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Patent Law Patentability Notes

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Requirements for a patentable invention

NoveltyFor an invention to be patentable it must be new
? PA s1(1)(a)
? EPC 2000 Art 52(1) An invention is not new if it does not form part of the "state of the art" (PA s2(1), EPC Art 54(1)) State of the art - broadly framed - includes all matter that is available anywhere in the world before the priority date of the invention Where an invention is disclosed or "anticipated" by the state of the art, a patent will not be granted, or, if it has been granted, the parent is liable to be revoked

Novelty v inventive step
- Novelty requires that the invention be "qualitatively different" from what has previously been disclosed - that the technical information disclosed by the patent is not already available to the public
- Novelty is diff to the requirement that the invention must have involved an "inventive step"
- this is a qualitative examination of whether the contribution is creative enough to warrant a monopoly Why do we have novelty?
- Novelty ensures that patents are not used to stop people from doing what they had already done before the patent was granted
? This "right to work" argument has been modified as a result of how novelty is determined
- Overall rationale for the grant of patents is supported by novelty - that the public is willing to pay the costs of patenting if and only if they are able to get access to information that would not otherwise have been available to them
? Contract analogy - novelty provides the consideration necessary to warrant the patent being granted in the first placeBritain's entry into the EPC introduced some changes in the way the novelty requirement is applied in the UK
? The 1977 Act and EPC operate on the principle of "objective novelty" so as to avoid subjective judgments that lead to uncertainty
? Both British and European law have adopted the principle of "absolute novelty" - meaning that the novelty of an invention is judged against all the information which is available at the priority date of the invention, irrespective of where the info was released or the form that it was released in
? Criticised - allowing obscure materials to anticipate - harsh results
? BUT absolute novelty - provides a "bright line" test thus "avoiding subjectivity and most questions of degree" - Milliken Denmark AS [1996]

The task of determining whether an invention is novel
- What is the invention?
- What information is disclosed by the prior art?
- In light of the above, is the invention novel/ is the invention part of the state of the art?
What is an invention?
- This Q has received little attention What information is disclosed by the prior art?


What material forms part of the state of the art?
State of the art defined in broad and inclusive terms to include all matter (products, process, information) which, at the priority date of the application, has been made available to the public by written or oral description, by use or in any other way - PA s2(2), EPC Art 54(2) No geographical limits on where the state of the art must be disclosed - info that is available anywhere in the world No restrictions on the mode of disclosure - info part of the state of the art irrespective of how it is made available to the public No requirements on how widely the info must be published - a single copy of a document is sufficient Material is part of the state of the art if it is capable of being accessed - no need to demonstrate a person actually had access to the info, only that if they wanted to, they could have The date at which novelty is assessed = the priority date of the invention - state of the art only includes info made available before this date
? In contrast with other patent regimes, applicants for UK and European patents are not provided with a "grace period" - a period prior to filing where they are able to practice their inventions
? Consequently, patents are frequently anticipated and rendered invalid for want of novelty as a result of the applicant's own acts and disclosures
? Priority date is therefore important because it is the date from when inventors are able to exploit their inventions without jeopardising potential patents
? NOTE - US used to require novelty at the date of invention not the date of application
? Leahy-Smith America Invents Act 2011 adopted the date of application
? BUT US still have a "grace period" - during which a scientist can disclose his invention without depriving a later patent application of novelty
? America Invents Act 2011 - 102(2)
? 2) EXCEPTIONS.---'(1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION.---A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if---
? (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor
? SO the invention will not enter into the state of the art by virtue of your own disclosure
? Benefits of this - the fact that scientists don't have to keep their inventions secret allows for more scientific discussion
? The Manchester Manifesto: Who owns science? - "Restrictions on access to information at any stage of the innovative process obstruct the flow of scientific information and thereby impede scientific progress" Material obtained unlawfully or disclosed into the public as a breach of confidence is not taken into account Info is also excluded from the state of the art where the disclosure was sue to the inventor displaying the invention at an "international exhibition" BUT these exclusions only apply to disclosures that are made in the 6-month period immediately preceding the date of filing

