Patentability Of Inventions

Dr Amitava Chakraborti Assistant Controller Of Patents And Designs The Patent Office, Kolkata

What is Intellectual Property (IP)?

Real Property
tangible asset e.g. a house, a machine, a car, a watch

Intellectual Property
intangible asset e.g.
in the area of science & technology, an invention is IP in the area of business, a customer / price list is IP in the area of production, a secret production method is IP in the area of art, a particular way of representation is IP in the area of fashion, a brand / trade name is IP

What is Intellectual Property Right (IPR)?

Intellectual Property Right
not to be confused with IP it is a right vested in the asset, not the asset itself e.g.
an idea / invention is IP, a patent registration is an IPR a customer / price list is IP, a right of confidentiality is an IPR a secret production method is IP, a right to a trade secret is an IPR a particular way of representation is IP, copyright or a design registration is an IPR a brand / trade name is IP, a trade mark registration is an IPR
3

Intellectual Property Rights

Patents Designs Trade Marks Copyrights Geographical Indications

What is Patent ?
Intellectual Property Industrial Intellectual Property Ownership Nature of Property Intangible Transferable Grant from the Government y Monopoly of right y to the owner y for invention y on application y for limited period

What is a patent?
A patent is a legal title granting its holder the exclusive right to make use of an invention for a limited area and time by stopping others from, among other things, making, using or selling it without authorization.

Benefits Of Patent

The burden of duplication of the invention is avoided : it saves further spending of time and money; STOPS WATAGE OF RESOURCES.

Any interested person may buy the Patent, wherein the Patent becomes a nice tool for the transfer of technology. Patent provides protection to the Patentee, wherein, if the Patent is infringed, the Patentee may seek the legal remedies. Thus Patent is a form of social security to an inventor. Once, the life of the Patent is over, any person may freely, without paying any royalty to the Patentee, may enjoy the invention.

Amendments of Patents Act

Amendment of 1999 Amendment of 2002 (effective from May 2003) Amendment of 2005 (Ordinance of December 2004 Later ratified by Amendment 2005

Pre-amendment
No product on certain category of inventions Shorter term for drugs and foods related patents No living forms; neither process nor product

Amendment of 1999
Mailbox provision Exclusive marketing rights

Amendment of 2002 effective from May 2003

New definition of invention: product or process: Novelty, Inventiveness and Industrial applicability. Process for microorganisms patentable. Product patents in chemicals, pharmaceuticals, foods were not still allowable. EMR provisions still effective.

Mandatory disclosure of Geographical origin of the Biological material used: ground for opposition as well as revocation. Plants and animals including parts thereof explicitly excluded: exclusion encompasses variety, seeds, species etc. : essentially biological process for production or propagation thereof Microorganism: process only Mere traditional or indigenous knowledge excluded Twenty years term for all category of inventions

Bolar provision: using the invention for making a report to a regulatory authority: no infringement Importation of a product from a duly authorized person: not infringement of the patent right

Salient features of Patents Act 1970 after the ordinance of 2004 ratified by the Act of 2005
1. Section 5 repealed 2. Exclusive marketing rights repealed 3. Definition of medicine: deleted 4. The right of the patentee in respect of applications filed under Section 5(2) shall accrue from the date of the grant of the patent. 5. Deposit of biological materials in International depository institutes be made to complete the description of the biomaterials.

Definition of Invention under new Act Invention means a new product or process involving an inventive step. Inventive step means a feature that makes the invention not obvious to a person skilled in the art SEC 2.1.(j),(ja) Section 2(ac): capable of industrial application means that the invention is capable of being made or used in an industry

Inventions Not Patentable

Frivolous or contrary to well-established natural laws Contrary to law or morality or injurious to public health Scientific principle or formulation of abstract theory New property or use of known substance Mere use of known process, machine or apparatus Substance by mere admixing Mere arrangement/rearrangement/duplication of known devices Method of agriculture/horticulture Method of treatment of human beings, animals

Plants and animals as a whole or part thereof excluding the micro-organisms. Seeds, varieties and species and essentially biological processes Mathematical/business methods or a computer program per se or algorithms. Literary/dramatic/musical/artistic/aesthetic work. Mere scheme/rule/method for performing mental act or for playing game.

