Article contributed by: Shann Kerner, Ph.D., Andrej … Requirements for Patentability of Inventions...

Examples Requirements for Patentability of Inventions in US and Foreign Jurisdictions

Article contributed by Shann Kerner PhD Andrej Barbic PhD Kyle Robertson

Wilmer Cutler Pickering Hale and Dorr LLP

I Introduction

At precisely which stage of an inventions development should an inventor apply for patent protection This question should figure prominently on the mind of every inventor in-house attorney and licensee Few practitioners and readers will find it surprising that the answer is ldquoit dependsrdquo We have set out to evaluate how patentability requirements in foreign jurisdictions may influence what is the best time to file a patent application In particular we have focused on the requirements for and restrictions on experimental datamdashworking and prophetic examplesmdashin foreign jurisdictions querying our foreign associates1 about the law and practice in their jurisdictions In this article the degree of description detailed is that considered necessary to obtain a claim even as narrow as a species claim

It is important at the outset to recognize that national policy decisions control the requirements of a particular patent regime regarding examples and experimental data Each particular country has determined what degree of description is required by an applicant in order to enjoy the exclusive right to keep others from practicing his invention Further while the wording of various countries statutes is effectively the same the manner in which the law is applied may differ The requirement of examples is closely related to the amount of uncertainty perceived in a certain scientific field Working examples and experimental data help alleviate concerns of uncertainty and unpredictability in an applicants disclosure Disciplines traditionally considered more predictable such as the mechanical and electrical arts are less likely to require working examples Unpredictable arts such as inventions in the fields of biology and chemistry have more rigorous requirements and are generally more likely to require a working example to satisfy patent examiners This article treats the requirements of each country for predictable and unpredictable arts separately since their respective patent offices often apply different rules in the two areas

copy 2009 Bloomberg Finance LP All rights reserved Originally published by Bloomberg Finance LP in the Vol 3 No 36 edition of the Bloomberg Law Reports ndash Intellectual Property Reprinted with permission The views expressed herein are those of the authors and do not represent those of Bloomberg Finance LP Bloomberg Law Reportsreg is a registered trademark and service mark of Bloomberg Finance LP


We first examine the requirements for experimental data and examples for patents in the United States as a comparative reference point and then proceed to the requirements in Australia Canada China European Patent Office India Japan Korea South Africa and Taiwan

II Requirement for Examples in the United States

In the United States experimental examples whether working or prophetic are not required if the claimed invention is otherwise enabled As used herein a ldquoworking examplerdquo is a description of work actually performed for which data are available In contrast a ldquoprophetic examplerdquo describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved The Manual of Patent Examining Procedure2 published by the US Department of Commerce Unites States Patent and Trademark Office (ldquoMPEPrdquo) sect 216402 states

Compliance with the enablement requirement of 35 USC sect 112 first paragraph does not turn on whether an example is disclosed An example may be lsquoworkingrsquo or lsquopropheticrsquo The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation In re Borkowski 422 F2d 904 908 164 USPQ 642 645 (CCPA 1970)

Not surprisingly the requirement for working examples is closely related to the predictability of the art According to the MPEP

The ldquopredictability or lack thereofrdquo in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains then there is predictability in the art On the other hand if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains then there is lack of predictability in the art Accordingly what is known in the art provides evidence as to the question of predictability

MPEP sect 216403


A Predictable Arts

The mechanical and electrical arts are considered to be predictable and a single embodiment may enable a broad claim In re Vickers 141 F2d 522 526ndash27 61 USPQ 122 127 (CCPA 1944) In re Cook 439 F2d 730 734 169 USPQ 298 301 (CCPA 1971) As in the majority of other countries the United States typically does not require working examples in the predictable arts However as will be seen below some other countries do require working examples in the unpredictable arts in circumstances in which the United States would not

B Unpredictable Arts

In biological chemical and pharmaceutical inventions ldquo[l]ack of a working example is a factor to be considered [by the USPTO]rdquo as these fields are considered ldquounpredictable and undeveloped artrdquo MPEP sect 216402 Furthermore working examples are often helpful in enabling a claim that is more broad than a single embodiment

A single working example in the specification for a claimed invention is enough to preclude a rejection which states that nothing is enabled since at least that embodiment would be enabled However a rejection stating that enablement is limited to a particular scope may be appropriate

Id

Special situations arise with pharmaceutical and biotechnological inventions allegedly having therapeutic utility An applicant may be required not only to include in vitro working examples but also to show correlation between an in vitro example and claims that cover in vivo effect

The issue of lsquocorrelationrsquo is related to the issue of the presence or absence of working examples lsquoCorrelationrsquo as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use An in vitro or in vivo animal model example in the specification in effect constitutes a lsquoworking examplersquo if that example lsquocorrelatesrsquo with a disclosed or claimed method invention If


there is no correlation then the examples do not constitute lsquoworking examplesrsquo

Id

In applications directed to inventions in the unpredictable arts the disclosure of a single species usually does not provide an adequate basis to support generic claims In re Soll 97 F2d 623 624 38 USPQ 189 191 (CCPA 1938) However a generic claim may be enabled by inclusion of a sufficient number of working examples As explained in the MPEP

For a claimed genus representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art (in view of level of skill state of the art and the information in the specification) would expect the claimed genus could be used in that manner without undue experimentation Proof of enablement will be required for other members of the claimed genus only where adequate reasons are advanced by the examiner to establish that a person skilled in the art could not use the genus as a whole without undue experimentation

Id

Similarly technology involving unpredictable factors such as most chemical reactions and physiological activity may require more for enablement In re Fisher 427 F2d 833 839 166 USPQ 18 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity) What constitutes sufficient ldquocorrelationrdquo depends on the state of the prior art

