1. Introduction & Novelty PDF

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Patents What is a Patent? ● Patents protect inventions ● All inventions have to be (1) new/novel, (2) inventive, (3) capable of industrial application ● Art 52 EPC ○ “European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application” ● S.1(1) PA 1977 ○ “A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say■ The invention is new; ■ It involves an inventive step; ■ It is capable of industrial application the grant of a patent is not excluded…” ● Patents grant an exclusive/ monopoly right to prevent others from making, using, offer for sale, selling or importing the patented product. ● Patents are a unilateral declaration to the rest of the world that it is your invention. Patents foster innovation! ● Stronger monopoly right than copyright; you’re not even allowed to make independent products. ○ This is why patents have a registered right lasting for 20 years from the date of filing (much shorter than copyright) ○ Patents cannot be renewed, but 5 extra years can be granted to pharmaceutical products due to the fact that it took around 5-7 years for the original patent to be granted. ● S60 of the PA 1977- Sets out the different rights for both product and process claims ● 2 MAIN TYPES: ● Product ○ A claim to an apparatus; an object or thing

● Process ○ Claims to a recipe, a method or manner of use

Justifications ● Utilitarian argument ● Incentive to innovate, disclose and commercialise that invention ● Lockean labour theory ● Economic incentive to invent, invest, and disclose. ● Four main arguments: ○ The Natural Property Right in Ideas ○ The Just Reward for the Inventor ○ The Best Incentive to Invent ○ The Best Incentive to Disclose Secrets International and regional framework ● Paris Convention 1883 ○ Principle of no discrimination - cannot prioritise UK patent protection to UK inventions over those from other member states ○ 12 month priority rules gives you the opportunity to file in a single Paris Convention country and the right to file in any other country for up to 12 months ● Patents Co-operation Treaty 1970 ●

Creates a mechanism for international patent applications ○ If someone wants to get patented in multiple countries

● TRIPS Agreement 1994 ○ Incorporates Paris provisions; sets down minimum standards for substantive patent law ● European Patent Convention 1973 & 2000 ○ Establish a centralized system of obtaining patents in contracting states. How to get a Patent? 1. Application to UK IP Office

2. Single application to European Patent Convention/ Organisation a. Results in bundle of national patents b. Lower costs than filing in each individual country c. This is not an exclusively EU measure, it is an international framework 3. Single application via the PCT a. PCT checks formalities and takes note of a filing date b. Forwards a copy to the international bureau c. Passes it to patent office of a contracting state NOTE: ● Opposition proceedings in the European Patent Office must be initiated within 9 months of the date of grant of the patent. ● A third party can challenge the grant of a European Patent (UK) through i. the EPO, ii. the UK IPO and iii. UK High Court.

UK & EPC interrelationship: S130(7) PA 77 provisions ‘are so framed as to have, as nearly as practicable, the same effets in the UK as the corresponding provisions of the EPC’ Thus, heed should be taken of EPO Board of Appeal Decisions: Eli Lilly v HGS Lord Neuberger: ‘It is plainly appropriate in principle, and highly desirable in practice, that all these tribunals [EPO and national courts] interpret the provision of the EPC in the same way’ ‘While national courts should normally follow the established jurisprudence of the EPO, that does not mean that we should regard the reasoning in each decision of the Board as effectively binding on us… there has to be room for dialogue between a national court and the EPO… Nonetheless, where the Board has adopted a consistent approach to an issue in a number of decisions, it would require very unusual facts to justify a national court not following that approach.’

When different decisions are reached: -

Virgin Atlantic v premium Aircraft Interiors- Patent in relation to a seating system for a plane. They had obtained European patent and one of the nominated nations was the UK. Claimants sued in UK for infringement of their patent. There was counter sue to say that they did not have a valid patent and it should be revoked.

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The patent had to be amended to be valid and because of the amendment there was no more infringement of the patent. o Where judgment is given in an English court that a patent is valid and infringed and the patent is subsequently revoked or amended by the EPO, the D is entitled to rely on this fact in an inquiry as to damages.