A presentation of information Topography of integrated circuits. An invention which in effect is Traditional Knowledge or which is an aggregation or duplication of Traditionally known properties or components.

"new invention" means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e. the subject matter has not fallen in public domain or that it does not form part of the state of the art;

"pharmaceutical substance" means any new entity involving one or more inventive steps;'.

3(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery if any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.For the purposes of this clause, salts, esters, ethers, polymorphs,metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;".

(ja) "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;';

Obvious The word obvious means plain, that is an invention is obvious if the technical effect achieved could be materialized easily by any skilled person in the Art who can assemble the prior arts and do it without any inventive ability.

Anticipation
NOVELTY-DESTROYING ELEMENTS

Prior Publication Prior Claiming Prior Public Use Prior Public Knowledge

OBVIOUSNESS ELEMENTS RELIED ON EXISTING KNOWLEDGE PRIOR PUBLICATION PRIOR PUBLIC USE PRIOR KNOWLEDGE EVERYTHING OTHER THAN PRIOR CLAIMING

ANTICIPATION UK PRACTICE

To anticipate the patentee's claim the prior publication must contain clear an unmistakable directions to do what the patentee claims to have invented (citation omitted) A signpost, however clear, upon the road to the patentees invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. [General Tire & Rubber Company v Firestone Tire & Rubber Company Limited, Limited, [1972] RPC 457].

Anticipation
As per US practice disclosure of a broad genus in a prior art reference is generally not considered novelty destroying as anticipating each individual member of the genus [ In re Arkley., 455 F.2d 586 (CCPA 1972)]. Arkley.,

To establish anticipation, it is required that the compound be individually disclosed in the prior art or disclosed as a member of recognizable class of compounds with common properties. [In re Arkley., 455 F.2d 586 (CCPA 1972), Arkley., In re Rushig, 343 F.2d 965 (CCPA 1965)]. Rushig,

In the EPO this is reflected in T_0007/86 in Xanthine derivatives :

A class of chemical compounds defined only by a general structural formula having at least two variable groups does not specifically disclose each of the individual compounds which would result from the combination of all possible variants within such groups (following decisions T 12/81 OJ EPO 1982, 296 and T 181/82 OJ EPO 1984, 401, point 7 of the Reasons).

Inherency
Anticipation is not avoided where the prior achievement was deliberate or necessary consequence of What was intended, even though the achiever did not Fully appreciate or recognize the uses, purposes or Properties of the product or process. Courts and practitioners Describe such inevitable though unappreciated anticipation as Anticipation by inherency. [Chisum on patents, Lexis Nexis $3.03]

Inherency/Inevitability Kirin-Amgen Inc. v Roche Diagnostics GmbH [2002] RPC 1: the law of patents is ultimately concerned with practicality, and so a prior art experiment which, when performed, reliably produced a particular result more than 99 percent of the occasions on which it is conducted would be regarded for the purposes of disclosure as inevitably leading to the result in question.

Mosaic citations:not permissible in the case of anticipation. In order to demonstrate lack of novelty the anticipatory disclosure must be entirely comprised within a single document. If more than one document is cited, each must stand on its own. The cumulative effect of the disclosures cannot be taken into consideration (Ammonia's Application, 49 RPC 409), nor may lack of novelty be established by forming a mosaic of elements taken from several documents (British Ore Concentration Syndicate Ltd v Mineral Separation Ltd, 26 RPC 124 at page 147; Lowndes' Patent, 45 RPC 48 at page 57); this may be done only when arguing obviousness. However if a cited document refers to a disclosure in another document in such a way as to indicate that this disclosure is intended to be included in that of the cited document, then the two may be read together as though they were a single document.[UK practice manual, paragraph 2.10].

PRIOR ART MUST BE ENABLING

Also to be novelty destructive the prior art must disclose : an enabling methodThe House of Lords discussed the need for "enabling disclosure" in Asahi Kasei Kogyo KK [1991] RPC 485. With regard to s.2(2), an invention cannot be said to have been made available to the public merely by a published statement of its existence (unless the method of working is so self-evident as to require no explanation); an enabling selfdisclosure is necessary. [UK manual, 2.10.2] The test for deciding whether a prior art anticipates an invention is that which infringes, if later, anticipates if earlier.