[I]f the art is such that a particular model is recognized as correlating to a specific condition then it should be accepted as correlating unless the examiner has evidence that the model does not correlate Even with such evidence the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition In re Brana 51 F3d 1560 1566 34 USPQ2d 1436 1441 (Fed Cir 1995) (reversing the PTO decision based on finding that in vitro data did not support in vivo applications)

Id


In certain instances insufficiency of working examples can be remedied by post-filing submission of data for example to traverse a rejection of claims as lacking enablement lacking utility or being obvious3 A commonly used procedure for submission of evidence to the USPTO is a declaration under 37 CFR sect 1132 In particular such a Rule 132 declaration can be used (a) to show what one skilled in the art knew at the time of filing the application for enablement purposes (in lieu of references) (MPEP sect 216405) (b) to rebut a prima facie case of no specific and substantial credible utility (MPEP sect 2107) or (c) to provide evidence of secondary considerations to rebut an obviousness rejection (eg with unexpected results supported by the declaration)

Thus in the unpredictable arts United States practice often requires working examples to enable both specific and generic claims and to correlate in vitro and in vivo relationships In most circumstances these examples must be included in the application as filed although there are circumstances in which later filed examples will be considered US practice differs somewhat from that many other countries such as those described below in terms of both timing and in the level detail required

III Foreign Country Requirements Individual Country Details

A Australia

Under Australian law there is no test for enablement per se The closest is the requirement under section 40(2)(a) of the Australian Patents Act 1990 This section states that

(2) A complete specification must (a) describe the invention fully including the best method known to the applicant of performing the invention

The test for determining whether the invention has been sufficiently described was considered by the High Court of Australia in Kimberly-Clark Australia v Arico Trading Intl Pty Ltd 50 IPR 513 ldquoThe question is will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or prolonged study of matters presenting initial difficultyrdquo (emphasis added)

Ascertaining whether the invention has been fully described therefore will be determined with reference to the knowledge of the skilled person and the nature and degree of knowledge of that hypothetical skilled person will depend upon the


facts in each case Typically a sufficient description of the invention can be achieved by including a description of one or more ldquoembodimentsrdquo of the claimed invention in the specification

With regard to the time at which the specification must fully describe the invention including the best mode recent authority4 has established that the relevant date for judging sufficiency of the description is no earlier than the date of grant of the patent in Australia This is different from practice in the United States where the sufficiency of the description is based on the application as filed However the safer approach is to ensure that the description is sufficient at the time of filing

1 Predictable Arts

Working examples in Australia are desirable but not necessarily essential to enable inventions in the predictable arts Australias absence of a requirement for working examples in the predictable arts is similar to the United States stance on the matter but Australian practice may make inclusion of working examples highly desirable in situations where they would not be required in the United States

2 Unpredictable Arts

For product and process inventions in the unpredictable arts the compounds must be suitably described to enable the skilled person to produce the claimed product If data is not available at the time of filing prophetic examples are allowable and should be written with a level of detail equivalent to that of a working example However in Australia it is possible to amend the specification to add working examples as long as the amendment does not result in the claims encompassing matter that was not ldquoin substance disclosedrdquo in the specification as filed Alternatively supporting data can be provided to the Examiner during prosecution rather than added to the specification by amendment

For a ldquomedical userdquo claim a working example containing pharmacological data is typically not required However a detailed example describing the treatment of a patient with the composition is required in practice even if it is prophetic Additionally an example with in vitro data may enable a medical use claim in humans or animals if a person of ordinary skill in the art could perform the method in vivo without undue experimentation and there is at least some utility for administering the compound to treat the defined disease


Thus in Australia working examples are preferred but not strictly required as described in Kimberly-Clark Australia In practice the Australian requirements are much the same as in the United States with the important difference that Australia permits a specification to be amended to add working examples

B Canada

According to the Canadian Patent Act5 the specification of a patent application must

a) correctly and fully describe the invention and its operation or use as contemplated by the inventor

b) set out clearly the steps in a process or the method of making or using a machine or composition of matter in such full clear concise and exact terms as to enable any worker skilled in the art to make or use it

c) in the case of a machine explain the principle of the machine and describe the best mode

d) in the case of a process explain the necessary sequence if any of the various steps so as to distinguish the invention from other inventions

Under Canadian patent law a full and enabling description is required to permit ldquoa person skilled in the artrdquo to understand and make the invention6 In addition the description is the window through which one views the claims (ie in Canada the claims of a patent are to be read ldquopurposivelyrdquo and a purposive construction of the claims is based on the unimaginative skilled technicians reading of the description)7 For purposes of enablement a ldquoskilledrdquo reader should not be required to carry out ldquounduerdquo experimentation but a certain amount of ldquoroutinerdquo experimentation is acceptable

If available data to support utility of the invention should be included in the application However if the utility of the subject matter which forms the basis of a claim is not readily apparent to a worker skilled in the art then utility must be established either through direct demonstration (ie by examples of post-filing submission of experimental results proving the utility of the invention) or in the absence of such results through ldquosound predictionrdquo It should be noted that Canadian Examiners are under no obligation to review post-filing submissions

The doctrine of ldquosound predictionrdquo was established by the Supreme Court of Canada in Apotex Inc v Wellcome Foundation Ltd (2002) 21 CPR (4th) 499 The purpose of ldquosound predictionrdquo is to balance the public interest in having early


disclosure of new and useful inventions prior to full verification of utility while avoiding a grant of patent rights based on only speculative information Assuming an invention is new and nonobvious the Supreme Court identified a three-component test that must be satisfied in order to obtain a patent through reliance to one degree or another on a sound prediction of the claim scope desired

a) there must be a factual basis for the prediction b) the inventor must have at the date of the patent application an articulable

and lsquosoundrsquo line of reasoning from which the desired result can be inferred from the factual basis and

c) there must be proper disclosure by a full clear and exact description of the nature of the invention and the manner in which it can be practiced

