Intellectual Property - More Materials

Patent law, copyright law, trademark law - more course materials follow.

The Biotechnology Directive
To what extent can it be argued that the law relating to the patenting of biotechnological inventions has been clarified as a result of the Biotechnology Directive?

The Biotechnology Directive provides in pertinent part:

Article 3

1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.

2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

Article 5

1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene cannot constitute patentable inventions.

2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Article 5

1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene cannot constitute patentable inventions.

2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

European patent attorneys comment:

   "These Articles were drafted to clarify the distinction between a discovery and an invention in relation to biological material. This issue was debated before the Opposition Division of the EPO in the Howard Florey/Relaxin case in which the Opposition Division re-emphasised the long-standing practice of the EPO that “To find a substance freely occurring is (also) a mere discovery and therefore unpatentable. However, if a substance found in nature has first to be isolated from its surroundings and a process for obtaining it is developed, that process is patentable. Moreover, if the substance can be properly characterised either by its structure, by the process by which it is obtained or by other parameters and it is “new” in the absolute sense of having no previously recognised existence, then the substance per se may be patentable” (Part C, Chapter IV.2, Guidelines for Examination in the EPO). Thus, although the provisions of Articles 3, 5(1) and 5(2) do not presently have direct equivalents in the articles of the EPC they essentially confirm the established practice of the EPO of not excluding from patentability inventions which concern biological material providing they satisfy the usual criteria for patentability."

Critically in response to the above question: "...under the EPC. Indeed the EPO has to date already granted more than 3000 patents for biotechnological inventions which fall within the scope of the Directive."

Another important component of the Directive involves the exclusions from patentability. The Directive Provides:

Article 4

1. The following shall not be patentable:

(a) plant and animal varieties;

(b) essentially biological processes for the production of plants or animals.

2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.

3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process.

Article 6

1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following in particular, shall be considered unpatentable:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

Article 53 EPC

European patents shall not be granted in respect of:

(a) inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.

This langauge "essentially restates the existing provisions of Article 53 of the EPC in respect of exceptions to patentability. However it does include some subtle differences and sets out to provide some clarification of the meanings of these exclusions which have resulted in much uncertainty in practice under the EPC." These are, in a nutshell: "The end result of the decisions reached in the Oncomouse and Plant Genetic Systems cases was that it appeared to be possible to obtain broad claims to transgenic animals but not to transgenic plants. To resolve this apparent inconsistency the matter was referred to the highest authority of the EPO, the Enlarged Board of Appeal (G3/95, Plant Genetic Systems9). However, the referral failed on a technicality....s in the EPC, the Directive also excludes plant and animal varieties from patentability. However, by way of clarification, it goes on to say that “inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety”....Furthermore the painstaking care with which the Directive clarifies the meaning of “plant variety” indicates that the drafters of the Directive supported the approach taken prior to T356/93 and that their intention was to overturn the decision of T356/93 so as to re-enable the patenting of transgenic plants per se in the EU Member States."

Note that the Directive accomplishes other subtle clarifications of law as regards essentially biological and microbiological processes, morality and ordre public, and similar matters.

Further clarifying the above, Findlaw notes that the Directive is based on the following principles:

"- biotechnological inventions are of fundamental importance for the industrial development of the European Community,

- biotechnological advances require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable,

- effective and harmonised protection is essential in order to maintain and encourage investment in the field of biotechnology,

- differences could create barriers to trade and hence impede the proper functioning of the internal market; and

- research aimed at obtaining and isolating such elements valuable to medical production should be encouraged by means of the patent system."

According to the European Public Health Alliance, the Biotechnology Directive offers no definitive answer on some questions regarding patentability:

"The Biotechnology Directive (98/44/EC) obliged the Commission to report on the scope of patents on sequences of genes which have been isolated from the human body; and the patentability of human stem cells and cell lines obtained from them.

The Commission report states that:

* With regard to patents on gene sequences, the Commission will continue to monitor the economic consequences of the differing legisative environments in Member States;

* Totipotent stem cells (i.e; cells that are capable of developing into a human being) should not be patentable, on grounds of human dignity;

* Because of the divergence of laws and laws among Member States, the patentability of pluripotent stem cells (ie cells that can develop into other types of cells but not into a human being) cannot be solved and the Commission report considers that it is premature to come to a definitive conclusion on this issue."