What info is disclosed by the prior art?
- The info disclosed by the prior art is restricted to the info that a person skilled in the art is able to derive form the prior art in Q
- Documents

?Documents are interpreted as if they were being read at the date of their publication
? The info available is that which a person skilled in the art would derive from reading the document in light of common general knowledge - no ability to extend the meaning of the doc beyond that which would be provided by a literal reading BUT he can correct obvious mistakes
? The info must be drawn from a single document - it is not possible to combine together items in the prior art Products
? Where the product is the same as the invention - few problems arise
? Task of interpretation is harder where the technical info necessary to anticipate the invention is not immediately apparent from looking at the product but can only be obtained if the product is analysed
? It has long been recognised that the info disclosed by a product is not limited to the info that is immediately apparent from looking at the product
? Info available to the public includes the info that a skilled person would be able to derive from the product if they analysed or examined it
? Any info obtained as a result of analysis by a skilled person must be obtained without undue burden or without the need to exercise any additional inventive effort - Availability to the Public Decision [1993]
? If the person skilled in the art needed to embark on exploratory research to reveal the info then the info would not form part of the state of the art

Is the invention novel?
- If the prior art and the invention are identical/ the prior art leads directly to the patented invention then the Q is easy
- Task is harder where there is a gap between the prior art and the invention
- This is because the same thing may be known by the public in a number of different ways - things can be described differently
- Merrell Dow v Norton [1996] HL
? Lord Hoffmann - this is essentially an epistemological question - what does it mean for the public to know something so that it can anticipate?
? The problem is that there is often a marked difference between something being "known" by the general public and being known for the purposes of patent law --Lord Hoffmann's comments about the specific epistemological basis of patent law
- Hill v Evans (1962) - Lord Westbury LC
? "I apprehend the principle is correctly thus expressed: the antecedent statement must be such that a person of ordinary knowledge of the subject would at once perceive, understand and be able practically to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful. If something remains to be ascertained which is necessary for the useful application of the discovery, that affords sufficient room for another valid patent..."
- General Tire [1972] - C of A
? "If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would have infringed 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, that is to say, it will have been anticipated.
? If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to what the patentee claims to

-have invented. A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee." An invention will lack novelty if, at its priority date, it has been "made available" to the public - Mobil [1990]
? How specific must a disclosure be for an invention to be "made available" to the public?
? Available "carries with it the idea that, for lack of novelty to be found, all the technical features of the claimed invention in combination must have been communicated to the public, or laid open for inspection" - Mobil Oil/Friction reducing additive [1990] - the communication principle - see Floyd article - it may have gone too far!
An invention is said to have been made available to the public if there has been an "enabling disclosure"

Synthon BV v SmithKline Beecham [2006]
- House of Lords
- "Enabling disclosure" consists of two separate requirements which need to be satisfied if an objection of lack of novelty is to succeed
? Prior disclosure
? Enablement
- Lord Hoffmann - disclosure and enablement are distinct concepts - said there was a serious risk of confusion if the two concepts were not kept separate
- It is important to note that in some situations the same disclosure may satisfy both requirements
- Lord Hoffmann - "the prior art description may be sufficient in itself to enable the ordinary skilled man, armed with general knowledge of the art, to perform the subject matter of the invention. Indeed, when the prior art is a product, the product itself, though dumb, may be enabling if it is "available to the public" and a person skilled in the art can discover its composition or internal structure without undue burden"
- In other cases, different factors will be used to show disclosure and enablement
- as in this case
- The difference between the concepts is clear from the facts in this case
- The patent in question identified and claimed a crystalline chemical
- The prior art contained both a description of such a product and a recipe for making it
- If the skilled man tried to follow the recipe using his ordinary skill and knowledge he would have failed
- The recipe was, as such, not enabling
- But even without it, the skilled man would have been able, with a little trial and experiment, to make the described product
- So the prior art satisfied both the "necessary result" and the "enablement" requirements Disclosure
- To show that a patent has been anticipated, the first step is to show there has been a "disclosure"
- Prior art will disclose a patent if it reveals subject matter which, if performed, would necessarily result in an infringement of the patent - Synthon [2006]
- The prior art must place the person in a position where they are able to work the invention without the need for further info/to engage in some additional inventive activity
- If it is an inevitable consequence of following the information disclosed in the prior art that the invention is made, the invention will have been disclosed
- If the instructions probably, normally or only sometimes produce the product then there will be no anticipation
? Inevitable disclosure