Id (emphasis added) The Supreme Court of Canada noted that the soundness of the prediction is a question of fact and that cases will turn on the specific details associated with the discipline to which the subject matter relates and the evidence presented Subsequent case law at the Federal Court of Appeals level suggests that the soundness of the prediction is to be assessed as of the Canadian filing date and not the priority date8

1 Predictable Arts

Working examples are not specifically required to satisfy the enablement requirement in Canada This position is in harmony with the United States position that working examples are not usually necessary in the predictable arts


Examples may be required however to enable a Canadian apparatus product or process claim in the unpredictable arts Prophetic examples will suffice if the utility of the claim can rely on the doctrine of ldquosound predictionrdquo

In the unpredictable arts the requirement of examples turns on the application of ldquosound predictionrdquo While compound claims do not specifically require characterization data the Canadian Patent Office may question the validity of a product containing the compound in cases where the compound is a part of a novel or poorly documented class in the art or if the reactions used to make the claimed compound is uncommon or complicated In such cases exemplary support may be required to enable the claim9


The utility of a ldquomedical userdquo claim must be established either experimentally or through the doctrine of ldquosound predictionrdquo If the compositions used in the medical use claims are known experimental data are required to establish the claimed use The case law discussed above has established that in vitro data may be sufficient to soundly predict utility of a medical use claim in humans

Submission of data during examination is allowed to show that the invention as described in the application when filed was operable or reduced to practice However because Canadian Examiners are under no obligation to review post-filing submissions data to support utility of the inventions should be included in the application For a second medical use claim (ldquoSwiss-stylerdquo claim) working examples are required

Thus as applied Canadian practice typically requires working examples for inventions in the unpredictable arts This is similar to the United States approach where working examples are usually highly beneficial but are not always specifically required

C China

Article 26 paragraph 4 of the Patent Law of the Peoples Republic of China (ldquoPatent Lawrdquo) states in part ldquoThe claims shall be supported by the description and shall state the extent of the patent protection asked forrdquo

In practice this provision requires that the specification of a patent provide a sufficient number of examples to allow a person skilled in the art to understand how to carry out the invention and to determine that the invention when it is carried out will achieve the effect as expected through the entire scope of the claims The number of examples needed in the description varies according to the field of invention

In addition Rule 18 of the Implementing Regulations of the Patent Law provides a best mode requirement

The description shall contain [ ] [a] specific mode for carrying out the invention or utility model indicating in detail the optimum mode contemplated by the applicant for carrying out the invention or utility model this shall be done in terms of examples where appropriate and with reference to the drawings if any (emphasis added)


1 Predictable Arts

Chinese law does not have specifically required examples for inventions in the predictable or unpredictable arts Examples however should be used where appropriate to satisfy the ldquooptimumrdquo mode requirement In the predictable arts prophetic examples satisfy this requirement as they do in the United States


Although there is no statutory requirement for examples in practice inventions in the unpredictable arts such as chemistry and pharmacology require such examples for patentability A claim must be enabled in the application as filed as submission of data during examination in support of enablement is not allowed On the other hand comparative data with prior art species in support of inventive step may be accepted

As set forth in the Examination Guidelines of Chinese Patent Office if the alleged technical effect or use of a chemical invention is unpredictable to those skilled in the art the specification must provide experimental data to show one alleged technical effect or use which means that at least one working example with experimental data is necessary For the purposes of this requirement a chemical invention includes a chemical product and its use The Examination Guidelines do not specifically require experimental data for a chemical process invention but we expect that it could be beneficial to provide such data if it is available

In chemical and pharmaceutical arts characterization data for at least one compound is required to enable a compound claim Similar to experimental data for a chemical process invention if an invention relates to preparation or use of a known product characterization data may not be necessary if the preparation does not affect the properties or use of the final product

Although methods of treatment are not patentable per se medical use claims are patentable An example providing in vitro data will normally suffice to enable a medical use claim if a person skilled in that art would consider the in vitro model a good predictor of in vivo results Note that prophylactic methods and methods of immunization of humans are regarded as methods of treatment for diseases and are not patentable


Thus in China patentability of inventions in the unpredictable arts is limited and such inventions must be supported by working examples This is somewhat different than in the United States where it may be possible to enable a claim in the unpredictable arts using a prophetic example

D European Patent Office (EPO)10

Article 83 of the European Patent Convention (EPC) provides ldquoThe European patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the artrdquo

In addition Rule 42 of Chapter II of Part III of the Implementing Regulations to the Convention on the Grant of European Patents entitled ldquoContent of the descriptionrdquo provides that ldquo1) The description shall [ ] (e) describe in detail at least one way of carrying out the invention claimed using examples where appropriate and referring to the drawings if any [ ]rdquo

Thus the sufficiency of disclosure standard in the EPO requires that at least one embodiment of the invention must be disclosed in sufficient detail for it to be carried out by a person skilled in the art

Use of working examples is ldquoappropriaterdquo to describe at least one way to carry out the invention as required by EPC Rule 27(1)(e) A single example may suffice but if the claims cover a broad field the application must include multiple examples or alternative embodiments extending over the entire range of claimed subject-matter in order to satisfy the Article 83 EPC (see Examination Guidelines (ldquoEGrdquo) C-II 4911

1 Predictable Arts

In the EPO examples are not strictly required for inventions in the predictable arts provided that the claimed invention is ldquosufficiently disclosedrdquo in the specification However while working examples are generally not required in practice to enable an apparatus or a process claim they may be required to enable a product claim if what the application discloses is not sufficiently clear and complete for the invention to be carried out by a person skilled in the art The potential requirement of working examples to enable a product claim distinguishes the EPOs guidelines from that of the United States where a prophetic example may be sufficient



