Center for Advanced Study & Research on Intellectual Property

 

CASRIP Newsletter - Spring/Summer 1997, Volume 4, Issue 2

Highly Anticipated UK Decision of Biogen v. Medeva about Validity of BiotechnologyPatents

On October 31, 1996, the House of Lords handed down a long-awaiteddecision regarding the patentability of a biotechnology invention in Biogen v. Medeva.1 Because the unanimous decision revoking the patent is the firstconsideration by the House of Lords of a genetically engineered product, it willsignificantly impact the validity of biotechnology patents in the futures. Particularly,its approach to the assessment of broad claims will be of immense significance.

This landmark decision was an appeal from the October 27, 1994 Court ofAppeal Decision2 which held that Biogen’s patent wasinvalid due to insufficiency, obviousness and failure to pertain to an"invention." Although the House of Lords upheld the Court of Appeal’sjudgment, it followed a significantly different route and sharply disagreed with variousaspects of the Court of Appeals’ decision.

Instead the House of Lords reinstated the trial judge’s finding offact and admonished the Court of Appeal to exercise appellate caution in reversing thetrial judge’s evaluation of the facts, as even the most specific findings of factwere inherently an incomplete statement of the impression which was made upon the judge bythe primary evidence. The House of Lords’ opinion, delivered by Lord Hoffmann,embraced a clear and well reasoned analysis, which carefully balanced the interests of thepatentee against those of the public.

In addition, the House of Lords’ decision is worthy of praisebecause it reflects the global convergence of patent law and the corresponding awarenessof foreign patent doctrine (Lord Hoffmann cites Professor Chisum’s treatise, as wellas Merges’ and Nelson’s influential article on patent scope) by investing thedecisions of the EPO with considerable persuasive authority in accordance with therequirements of Section 91(1)3 and 130(7).4

Biogen v. Medeva concerned Biogen Inc.’s patent relating tothe exploitation of Hepatitis B virus (HBV) using recombinant DNA (rDNA) technology. Thepatent was based upon experimental work done in 1978 by Professor Sir Kenneth Murray ofEdinburgh University. At that time, recombinant DNA technology was in its promisinginfancy. In February of that year, Professor Murray and a number of other molecularbiologists of international repute founded Biogen, Inc. to exploit the new recombinant DNAtechnology for commercial purposes. One of the first projects undertaken by the companywas the production of antigens of HBV. Professor Murray began work in the spring of thatyear and in November, reported that he had produced two of the known HBV antigens incolonies of cultured bacteria.

On December 22, 1978, Biogen filed a UK patent application (hereinafterreferred to as "Biogen 1") based on Professor Murray’s work. The UKapplication formed the basis for a priority claim for a later application filed at theEuropean Patent Office (EPO) on December 21, 1979 (EP B-1 182 442). The European patentwas finally granted on July 11, 1990. Subsequently, it was subject to an extensiveopposition action, which was dismissed on appeal by the EPO on July 28, 19945, the last day of the Court of Appeal hearing.

At the time of filing the first patent application, the genome for HBVhad not been sequenced. However, many details of HBV had been ascertained during the1970s. In 1970, the infective agent of Hepatitis B was discovered. This so-called"Dane particle" appeared to include a circular molecule of DNA in a protein coreand to be surrounded by a protein surface. Correspondingly, it seemed to have at least twoantigens, one at the core (HBcAg) and one at the surface (HBsAg). One way to obtain theseantigens was to purify them from the Dane particles taken from the blood of peopleinfected with the virus. But there were concerns about the safety of such derived vaccinesand supplies were obviously limited by the number of donors. Alternatively, antigens couldbe made artificially by chemical synthesis, but this required knowledge of the sequenceand structure of the amino acids. However, in 1978 little was known about them.

A promising third approach was recombinant DNA technology. At theclaimed priority date, two experimental rDNA strategies were available. One way was tosequence the HBV genome, i.e. to identify the order of each base of the viral DNAmolecule. A second, high-risk strategy involved randomly cutting the HBV DNA into largefragments and to then clone and express them. Biogen chose the latter "shotgun"approach. Contrary to any expectations, the technique had been successful. However, sixmonths after filing Biogen 1 and three months before EP ‘442, the genome wassequenced by researchers at the University of California at San Francisco. Biogentherefore conceded that the claimed invention was obvious at the filing date of EP‘442. It was thus vital for Biogen to convince the court that Biogen 1 indeedsupported the invention in the later EP ‘442.