Thus, the Biotechnology Directive both codifies and modifies prior law, and leaves several major legal issues unresolved.

Enabling Disclosure

The concept of an enabling disclosure was discussed in Synthon:

"Enablement means that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure. This requirement applies whether the disclosure is in matter which forms part of the state of the art by virtue of section 2(2) or, as in this case, section 2(3). The latter point was settled by the decision of this House in Asahi Kasei Kogyo KK's Application [1991] RPC 485."

In broader terms, enabling disclosure relates to several aspects of patent law. Notes the court in Synthon:

    "Asahi's case was decided on the assumed facts that there had been a prior disclosure of the same invention (a particular polypeptide) but that neither the disclosed information nor common general knowledge would have enabled the skilled man to make it. The House therefore did not have to consider the test for deciding what degree of knowledge, skill and perseverance the skilled man was assumed to have. But the concept of enablement is used in other contexts in the law of patents (see Biogen Inc v Medeva Plc [1997] RPC 1, 47) and in particular as a ground for the revocation of a patent under section 72(1)(c): "the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art"."

Let's review the statute before discussing the areas implicated.

UK Patents Act 1977

Patentability

1.- (1) A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say -

(a) the invention is new;
(b) it involves an inventive step;
(c) it is capable of industrial application;
(d) the grant of a patent for it is not excluded by subsections (2) and (3) below;

and references in this Act to a patentable invention shall be construed accordingly.

(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, that is to say, anything which consists of -

(a) a discovery, scientific theory or mathematical method;
(b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever;
(c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer;
(d) the presentation of information;

but the foregoing provision shall prevent anything from being treated as an invention for the purposes of this Act only to the extent that a patent or application for a patent relates to that thing as such.

(3) A patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality.

Novelty
Section 2: Novelty

2.-(1) An invention shall be taken to be new if it does not form part of the state of the art.

(2) The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way.
(3) The state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to comprise matter contained in an application for another patent which was published on or after the priority date of that invention, if the following conditions are satisfied, that is to say -

(a) that matter was contained in the application for that other patent both as filed and as published ; and
(b) the priority date of that matter is earlier than that of the invention....

Inventive step

3.- An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only ofsection 2(2) above (and disregarding section 2(3) above.

The basics of (a) inventive step, (b) novelty, and (c) being capable of industrial application are well-known.

An "enabling disclosure" is relevant in several respects:

(A) PATENT DESCRIPTION/SPECIFICATION
s. 14(3): "The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art." Under Biogen and Asahi, the enabling disclosure is critical to the specification.

s. 14(5)(c): "The claim or claims shall - be supported by the description." The desciption will not support the claim unless it contains sufficient material to enable the specification to constitute an enabling disclosure.

(B) PRIORITY

s. 5(1): "For the purposes of this Act the priority date of an invention to which an application for a patent relates and also of any matter (whether or not the same as the invention) contained in any such application is, except as provided by the following provisions of this Act, the date of filing the application."

s. 5(2): "If in or in connection with an application for a patent (the application in suit) a declaration is made, whether by the applicant or any predecessor in title of his, complying with the relevant requirements of rules and specifying one or more earlier relevant applications for the purposes of this section made by the applicant or a predecessor in title of his and the application in suit has a date of filing during the period allowed under subsection (2A)(a) or (b) below, then -

(a) if an invention to which the application in suit relates is supported by matter disclosed in the earlier relevant application or applications, the priority date of that invention shall instead of being the date of filing the application in suit be the date of filing the relevant application in which that matter was disclosed or, if it was disclosed in more than one relevant application, the earliest of them...."

For a matter to support an invention, it must disclose the invention in a manner which enables it to be performed by a person skilled in the art (Asahi/Biogen).

(C) Revocation

s. 72(1): "Subject to the following provisions of this Act, the Court or the Comptroller may by order revoke a patent for an invention on the application of any person (including the proprietor of the patent) on (but only on) any of the following grounds, that is to say ...

(c) the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art...."

Lord Hoffman in Biogen v. Medeva noted "the substantive effect of section 14(5)(c), namely that the description should, together with the rest of the specification, constitute an enabling disclosure, is given effect by section 72(1)(c)." This principle was reiterated in the case of Kirin-Amgen Inc. v Transkaryotic Therapies Inc. [2003] RPC 3.