In practice working examples are required if the skilled person cannot ascertain from the specification and general common knowledge how to obtain the starting materials and intermediates Otherwise working examples are generally not required in practice to enable a process claim but as in the predictable arts they may be required to enable a product claim Characterization data for a compound is not required if the compound can be identified by other means (eg as a ldquoproduct-by-processrdquo) However experimental data may be helpful in showing inventive step12 and are often required to satisfy Article 83 above Both first and second medical use claims13 require experimental evidence that a specific disease can be treated with the composition In vitro data may suffice to enable a medical use claim

Working examples must be submitted at the filing date for the disclosure to be considered complete A seriously insufficient disclosure cannot be cured by subsequently submitting further examples or features without violating Article 123(2)14 of the EPC because no amendment may be made that introduces subject-matter extending beyond the content of the application as filed (see EG C-II 41015 and C-VI 5316) As in other jurisdictions later filed examples or new effects however may be taken into consideration by the EPO to support patentability of an invention in the unpredictable arts For example later filed examples or new effects may be used as evidence that the invention can be readily applied (on the basis of what was in the application as filed) over the whole claimed field In addition a new effect can be considered as evidence in support of inventive step if the new effect is implied by or related to an effect already disclosed in the originally filed application (see EG C-VI 53517) Likewise submission of experimental data for additional compositions may be permitted during examination to show that other compositions disclosed at the filing date have the same effect and support a broader claim

Examples can also be used to satisfy the requirement for industrial applicability of an invention in the unpredictable arts such as a nucleic acid sequence inventions18 However an invention will satisfy the utility requirement if it can be used in any sort of industry Thus working examples may be required in the EPO for patentability in the unpredictable arts and may also be submitted after filing


for the limited purpose of rebutting enablement and inventive steps rejections during examination Similar to the United States it is possible to enable a claim in the unpredictable arts without a working example although it is difficult to do so for both product and process claims

E India

Section 64(1)(h) of the Indian Patents Act of 197019 provides that a patent can be revoked if

[T]he complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed that is to say that the description of the method or the instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in and average knowledge of the art to which the invention relates to work the invention or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection

1 Predictable Arts

In India working examples are not required to support apparatus and device claims in the predictable arts where it is sufficient to provide illustrative drawings They are required to support other claims such as method claims for example This is a higher enablement requirement than that faced by applicants in the United States


In practice chemical inventions directed to compounds and compositions require working examples including characterization data Generally it is not sufficient to provide only the efficacy of the claimed compound it also is necessary to show that the efficacy of the claimed compound or composition is superior as compared to prior art compounds or compositions As explained in Sections 3(d) and 3(e) of the Patents Act of 2005 the following are not patentable inventions within the meaning of the Patents Act

(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 of 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 reactant20

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance

For a composition with known elements ldquosynergyrdquo or ldquounexpected resultsrdquo must be established relative to its known elements

Section 10(5) of the Indian Patents Act requires identification of the source of biological material described in the specification In case of new biological material not readily available to the public the particulars of the deposit with notified depository authority under the Budapest Treaty must be disclosed within 3 months of filing the application The biological material so deposited on or before the Indian filing date becomes accessible only after priority date or Indian filing date (where no priority is claimed) However if no deposit has been made and no objection has been raised in this regard in the international phase of a PCT application that is the ldquodisclosurerdquo made in the specification for PCT application has been held to be sufficient for identifying the biological mattersubstance then this requirement may be waived by the ExaminerSupervising Controller for a national phase application in India

In practice for pharmaceutical composition claims the specification must provide at least in vitro efficacy data The Indian Patent Office may also request toxicity data Prophetic examples will generally suffice but their submission faces a higher risk that the invention will be characterized as ldquonot workablerdquo Applicants may submit data eg experimental data in support of efficacy of the active pharmaceutical ingredient during examination only if such data are requested by the Patent Office Method of treatment and medical use claims do not constitute patentable subject matter in India Note that the Indian Patent Office often allows claims previously allowed by the EPO provided they are considered patentable subject matter in India

Thus as often will be the case in the United States applications submitted to the Indian Patent Office face a requirement of enabling examples for patentability of a claim with ldquosynergyrdquo or ldquounexpected resultsrdquo This may also be so for claims in the unpredictable arts


F Japan

Section 36(4) of Japanese Patent Law provides that

The detailed description of the invention under the preceding Subsection (iii) shall state the invention in a manner sufficiently clear and complete for the invention to be carried out by a person having ordinary skill in the art to which the invention pertains

The interpretation of this statute can be found in the Japanese Patent Examination Guidelines (ldquoEGrdquo) which provide in Part I Ch 1 sect 321 (5)

In cases where it is possible to explain the invention so as to enable a person skilled in the art to carry out the invention neither embodiments nor working examples are necessary

In the case of inventions in technical fields where it is generally difficult to infer how to make and use a product on the basis of its structure (eg chemical substances) normally one or more representative embodiments or working examples are necessary which enable a person skilled in the art to carry out the invention Also in the case of use inventions (eg medicine) using the character of a product etc the working examples supporting the use are usually required

Thus in Japan working examples are only required in areas of technology where it is ldquodifficult to inferrdquo how to make and use a product on the basis of its structure (eg areas which are unpredictable such as chemistry and biotechnology)

1 Predictable Arts

Mechanical inventions are less likely to require a working example because of their predictability However working examples are usually required for a product claim unless a person skilled in the art can carry out the invention based on the detailed description This is similar to the United States where an example is unnecessary if a person having ordinary skill in the art would be able to make and use the invention without undue experimentation based on the disclosure and what is generally known in the art



Patentability of medicinal inventions is described Part VII Chapter 3 sect 121 of the Examination Guidelines which provides that

