Patents Require registration. Protects novel inventions. Identical inventions can infringe even if independently created. Unlike copyright.

Negative right prevent others from using the protected inventions. Economic importance. What is a patent? A contract between the inventor and the State. Inventor given right to control use of patented information. In return the information contained in the patent is placed in the public domain. Right limited in time and space 20 years. Limited to territory of grant. Product, process, product made by particular process. Protection for the physical results of research and development

European Patent Law European Patent Convention EC Directive 98/44/EC on the Legal Protection of Biotechnological Inventions Community Patent Convention never ratified. Community-wide patent one day? Establishment of a European Patent Court? EPC: Not a body of the EU although all EU members states are members. Provide a patent as a bundle of national rights To harmonize type and extent of protection. Since EPC was NOT a EU body, cannot interpret EU. Directive served to clarify and influence EU decisions. Implemented into national law. Has been adopted by the European Patent Office in the form of a supplementary means of interpretation of the EPC.

Directive on the Legal Protection of Biotechnological Inventions

UK Patent Law Patents Act 1977 CDPA 1988 Established the Patents County Court S.1(1) of Patents Act 1977 (patentable inventions) The invention is new It involves an inventive step Capable of industrial application Not excluded.

All in all, 6 granting criteria have to be met. Invention, novelty, inventive step, industrial application, not excluded, sufficient

disclosure. Invention: NO definition. Instead the law sets out what are not inventions and inventions specifically excluded from protection for reasons of public interest. Please note the emphasis is on inclusion. The excluded material are given a restrictive interpretation. Non-inventions: S.1(2)(a) discovery, scientific discovery, mathematical models Genentech v Wellcome You cant invent water, although you can certainly invent ways in which it may be distilled or synthesized. Naturally occurring elements are patentable provided a novel and inventive application is disclosed. Discovery v Invention Discovery is something you find. Invention is the use/function of it. S.1(2)(b) literary, dramatic, musical or artistic work. Copyright. S.1(2)(c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer. Novelty: S.2(1) of PA1977. Shall be taken to be new if it doesnt form part of the state of the art. The state of the art shall be taken to comprise all matter which has at any time before the priority date been made available to the public, by written or oral description, by use or in any other way. The test is quantitative the invention must be quantitatively different from that already disclosed. In order to ensure that a monopoly right is not granted over that which people already use prior to the application. Re IBMs European Patent Application where the program creates a technical effect, it is patentable. Proposals for change in the EU. S.1(2)(d) the presentation of information EPC Art. 53(a) plant or animal varieties or essentially biological processes. However, microbiological processes or the product thereof not excluded. Treatment, surgery excluded. Reflected in Schedule 2(3) and (4) of the Patents Act.

Non-patentable inventions: s.1(3) public policy or morality.

State of the art assessed on a global basis. No geographical restriction. IRRESPECTIVE of how information was disclosed. S.2(1) novelty will be assessed from the priority date of the invention. (when info has been received by the patent office) Patents Offices criteria Was the information in the form claimed: (in order to assess the state of the art) Directly accessible? And was it potentially accessible? Court/Patent Office will assess novelty with regards to the information available to it from the priority date. It is not required to look at the subjective approach of where the information was released or in fact what form that information was served.

Fomento v Mentmore Upside down point pen presented to sales people. Pamphlet. Novelty destroyed. Very broad definition of public.

Monsanto (Brignacs) Application Essentially a question of fact. This can include the release of one document/one single sale. Then it becomes state of the art.

Windsurfing International v Tabor Marine It depends on whether the information COULD have been obtained, not whether it has actually been obtained.

Japan Styrene Paper the fact that the material is available to the public may anticipate the invention, thus constituting state of the art. Lux Traffic Controls v Pike Signals if a person skilled in the art on seeing it would be able to determine its core features with sufficient detail to reproduce the invention.

Merrell Dow v Norton metabolite case. When deciding novelty the starting point was whether there had been an enabling disclosure of the claimed invention. All in all, the test for novelty comes down to this 2 stage test: Was the information POTENTIALLY ACCESSIBLE or DIRECTLY ACCESSIBLE to the public? Fomento, Monsanto, Windsurfing, Japan Styrene Paper, Lux Traffic Controls If yes, then see if there is disclosure or enablement Disclosure (would destroy novelty) Person skilled in the art. With common general knowledge.