(D) Validity

Enabling disclosure constitutes an implicit requirement for determining the state of the art for: (i) anticipation (s. 2(2) and (3), and (ii) inventive step (Synthon).

More on Biogen v. Medeva (cited above):

Notes specialist patent firm Jenkins:

    "In Biogen v Medeva [1997] R.P.C. 1, Biogen's patent for recombinant DNA coding for a polypeptide having hepatitis B virus (HBV) antigen specificity was held by the House of Lords in 1996 to be insufficiently enabled by its specification, not because of any inability for the described invention to deliver all the promised results, but because the same claimed results could be produced by different means which owe nothing to the teaching of the patent or any principle it disclosed. The Patents Court in Kirin-Amgen v Roche Diagnostics [2002] RPC1 referred to these two grounds for insufficiency in a patent as "classic insufficiency" and "Biogen insufficiency", but the Court of Appeal said that these are not different grounds for insufficiency. (Kirin-Amgen v Hoechst, 31 July 2002, unreported)."

In Biogen, Lord Hoffman wrote that: "the specification must enable the invention to be performed to the full extent of the monopoly claimed. If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved its application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them....There is more than one way in which the breadth of a claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention."

Jenkins explains:

 "In view of this, their Lordships revoked the patent under section 72(1)(c) as being insufficient because "the claims cover other ways in which [the goods] might be delivered: ways which owe nothing to the teaching of the patent or any principle which it disclosed" (page 50), i.e. due to the fact that the same result could be produced by different means (page 51).

    "Their Lordships likened the claimed invention to a famously overbroad claim of Samuel Morse to the use of electricity for "making or printing intelligible characters, signs or letters, at any distances". Morse had discovered one means of achieving communication by electric current but attempted to claim all others.

    "The metaphor used by one of the witnesses was that before the genome had been sequenced everyone was working in the dark. Professor Murray invented a way of working with the genome in the dark. But he did not switch on the light and once the light was on his method was no longer needed.

    "Accordingly, such over-broad claiming of a principle of general application without also disclosing a new and inventive principle of general application gives rise to a ground for revocation. The Patents Court in Kirin-Amgen chose to call this "Biogen insufficiency", until the Court of Appeal slapped down on coining separate terms for Lord Hoffman's two ennumerated "way(s) in which the breadth of a claim may exceed the technical contribution"."

The bottom line, according to Jenkins: " The effect of Biogen is not solely to expand the validity attack of insufficientcy to over-broad claims. The decision links the permissible breadth of a claim to the contribution the invention makes to the art. It recognizes that there are inventions that disclose a principle capable of general application and there are those that do not. The former are entitled to be claimed more broadly. An analysis of the scope of the technical contribution to the art must be the starting point for the analysis of sufficiency of disclosure."

To make sense of this, recall from Synthon BV (Appellants) v. Smithkline Beecham plc:

"Thus, in Merrell Dow, the ingestion of terfenadine by hay-fever sufferers, which was the subject of prior disclosure, necessarily entailed the making of the patented acid metabolite in their livers. It was therefore an anticipation of the acid metabolite, even though no one was aware that it was being made or even that it existed. But the infringement must be not merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. If there is more than one possible consequence, one cannot say that performing the disclosed invention will infringe. The flag has not been planted on the patented invention, although a person performing the invention disclosed by the prior art may carry it there by accident or (if he is aware of the patented invention) by design. Indeed, it may be obvious to do so. But the prior disclosure must be construed as it would have been understood by the skilled person at the date of the disclosure and not in the light of the subsequent patent....

"It is very important to keep in mind that disclosure and enablement are distinct concepts, each of which has to be satisfied and each of which has its own rules. As Laddie J said in relation to sufficiency in University of Southampton's Applications [2005] RPC 220, 236:

"In my view, devising an invention and providing enabling disclosure are two quite different things. Although both may be necessary to secure valid protection, as section 14 of the Act shows, they relate to different aspects of the law of patents. It is very possible to make a good invention but to lose one's patent for failure to make an enabling disclosure. The requirement to include an enabling disclosure is concerned with teaching the public how the invention works, not with devising the invention in the first place".

Applying the law to the facts, the Court in Synthon decided:

"(a) Disclosure

"Did the Synthon application disclose an invention which, if performed, would infringe the SB patent? Because it covered a class of chemicals defined by reference to a formula, it disclosed a myriad of compounds, each of which may be regarded as an invention. But that does not matter if one of those inventions was the crystalline PMS claimed in the patent.