As a medicinal invention in technical field where it is generally difficult to infer how to make and use a product on the basis of its structure normally one or more representative embodiments or working examples are necessary which enable a person skilled in the art to carry out the invention As for working examples supporting the medicinal use a description of the result of the pharmacological test is usually required (Refer to Examination Guidelines Part I Chapter 1 321 (5) and 323(2))

Submission of data during examination is allowed in support of enablement or inventive step and is described in Part I Chapter 1 sectAcirc 333(2)

Against the notice of reason for refusal an applicant may argue or clarify by putting forth written arguments or experimental results etc (Note) For example through a written opinion or a certified experiment result etc the applicant may clarify that the experiment or the method of analysis not considered by the examiner is actually pertaining to the common general knowledge as of the filing and that a person skilled in the art can carry out the claimed invention based on such an experiment or method for analysis as well as the description in the specification and the drawings

Submission of data during examination in support of arguments for both enablement and inventive step can be achieved by providing the Japanese Patent Office with ldquocertified resultsrdquo However submission of data in support of the inventive step is more likely to be considered than submission of data for enablement purposes Certified results submitted to show the interpolated values between the working examples will be considered to enable the full scope of the claims

The JPO may issue a rejection that is a combination of the ldquoenablement requirementrdquo and ldquosupport requirementrdquo Note that the combination rejection may


not be withdrawn even if Applicant submits data to support enablement of the invention

In practice characterization data are required for enablement of compound claims Furthermore characterization data as well as pharmacological data such as in vitro animal or human data are required to enable a medical use claim21 22

Thus working examples are generally required for the unpredictable arts in Japan which is somewhat different than the United States where a claim may be enabled without such an example

G Korea

Article 42(3) of the pre-revision Korean Patent Act applicable to applications filed prior to July 1 2007 provides that

The detailed explanation of the invention [ ] must state the purpose construction and effect of the invention in such a manner that it may easily be carried out by a person with ordinary skill in the art to which the invention pertains

Article 42(3) of the revised Korean Patent Act applicable to the applications filed on or after July 1 2007 provides that

The detailed explanation of the invention under Article 42(2)(iii) of the Korean Patent Act must clearly and in detail state the invention in accordance with the description requirements promulgated by the Ministry of Knowledge Economy so that the invention may easily be carried out by a person with ordinary skill in the art to which the invention pertains (emphasis added)

Under both the pre-revision and revised acts the specification should provide examples describing the claimed invention sufficiently to enable one skilled in the art to easily practice the invention

1 Predictable Arts

Working examples are not required to enable a claim to an invention in the predictable arts in Korea Similar to the United States the goal of enabling one skilled in the art to practice the invention without undue experimentation can be achieved in the absence of such a working example



In Korea working examples are usually required for biotechnological chemical and pharmaceutical inventions and should be in a section of the patent entitled ldquoExamplesrdquo23 The scope of subject matter claimed is limited to the disclosure or specific examples in the detailed description Thus it is advisable that the specification include more than one example In practice applicants can obtain broader coverage when supported by multiple examples

In two court decisions Case Nos 99 Heo 3177 and 2001 Heo 5213 the Patent Court held that since it is generally difficult to grasp the subject of an invention in the field of chemistry and predict its effect without a direct experiment confirmation and analysis the specification should describe examples of the invention24 Based on these holdings if the specification of a chemical invention fails to provide a working example the specification may be considered defective because the invention disclosed therein is considered incomplete and prophetic examples are not accepted25 Examples written in the present tense will be considered as work actually completed and applicants may be required to provide actual experimental data during the prosecution of the case

Characterization data are required for compound claims unless a person skilled in the art at the time of filing of the application can sufficiently predict whether a chemical substance can be produced based on the disclosure in the specification

To enable a ldquomedical use claimrdquo the specification must include pharmacological data in support of the pharmaceutical use at the time of filing The specification must also describe an effective amount administration process and other information relating to the formulation to enable the invention to be practiced by one skilled in the art The use of a pharmaceutical composition must be described in connection with a specific disease or pharmacological effect and the claimed pharmacological effects should be supported by in vitro animal or clinical tests Applicants may submit reference materials such as experimental data in support of an argument for inventive step or enablement after the filing of the application


In contrast to the United States where prophetic examples may suffice to support the patentability of biotechnological chemical and pharmaceutical inventions Korea requires working examples for patentability Under Korean practices the greater the number of the examples provided the greater the scope of the claims allowed

H South Africa

There are no substantive patent examination guidelines or procedures in South Africa and a patent is granted regardless of whether the requirements for patentability have been met However the law does set forth various validity requirements which become relevant during post-issuance litigation proceedings If a patent is challenged in litigation working examples may be required to withstand the validity challenge

Section 32(3)(b) of the South African Patents Act26 provides that

A complete specification shall ndash (b) sufficiently describe ascertain and where necessary illustrate or exemplify the invention and the manner in which it is to be performed in order to enable the invention to be performed by a person skilled in the art of such invention

In addition Section 61(1)(e) of the Patents Act provides that

Any person may at any time apply in the prescribed manner for the revocation of a patent on [the ground] that the complete specification concerned does not sufficiently describe ascertain and where necessary illustrate or exemplify the invention and the manner in which it is to be performed in order to enable the invention to be carried out by a person skilled in the art of such invention

Thus the Patents Act requires that the specification enable the invention to be performed by a person skilled in the art which is determined on a case-by-case basis Accordingly if a person skilled in the art would know how to carry out the invention based on the description of the invention in the specification examples will not be needed

1 Predictable Arts


In stark contrast to every other country described in this article in South Africa the requirement of a working example may arise only during litigation Thus the sufficiency of the description in the patent will only be tested if a patent is challenged in litigation There are no examination guidelines and whether a particular description is sufficient is determined on a case-by-case basis