Most often biotechnological products, such as proteins are described either as a product of process or by some other unambiguous way of characterization. This applies for the characterization. patent claim as well as for the prior art. A substance will be art. novelty destroying when so many parameters are already available in the prior art that the biological substance is unambiguously identifiable in the prior art. Unfortunately art. biobio-molecules including proteins have low determinative value of physico-chemical parameters and one cannot physicounequivocally conclude that the said protein is automatically novel if the value of a certain parameter deviates only slightly from that of prior art. [P.G.Ducor, art. [P. Patenting the recombinant products of biotechnology, Kluwer Law International, p.13] 13] .

In case of traditional chemistry a purer composition is always held novel. ..By definition, pure materials necessarily differ from less pure or impure materials and if the latter are only ones existing and available as a standard of reference the pure materials are new with respect to them[In re Bergstrom, 427 F.2d them[In 1394,166 USPQ 256,262(CCPA,1970)][Ducor,ibid]. 256,262(CCPA,1970)][Ducor,ibid]. Normally recombinant proteins are usually obtained in much purer form than the natural proteins. And if the position of the Bergstrom is strictly followed all recombinant proteins should be treated as novel. In Ex parte Gray the PTO board, at lest indirectly, held a recombinant human nerve growth factor anticipated by its natural counter part

Another important issue in respect of the recombinant proteins is that naturally occurring proteins are frequently linked to sugar moiety whereas recombinant proteins are not. In principle such natural proteins not. should not anticipate the recombinant proteins. proteins. However, in Ex parte Gray the recombinant non-glycosylated form was nonfound anticipated by natural glycosylated form [Ex parte Gray, 10USPQ 2d 1922 10USPQ (1989)]. 1989)].

Inventive Steps
In US the current practice of analysis of inventiveness as applied to these molecules of traditional chemistry are based on the findings of the presence of three elements: Structural similarity between the claimed invention and the prior art. Prior art motivation Method of making the claimed compound is disclosed in the prior art (prior art enablement).

Structural similarity The doctrine of structural similarity was spelled in In re Hass [141 F.2d (CCPA 1944)] and In re Henze [181 F.2d 196 1944)] (CCPA 1950)]. In these cases the claimed compounds were 1950)]. homologues of prior art compounds. A long line of cases show compounds. that prior art structural similarly can be extended to adjacent and non-adjacent homologues, positional isomers, N-alkyl nonsubstituted amines, alkylated aromatic compounds and other structurally similar compounds. [Ducor, ibid, p.25]. compounds. 25]

Prior art motivation Usefulness of structurally similar compounds of the prior art provide motivation to the invention. In re Stemninsky [444 F.2d 581,170 USPQ invention. 581, 343(CCPA 1971)] 343(CCPA 1971)] the claimed Tin composition had a lubricating property. property. The prior art substances lacked any known utility. The court utility. held that without any known utility of the prior art compounds, the applicants were not motivated by the prior art. art. In 1979, In reGyurick the CCPA held : 1979, An element in determining the obviousness of a new chemical compound is the motivation of one ordinary skilled in the art, to make it. That motivation is not abstract, but practical, and is always related to the properties or uses one person skilled in the art would expect the compound to have, if made.

Claimed invention Prior Art Similar Compound

Anthelminthic property Intermediate Of a reaction

Prior art analogues

Tri-orthoester in fuel For dewatering purposes

Tetra-orthoester as water Scavenger in hydraulic fuel

Claimed invention

A composition of Hydrocarbon Fuel and tetraorthoester Producing less soot during coombustion

In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed.Cir.1990)

In In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed.Cir.1990) (en banc), the court noted the effect of unexpected results in the obviousness determination for chemical entities, but rejected as a requirement for establishing prima facie obviousness that there be an expectation or suggestion in the prior art that the claimed compound will have similar utility as the one newly discovered by applicant. The previously disclosed properties of a prior art compound can provide sufficient motivation to trigger a prima facie case of obviousness case, even though the new compound has unrelated, different and unexpected properties [Ducor, p.27].

Prior art enablement Claimed invention Physiologically Active Furanoside

Prior art analogue

No enabling method

In re Hoeksema, 399 F.2d 269, 274, 158 USPQ 596(CCPA, 1968) ..unless there is some known or obvious way to make the Compound, the invention is nothing more than a mental concept Expressed in chemical terms and formulae on a paper

If the prior art of record fails to disclose or render obvious a method for making a claimed compound, at the time the invention was made, it may not be legally concluded that the compound itself is in the possession of the public. In this public. context, we say that the absence of a known or obvious process for making the claimed compounds overcomes a presumption that the compounds are obvious, based on close relationships between their structures and those of prior art compounds.( Ibid-601). compounds. Ibid-601).

