Patentability and Priority

Question 1

Criteria for patentability set out in Section 1(1) UKPA

Answer 1

A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say—

(a) the invention is new;

(b) it involves an inventive step;

(c) it is capable of industrial application;

(d) the grant of a patent for it is not excluded by subsections (2) and (3) or section 4A below

Question 2

Exclusions from patentability in sections 1(2), (3) and (4)

Answer 2

It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, that is to say, anything which consists of—

(a) a discovery, scientific theory or mathematical method;

(b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever;

(c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer;

(d) the presentation of information;

but the foregoing provision shall prevent anything from being treated as an invention for the purposes of this Act only to the extent that a patent or application for a patent relates to that thing as such.

(3) A patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality.

(4) For the purposes of subsection (3) above exploitation shall not be regarded as contrary to public policy or morality only because it is prohibited by any law in force in the United Kingdom or any part of it.

Question 3

Exclusions from patentability under Schedule A2 introduced by section 76A

Answer 3

the human body and gene sequences discovered in it (though an isolated gene may be patented in conjunction with an industrial application of it);
cloning humans;
modifying the human germ line;
industrial or commercial exploitation of human embryos including stem cells where harvested from embryos - see also decisions G2/06 and C-34/10 for the EPC.
meanwhile parthenotes (being non-viable due to a lack of paternal DNA) are not excluded - see International Stem Cell Corporation v Comptroller C-364/13;
genetic modification of animals that is likely to cause suffering without giving rise to significant medical benefits; and patenting the resulting animals themselves; and
inventions relating to individual plant or animal varieties (covered by UPOV)

Question 4

Patentably inventions under Schedule A2

Answer 4

An invention shall not be considered unpatentable simply because it concerns a product comprising biological material, or a process using, producing or processing biological material. It similarly allows the patentability of biological material isolated from its natural environment by a technical process

Question 5

Interpretation of Section 1(2)

Answer 5

“As such”
Aerotel /Macrossan [2006] EWCA Civ 1371 and Aerotel [2007] R.P.C.7:
i. Properly construe the claim;
ii. Identify the actual contribution;
iii. Ask if this falls solely within an exclusion;
iv. (Check if the actual contribution is technical).
Jacob LI. suggests that step ii. (which is basically where ‘as such’ gets decided) equates to ‘What the inventor really added to human knowledge’.

Question 6

Definition of “inventor” in section 2

Answer 6

5) ‘Inventor’ includes ‘proprietor’ for the purpose of the above subsections.

Question 7

Definition of state of the art

Answer 7

2) The state of the art is all matter made available to the public at any time before the priority date of the invention’s application.
3) a)b) For the purposes of novelty only, the state of the art also comprises matter in a patent or application having an earlier priority date than the invention’s application, but published on or after the priority date of the invention’s application.

Question 8

When is a disclosure not considered to be part of the state of the art?

Answer 8

4) A disclosure of the invention shall not be considered part of the state of the art if the disclosure occurred during a six-month period preceding the filing date in the UK of the invention’s application, and either:
a) the disclosure was due to or resulted from the invention being obtained by anyone unlawfully or in breach of confidence…
i) ii) … from the inventor or anyone holding the invention in confidence or to whom the matter was disclosed in confidence by either the inventor or someone already in confidence, or
b) the disclosure was made in breach of confidence by anyone (already) holding the invention in confidence or to whom it was disclosed in confidence, or
c) the disclosure was due to or resulted from the inventor displaying the invention at an officially recognised international exhibition, and the inventor subsequently states this on filing the application, and supplies confirmatory evidence within four months of filing (R5(2)).

Question 9

What types of application can be used as novelty-only prior art?

Answer 9

1. GB application. Yes.
2. EP application. Yes, even if GB designation withdrawn before publication
3. PCT application validly entering GB national phase. Yes.
4. PCT application not entering GB national phase. No.
5. PCT entering EP regional phase. Yes.
6. Any other non GB, EP or PCT application. No.

Question 10

If withdrawal of application was received too late to prevent publication, was application validly published?

Answer 10

No so cannot be used as section 2(3) novelty-only prior art (can be used for section 2(3)

Question 11

Purpose of section 2(3)

Answer 11

To prevent double patenting

Question 12

When is a document having its own URL available to the public?

Answer 12

Found using a public search engine and keywords related to the essence of the content of the document; and
Remains online long enough for member of public to have direct and unambiguous access to document

Question 13

Are emails available to the public?

Answer 13

Depends but not merely by virtue of being conveyed via the internet

Question 14

UKIPO/EPO approach to internet publication date

Answer 14

Where content can change subsequent to a supposed publication date, the UKIPO and EPO require that evidence for a particular date is convincing, but do not require proof `up to the hilt; rather, they use a balance of probabilities approach to the content and/or the marked date, based for example upon the reputation of the publisher and how any date is applied to the document (e.g. if generated automatically with a blog post it is likely reliable) — plus of course on any concrete evidence either way.