In general working examples are not required but they are recommended for apparatus product and process claims For a compound claim characterization data may be necessary to show enablement of the invention if the patent is challenged If experimental support for a medical use claim is deemed to be required case law seems to suggest that in vitro data will suffice

Submission of supplementary disclosure is allowed after the filing but before the grant of the patent However the newly added material is deemed new matter and receives the filing date of the supplementary disclosure Although it is possible to amend a patent after grant to overcome its invalidity it is not possible to do so if the necessary amendment would add new matter to the specification

Thus in South Africa the requirement for examples and thus the sufficiency of the description will only be tested if a patent is challenged in litigation Because there are no examination guidelines sufficiency of description is determined on a case-by-case basis This procedure is very different from that of the United States and all other countries studied in this article

I Taiwan

The Taiwanese Patent Act27 provides that

The description of invention shall contain a sufficiently clear and complete disclosure of contents of the invention so as to enable a person skilled in the art to understand the contents of and to practice said invention

Thus in Taiwan as in most other countries the statute does not explicitly require ldquoworking examplesrdquo when a patent application is filed

1 Predictable Arts


In the predictable arts examples usually are not required for an apparatus product or process claim the general description of the invention in an application will normally suffice to enable such claims This appears consistent with the United States


In practice working examples are required to enable chemical biochemical and pharmaceutical inventions and should be in a section entitled ldquoExamplesrdquo Prophetic examples are generally not accepted in Taiwan Working examples such as those providing for compounds and characterization data are required in practice to enable a compound and pharmaceutical composition claims Generally to enable a medical use claim in vitro or animal in vivo data provided in the specification at the time of filing or by supplementing the application after the filing will suffice Submission of data during examination of the application in support of inventive step is also allowed

Thus in Taiwan in practice working examples are required for chemical biochemical and pharmaceutical inventions This goes farther than the requirement in the United States where working examples may be very helpful but are not strictly required for enablement

IV Summary

When devising an appropriate filing strategy for a particular invention the specific requirements for description and support of the disclosure should be considered on a country by country basis

This is especially important as the requirements vary not only from country to country but also by the field of invention For scenarios discussed below we will assume that the first-filed application is always a US provisional patent application followed by a PCT or a direct national or regional stage patent application

An important consideration arises if a previously filed priority application or PCT is updated with material information necessary for patentability If the applicant (or anyone else) publishes relevant material between the original priority or PCT filing and the submission of additional material in support of patentability and the original priority or PCT application itself is insufficient that publication may serve as prior art to the updated application


For inventions in the ldquopredictablerdquo arts such as mechanical and electrical engineering inventions the inclusion of working examples in the specification will most likely be required in India and the EPO and also in South Africa if the sufficiency of the disclosure is challenged post-issuance Thus if patent protection in India and Europe is important to the client it may be advisable to wait until working examples can be included before filing a PCT national or regional patent application As working examples in the predictable arts are not required in Australia Canada Korea and Taiwan and typically are not required by the US filing could be accomplished earlier Other countries fall somewhere between these two groups

For the ldquounpredictablerdquo arts such as biotechnology and chemistry working examples generally should be included with the application as filed It is evident that requirements for such inventions are more strict than for the predictable mechanical and electrical inventions Out of the countries surveyed China India and Korea require working examples and may limit applicants claims to the disclosure in the examples in the US working examples may be necessary particularly to enable a generic claim or to support correlation Although not required to obtain a patent in South Africa working examples may be required to defend the validity of a patent challenged in litigation

Submission of supporting data after filing is allowed in Australia Canada the EPO Japan Korea and Taiwan In countries where it is difficult or impossible to submit data after filing in support of enablement such as in the United States China India and Japan applicants should consider including as much of experimental data as possible in the first priority application Similarly in countries where it is difficult or impossible to submit data after filing in support of inventive step such as in Canada China and India applicants should consider including experimental data in the application as filed that compares the invention with the prior art or that shows unexpected results In addition as claims allowed by the EPO are likely to be accepted in India delaying the Indian prosecution (eg by delaying the filing of the request for examination) until the claims are allowed by the EPO may lead to issuance of broader claims by the Indian Patent Office

The chart below summarizes the most important requirements for exemplification in the countries discusses above For convenience we have separated the arts into mechanicalelectrical and biotechchemistry groups


Country Exemplification required for patentability

Post-filing data submission for BiotechChemistry

MechanicalElectrical

BiotechChemistry

Australia

Prophetic examples with a level of detail equivalent to a working example

Pharmacological data not required if detailed example of administration and treatment with the composition is provided Characterization data for at least one compound are likely required

Allowed to support information already in the specification

Canada

Prophetic examples and Sound prediction or working examples

Working examples unless utility of claimed subject matter can be soundly predicted (in practice working examples are always required for a second medical use claim ndash in vitro data will suffice)

Allowed to show that the invention as described in the application when filed was operable or reduced to practice but Examiners need not consider post-filing submissions

China Prophetic examples

Working examples (in vitrodata normally suffice)

Not allowed to support enablement Comparative data with prior art species allowed to support inventive step

European Patent Prophetic Medical use Allowed to support


Office examples but working examples may be required for product claim

claims require experimental evidence that a specific disease can be treated with the composition (in vitro data suffice)

inventive step and enablement

India

Working examples except for an apparatus or device claim

Working examples (medical use claims are not patentable)

Allowed if requested by the Patent Office

Japan

Working examples for product claims unless skilled artisan can predict effects of invention from description

Working examples (in vitrodata suffice only in some cases in vivo data preferred)

Allowed to support inventive step and perhaps enablement

Korea Not required

Working examples (in vitrodata suffice for medical use claims)

Allowed to support inventive step and enablement

South Africa

Not required for patentability Working examples may be required if patent is challenged in litigation

Not required for patentability Working examples may be required if the patent is challenged in litigation (in vitro data will suffice)