Both the Patent Act and the case law give indication concerning the reliability of the method constituting an enabling disclosure. According to the law of enablement an enabling method should not require undue experimentation from the skilled person to practice the invention [Lindemann Maschinenfabrik, GmbH v. American Hoist, 730 F.2d 1367,231 USPQ 81( Fed. Cir. 1986)]. In other words, it must provide a reasonable expectation of success to obtain the invention. [ In re Dow Chemical Co. 837 F.2d 469, 5 USPQ 2d 1529 ( Fed. Cir. 1985)].[Ducor,ibid,p.29].

In UK: the test of obviousness is as far as is possible, be an objective one. The question is whether the invention would have been obvious to a skilled person in the art, and not whether it was or would have been obvious to the inventor or to some other particular worker. In the judgment of the Court of Appeal in Windsurfing InternationalInc. v Tabur Marine (Great Britain) Ltd, Ltd, [1985] RPC 59 (in considering whether claims relating to a sailboard were obvious) it was stated that the question of whether the alleged invention was obvious has to be answered objectively by reference to whether, at the material time (that is, immediately prior to the priority date), the allegedly inventive step or concept would have been obvious to a skilled addressee and that what has to be determined is whether what is now claimed as inventive would have been obvious, not whether it would have appeared commercially worthwhile to exploit it..[UK practice manual, paragraph 3.03].

EPO: EPO: To assess inventive step, the boards normally apply the "problem and solution approach. This consists essentially in approach. (a) identifying the "closest prior art", (b) assessing the technical results (or effects) achieved by the claimed invention when compared with the "closest state of the art" established, (c) defining the technical problem to be solved as the object of the invention to achieve these results, and (d) examining whether or not a skilled person, having regard to the state of the art in the sense of Art. 54(2) EPC, would have suggested Art. 54( the claimed technical features for obtaining the results achieved by the claimed invention (see also Guidelines, C-IV, 9.5). [EPO case laws, p.101]. ). 101]

Rebuttal of obviousness Rebuttal of obviousness can be proved by showing (1) Lack of structural similarity with prior art compounds (2) Lack of prior art motivation (3) Lack of enabling methods. methods. In Re Papesh, [315 F 2d 381, 137 USPQ 43 CCPA 1963] the 381, 1963] US court established the doctrine of unexpected properties. properties. The applicant had claimed a pyrazole compound with antiantiinflamatory property. The prior art homologues did not have property. this property. The PTO refused the patent, CCPA upheld the property. patent overturning PTO Boards decision of refusal while accepting the applicants argument of unexpected properties of the claimed compounds. compounds.

Unexpected property: difference in degree property: The US court in In re Papesh held that a mere difference in degree is not the marked superiority which ordinarily will remove the unpatentability of adjacent homologues of old substance. However, regarding the quantitative departure in respect of the prior art as far degree of superiority of the same property is at issue there is no straightforward answer. In the answer. United States v Ciba Geigy a thiazide anti-hypertensive anticompound ten times more potent than prior arts was held nonnonobvious. obvious. In re Lunsford, an increase in potency of 4.4 to 7.0 times anti-convulsant potency was deemed non-obvious. In ex antinon-obvious. parte Thim, a pro-insulin analog leading to an expression yield pro1.6 to 2.0 times greater than pRior art pro-insulin was held proobvious because the yield was not sufficient to rebut the prima facie obviousness. In EPO technical board of appeal in Biogen obviousness. Alpha Interferon case, an interferon having a 30-fold 30increase in antiviral property was held non-obvious[ Ducor, non-obvious[ p.31,ibid], . 31,ibid],

Claimed invention Pyrazole compound Papesh Prior art analogue United States v Ciba-geigy Thiazide antihypertensive compound

Anti-inflammatory Property No known utility In re Papesh

Ten times more Potent than prior art analogue

In re Lunsford Claimed Anticonvulsive compund

4.4-7.0 times More potent Than prior art analogue

Molecular modification In ex parte Anderson [ 30 USPQ 2d 1866 (1994)] the prior art claimed a DNA sequence encoding for human Interleukein 3 (IL-3). The (ILdifference with the prior art was in the claimed compound at position 8, there was a proline moiety whereas in the prior art compound in the same position there was a serine molecule.