A solution? European patent with unitary effect (Reg 1257/2012 and 1260/2012)- hasn’t yet come into effect) Unified Patent court (Agreement made on 19.2.13)

The Application: S14(2) PA 77- Corresponds to Art 78(1) EPC ‘Every application for a patent shall contain— a. A request for the grant of a patent; b. A specification containing a description of the invention, a claim or claims and any drawing referred to in the description or any claim;’

The Specification: Consists of the invention (THE DESCRIPTION)- How to do or make the things in question (and associated drawings, -and it ends with the claim. Typically the description will contain: -

Background to the invention Advantages of the invention compared to the state of the art Instructions as to how to perform the invention

Sufficiency: s14(3) PA 77 ‘ The specification for an invention 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.’ Echoes the wording of insufficiency ground of revocation found in s72(1)©

Claims- The claims are the heart of the patent: -

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They refine the invention and determine its scope of protection –s125 PA 1977/ Art 69 EPC The requirements of the claims are found in s14(5) PA 1977 (See also Art 84 EPC) ‘The claims or claims shalla. Define the matter for which the applicant seeks protection; b. Be clear and concise; c. Be supported by the description; and d. Relate to one invention or a group of inventions which are so linked as to form a single inventive concept.’ Two main types of claims: product (a claim to an apparatus or object). Process (claims a recipe, a method or manner of use)

Novelty Test for novelty ● S. 2(1) PA 1977: “An invention shall be taken to be new if it does not form part of the state of the art.” ● S.2(2) PA 1977: “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.” WHAT TO DO IN DETERMINING NOVELTY (STEP-BY-STEP) 1. Examine the priority date a. As a general rule, it is the date of filing. b. We are judging in comparison with existing inventions prior to this date. i.

EXCEPTION: if you are claiming Paris Convention Priority. This occurs when you have filed 12 months prior in another country, but you claim this priority so that the EARLIER priority date is used instead.

ii.

This shortens the time frame in which you have to consider the prior art

2. Interpret the state of art then compare with the prior art A. The state of art i.

s2(3) PA 1977- provides that the state of art includes earlier unpublished patent applications –i.e matter contained in other patent applications where that other application is published on or after the priority date of the invention. 1. Reasoning: Woolard’s Application a. To avoid the potential co-existence of two patents for the same subject matterLaddie J

ii. s.2(4) PA 1977- the disclosure of matter constituting an invention shall be disregarded in the case of a patent if occurring within SIX months before the date of filing. See University Patents [2001] 1. Disclosure was due to the matter having been obtained unlawfully or in breach of confidence 2. Display at an international exhibition a. International exhibition described as one that is not commercial, with a duration of more than 3 weeks, and which is officially organised by a nation to which other nations are invited. b. See Convention on International Exhibitions 1928 B. Interpreting the Prior Art

iii. Interpreted through the eyes of the person skilled in the art iv. Cannot ‘mosaic documents v.

Skilled in the art: deemed to have common general knowledge of the field- (this is further touched upon in the notes under Inventive Step) 1. Rely on his general knowledge to gather all information enabling him to prepare the said product and to reproduce it without undue burden. - Enlarged Board of Appeal in Availability to the Public

vi. Approach under the Patents Act 1949 (old legislation) NOTE: Reverse infringement test: 1. General Tire and Rubber Co. v Firestone Tyre and Rubber Co Ltd. a. ‘If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty’ i. BASICALLY (in normal english), if you were to compare the two, would the prior art have infringed the latter patent? If yes, that means the latter invention is not novel. ii. To satisfy this test it must point to exactly what your invention is, a mere signpost is not enough. 2. Merrell Dow v Norton (Concerns Prior use) [1996] Lord Hoffmann made the following observations about Bristol Meyers: ‘The reasoning of the HoL was rounded upon two principles of the old UK patent law. ‘1. The crown could not grant a patent which would enable the patentee to stop another trader from doing what he had done before. 2. The test for anticipation before the priority date was in this respect co-extensive with the test for infringement afterwards.’ ‘If the use would have been an infringement afterwads, it must have been an anticipation before. For the purpose of infringement, it was not necessary that the defendant should have realised that he was doing an infringing act. Such knowledge was therefore equally unecessary for anticipation.