Question 15

Requirements for breach of confidence

Answer 15

“air of confidence” at time that information is imparted or acquired that causes the recipient to understand information is confidential
try to get proof via NDA or affidavit
if no proof available, discuss both situations in your answer

Question 16

When is an air of confidence unlikely?

Answer 16

if a document is simply forgotten and left somewhere as a consequence of carelessness.
Ask if the document was marked ‘confidential. File an application ASAP before a verifiable publication of the information occurs, but warn the client that grant may not be possible depending on the facts.

Question 17

What should you do if partial or non-enabling version published by third party?

Answer 17

Request document returned and no further publications are made. File UK/EP application as soon as possible. Warn client that grant may not be possible depending on the facts.

Question 18

When there is no air of confidence

Answer 18

Consider registered design (one-year grace period in UK and EP)

Question 19

What to do if you think someone will breach confidence e.g. disgruntled employee about to leave?

Answer 19

File an application immediately so as to forestall any problems; in principle in this situation you will have the six-month grace period of s2(4), but it is inadvisable to rely on this if a safer alternative is available; you may have no proof of the provenance of follow-on publications, making s2(4) hard to use, and it can complicate overseas filing if you have to rely on respective protections provided elsewhere for these

In FD1 such a person is also likely to file their own patent or work the invention, so monitor them (e.g. using a caveat, PF49) and in time consider use of s8 (entitlement proceedings) and/or s61 (infringement proceedings) as appropriate.

Question 20

When does an invention comprise an inventive step?

Answer 20

An invention comprises an inventive step if it is not obvious to a person skilled in the art who knows all matter in the state of the art (excluding novelty-only art falling under s2(3)).

Question 21

Windsurfer/Pozzoli test

Answer 21

i. identify the notional person skilled in the art and the relevant common general knowledge of that person:
ii. identify or construe the inventive concept in the claim;
iii. identify what, if any, differences there are between the material forming the state of the
art and the invention as identified or construed; and
iv. decide, without any knowledge of the proposed invention as claimed, whether these
differences would have been obvious to the skilled person or whether they required any
degree of invention.

Question 22

Who is the skilled person?

Answer 22

A hypothetical person (or team of people, including people from interacting disciplines where this is applicable, such as in a multidisciplinary invention), who is of average skill in the art and is not themselves inventive, but who nevertheless knows all the prior art.

Question 23

What is inventiveness a question of?

Answer 23

Inventiveness is essentially a question of whether the skilled person would have a clear reason or direct motivation to make the particular modifications to the prior art required to arrive at the invention.

Question 24

Secondary indications

Answer 24

E.g. prejudice in the art against an approach, or a long-felt want for the effect the invention achieves, which can be used to bias a consideration of reason or motivation. Generally these cannot be relied upon as evidence of inventiveness per se, though see Virgin Atlantic Airways v Premium Aircraft Interiors UK [2009] EWCA Civ 1062 for a case where the previous failure of anyone to implement a simple alternative seating pattern for aircraft suggested its inventiveness.

Question 25

When is invention industrially applicable (section 4)?

Answer 25

An invention is industrially applicable if it can be used in any kind of industry, including agriculture. Conforms with Article 57 EPC/EPO Guidelines G-III, 1 - 'industrial' is 'physical activity of "technical character"' belonging to 'useful or practical arts'.

Question 26

Section 4A Methods of treatment or diagnosis

Answer 26

1) A patent shall not be granted for: a) a method of treatment of the human or animal body by surgery or therapy; or b) a method of diagnosis practised on the human or animal body. 2) However, substances and compositions for use in such methods are allowed. 3) The use of a substance or composition in such a method is considered new even if the substance or composition itself is known in the art. 4) A (further) specific use of a known substance for such a method is considered new if the specific use is new.

Question 27

Definition of treatment

Answer 27

Treatment is 'of the human or animal body'. Therefore, a method of purifying donated blood plasma to go in packs does not fall under this exclusion, whilst purification of a patient's blood through a dialysis machine does fall under this exclusion. s4A(1)(a) suggests that the purpose of a non-surgical 'treatment' is to achieve a therapeutic effect. This is not limited to curative or preventative treatments, but to any treatment that alleviates a cause or symptom of a medical condition. Purely cosmetic treatments by contrast are not considered therapeutic, and therefore do not fall under the exclusion. However, whilst there is also some European case law (e.g. T144/83) to suggest that treatments where the primary intent is purely cosmetic are allowable, any incidental or potential therapeutic effect can militate against this (see BB 9th Ed. §4A.04)). In general, a treatment comprising a step which requires or affects the action or supervision of a physician is not patentable, as the purpose of the exclusion is to allow the free practice of medicine.