In 1992, Biogen instigated infringement proceedings against therespondent, MedevaPLC, which was proposing to market what it described as athird-generation Hepatitis B vaccine (HEPAGENE) made by rDNA technology in colonies ofmammalian cells. Medeva counterclaimed, alleging that the Biogen patent was invalid underthe UK Patents Act on four grounds: (1) lack of invention under sec. 1(1)6; (2) lack of inventive step under sec. 1(1)(b) and 3; (3)nonentitlement to the priority date of Biogen 1, because it did not support the claimedinvention under section 5(2)(a); (4) insufficient description in the specification undersec. 72(1)(c).

The principal claim for the appeal concerned a product claim in whichthe molecule was identified partly by the way in which it had been made (rDNA techniques)and partly by the way it was expressed to produce HBV antigens.7Subsequent claims, based on the principal claim, covered both the distinct HBV"surface" and "core" antigens and their expression in bacterial, yeastand mammalian host cells.8

In addressing whether the Biogen claims constituted an"invention" as required by sec. 1(1), Lord Hoffmann rejected the approach of theCourt of Appeal, which first required an examination of whether or not the claimsconstituted an invention before assessing whether the requirements for patentability hadbeen satisfied. He reasoned that such an approach would cause unnecessary difficulty andwould almost invariably be academic. Recognizing that the four conditions of patentabilityin section 1(1) not only restrict the class of inventions which may be patented but alsocomprise every element of the concept of invention in ordinary speech, Lord Hoffmannrecommended that courts first consider the conditions for patentability such as novelty,inventiveness, industrial application, as well as the excluded categories, before tacklingthe question of whether the claims satisfy the definition of invention.

A caveat was voiced in a short opinion by Lord Mustill, who had been amember of the Court of Appeal in the infamous Genentech v. Wellcome9decision. Though he agreed with Lord Hoffmann that in the great majority of cases therewould be no need to complicate the enquiry by looking outside the conditions ofpatentability, he espoused that some instances may require a closer conceptual analysis.Apparently, he continued to entertain the same concern expressed in Genentech: thatproducts, such as proteins existing in nature, ought not to be granted patent protection.

With regard to inventive step, he sidestepped the ultimate issue byaccepting the judgment of the first instance court on this point. Perhaps the mostinteresting comment on inventive step was Lord Hoffmann’s acknowledgment thatcommercial reasoning in itself could not justify lack of inventive step. Previously, theCourt of Appeal had determined that Professor Murray’s "shotgun" approachlacked an inventive step because it was "a mere commercial decision" and "amatter of business judgment." This pronouncement distressed the patent andbiotechnology community at the time, and many thought it heralded disaster for theresearch and development programs of biotechnology companies, since any decision to pursuethe expression of a particular gene and the recombinant production of a particular proteinwas commenced after precise calculation of the potential payoff.

However, as the House of Lords correctly observed, a given experimentalstrategy is usually adopted for commercial reasons because the anticipated rewards seemedto justify the necessary expenditure. Therefore, commercial reasoning in itself should notjustify lack of inventive step. Moreover, as Lord Hoffmann correctly concluded, it runscounter to the very function of inventive step to suggest that an inventor needs to pursuehis experiments untouched by thoughts of gain. Indeed, the sole question is whether therewas an inventive step, irrespective of the inventor’s reasons for pursuing therespective invention.

The crux of the decision hinged on whether Biogen 1 supported theinvention claimed in EP ‘442, as the House of Lords assumed that the invention wasnot obvious at its first priority date. In reference to the earlier House of Lordsdecision in Asahi Kasei Kogyo KK’s Application10,Lord Hoffmann explained that for matter to support an invention under sec. 5(2)(a) of thePatent Act of 1977, it must disclose the invention in a manner which enables it to beperformed by a person skilled in the art. The same principle applies to the relationshipbetween sec. 14(3) and 14(5)(c). That is, a description does not "support" theclaims for the purpose of sec. 14(5)(c), unless it contained sufficient material toqualify the specification as an "enabling disclosure" within the meaning of sec.14(3).

This correspondence between these two patent principles resolves theproblem that has irked the British patent community since the inception of the 1977 PatentAct, namely that lack of support or "fair basis," as it was previously called,was not a separate ground of revocation11. The substantiveeffect of section 14(5)(c), that the description should, together with the rest of thespecification, constitute an enabling disclosure, is given effect by sec. 72(1)(c).Accordingly, Lord Hoffmann held "enabling disclosure" to be central to the lawof patents, as the underlying concept relates to sec. 5(2)(a), 14 and 72(1)(c).