vii. Approach under Patents Act 1977

Merell Dow v Norton- MD patented terfenadine in 1972; patented acid metabolite in 1980. Defendant started marketing terfenadine as it had expired, MD sued for contributory infringement or second patent, defended counter claimed the patent was invalid due to lack of novelty. a. HELD: invalid for lack of novelty by Aldous J. The patent was invalidated after the discovery that the effect was produced naturally from an acid metabolite � PRIOR USE. b. In House of Lords, the prior use wasn’t what anticipated the invention (merley swallowing the tablet did not make the volunteers aware of the acid metabolite) it was prior disclosure. The patent specification for terfenadine. i. Prior use- used in clinical trials. Lord Hoffmann: Art 54 EPC ‘makes it clear that to be part of the state of the art, the invention must have been available to the public. An invention is a piece of information. Making available to the public within the meaning of s2(2) therefore requires the communication of information. The use of a product makes the invention part of the state of the art only so far as that use makes available the necessary information. ii. Prior disclosure Lord Hoffmann: ‘In this case, knowledge of the acid metabolite was in my view made available to the public by the terfenadine specification under the description ‘a part of the chemical reaction in the human body produced by the ingestion of terfenadine and having an anti-histamine effect’. Was this description sufficient to make the product part of the state of the art? For many purposes, obviously not. It would not enable anyone to work the invention by making the acid metabolite in the body by ingesting terfenadine, I think it plainly was. It enabled the public work the invention by making the said acid metabolite in their livers.’

c. Patent infringement does not require that one should be aware that one is infringing: ‘whether or not a person is working [an] . . invention is an objective fact independent of what he knows or thinks about what he is doing . .’

*Synthon BV v SmithKline a. Synthon filed an international application for

a patent for

Paroxetine

methanesulfonate (PMS) in a particular crystalline form. Before it was published, SB filed a similar application in the UK patents registry. Synthon applied for revocation for lack of novelty- this was based on a patent application they had made (and which was granted) which claimed a broad class of sulfonice acid salts which included PMSrelied on s2(3) PA 77. b. Held to be invalid as SmithKline patent lacked novelty. c. ESTABLISHES THE REQUIREMENTS OF PRIOR DISCLOSURE AND ENABLEMENT. SEE BELOW. NOW, MOVE ON TO THE TWO STAGE TEST- *Synthon BV v SmithKline (1. Disclosure 2. enablement) 3. Consider whether or not the invention has been made available to the public. Is there a disclosure? PRIOR DISCLOSURE a. Has the information been put out to the public? It CANNOT be readily available to the public. Information, in this case refers to descriptions of the invention and any form of disclosure of information. i.

It does not matter who discloses it. 1. Disclosure can be in the form of writing, verbal or use in any other way 2. Territorial restrictions: it is the GLOBAL public, and not just restricted to the UK.

ii.

Refer back to rationale of information disclosure- encouragement of new learning.

iii.

EXCEPTION: disclosure to a third party is allowed as long as there is a condition of confidence, i.e NDA or confidentiality clause

b. Reverse infringement test i.

General Tire v Firestone 1. ‘The matter relied upon as prior art must disclose subject-matter, which, if performed, would necessarily result in an infringement of

the patent... the prior art discloses the same invention…. But patent infringement does not require that one should be aware that one is infringing.’ 2. According to Synthon, the reverse infringement test is still relevant, but TO WHETHER THERE IS DISCLOSURE of the invention. (how it is reconciled with the decision in Merell Dow) c. What is known to a person skilled in the art? 4. Is there an enablement? ENABLEMENT a. Legal consent given. Can a person skilled in the art, with the instructions and processes, make the invention? b. ‘Means that the ordinary skilled person would have been able to perform the invention which satisfies the requirement of disclosure’- Synthon Note: there is a need for a distinction between ‘Enablement’ and ‘Disclosure’ because there is a practical significance when evaluating between low-tech or high-tech innovations. -

For low tech inventions ‘the simple disclosure of the invention will probably be enough to enable the skilled person to perform it’ but this is unlikely to be the case for high-tech inventions.