NA (no examination)

Taiwan Not required

Working examples (in vitro and in vivo animal data suffice)



V Acknowledgements

We would like to thank the following of our foreign associates for providing us with valuable information regarding patent law and practice in their countries

Australia Ian Rourke FB Rice amp Co Melbourne George Griziotis Peter Maxwell and Associates Sydney

Canada Elaine Johnson PhD MBM amp Co Ottawa

China Chuanhong Long CCPIT Patent amp Trademark Law Office Beijing Gesheng Huang Zhongzi Law Office Beijing

EPC Dr Martin Grund Grund IP Group Munich India DP Ahuja amp Co Calcutta Japan Suguru Okabe Shimizu Patent Office Tsukuba Science City Korea Lee International IP amp Law group Seoul South Africa Sandra Clelland Spoor amp Fisher Johannesburg

Taiwan Thomas QT Tsai Tsai Lee amp Chen Taipei

VI Authors Biographical Information

Shann Kerner PhD JD Partner WilmerHale 60 State Street Boston MA 02109 617-526-6192 (shannkernerwilmerhalecom)

Dr Shann Kerner is a partner in the IP Dept and a member of the IP Litigation Practice Group at WilmerHale Dr Kerner obtained a BA in Biology from Boston University a PhD in Biomedical Sciences Molecular Biology and Biochemistry from University of Connecticut Medical School and a JD from Suffolk Law School Dr Kerner practices primarily in the biotechnology area in all aspects of patent prosecution IP due diligence internal audits and patent litigation Previously Dr Kerner held a joint faculty appointment at Harvard Medical School and at Childrens Hospital Medical Center in Boston

Andrej Barbic PhD JD WilmerHale 60 State Street Boston MA 02109 617-526-5053 (andrejbarbicwilmerhalecom)

Dr Andrej Barbic is an associate in the IP Dept at WilmerHale Dr Barbic obtained a BA in chemistry from Lawrence University a PhD in Biophysical Chemistry from Yale

University and a JD from Suffolk Law School in Boston Dr Barbics practice focuses on US and foreign patent prosecution and due diligence analyses Before joining the firm Dr Barbic did a postdoctoral research fellowship at Yale University where he served as graduate researcher and teaching fellow

Kyle Robertson WilmerHale 60 State Street Boston MA 02109 617-526-6338 (kylerobertsonwilmerhalecom)

Kyle Robertson is an associate in the IP Dept of WilmerHale Mr Robertson graduated with a BS in Computer Engineering and Economics from Iowa State University He obtained his JD from Boston College Law School where he was the managing editor on the Boston College International and Comparative Law Review Prior to beginning his legal studies Mr Robertson was a software engineer and lead network designer at two software companies in Austin Texas before becoming Vice President of Engineering at Quest Research and Development in Wichita Kansas

1 Infra Part V 2 Original Eighth Edition August 2001 Latest Revision September 2007 3 Obviousness is often referred to as ldquolack of inventive steprdquo in foreign

jurisdictions 4 See Pfizer Overseas Pharmaceuticals and Others v Eli Lilly and Co and

Others 68 IPR 1 5 Subsection 27(3) of the Canadian Patent Act as amended in 2005 (emphasis

added) 6 Subsection 27(3)(b) of the Canadian Patent Act as amended in 2005 7 The concept of ldquopurposiverdquo claim construction originated in the British House of

Lords in the 1981 decision Catnic v Hill amp Smith [1982] RPC 183 8 Aventis Pharma Inc v Apotex Inc et al [2006] FCA 64 (Federal Court of

Appeals) 9 In practice prosecution before the Canadian Patent Office is much more

challenging in the absence of working examples 10 The EPO examines patent applications for states that are members of the

European Patent Convention (EPC) Current EPC contracting states are Austria Belgium Bulgaria Croatia Cyprus the Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Monaco the Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden



Switzerland Turkey and the United Kingdom Member States of the European Patent Organization available at httpwwwepoorgabout-usepomember_stateshtmlcontracting

11 Section 49 entitled Sufficiency of disclosure states in part

A detailed description of at least one way of carrying out the invention must be given Since the application is addressed to the person skilled in the art it is neither necessary nor desirable that details of well-known ancillary features should be given but the description must disclose any feature essential for carrying out the invention in sufficient detail to render it apparent to the skilled person how to put the invention into practice A single example may suffice but where the claims cover a broad field the application should not usually be regarded as satisfying the requirements of Art 83 unless the description gives a number of examples or describes alternative embodiments or variations extending over the area protected by the claims However regard must be had to the facts of the particular case There are some instances where even a very broad field is sufficiently exemplified by a limited number of examples or even one example (see also III 63) In these latter cases the application must contain in addition to the examples sufficient information to allow the person skilled in the art using his common general knowledge to perform the invention over the whole area claimed without undue burden and without needing inventive skill (see T 72795 OJ 12001 1) If the Examining Division is able to make out a reasoned case that the application lacks sufficient disclosure the onus of establishing that the invention may be performed and repeated over substantially the whole of the claimed range lies with the applicant (see VI 23)

12 Supra note 2 13 See Introduction for examples of medical use claims EPC 2000 with the entry

into force of the European Patent Convention referred to as the format used for first medical use claims is an acceptable format for second and subsequent medical use claims An example of a first medical use claim would be ldquoUse of substance X in the manufacture of a medicament for the treatment of condition Yrdquo See Opinion G583 of the EPO Enlarged Board of Appeal

14 Article 123(2) of the EPC states ldquoA European patent application or a European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filedrdquo