Position 8 Prior art IL-3

O HO NH2 OH

Serine (Ser)

Claimed Human IL-3 Position-8

H N O OH

Proline (Pro)

The PTO Board observed that: ..the primate IL-3are part of a family proteins which are ILsimilar in their amino acid sequence but are minor variants or point mutations of each other.a single variation in the amino acid sequence does not normally change the activity and function of the protein unless the single variation is in a critical region of the protein..Appellants have not provided evidence that the protein coded for by the claimed DNA is any different from that of the prior art in its chemical properties.

In ex parte Thim: The applicant claimed a proThim: proinsulin having a C-peptide (human proinsulin is comprised of three chains, A, B and C, in the insulin the two chains are combined eliminating the third chain, i.e. the C chain consisting of thirty amino acids) encompassing only two amino acids, selected from Arg-Lys, Lys-Lys and Lys-Arg. ArgLysLys-Arg. Facing the objection of prima facie obviousness from the examiner he argued that the yield of the claimed protein is 1.6 to 2.0 mmol/l whereas the yield of the prior art proinsulin with a C chain of ArgArg-Arg is only 1.0 mmol/l. The PTO Board ruled mmol/l. that such a difference in change did not constitute unexpected property. property.

Ex Parte Thim Insulin

NH2

O H2N NH2 OH
HN NH NH2 OH

Prior Art 1.0 mMol/l Arg-Arg

Lysine (Lys)

Arginine (Arg)

Claimed Invention

Arg-Lys, Lys-Lys and Lys-Arg 1.6-2.0 mMol/l

In Biogen T 301/87 the technical board of appeal of EPO had to decide the obviousness of Interferron 2 over its nearest known prior art Interferron 1. Admitting that the claimed compound is structurally close to the prior arts the board held the alleged invention as non-obviouness judged from the nonfact that the claimed compound is thirty times more potent in antiviral property than its prior art analogue. Claimed IFN, Alpha-2

Thirty Times More potent Prior art IFN, Alpha-2

Doctrine of equivalents
H C N S
CH3 CH3

CH-CO-NH

CH CO

NH2

CH

COOH

6 Amino benzyl penicillin

CH-CO-N NH C CH3

CH CO

H C N

CH3 CH3

CH

COOH

CH3

Hetacillin

If a compound is pharmacologically active it is said to be a drug and a compound after being administered is metabolized in vivo, into an active compound it is called a pro-drug. An interesting example is Ampicilin and Hetacillin,, an Acetone adduct of Ampicillin. Hetacillin hydrolyzes to ampicillin in the body, immediately after its administration. House of Lords held import of Hetacillin in UK as an act of infringement to Ampicillin patents. It was held that Hetacillin was ampicillin in disguise. [1977 FSR 215 ]. [Doctrine of equivalents or Pith and Marrow test]

Active Metabolites Active metabolite, as the name implies, is a compound, which is produced in the body upon administration of a drug and is the active end product, which produces the desired result. If the subject matter complies with the requirement of Novelty and inventive step the active metabolite should be patentable. Terfenadine Formula II

Fexofenadine Formula I

Merrel Dow patented the antihistaminic drug Terfenadine, GB1413138, which expired in 1992. After the expiry of the terfenadine patent a generic manufacturer started preparing this compound. Meanwhile, MD discovering the active metabolite patented the same GB 2048258 and subsequently sued the generic manufacturers on the ground that generic manufacturers infringed the patent of active metabolite by selling the drug terfenadine, thereby supplying to the consumers a means for producing the active metaboliteit is said, the defendants are supplying a means for putting the invention into effect [ 1995 RPC 236]. The defendants filed a suit for counter revocation. In the Patents Court the judge found the patent of active metabolite bad for lack in novelty and ordered it to be revoked. An appeal to the Court of appeal was dismissed. On a further appeal to the House of Lords, the sole issue was whether, so far as the claim to the metabolite included its manufacture by the action of the terfenadine in the human body, the patent, in suit was invalid because the invention was not new.