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There is also a risk of confusion- different role of the person skilled in the art.

The two part test of disclosure and enablement in relation to the facts of Synthon: ● To establish disclosure, Synthon relied on the fact that their patent application had disclosed PMS in crystalline form. The problem was that the crystalline form disclosed in their application was different to the crystalline form found in SmithKline’s application. ○ However, PMS had only one crystalline form, rather than several forms, so that performance of their invention would inevitably have infringed the SmithKline’s patent. ● To establish enablement, the difficulty for Synthon was that the method described in their application, when performed, did not produce seeding crystals. ○ However, they argued that a person skilled in the art would engage in reasonable trial and error and subsequently be able to crystallize the PMS. ○ House of Lords accepted this argument of enablement.

Reconciling Merell Dow & Synthon? -

The reverse infringement test, according to Synthon, is still relevant, but to whether there is disclosure of the invention

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Why then was the prior use in Merrell Dow not anticipation? Lack of disclosure or lack of enablement?- Lack of enablement in MD

Rationale 1. Right to work: Someone should be entitled to use something that already exists. We

should not be able to monopolise something that is already being used in the widespread community. 2. Information disclosure: encourage dissemination of NEW LEARNING, only disclosing

things that we can benefit and use. (Bristol-Meyers)

Novelty in Pharmaceuticals Pharmaceutical industry has directed much of its research not towards the creation of new substances or drugs but to discovering new uses or new benefits of known ones. Two explanations for this: 1. Difficulty in coming up with truly new substances 2. Ability to satisfy regulatory approval more easily if there is new use of an already existing substance. The EPC/PA 77 excludes methods of treatment by therapy, surgery and diagnosis from being patentable.

Difficulty in this: ● Patenting a new use of a known substance may risk being caught by the method of medical treatment exclusion as discussed in Eisai/ Second Medical Indication: Art52(4) EPC excluded inter alia methods of treatment of the human or animal body by therapy from being capable of industrial application ○ A claim directed to ‘the use of a substance or composition for the treatment of

human or animal body’ was in no way different in essential content from a claim directed to ‘a method of treatment of the human or animal body by therapy with the substance or composition’. The difference between the two claims is one of form only and the second form of claim is plainly in conflict with the Article 52(4) EPC [now Article 53(c) of the EPC]. ○ Art 53(c) EPC 2000 which retained the exclusion but removed this legal fiction The solution to this difficulty was to include Art 54(5) EPC (Now Article 54(4) and (5) of EPC 2000), which provides: ○ ‘The provisions of para 1 to 4 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52, para 4 provided that its use for any method referred to in that para is not compromised in the state of the art. ○ Equivalent provision to the previous Art 54(5) of the EPC is S2(6) PA 1977. Corresponding provisions to the new Art 54(4) and (5) is reflected in s4A(3)-(4) PA 1977. Eisai/ Second Medical Indication ● In this judgment, the Enlarged Board of Appeal refers to the old provision excluding methods of medical treatment (Art 52(4) of the EPC- lack of industrial application) ● Held: Article 54(5) of the EPC was an exception to novelty for pharmaceutical substances. ○ use of an existing substance in a medical treatment, satisfies the novelty requirement provided that the use of the substance for any such method is not already known and also that the invention is claimed as a purpose-limited product. (thus avoiding Art 52(4) prohibition on patenting of methods of medical treatment. ) ● Also held that second and subsequent uses of a substance could be novel under Art 54(4) EPC ○ Special approach to Swiss-form claims: ‘use of a substance or composition for the manufacture of a medicament for a specified therape...