15 Section 410 entitled Art 83 vs Art 123(2) recites

It is the responsibility of the applicant to ensure that he supplies


on filing his application a sufficient disclosure ie one that meets the requirements of Art 83 in respect of the invention as claimed in all of the claims If the claims define the invention or a feature thereof in terms of parameters (see III 47a) the application as filed must include a clear description of the methods used to determine the parameter values unless a person skilled in the art would know what method to use or unless all methods would yield the same result (see III 410a) If the disclosure is seriously insufficient such a deficiency cannot be cured subsequently by adding further examples or features without offending against Art 123(2) which requires that amendments may not result in the introduction of subject-matter which extends beyond the content of the application as filed (see VI 53) Therefore in such circumstances the application must normally be refused If however the deficiency arises only in respect of some embodiments of the invention and not others it could be remedied by restricting the claims to correspond to the sufficiently described embodiments only the description of the remaining embodiments being deleted

16 Section 53 of Chapter VI entitled Additional subject-matter states

There is normally no objection to an applicant introducing by amendment further information regarding prior art which is relevant indeed this may be required by the examiner (see II 43 and II 418) Nor will the straightforward clarification of an obscurity or the resolution of an inconsistency be objected to If however the applicant seeks to amend the description (other than references to the prior art) the drawings or the claims in such a way that subject-matter which extends beyond the content of the application as filed is thereby introduced the application as so amended cannot be allowed

17 Section 535 entitled Evidence provides that

Under certain circumstances however later filed examples or new effects even if not allowed into the application may nevertheless be taken into account by the examiner as evidence in support of the patentability of the claimed invention For instance an additional example may be accepted as evidence that the invention can be readily applied on the basis of the information given in the originally filed application over the whole field claimed (see III 63) Similarly a new effect (eg the one mentioned in VI 534) may be considered as evidence in support of inventive step provided that this new effect is implied by or at least related to an effect disclosed in the originally filed


application (see IV 911) 18 Pursuant to Article 57 of the EPC This cites decisions of the Enlarged Board

of Appeal G183 G583 G683 G103 and G203 (Annex 1) 19 The Amendments to the act per Indian Patents Act of 2005 do not affect this

section 20 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

21 Part VII Chapter 3 sect 121 (1) of the Examination Guidelines entitled Description of the Result of the Pharmacological Test states

Since the result of the pharmacological test is to confirm the pharmacological effect of the claimed medicinal invention all of the following should be made sufficiently clear in principle (i) which compound is (ii) applied to what sort of the pharmacological test system (iii) what sort of result is obtained and (iv) what sort of relationship the pharmacological test system has with the medicinal use of the claimed medicinal invention It should be noted that the result of the pharmacological test should be described with numerical data as a general rule but when the result cannot be described with the numerical data due to the nature of the pharmacological test system an acceptable objective description equivalent to the numerical data may be provided for example a description of the objective observation result by a doctor could be accepted Furthermore as the pharmacological test system employed a clinical test an animal experiment and in-vitro test are listed

22 Method of treatment claims are not patentable in Japan However Swiss-type claims and pharmaceutical composition claims are patentable

23 See Case Nos 99 Heo 3177 and 2001 Heo 5213 holding ldquochemistry inventions [that] fail to provide an example [will render the] specification defectiverdquo

24 See id 25 See id 26 Patents Act 57 of 1978 as amended by Patents Amendments Act 58 of 2002 27 Amended and promulgated on February 6 2003 enforced on July 1 2004


We first examine the requirements for experimental data and examples for patents in the United States as a comparative reference point and then proceed to the requirements in Australia Canada China European Patent Office India Japan Korea South Africa and Taiwan

II Requirement for Examples in the United States

In the United States experimental examples whether working or prophetic are not required if the claimed invention is otherwise enabled As used herein a ldquoworking examplerdquo is a description of work actually performed for which data are available In contrast a ldquoprophetic examplerdquo describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved The Manual of Patent Examining Procedure2 published by the US Department of Commerce Unites States Patent and Trademark Office (ldquoMPEPrdquo) sect 216402 states

Compliance with the enablement requirement of 35 USC sect 112 first paragraph does not turn on whether an example is disclosed An example may be lsquoworkingrsquo or lsquopropheticrsquo The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation In re Borkowski 422 F2d 904 908 164 USPQ 642 645 (CCPA 1970)

Not surprisingly the requirement for working examples is closely related to the predictability of the art According to the MPEP

The ldquopredictability or lack thereofrdquo in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains then there is predictability in the art On the other hand if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains then there is lack of predictability in the art Accordingly what is known in the art provides evidence as to the question of predictability

MPEP sect 216403


A Predictable Arts





Id





Id



Id



Id





A Australia








1 Predictable Arts







B Canada















1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements


















































A Predictable Arts





Id





Id



Id



Id





A Australia








1 Predictable Arts







B Canada















1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements



















































Id



Id



Id





A Australia








1 Predictable Arts







B Canada















1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements





















































A Australia








1 Predictable Arts







B Canada















1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements




















































1 Predictable Arts







B Canada















1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements



















































B Canada















1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements























































1 Predictable Arts









C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements





















































C China






1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements


















































1 Predictable Arts














1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements
























































1 Predictable Arts









E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements
























































E India



1 Predictable Arts













F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements

























































F Japan







1 Predictable Arts














G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements





























































G Korea






1 Predictable Arts










H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements

























































H South Africa







1 Predictable Arts







I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements























































I Taiwan




1 Predictable Arts






IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements






















































IV Summary













BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements


























































BiotechChemistry

Australia




Canada












India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements





















































India




Japan




Korea Not required



South Africa



NA (no examination)

Taiwan Not required




V Acknowledgements


















































V Acknowledgements

















































Article contributed by: Shann Kerner, Ph.D., Andrej … Requirements for Patentability of Inventions...

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Transcript of Article contributed by: Shann Kerner, Ph.D., Andrej … Requirements for Patentability of Inventions...