In this case, the 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 in the form of isolating or synthesizing the acid metabolite. But for the purpose of working the invention by making the acid metabolite in the body by ingesting the terfenadine, I think it plainly was. It enabled the public to work the invention by making the acid metabolite in their livers. The fact that they would not have been able to describe the chemical reaction in these terms does mean that they were not working the invention. Whether or not a person is working a product invention is an objective fact independent of what he knows or thinks what he is doing (the possession may be different when the invention is a use for a product; in such a case, a person may only be working the invention for a patented purpose). [Lord Hoffman, 1996 R.P.C. 90].

In Germany the courts found that there was no infringement. The plaintiff alleged that the defendant had infringed the patent suit by marketing pharmaceutical products containing terfenadine as an active anti allergic agent. Lower court held that the patent DE3007498 was not infringed. The Regional Court Of Appeal in Munich also held that the patent on acid metabolite was not infringed [1998FSR145]. In USA, the patent of terfenadine acid metabolite was held valid but not infringed [1998FSR158].

Schering Corp. v. Geneva Pharms., Inc. et al U.S.. 4,659,716 Active metabolite DCL

Loratidine

Desloratidine

716 patent expired. Scherring sued for infringement of DCL Patent.

Scherings theory was that every time a patient ingests loratadine, the patients body produces DCL (the patented substance) as a metabolic byproduct. So even if the generic drug companies sold only unpatented loratadine, they would cause the unauthorized production of patented DCL in the patients bodies. And that would infringe the new patent. The court invoked the doctrine of inherent anticipation: Since the prior art patent disclosed a process administering loratadine to patients that inherently produces DCL as a byproduct, in effect the loratadine patent disclosed DCL production. And it did so before the priority date of the DCL.

Isomers

EPO however, considers an optical isomer to be novel per se and holds that the patentability of these compounds are basically a question of obviousness [Hoecst Enantiomers , T 296/87. The UK and US practice is also in the same line as that of EPO [ ICI (Howes) application [ 1977] RPC 121 and In re May and Eddy, 197 USPQ 601 ( CCPA 1978) ].

If a molecule contains an asymmetric carbon atom it is obvious that it will have enantiomers. Also it is obvious that methods of isolating such enantiomers can be done by any standard method available. Also, as of today it is an established fact that one enantiomer usually have a better physiological property than another. However, obviousness can be rebutted only if it is shown that an enantiomer isolated is having a surprisingly superior property.

Decisions of the Technical Boards of Appeal of EPO T 0012/81 1.A compound having the formula (FORMULA) in the form of the diastereomer whose melting point is 158 - 159C, and its physiologically tolerated acid addition salts 4. A process for preparing the compound according to Claim 1, characterised in that 1-(4-chlorophenoxy)-1-(1-imidazolyl) - 3,3dimethyl -2-butanone, having the formula (FORMULA) is stereoselectively reduced with secondary alcoholates in the presence of a diluting agent and the product is optionally converted into the salts by reaction with acids.

The examining division refused the case on the ground that the subject matter was not new. DE-A 2 333 354 and 2 333 355 described a process for the reduction of alpha-phenoxy-alpha-(1-imid-azolyl)-ketones, including 1-(4-chloro-phenoxy) - 1-(imidazol-1-yl) - 3,3-dimethylbutan2-one, in accordance with process variant b described on page 6 of the latter document using aluminium isopropylate as an agent, to the corresponding secondary alcohols, which could give rise to two diastereomeric forms. These documents anticipated all the technical features of Claim 2, so that the product of this reduction process, i.e. the substance according to Claim 1, also formed part of the state of the art.

The Board held that ; [T]he teaching of the cited document also covers the substance which is the inevitable product of the reduction of the p-chloro-phenoxy ketone in the above mentioned list and Example 3 in Variant b While dismissing the appeal the board held that : In the case of one of a number of chemical substances described by its structural formula in a prior publication, that substance's particular stereospecific configuration (threo form) - though not explicitly mentioned - is anticipated if it proves to be the inevitable but undetected result of one of a number of processes adequately described in the prior publication by indication of the starting compound and the process. In such cases, novelty by selection cannot be claimed, since none of the possible combinations of all the listed starting compounds and process variants introduce a new element - indispensable for substance selection - that would result in a true and not just "identical" modification of the starting substances..