Question 28

Definition of by surgery

Answer 28

Surgery can be defined as a 'substantial physical intervention' and current UKIPO guidelines suggest that an excluded surgical procedure would require professional skill and carry a potential risk — hence for example a simple vaccine injection would not be surgical, where as an epidural injection would be. Surgery is not necessarily of an invasive nature; e.g. the setting of a broken bone meets the skill and risk criteria (whereas applying a cast afterwards does not). Note that surgery is not explicitly limited to therapeutic surgery by s4A(1)(a) and so encompasses both therapeutic and non-therapeutic / cosmetic surgery. The EPO holds a similar position ( see G1/07).

Question 29

Definition of by therapy

Answer 29

* A therapy can be corrective (e.g. chemotherapy) and/or preventative (e.g. a vaccine), or simply alleviate a medical condition (e.g. painkillers): "... any treatment which is designed to cure, alleviate, remove or lessen the symptoms of, or prevent or reduce the possibility of contracting any disorder or malfunction of the [human or] animal body" (T24/91). A therapy can thus address a symptom and/or an underlying cause. o Since therapy assumes relief of a medical condition, a claim to the 'Use of X to combat troublesome snoring' would not be considered therapy and so would be allowable. * Pest control is a therapy for the pest's victims (e.g. killing tapeworms or tics).

Question 30

Definition of diagnosis

Answer 30

G1/04 characterised diagnosis as the i. collection and ii. comparison of data to iii. identify any deviation from the norm, and iv. attributing that to a particular 'clinical picture'. Typically if in particular step i. or iv. is missing then the method may not be a diagnosis. * In addition, it must be practiced on the body (e.g. the examination and collection of data is practised on the body). Therefore extra-corporeal diagnoses such as cancer screening of smears can be patented, as can epidemiological analyses. * Like therapy, diagnosis also assumes a medical condition (i.e. a pathology) - therefore for example pregnancy tests are not diagnoses and so are patentable.

Question 31

Form of first medical use claim

Answer 31

'Substance X for use in therapy' or 'Substance X for use as a medicament' (X is active ingredient)

Question 32

Form of second medical use claim

Answer 32

Substance X for use in the treatment of medical condition Y (X is active ingredient)

Question 33

Can existing apparatuses and devices for surgical and other medical uses be protected by first/second medical use claims?

Answer 33

No

Question 34

When is the priority date?

Answer 34

1) By default the priority date is the date of filing... 2) ... but one can declare (Rule 6) one or more earlier relevant application(s) filed by the applicant or their predecessor in title as a priority document within the period specified below (see 2A). If so declared, then a)b) the priority date of any matter, including any supported invention, is the filing date of the earliest disclosure (Rule 3) of that matter in the priority document(s).

Question 35

How long is the priority period?

Answer 35

2A) a) The normal filing period for the application is 12 months from the earliest claimed priority, b) but with permission of the Comptroller under 2B below, this can be further extended by a prescribed period of two months (Rule 7(1)). 2B) The applicant can request a late declaration (for use with a 'late' filing under 2A(b)) from the Comptroller up to two months after the end of the priority year (i.e. two months after the 12-month period of subsection 2A(a)).

Question 36

When will a comptroller grant a request for late declaration of priority under Section 5 2B?

Answer 36

The Comptroller will grant the request under 2B, only if a) the request complies with the rules (use form PF3, within the two-month period), and b) the Comptroller agrees that the failure to file the application claiming priority within the normal time was unintentional (requires evidence).

Question 37

When can a second filing of subject-matter be basis for priority itself? (section 5(3))

Answer 37

The first filing lost all rights by withdrawal or refusal before publication, including the right to act as priority for any application anywhere - and hence has no rights outstanding - on or before the day the second application was filed in the same country as the first

Question 38

What can be used for priority?

Answer 38

From a suitable application from the UK or any convention country.

Question 39

When can priority be declared (Rule 6)?

Answer 39

1) Either declare priority at the time of filing... 2) ... or within 16 months from the declared priority date (using PF3 and paying £40) 3) - provided in this latter case there is no effective request for early publication. 4) The declaration includes the country and date of filing of earlier application(s). - The application number(s) and a certified copy are also required — see R8. 5) One cannot add (further) priorities when filing divisionals.

Question 40

When can priority not be filed within 16 months from priority date?

Answer 40

If there is an effective request for early publication

Question 41

When can a declaration be made late?

