimes, it is the idea of using established techniques to do something which no one had previously thought of doing. In that case, the inventive idea will be doing the new thing. Sometimes, it is finding a way of doing something which people had wanted to do but could not think how. The inventive idea would be the way of achieving the goal.
In yet other cases, many people may have a general idea of how they might achieve a goal but not know how to solve a particular problem which stands in their way. If someone devises a way of solving the problem, his inventive step will be that solution, but not the goal itself or the general method of achieving it. To discover precisely what constituted the inventive step, one must therefore examine the state of the art of molecular biology in Would it have been a new idea to think of making HBV antigens at all?
Or would that have been a goal which people had thought about but did not know how to achieve? If the latter, would it have been inventive to think in general terms of using recombinant DNA technology? Or would that also have been something which many molecular biologists would have wanted to do if only they could think of how to overcome particular difficulties which stood in their way? To answer these questions, I must try to describe, as briefly as the nature of the subject will permit, what was the state of knowledge in December , firstly, about the DNA of HBV, and, secondly, about the techniques of recombinant DNA technology.
Both branches of knowledge were then advancing at a considerable pace. It is not altogether easy to present a snapshot of the state of the art on the precise date when Biogen 1 was filed. As one would expect, some of the expert witnesses at the trial thought that the next steps were clear and obvious and others thought that they were difficult and doubtful.
The judge made findings of fact on these questions to which I shall in due course return. For the moment, I can confine myself to matters which were not in dispute. A paper published in by D. Dane and others Lancet, i, had made the suggestion, which by was generally accepted, that the infective agent of hepatitis B was a certain particle about 42 nanometres in diameter which had been found in the blood of infected people. A nanosecond is to a second what a second is to 30 years.
The "Dane particle" appeared to include a circular molecule of DNA in a protein core and to be surrounded by a protein surface. Proteins are complex molecules their main elements are carbon, hydrogen, oxygen and nitrogen formed from chains of amino acids linked to each other by peptide bonds hence also known as "polypeptides" and folded into three-dimensional structures. There are twenty different amino acids and the order of amino acids in the chain will determine the geometric shape and chemical characteristics of the polypeptide.
The chemical structure of a viral protein may enable it to recognise a complementary structure on the surface of a suitable cell in its host organism, attach itself to that cell, introduce its own genetic material and thereby use the resources of the host cell to replicate itself. But similar processes of recognition may stimulate the immune system of the host organism to produce "antibodies," proteins which attach themselves to the virus and render it noninfectious.
The proteins in the virus which cause the production of antibodies are called "antigens. The relationship between antibody and antigen provides the means of both diagnosing and vaccinating against infection by the virus. If a patient has been infected with the virus, his blood will contain the corresponding antibodies. This will indicate prior infection. A polypeptide which, by reason of having the right epitope, complements a particular antigen is said to display "antigen specificity" in respect of that antigen.
Antigens can also be used for vaccination because once the immune system has been exposed to the antigen it will produce the relevant antibodies. Upon subsequent challenge by the antigen, it will produce the same antibodies much more quickly and copiously.
A polypeptide which causes the immune system to produce an antibody is said to display "antigenicity. Thus the immune response will prevent or reduce the severity of infection on a subsequent exposure to the virus. The Dane particle appeared to have at least two antigens, one at its core hepatitis B core antigen or HBcAg and one upon its surface hepatitis B surface antigen or HBsAg.
One way to obtain these antigens was to purify them from Dane particles taken from the blood of people infected by the virus. This had been done with some success. But there were concerns about the safety of such vaccines and supplies were limited by the number of donors. They could not be greatly enhanced by using infected laboratory animals because the virus infects only human beings and a few higher primates like chimpanzees.
Another theoretical possibility was to make the antigens artificially by orthodox chemical synthesis. But this required knowledge of the sequence and structure of the amino acids.
Sufficiency: when is a product a product - Biogen v Medeva revisited?
As such, an appellate court should be reluctant to disturb it. If it was so obvious, the patent was invalid. Cited — Benmax v Austin Motor Co Ltd HL  AC , 72 RPC 39 Except for cases which are expressly limited to questions of law, an appellant is entitled to appeal from the Court of Session to the House against any finding, whether it be a finding of law, a finding of fact or a finding involving both law and. Held: On the assumed facts that there had been a prior disclosure of the same invention neither the disclosed information nor common. Held: There was material before the judge on which he could properly conclude as he did on the presence of common. Held: The appeal failed Majority decision.
Biogen Inc v. Medeva Plc
Please sign up to view Summary. Biogen Inc v. Medeva Honble Shri S. Chandrasekaran, Technical Member: This is an original application for revocation filed under section 64 read with section D of the Patents Act herein after referred to as the Act for revoking the patent No. Germany applied for the revocation of the Patent on the following grounds.
Biogen v. medeva — the highest court in the UK delivers judgement