He then considered the meaning of the concept of enabling disclosure.He referred to the Technical Board of Appeal decision in GENENTECH I/PolypeptideExpression,12 which has, on numerous occasions, beenmisinterpreted as supporting the proposition that one example of, or one way of carryingout, the invention is sufficient to meet the disclosure requirement of Art. 83 EPC. LordHoffmann rectified this misconstruction by indicating that the applicants had invented ageneral principle and was therefore entitled to claims in general terms.

He asserted that the Board in GENENTECH I/Polypeptide Expressionhad done no more than apply a principle long established in British patent law, namely,that a specification must enable the invention to be performed to the full extent of themonopoly claimed. This was affirmed several times by the Technical Boards of Appeal,particularly in EXXON/Fuel Oils13. Some see thelatter decision as reversing the liberal trend set in GENENTECH I.

However, as Lord Hoffmann pointed out, these decisions are notinconsistent but are actually easily reconcilable on their respective facts. Both endorsethe general legal principle that the extent of the patent monopoly, as defined by theclaims, should correspond to the technical contribution to the art in order for it to besupported, or justified.

According to this postulate, if the invention discloses a principlecapable of general application, the claim may be in correspondingly general terms. In thatcase, the patentee need not show that he has proved its application in every individualinstance. On the other hand, if the claims include a number of discrete methods orproducts, the patentee must enable the invention to be performed in respect of each ofthem.

Thus if the patentee has hit upon a new product which has a beneficialeffect but cannot demonstrate that there is a common principle by which that effect willbe shared by other products of the same class, he will be entitled to a patent for thatproduct but not for the class, even though some may subsequently turn out to have the samebeneficial effect. On the other hand, if he disclosed a beneficial property which iscommon to the class, he will be entitled to a patent for all products of that class eventhough he has not himself made more than one or two of them.

But the fact that the skilled man following the teaching of Biogen 1would have been able to make HBcAg and HBsAg in any cell does not conclude the matter. Thecritical issue in this case is not whether Professor Murray’s invention could deliverthe goods across the full width of the patent or priority document, but whether the claimscovered other ways in which they might have been delivered: ways which owe nothing to theteaching of the patent or any principle disclosed. The breadth of claim may thus exceedthe technical contribution to the art, not only by the results which it does not enable,but also by claiming ways of achieving a result, when it enables only one way.

In that context, the House of Lords cited the famous US Supreme Courtdecision in O’Reilly v. Morse14 as an example ofa case concerning excessively broad patents. To elucidate the significance of this case,Lord Hoffmann cited Professor Chisum’s Treatise: "Before Morse’s invention,the scientific community saw the possibility of achieving communication by the‘galvanic’ current but did not know any means of achieving that result. Morsediscovered one means and attempted to claim all others."15

In a similar vein, Lord Hoffmann held the patent in suit to be toobroad. Its excessive breadth was due, not to the inability of the teaching to produce allthe promised results, but to the fact that the same results could be produced by differentmeans. Despite Professor Murray’s brilliant Napoleonic victory in cutting through theuncertainties which existed in his day to achieve the desired result, his success did notestablish any new principle which his successors had to follow if they were to achieve thesame results. Once the DNA had been sequenced, none would choose the restriction enzymesProfessor Murray had employed.

Similarly, it was not enough that Professor Murray had shown by hisinvention that it could in fact be done, and that this would provide those who followed bydifferent routes with greater confidence. To grant a monopoly to the first person who hasfound a way of achieving an obviously desirable goal for every way of doing so would, inthe words of Merges and Nelson16, stifle further researchand healthy competition in the post grant phase.

Lord Hoffmann was aware of the fact that the patent in suit hadsurvived an opposition before a Specialist Technical Board of Appeals of the EPO. Similarto his earlier leading judgment in Merrell Dow Pharmaceuticals Inc. v. H.N. Norton& Co. Ltd.17, he took pains to emphasize theconsiderable persuasive authority of EPO decisions. He distinguished the contrary judgmentof the Technical Boards of Appeal on the ground that it directed its attention solely tothe question of whether the teaching in Biogen 1 would enable the man skilled in the artto achieve expression of HBsAg as well as HBcAg. It did not concern itself with the issuewhether the claims were too broad because expression could also be achieved without theuse of the teaching which it contained. This same principle was also clearly stated in GENENTECHI and EXXON so that in Lord Hoffmann’s opinion no divergence between thejurisprudence of this court and that of the EPO is suggested.