Would be able to work the invention? Or General Tire v Firestone Person skilled in the art Through trial and error Would be able to work the invention Synthon BV v SmithKline Beecham (Crystalline chemical. Description disclosed. Recipe not enough but with a bit of trial and error)

Enablement

Inventive Step Novelty is the quantitative criteria. Inventive step is the qualitative criteria. IP law would not protect the obvious. The qualitative gateway. (remember a patent is a monopoly right!) Problems: secrecy in research work vs. competitive activity. When applying for a patent you might want to keep something secret. However, this would mean something less than full disclosure of the invention. Hindsight Knowledge of the patent examiners As more is invented, some things become obvious. As a result, the full picture only often reveals itself in court. An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art. The test is objective. Lily Icos v Pfizer. Questions What is the art? What is the state of the art for the purposes of s.3? What is the invention in question? Who is a person skilled in the art? What is obvious? Much more sector-specific when deciding what is state of the art in this step. Mobius/Pencil Sharpener Assessment: Age documents, role of references in linking one document to others, proximity of fields, effort and analysis of skilled person in identifying the relevant features in prior art, ubiquity of some

S.3 PA 1977

State of the art:

documents in the field such that they form part of common general knowledge. It is permissible to make a mosaic out of relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity. Technograph v Mills & Rockley. If unimaginative man can put this picture together, then it would form state of the art. Qualities of the person skilled in the art Notional person skilled in the art. Ordinary member of the field who is aware of everything in the state of the art and capable of making routine developments. Unimaginative. Dyson Appliances ltd v Hoover Ltd Bagless vacuum cleaner. Routine development. Patent infringed. Skilled person those working in the area. In this case, it meant postdoctoral researchers. Those most likely to be innovative. As they provide the benchmark it is harder to prove inventive step as all likely to follow the same route. Maybe different standards for different areas?? What is the invention? Approach by EPO a solution to a problem Approach by the UK Four Stage test in Windsurfer. Inventive concept in the patent application? What is the common general knowledge? What are the differences between the application and the art? Is the invention unobvious? Genentech

The two tests are really not so different. When you address the inventive concept you inevitably address a problem and its solution. Haberman v Jackel - AnyWayUpCup Something very obvious might also be inventive. What was the problem the invention solved? How long had the problem existed? How widely known was the problem? How many were seeking a solution? How well known was the prior art? What other solutions were offered? How successful were they?

obviousness Seen from the viewpoint of person skilled in the art. Possibility of failure? Technically creative? Known technique to

known problem? Purely commercial decisions Biogen v Medeva If you follow this research path you would come to the result no matter what, not innovative. In the House of Lords, Lord Hoffman: there is no requirement that the inventive step was NOT adopted for commercial reasons. The ECs approach: if commercial applicability then should be protected even if not very inventive. The Granting Offices/Industry are not very happy with this as the main approach as this could mean too many patents and render them vulnerable to challenge. Industrial Application S.4(1) PA 1977 An invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture. In its widest sense. If it can be used in some way. Chiron v Murex includes non-profit British Technology Group/Contraceptive Method private use. Not industrial application. Guidelines: Specific, substantial and credible use. Icos Corporation (US guidelines used in UK and EPO) Amino Sequence. Very broad claim. No specific use. You have to narrow down.

Infringement What is protected? Product Patents, process patents, Product by process patents. Anything claimed in patent specification If the patent is over a process protection extends to anything directly produced by that process. Three criteria Activity that constitutes infringement Activity complained of falls within scope of monopoly Defences First limb S.60(1) To make, use, dispose of, import, offer for use, offer to dispose of. NO action can be brought until patent has been granted If between publication and actual grant, you can bring an action but would not succeed until patent is actually granted. Doctrine of implied licence once sold, cannot prevent resale Doctrine of exhaustion stops patentee using patent to prevent further disposal of article in EEA once placed on the market with consent Right to import covers when dealing with a patented product in the course of trade or for purposes of profit Second Limb Interpretation of claim (Key Question!) Scope of legal protection conferred Demarcate and define patented invention Delineate the nature, breadth and scope of the monopoly When drafting, broad enough to stop others from getting too close, but not too broad as to invalidate the patent. Literal Construction C Van Der Lely NV v Bamfords Ltd Rearmost wheels alleged infringement = foremost wheels. No infringement. Rodi & Wienberger AG v Henry Showell Ltd Watch straps. U-shaped vs C-shaped. No infringement. Patentee can stop it from being re-imported into the EEA. Direct Infringement use of patented product or process Indirect infringement facilitate act of infringement

Pith & Marrow Construction

Slightly wider construction. The words + what the invention actually does. Beecham Group Ltd v Bristol Laboratories Ltd. Catnic v Hill & Smith Claim referred to vertical. A lintel 6 degrees off vertical. Look at the purpose. What is it trying to do? Bear the function of the invention in mind. Defendant would have understood that strict compliance with a particular word, vertical was not intended by the patentee. To a person skilled in the art. Would it have the same function? NO requirement that the patent be construed in the patentees favour! Bear in mind that a broad interpretation isnt always beneficial. Might constitute prior art. Invalidation.

Purposive Construction

EPC introduced protocol of Art. 69 (Art 69 + Protocol to Art 69) Claims should not be read literally. Claims should not be used as a mere guide to interpretation. The claims are to be interpreted as defining a position between those extremes which combines a fair position for the patentee with a reasonable degree of certainty for 3rd parties. Improver Corp v Remington Lady shaver. Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim; If no, would this (the fact the variant has no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes, would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. Improver/Protocol questions

What is the law now? Kirin-Amgen v TKT KA putting DNA into cell to create chemical. Downstream Production. TKT putting DNA that controls production of chemical. Upstream approach. No infringement.