?Fomento [1956] - inevitably has been defined to mean in 99 cases out of 100
? Allied Signal [1996] - EPO said the inevitability of the disclosure needs to be satisfied "beyond all reasonable doubt" The question whether a disclosure enables the public to work an invention is decided objectively There is no need to show that a member of the public actually worked the invention/were aware of its existence All that matter is that the subject matter described is capable of being performed Merrell Dow [1996] - "if the recipe which inevitably produces the substance is part of the state of the art so is the substance made by that recipe" - it does not matter that the cook was ignorant of the fact they were producing the product

- The disclosure must be "enabling"
- A disclosure will be enabling and thus destroy novelty if the public is given sufficient info to enable the invention to be put into effect
- Merrell Dow - a disclosure will anticipate an invention if it enables the invention to be "worked" or "practised"
- Disclosure - prior art must reveal an invention which, if performed, would necessarily infringe the patent --- disclosure must occur without further experiment or undue effort
- CONTRASTS ENABLEMENT - the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work - Synthon [2006]
- Disclosure and enablement also differ in terms of the role that the person skilled in the art plays
? The disclosure is either of an invention which, if performed, would infringe the patent, or would not (does the disclosure anticipate the patent) - the skilled person need not be able to work it
? This contrasts whether the disclosure was enabling - question is "no longer what the skilled person would think the disclosure meant but whether he would be able to work the invention which the court has held it to disclose" - Synthon [2006]
Secret or inherent use
- ISSUE - whether the existence of a previous secret of inherent use is enough to anticipate a subsequent patent
- A secret/inherent use occurs where something is created, usually either accidentally or as an unknown by-product of a process, without the public knowing of its existence
- While it was possible for a secret/inherent use to anticipate under the Patents Act 1949, this is no longer the case under the 1977 Act Merrell Dow v Norton [1996]
- Question of the status of secret/inherent use under the Patents Act 1977 was considered by the H of L
- In 1972 the claimant was granted a patent for the antihistamine terfenadine - a drug used in treating hay fever and other allergies
- Terfenadine transformed in the body into a number of different products (metabolites)
- While terfenadine was effective, it had a number of unwanted side effects
- As the initial patent was nearing the end of its duration, the claimant isolated and identified the particular metabolite that acted as an antihistamine - useful in the treatment of hay fever without any of the side effects associated with terfenadine
- It was accepted that prior to this the specific metabolite that acted as an antihistamine had not been identified
- In 1983 the claimant obtained a patent for the newly identified metabolite
- Specifically, it obtained a patent for the making of the metabolite within the body


