Patents- Novelty and Inventive Step Notes PDF

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Notes on Patents (Novelty and Inventive Step)...

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Patents- Novelty and Inventive Step NOVELTY A crucial element for patentability is that the invention is new or not anticipated. If it does not form already part of the state of the art- all matter that is available to the public before the priority date of the invention. This grants the right to work rationale and the information disclosure rationale Test for novelty: What is the invention? What information is disclosed by prior art? In light of questions 1 and 2 is the invention novel? Is it part of the state of the art? The prior art is interpreted through the person skilled in the art- deemed to have a common general knowledge of their filed. The person is using documents interpreted as at the date of publication and other prior art interpreted as at the priority date. S.1(1) PA 77 An invention shall be taken to be new if it does not form part of the state of the art. ( involves an inventive step, capable of industrial application, not excluded and does not form part of the state of the art) S.2- TEST FOR NOVELTY S.2(2) of PA 77 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.  The priority date is essential to establishing the prior art (the date in which the application was filed)  Absolute approach- can be in the UK or anywhere in the world unlike old more relative law  It is not required that the material has been disseminated at large in order for it to form part of the state of the art (suffices that the document is placed in a library)  This section does not distinguish between whether the matter has been made available to the public by the inventor or by a third party S.2(4) PA 77- material deemed excluded from the state of the art For the purposes of this section the disclosure of matter constituting an invention shall be disregarded in the case of a patent or an application for a patent if occurring later than the beginning of the period of six months immediately preceding the date of filing the application for the patent and either— (a)the disclosure was due to, or made in consequence of, the matter having been obtained unlawfully or in breach of confidence by any person— (i)from the inventor or from any other person to whom the matter was made available in confidence by the inventor or who obtained it from the inventor because he or the inventor believed that he was entitled to obtain it; or (ii)from any other person to whom the matter was made available in confidence by any person mentioned in sub-paragraph (i) above or in this sub-paragraph or who obtained it from any

person so mentioned because he or the person from whom he obtained it believed that he was entitled to obtain it;  The six months is judged not from the priority date but from the date of filing.  Disclosure is disregarded when it was obtained unlawfully or when displayed in an international exhibition S.2(3) PA 77- Material deemed included in the state of the art 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.  Considered to be part of the state of the art even though published after the priority date INTERPRETING THE PRIOR ART The prior art is interpreted according to the perspective of a notional person, known as the person skilled in the art- having regard to the relevant surrounding circumstances which then existed and without regard to subsequent events  Where it is possible for the skilled person to discover the composition of the internal structure of the product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art. DETERMINING WHETHER THE INVENTION IS NEW 1. Old law- 1949 Act (right to work)- infringement if it had occurred AFTER the priority date (anticipation of the creation)  If the use would be an infringement afterwards it would have been anticipated before  Not necessary that D should have realised that he was doing an infringing act  Crown could not grant a patent which would enable the patentee to stop another trader from doing what he had done before Prior art: PA 1977 and EPC 2000 STEP 2: INTERPRETATION AND APPLICATION University patents- clarifies the calculation of the six month period referred in art.55(1) s2(4)PA- exclusion is for actual filing not priority date Woolards application- application is published 18 months after filing. Risk of subsequent similar patent during delay. Held that unpublished, filed patent applications are deemed to be included in prior act to stop the risk of double patenting. Chemical composition in product: availability to the public a chemical product composed was already inside an available product, but was never analysed. Held that PSA can derive information of chemical composition from an available product. It is irrelevant whether there is no motivation in analysing the existing product.

Practical possibility of access- Philips/ Public availability of documents on the world wide web Information was released on the internet. There was a mere theoretical possibility of access. Held that there must be practical possibility of having access to the information for it to be disclosed. Direct and unambiguous access at least to one member of the public. INTERPETATION: AVAILBILITY TO THE PUBLIC Leading case: Synthon BV v SmithKline Beecham Earlier patent disclosed a broad class of chemicals including the one in question. Could not be created by PSA through strict compliance of claim (prior disclosure) but would have been able through some trial and error (Enablement). Held- two stage test : Lord Hoffman 1. Disclosure- prior art must disclose matter which if performed would necessarily infringe the pending patent (right to work rationale). The reverse infringement test. 2. Enablement - whether PSA would have been able to perform the claimed invention using prior art and some trial and error (information disclosure rationale)  Synthon's formula had a mistake in the application- under the old law a stricter approach was adopted. Under New law it matters whether the person skilled in the art would be able to work the invention  Enablement with reasonable trial and error  SB invention lacked novelty because Synthon's first application is valid.