Answer 41

a request under s5(2B) must be a. made on form PF3 (paying a late fee of £150), and b. supported by proof that it was unintentional to file the application late. 3) If no proof is given, the Comptroller will specify a period in which to file it. 4) For divisionals and applications filed following disputes (s15(9) and s8, 12(6) or 37(4)), the request under s5(2B) can simply be in writing, with no proof required. 5) A request must be made within the plus two months specified by s5(2A)(b)... 6) ... but divisionals and applications following disputes that are filed after the plus two months may nevertheless make the request on the day they are filed. 7)8) The request can only be made if: a. there is no effective request for early publication of the application claiming priority (subsection 8); or b. the request is in relation to a PCT(GB) (included to conform with R49ter.2(f) PCT; designated offices can restore priority), in which case one has one month after the national phase begins to make a late declaration (R66(3)). 9) When requesting late under s5(2B), one must declare priority at the same time as filing the request (i.e. there is no 16-month option as in R6).

Question 42

Declaration when filing application within priority period

Answer 42

Can declare priority at same time or up to 16 months from earliest priority using PF3 and a fee of £40 (provided no request for early publication/request withdrawn prior to publication)

Question 43

Declaration when filing up to 2 months from end of priority period

Answer 43

Declare priority when filing request Pay late fee of £150 and declaration fee of £40 USE PF3 and provide evidence of why late filing was unintentional (provided no request for early publication/request withdrawn prior to publication)

Question 44

Period for late declaration at PCT

Answer 44

One month from beginning of national phase

Question 45

Multiple/partial priorities

Answer 45

If a broad claim encompasses embodiments with different priority dates, it only takes one embodiment being anticipated by prior art for the whole claim to be invalid, even if earlier priority dates exist within the claim scope. Similarly, different claims may have different priorities and hence have different prior art citable against them.

Question 46

Valid priority documents

Answer 46

WTO/WIPO/PCT member patent applications (including US provisionals) and utility models; see BB 9th Ed. see §5.31. Matter as first filed

Question 47

US application claiming priority from US provisional application or US continuation in part application

Answer 47

if one files a US application that adds new matter to an earlier US provisional application, one can only claim priority from the US application with regards to the new matter and one should claim priority from both documents to file a third application to the whole matter. A similar situation exists for a US Continuation-in-Part application. By contrast, a US Continuation application should not add matter beyond the original application and hence should never be used as a basis for priority.

Question 48

Requirements for filing priority documents

Answer 48

A certified copy of a priority document must be filed within the 16-month period (RS) unless a copy is already available to the Comptroller (e.g. if it is a PCT(GB) application and the priority document(s) were added to the WIPO priority document access service PDAS) A priority document that is not in English or Welsh does not need to be accompanied by a translation on filing (R113(2)(b)). However, the Comptroller can request translation of the priority document (R9(4)(a)) within a specified period if the exact nature of the matter in the priority document is in doubt or is key to a determination of novelty/inventive step (R9(1) (c)). Alternatively, one can provide a declaration that the application as filed is a translation of the priority document (R9(4)(b)).

Question 49

Valid applicants

Answer 49

it was not enough that the US and PCT applications had one applicant in common to validly claim priority; either the PCT application should have been ed with all three applicants, or Cook should have secured assignments from the other two applicants prior to claiming priority. It is advisable that any assignment explicitly assigns the right to claim priority for future patents as well as the current patent right(s).

Question 50

Proof of priority

Answer 50

The onus of proof is on the applicant to show that the priority document exists. If priority is contested, the onus of proof is on the objector to show that the priority document is insufficient (i.e. non-enabling - see legal notes to s14).

Question 51

How does a priority document show support for invention?

Answer 51

priority documents must disclose all essential features of the invention, or these must be 'clearly and unambiguously derivable' from them (similar to novelty)

Question 52

Withdrawal of priority document whilst still retaining right to claim priority

Answer 52

Loss of the priority document (e.g. abandoned, lapsed or refused) is OK. However, if the document is lost before filing the subsequent application claiming priority, it is advisable to explicitly reserve the right to claim priority from it, e.g. when notifying the Comptroller of withdrawal, or in response to a notification of refusal, to avoid it being interpreted as desiring a full loss of rights as per s5(3).

Question 53

When can declaration of priority be withdrawn?

Answer 53

A declaration of priority can be withdrawn in the case of a PCT(GB) before the national phase begins, or for any other GB case, before preparations for publication of the application

Question 54

Cons of late declaration

Answer 54

leaves less time to correct errors in the priority claim (the deadline for this being 16 months from priority), and also prevents the option to file missing matter without re-dating (see s15(7)(a)).

Question 55

Intervening acts priority (section 6)

Answer 55

1) Acts occurring between filing a first application and filing a second application claiming priority from the first don't affect priority. 2) Where an 'act' is, for instance, a relevant publication of the first invention, or the filing of another application by a third party that includes the invention of the first application. (restates section 5(2))