Merrell Dow, the claimant, brought an action against Norton claiming that by supplying terfenadine the defendant was facilitating the making of the patented metabolite, thus infringing the second patent
- The defendants counterclaimed arguing that the second patent had been anticipated by prior use
- The argument for anticipation by use relied on the fact that terfenadine had been made available to and used by volunteers in clinical trials before the priority date of the patent
- Since the patented metabolite was produced in the livers of the volunteers when they took terfenadine, it was argued that the second patent had been anticipated and was thus invalid House of Lords
- Lord Hoffmann - while under the 1949 Act mere uninformative use of this kind would have invalidated the patent, this was no longer the case under the 1977 Act
- Lord H - while an invention might have been in existence before the priority date through a secret or inherent use, this was not sufficient in itself to destroy novelty Judgment itself - H of L - Lord Hoffmann
- An anticipation - the traditional English term for that part of the state of the art which is inconsistent with the invention being new
- Norton - said that the invention had been anticipated in two ways
? It had been used before the priority date - terfenadine was used by volunteers in clinical trials and they had made the metabolite and experienced its antihistamine effects
? That before the priority date the invention had been disclosed in the specification of the terfenadine patent, a publically available document which told one how to make terfenadine
? Hoffmann - "I shall call these two arguments anticipation by use and anticipation by disclosure"
- Anticipation by use
? Anticipation by use solely relies on the fact that the volunteers in the clinical trials took terfenadine and therefore made the acid metabolite
? THE OLD LAW - "there can be no doubt that under the Patents Act 1949, uninformative use... would have invalidated the patent"
? In s32(1)(e) - a grounds for revocation if the invention "is not new having regard to what was known or used, before the priority date of the claim"
? In Bristol-Myers' Application [1975] HL decided that use included secret or uninformative use
? A principle of old patent law - if the use would have been an infringement afterwards it must have been an anticipation before. For the purposes of infringement, it was not nec that D should have realised he was doing an infringing act and so such knowledge was therefore equally unnecessary for anticipation
? THE NEW LAW - Mr Floyd submitted that Bristol-Myers was still good law
? S2(2) - state of the art comprised "all matter" which had been "made available to the public" in any way including by "use"
? Mr Floyd said that "all matter" must include products or processes which conveyed no info about themselves
? The acid metabolite had been made available to the public by use even though such use conveyed no info to the public about the nature of the product or how to make it
? This argument dissolves when one looks "as one must, at Art 54" - provision makes it clear that to be part of the state of the art, the invention must have been made available to the public
? "An invention is a piece of information"
? "Making matter available to the public within the meaning of section 2(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"
? The uninformative consumption of terfenadine, which secretly or inherently produced the metabolite, did not reveal or disclose info that would have allowed either the volunteers or the public to make the metabolite in their bodies
? The 1977 Act - a substantial qualification to the old principle that a patent cannot be used to stop someone doing what he has done before
? If the previous use was secret or uninformative then a patent CAN be used to stop someone doing what he has done before
? Likewise, a gap has opened up between the tests for infringement and anticipation
? Acts done secretly or without knowledge of the relevant facts, which would amount to infringements, will not count as anticipations before
? The use of terfenadine in the clinical trials conveyed no info that would have enabled anyone to work the invention (it was not enough that it had in fact been made) - H of L held that the prior use was not anticipatory
? Mr Thorley - right in saying that his claim cannot be dismissed simply on the ground that making the metabolite is something which has been done before Anticipation by disclosure
? On this ground the respondents succeeded before Aldous J and the C of A
? Ground - that the disclosure in the terfenadine specification had made the invention part of the state of the art
? This argument relies not on the mere use of the product by members of the public but upon communication of the information that would inevitably lead to the creation of the metabolite - it doesn't matter whether they knew they were making the metabolite or not
? Q - "whether the specification conveyed sufficient information to enable the skilled reader to work the invention"
? Mr Thorley, claimants, said that no one can know about something which he does not know exists and if he does not know that the product exists, he cannot know how to work an invention for making that product
? The prior art contained in the terfenadine specification gave no indication that it would create the acid metabolite in the body and therefore contained insufficient info to enable the skilled reader to make the substance
? Hence, it did not make the metabolite available to the public
? "But the same thing may be known under one description and not known under another"
? The present question is essentially an epistemological one - "what does it mean to know something, so that it can be part of the state of the art?"
? There may be descriptions under which something may be known without anyone being aware of its chemical composition or even that it has an identifiable molecular structure
? Mr Thorley argues that patent law has a specialised epistemology and so says that for a substance to be known so as to be part of the state of the art within the meaning of s2, it must be known by its chemical composition and no other description will do
? Lord H - s2(2) does not purport to confine the state of the art about products to knowledge of their chemical composition
? It is the invention that must be new and not be part of the state of the art
? It is part of the state of the art if the information which has been disclosed enables the public to know the product under a description sufficient to work the invention
? "For most of the purposes of a product claim, knowledge of its chemical composition will be necessary to enable the public to work the invention. It is something they will need to know in order to be able to make it"

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