To determine whether an invention has been anticipated by prior disclosure, apply the reserve infringement test Reverse infringement test. If A is filed first does it anticipate B? if B is filed first and you follow the invention instructions. If by doing so A infringes B. then it must be that A anticipated B. APPLICATION: PA 1949 Approach: Bristol Myers Application Application challenged on grounds of prior use of invention. Invention was never disclosed. Reserve infringement test: test for anticipation coextensive with test for infringement. Prior use would have infringed patent if granted (right to work rationale) Prior user need not know that use is infringing in order for it to be part of prior art Knowledge is unnecessary for anticipation (information disclosure rationale)

Bristol Myers v Beecham Beecham patented ampicillin and methods of producing it in 1962 but the methods were inconsistent. In 1963 Bristol Myers applied for a patent for one of this methods. B lodged an opposition under s.14(1) for prior publication . Under the old law although B didn’t disclose information on its application it didn’t matter. Preceding date was enough because this suggests it was anticipated. 2. New LAW, PA 1977- Enabling disclosure

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As long as it is available to the public. Under s.2(2) - requires disclosure and communication of information Invention must be new and not part of the state of the art Only if under s.64 the previous use was secret/ uninformative Whether the substance i

Merrell Dow Pharmaceuticals v Morton Merrell Dow obtained a patent in the UK in 1972 for a drug called terfenadine. MD later conducted research in the way the drug actually worked. They discovered that the drug passed through the stomach to be absorbed in the small intestine and was then 99.5 metabolized in the liver which explained why the drug did not produce any side effects. In 1980 he obtained a second patent in respect of the acid metabolite which was formed in the liver. After the first patent expired, pharmaceutical companies began manufacturing and selling terfenadine. MD brought an action for infringement under s.60(2) of PA 77. no action on the basis of lack of novelty  Anticipation by disclosure- the question is whether the specification conveyed sufficient information to enable the skilled reader to work the invention (the prior art contained in the specification gave no indication that it would have the effect of creating the acid metabolite in the human body. Thus it did not make the acid metabolite available to the public.  The terfenadine specification teaches that the ingestion of terfenadine will produce a chemical reaction in the body and for the purposes of working the invention in this form, this was a sufficient description of the making of the acid metabolite. Under the description this was part of the state of the art.  Enabling disclosure. Older drug metabolised into metabolites when taken. C applied for new patent isolating metabolite produced from drug for other uses. When D sold older drug, C argued that D was facilitating the making of the patented metabolite. D counter-claimed anticipation Held- anticipation occurs where disclosed matter could be worked or practiced. Bristol Myers prior use overruled.  Need enabling disclosure available to the public within s(2) PA 1977 requires communication of information.  If prior use was secret and uninformative (would not know how to make invention) then it does not anticipate disclosure)

Novelty of pharmaceuticals- right to work is now only a defence  Should we patent pharmaceuticals?  Should we patent methods of medical treatment? NB: patent laws in some countries previously excluded pharmaceuticals from being patentable The EPC/PA 77 excludes methods of treatment by therapy, surgery and diagnosis from being patentable STEP 1: PA 1977& EPC 2000 Section 4A(1)(a)-(b) & Article 53©- excluded subject matter: treatment of the human or animal body constituting surgical, therapeutic and diagnostic methods

Art 52(4) EPC excluded inter alia methods of treatment of the human or animal body by therapy from being capable of industrial application see now Art 53(c) EPC 2000 which retained the exclusion but removed this legal fiction Art.54(5) EPC provided: “The provisions of paragraphs 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, paragraph 4 provided that its use for any method referred to in that paragraph is not comprised in the state of the art.” (emphasis supplied) see now Art. 54(4) & (5) EPC 2000

STEP 2: Interpretation New use/ specific use: Dosage regime/ ABBOT RESPIRATORY Use of substance in existing drug in a specified dosage for a treatment. Held: specific use under Art. 54(5) extends to novel dosage for some illness  New use can be for different or same illness  No longer need a swiss type claim (scope of Art. 54(5) covers second medical uses)  Art 54(5) filled loophole by allowing for claims for further uses of the same substance STEP 3: Application Old swiss form: eisai/ second medical indication (1985 EPO BA) Use of an already disclosed substance which is novel and used for medical treatment Held: second/subsequent uses could be novel provided they are drafted in swiss form claims  Swiss form claim: use of substance/ composition for the manufacture of a medicament for a specified new therapeutic application (intended to avoid new therapeutic method)  Swiss form no longer needed after dosage regime

EU Patent Protection has some exclusions- they do not prevent the isolation of compounds  

G05/83 Eisai EBA held that Art 54(5) EPC was an exception to novelty for pharmaceutical substances  Use of a substance for a method of medical treatment could be novel provided it was claimed as a purpose-limited product (thus avoiding Art 52(4) prohibition)  Also held that second and subsequent uses of a substance for a method of medical treatment could be novel under Art 54(4) EPC Swiss form claim: “use of a substance or composition for the manufacture of a medicament for a specified (new) therapeutic application”....