T 296/87 Hoechst/ Enantiomers D-"-phenoxy-propionic acid derivatives of formula I Opposition division refused the patent. While ascertaining the novelty of the compounds in question the TBA commented: A chemical substance is held to be new if it differs from a known substance in a reliable parameter. The configuration is such a parameter. If the prior art describes specific racemates in more detail by reference to their structural formulae, that alone does not disclose their specific configurations (here D- enantiomers); see points 6 and 7 of the Reasons (in conjunction with T 12/81 "Diastereomers", T 181/82 "Spiro compounds" and T 7/86 "Xanthines" in OJ EPO 1982, 296; 1984, 401; and 1988, 381 respectively). The TBA refused to acknowledge any inventive activity of the compound in claim 1 on the basis of a 4 times enhanced effect

T 0181/82 1-oxa-3,8-diaza-spiro(4,5)-decane derivatives

R CH2 CH3
1

R2
3

O
R5

N N
R CH2 CH3
2

O
n

The claims were refused on the ground of the lacking of inventive step. Nearest state of the art cited was DE-A-2 606 026. This document describes similar compounds having property of using as UV stabilizers.

Industrial Application Can be made or used in any kind of industry? Chiron and others Vs Murex Diagnostic and others. [FSR (1996) 153(CA)].

The Patent at issue was related to the Hepatitis C virus. In the 1970s it virus. 1970s became apparent that recipients of blood transfusions were contracting a form of Hepatitis, which was neither Hepatitis A nor Hepatitis B. This was known as Non A , Non B Hepatitis(NANBH). Throughout the 1970s and Hepatitis(NANBH). 1970s 1980s 1980s numerous research groups, including some of the defendants tried to identify the etiological agent responsible for NANBH. NANBH. The English court of appeal held the second part of claim 11 (and other claims dependant on it) as invalid which encompasses:encompasses: a polypeptide in substantially isolated form .. whose sequence is encoded in a poly nucleotide selectively hybridizable with the polynucleotides as shown in figures .. ..

.. we accept the polypeptides claimed in the second part of the claim can be made . But the sections require that the invention can be made or used in any industry so as to be capable or susceptible of industrial application. The connotation is that of trade or manufacture in its widest sense and whether or not for profit. But industry does not exist in that sense to make or use that, which is useless for any known purpose. [1997 RP.C., 535, CA].

The US Supreme Court in Brenner V. Manson first confirmed the requirement of utility in US law. The claimed process produced a previously known compound without any known utility but several of its homologues were clearly useful. The court decided that a mere research interest or further investigation was not to be construed as a utility. [Brenner V. Manson, 383, U.S.S 19, 148 USPQ 689 (1966)].

Discovery v Invention The Courts in UK raised this issue It is the practical application of an idea or discovery which leads to patentability. It leads to patentability even if, as frequently happens, the practical application of the discovery is inherent in the discovery itself or is obvious once the discovery has been made and stated. [Nicholas LJ . Quoted in Chiron Vs Murex diagnostic Ltd. Etc. FSR[1996]153,176.It is trite law that you cannot patent a discovery but if on the basis of the discovery you can tell the people how it can be usefully employed, then a patentable invention may result. This is in my view would be the case, even though once you have made the discovery, the way in which it can be usefully employed is obvious enough..[Whitford J. in Genentech Inc.s Patent(1987) R.P.C.553 at 566].

In a German case decided by the German Federal Court it was held that discovery is finding something hitherto fore unknown; it is therefore purely perception. A discoverer turns into an inventor, however, if he provides- based on his perception instructions for purposeful industrial action.[IIC, 1979,494]. In the United States, similar views have been expressed. The US Supreme Court in Funk Brothers Seed Co. v Kalo Innoculant Co., [333 U.S. 127,76 U.S.P.Q. 280(1984) ] decided that an unknown compound or composition merely discovered from the nature is not patentable. The court observed, The patents cannot be issued for the discovery of the phenomenon of the nature.

This concern in the field of biotechnology was raised in 1992 when National Institute Of Health (NIH) filed applications in the US to patent partial gene sequences or Expressed Sequence Tags (ESTs) of unknown function. In a preliminary report rejecting these applications, one of the reasons given by the USPTO was that the claims lacked patentable utility. [ Wee Loon, IIC, 4/2002 p. 393].

Thanks