Literal approach is wrong. Improver questions intended as guidance, but not suitable for all circumstances

One question: What would a person skilled in the art understand the patentee to have used the language of the claim to mean?

Issues: Should patents be regarded as contracts? How about right of 3rd parties? Fence post concept. Or sign-post concept? Fence-post defines territory claimed. Certainty for 3rd parties. But limited protection for patentee. Sign-post concept more protection for patentee. But uncertainty for 3rd parties.

Third Limb (s.60(5)) Private non-commercial use: SKF v Evans Medical Immunity for acts done for experimental purposes relating to subject matter of invention. Monsanto v Stauffer Chemicals Stauffer experimented with herbicide. Research on patented inventions is permitted. Commercial exploitation requires licence. Determining factor is whether the material is being used with commercial objective in mind. Use in preparation of medicines Farmers Privilege Experimental use or the Research Exemption

Patents and Biotechnology Increasing recognition of the commercial importance of biological material Human Genome Project. UK vs US. US was gonna patent it. Luckily UK won. Commercial value vs public interest Protecting investment and market position Elimination of trade obstacles Consumer/environmental GM foods should we grant patent to these products? South Africa. HIV drugs. Access to new products and processes Relationship between science, law, society and economics. EU Law EPC: All EU members and other countries. Intergovernmental organization. To provide a patent enforceable in as many European member states as the applicant designates. Harmonization of type and protection. Issue of interpretation. Exclusions: Art. 52 Art. 53(a) Inventions the commercial exploitation of which would be contrary to ordre public or morality. (see schedule A2 of PA 1977) (ordre public and morality ground was established after Directive) Harvard/Oncomouse Genetically modified mouse. Issue over an animal and whether it is contrary to morality. Held court not ethicists. Challenge rejected. Plant Genetic Systems v Greenpeace the need to demonstrate actual harm rather than speculative harm in order to establish ordre public ground. Howard Florey/Relaxin patenting life? Nah. Enslaving people? Stupid. A patent is only a negative right. You could patent an animal, but not a breed nor a variety of animal. Art 53(b) Plant and animal varieties and essentially biological process for the production of plants and animals. Does NOT extend to microbiological processes or the products thereof. European Patent Convention EC Directive on the Legal Protection of Biotechnological Inventions (98/44)

Essentially biological processes only. The whole process has to be looked at as a whole. Entirely natural phenomena are excluded, but if human intervention involved

In the original text, no varieties

Art. 53(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

EC Directive on the Legal Protection of Biotechnological Inventions (98/44) Background: EU cannot revise EPC. Clarify and influence EPC decisions. The objective of the directive is to eliminate uncertainty and to promote bioscience research. To direct policy and practice. Has been adopted by the EPO in the form of a Supplementary means of interpretation of EPC To clarify what is and isnt patentable! If the process isnt confined to a variety, might be patentable.

Art 4 plant and animal varieties Art 5 human body, at various stages of formation and development Art 6 use of human embryos for industrial or commercial purposes. Supplementary means of interpretation in the EPC. These are exclusion to an exclusion in Art 53 of CPC. Clarifying what is excluded and what is not in EPC. Art 7 Commissions Group of Ethics in Science and New Technologies.

EPO decisions post Directive Harvard/Oncomouse. (concerns 53(a)) EPO cant look at things outside EPC. Have to look at whether its immoral or against order public. Cost vs Benefit. Edinburgh patent Embryonic Stem Cells (concerns 53(a)) Totipotent stem cells vs pluoripotent stem cells. Does it fall within the specific exclusions established after Directive? Uses of human embryos for industrial or commercial purpose? (EPC 2000 Rule 28) Should the onco-mouse benefit v cost test be applied? This case permits the patenting of plants in Europe provided a technical invention can be shown and plant varieties are not claimed specifically. (process claim?) Novartis/Transgenic Plant (concerns 53(b))


UK 2003

A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Art. 53(b). Subject matter of a claim and the scope of a claim are two different issues. If you claim your technical invention works on apples, you have a patent over all apples. If it only works on Granny Smiths, unpatentable. This exclusion very narrow interpretation. Why? Plant Varieties Rights. Convergence of subject matter.

UK IPO Practice Notice regarding Inventions involving human embryonic stem cells Human Embryonic totipotent stem cells unpatentable Uses of human embryos for industrial or commercial purposes unpatentable Human embryonic pluripotent stem cells patentable Recognition of potential new treatments for a wide range of disorders Debate concluded that inventions concerning human embryonic pluripotent stem cells would not be contrary to morality.

But harmonization? Human body protected by Art. 5 of EC Directive. Are human embryonic stem cells patentable? Those which can only be obtained through destruction of human embryos unpatentable. But if could be obtained by means other than destruction of human embryos, patentable.

The test: See if the patent falls within the established exclusions. (Schedule A2 (3) of PA 1977). If it does, thats the end of the matter. If it doesnt, see Art 53(a) of Convention.

Conflict between CJEU and EPO EPO: Inventions are not deemed to be immoral if the invention is based on human material which is obtainable without necessitating the destruction the destruction of human embryo.