Although the statements on insufficiency are strictly obiter, asthe House had already concluded that the patent was not entitled to an earlier prioritydate and therefore obvious, Lord Hoffmann pointed out that the same reasoning applied inrelation to support would also lead to the conclusion that it was insufficient. In thiscontext, he referred to the vexed question of the date on which the specification mustdisclose the invention, so as to enable a person skilled in the art to perform it. In thelower courts there had been a conflict as to whether the relevant date was the date ofpublication or application. On this issue the House of Lords sided with the Court ofAppeal and held the date of application to be relevant. Lord Hoffmann reasoned that itwould be illogical if a patent which ought to have been rejected under section 14(3) isrendered immune from revocation under sec. 72(1)(c) by intervening advances in the art. Aninsufficient application cannot become sufficient in light of developments in the state ofthe art after the filing date.

The primary significance of the House of Lords decision is founded onproviding a mode for reasserting the need for congruence between patent scope and thedisclosed contribution to the art. Lord Hoffmann thereby astutely affirmed the timehonored patent law principle that the effective disclosure is the quid pro quo forthe grant of a patent. By the same token, the House of Lords has shown a way how torectify the current imbalance in Europe between the conditions of grant, which include thedescription’s support of the claims, and the grounds of revocation. Under the guiseof insufficient disclosure, the House of Lords has introduced the patent law principle of"lack of support" as a ground of revocation, whereby the claims of a completespecification may not extend beyond what the patentee disclosed as his invention.

-- Michael Kern


1[1997] RPC 1.
2Biogen v. Medeva, [1995] FSR 4;[1995] RPC 25.
3According to sec. 91(1), judicialnotice shall be taken among others of the EPC and any decisions of, or expression ofopinion by, the relevant Convention court on any question arising under or in connectionwith the relevant Convention.
4Sec. 130(7) declares that varioussections, including sec. 1(1) to (4), 2 to 6, 14(3), (5) and 72(1) and (2) are so framedas to have, as nearly as practicable, the same effects in the United Kingdom as thecorresponding provisions of the EPC.
5T296/93, [1995] EPOR 1 –"BIOGEN/HBV antigen production."
6This ground of revocation waslater dropped by Medeva. Nonetheless, the House of Lords addressed the issue.
7Claim 1 read as follows:

  1. A recombinant DNA molecule characterized by a DNA sequence coding for a polypeptide or a fragment thereof displaying HBV antigen specificity, said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule and being expressed to produce a polypeptide displaying HBV antigen specificity when a suitable host cell transformed with said recombinant DNA molecule is cultured, the transformed host cell not producing any human serum proteins and any primate serum proteins other than the polypeptide displaying HBV antigen specificity.


8Claims 2 to 4 are based uponclaim 1 and state:

    1. A polypeptide free of any humThe recombinant DNA molecule according to claim 1, characterized in that the polypeptide displaying HBV antigen specificity also displays HBV antigenicity.
    2. The recombinant DNA molecule according to claim 1 or 2, characterized in that the DNA sequence codes for a polypeptide or a fragment thereof displaying the HBV antigen specificity of a hepatitis B virus core antigen.
    3. The recombinant DNA molecule according to claim 1 or 2, characterized in that the DNA sequence codes for a polypeptide or a fragment thereof displaying the HBV antigen specificity of a hepatitis B virus surface antigen.
    4. an serum proteins and any primate serum proteins which displays HBV antigen specificity, said polypeptide being produced by a host cell transformed with a recombinant DNA molecule according to claim 1 or 2.


9[1989] RPC 147.
10[1991] RPC 445, 24 IIC 247[1993}.
11Similarly, the EPC does notprovide for a ground of opposition that corresponds to the application requirement of"support" under Art. 84.
12T 292/85, [1989] O.J. EPO 275.
13T 409/91, [1994] O.J. EPO 653.
1456 U.S. (15 How.) 62 (1854).
15Vol. 1, § 1.03[2]. See alsoVol. 2, § 7.03[1].
16Robert Merges and RichardNelson, On the Complex Economics of Patent Scope, 90 Colum. L. Rev. 839 (1990).
17[1996] RPC 76, 82.

Last updated 4/27/2012