"There seems to me no doubt that the application disclosed the existence of PMS crystals of 98% purity and claimed that they could be made. Whether in fact they could be made is the question of enablement which I shall come to in a moment. But their existence and their advantages for pharmaceutical use were clearly disclosed in the application. And on the basis of the judge's finding of monomorphism, a PMS crystal of 98% purity must necessarily have all the characteristics of the crystals claimed in the patent, including the IR and XRD spectra...

"(b) Enablement

"Once one has decided that the disclosure in the application was crystalline PMS and that the IR spectrum was superfluous and irrelevant, the question of enablement is whether the skilled person would have been able to make crystalline PMS. If he did, he would necessarily have made the product claimed in the patent. There is no dispute that the disclosure enabled him to make PMS. The issue is whether he would have been able to get it to crystallise. That is a question of fact...

"The main reasons for the Court of Appeal's rejection of the judge's finding of fact appear from para 56 of the judgment of Aldous LJ:

'The crucial question was not whether the skilled addressee would expect success, but whether the application made available PMS as claimed. There was no attempt to ask Mr Ward whether there were directions in the application which, if followed, would produce the claimed form of PMS. No doubt that was because the answer would have been 'No'. Once it had been established that example 1 did not disclose a successful route to PMS as claimed in the patent, the skilled addressee might have adopted obvious modifications. But such an approach is not permissible when considering novelty.'

"This passage again suggests to me a serious confusion between disclosure and enablement. The evidence of Mr Ward was relied upon solely for the purpose of proving enablement. But the reference at the end to "obvious modifications" being impermissible is a reference to the requirement that the prior art must have planted the flag on the patented invention, which is a principle of disclosure. On that question Mr Ward's evidence about making crystals could have nothing to contribute.

"Paragraph 56 again leaves me in doubt about whether the Court of Appeal thought that the prior art did not disclose the invention or whether it did so but was not enabled. If it was the former, then, as I have said, I think that they were wrong. If it was the latter, then I do not think that they have offered adequate reasons for disturbing the judge's finding of fact. I would therefore allow the appeal and restore the decision of Jacob J."

Confidence

The law of confidence is considered part of intellectual property law though it is almost entirely case-law based and not statutory. No registration of interests is involved. Duties can arise both in equity and in contract. Thus, employees are considered to owe a duty of confidence to their employers even if no express confidentiality provisions appear in their contract of employment.

"During employment there is a duty of fidelity, which is faithful service. However, after the employee leaves the service of the employer there exists an obligation of a different nature." Discuss.


In cases involving former employees, courts focus on the former employee's righ tto earn a livelihood without unreasonable constraints.

Among other sources, see Faccenda Chicken Ltd v Fowler [1986] 1 All ER 617.

The plaintiffs owned a number of refrigerated vans and operated a mobile service selling frozen chickens to retail shops and catering companies. Fowler, an ex-employee set up in competition with his previous employers and they attempted to prevent him from doing so by raising an action for breach of confidence. The plaintiffs alleged that Fowler was using confidential information in breach of his obligation of confidence by using his knowledge of sales information and customer lists to compete with them.

Goulding J held that information acquire by an employee during the course of employment could be divided into three categories -

1. Information either trivial in nature or available from public sources which could not be regarded as confidential. For example, details of van routes which could be ascertained by following the plaintiffs delivery vehicles would fall within this category.

2. Information which an employee must treat as confidential either because this is expressly communicated to him or because the information is obviously confidential in nature. This information may become part of the employees own skill and knowledge and, if so, can be protected during the continuance of employment but can be used to the employees benefit once they leave. If an employer wishes to protect such information he must do so by express contractual provision usually in the form of a confidentiality clause or restrictive covenant. Price lists and sales information fall into this category.

3. Specific trade secrets so confidential that they cannot lawfully used for anyone's benefit except the original employer notwithstanding that the employee may have learned this information by heart.

The court held that the information used by the defendant fell into the first two categories as it had not been restricted to high-level employees in any way and he could not therefore be prevented from using it. Since Fowler was simply making use of information obtained in the course of his previous employment, rather than disclosing it to a third party for gain, he was not liable for breach confidence.