Patentability

Question 1

What are the requirements of Section 1(1)?

Answer 1

A patent will only be granted for an invention that is:

• New
• Involves an inventive step
• Capable of industrial application
• Not excluded by subsections 1(2) or 1(3), or section 4A (methods of treatment or diagnosis)

**Not an exhaustive list of exclusions, and section 76A includes further exclusions for biotech inventions**

Question 2

What are not inventions according to Section 1(2)?

Answer 2

At least the following are not inventions for the purposes of the Act:

• Discovery, scientific theory, or mathematical method
• LDMA work, or any other aesthetic creation
• Scheme, rule, or method for performing a mental act, playing a game or doing business, or a program for a computer
• The presentation of information

only to the extent that it relates to that thing as such.

Question 3

What does Section 1(3) say?

Answer 3

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

Question 4

What does Section 1(4) say?

Answer 4

“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”

i.e. immoral =/= illegal

Question 5

What does Section 4A(1) exclude from patentability?

Answer 5

• Methods of treatment of the human body or animal body by surgery or therapy
• Methods of diagnosis practised on the human or animal body

NB

• methods of treatment or diagnosis performed exclusively away from the body are not excluded
• non-therapeutic treatments may be patentable
• therapy assumes relief of a medical condition

Question 6

How does Section 4A subsections (2)-(4) modify subsection (1)?

Answer 6

• Substances/compositions for use in such methods allowed.
• Use of a substance or composition in such a method is new even if substance is known in the art (1st medical use).
• Further specific use of known substance for such a method is new if the specific use is new (2nd medical use).

Question 7

What does s76A relate to?

Answer 7

Section 76A relates to biotech inventions and says that Schedule A2 only affects biotech patents and patent applications

Question 8

What subject-matter is excluded from patentability by Schedule A2?

Answer 8

• Human body, at various stages of development, and simple discovery of its elements (includes genes)
• Processes for cloning humans
• Processes for modifying the germ line genetic identity of humans
• Uses of human embryos for commercial/industrial purposes
• Processes for modifying genetic identity of animals which are likely to cause suffering without substantial medical benefit, and animals resulting from such processes
• Any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a microbiological or other technical process or the product of such a process

Question 9

What biotechnological inventions are expressly permitted by Schedule A2?

Answer 9

• Plant/animal varieties not limited to a particular variety
• Elements isolated from the human body (including genes) but industrial application must be disclosed
• Biological material isolated from its natural environment or produced by means of a technical process even if its has occurred in nature

Question 10

What is the requirement for patentability set out in Section 2(1)?

Answer 10

An invention shall be taken to be new if it does not form part of the state of the art

Question 11

How is the “state of the art” defined in Section 2(2) and (3)?

Answer 11

• Comprises all matter made available to the public at any time before the priority date including written, oral and use
• (For novelty only) matter in a patent or applicaiton published on/after the priority date if:
  
  • matter was in the application both as filed and published
  • the priority date is earlier

NB:

• abstract not part of the art
• only documents which can become GB patents are citable as s.2(3) art
• includes applications whose publication was prevented under s.22
• if applicaiton not validly published (withdrawn too late to prevent publication) it won’t be s.2(3)

Question 12

Can EP applications be cited as s.2(3) prior art?

Answer 12

Yes, after Dec 2007 all states (inclueding GB) are designated by default

Question 13

Can a lapsed PCT application be cited as s2(3) prior art?

Answer 13

No, PCT application can only be cited once they have entered the GB national phase

Question 14

What are the conditions set out for the six month grace period in Section 2(4)?

Answer 14

1. Disclosure due to invention being obtained by anyone unlawfully or in breach of confidence:
   
   1. from the inventor, or anyone in confidence of the inventor, or anyone who obtained it from the inventor because they thought they were entitled.
   2. from anyone told in cofidence by anyone mentioned in 1.
2. Disclosure made in breach of confidence by anyone holding the invention in confidence or to whom it was disclosed in confidence (includes inventor?)
3. Disclosure due to display at an officially recognised international exhibition, provided application states this on filing and evidence is supplied within 4 months.

NB for a discloure so be a proper disclosure, it must be enabled

Question 15

When should confirmatory evidence be filed for a disclosure at an International Exhibition?

Answer 15

File application within 6 months

File declaration on filing

File confirmatory evidence within 4 months from filing of a GB application or 2 months for a PCT(GB) application (inform PCT receiving office on filing)

Question 16

When is an “air of confidence” considered to be present for a disclosure in breach of confidence?

Answer 16

If, at the time that the information is imparted or acquired, the recipient understands that the information is confidential

• Unlikely if a document is forgotten and left somewhere carelessly
• Consider if an NDA in in place
• Was the document marked “confidential” or password protected?
• Employees have obligation of confidence to their employer

Question 17

What is the interplay between breach of confidence and priority?

Answer 17

A priority claim does not mean that the breach of confidence will be disregarded for the newer application.

If there is a breach - file a PCT application immediately.

Every applicaiton, regardless of priority claim must be filed within 6 months of the breach or else the disclosure will become prior art.

Question 18

What requirement for patentability does Section 3 relate to?

Answer 18

Inventive step

An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above).

Question 19

What requirement for patentability does Section 4 relate to?

Answer 19

Industrial applicability

an invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture.

Question 20

What inventions are specifically permitted by Section 4A?

Answer 20

Substances and compositions for use (i.e. medical use claims)

First and subsequent medical use claims permitted

Question 21

How is “treatment” understood in Section 4A?

Answer 21

In general:

• ‘of the human or animal body’
• relief of a cause or symptom of a medical condition
• purely cosmetic treatments are not considered therapeutic (so generally excluded, but consider any incidental therapeutic effect)
• is supervision of a physician needed?

Question 22

How is ‘surgery’ defined in Section 4A?

Answer 22

• ‘non-insignificant intentional physical intervention’ (not necessarily invasive)
• encompasses both therapeutic and cosmetic surgery (case law leans toward therapeutic though)

Question 23

How is ‘therapy’ defined for Section 4A?

Answer 23

• corrective/preventative/alleviates a medical condition
• addresses a symptom or the cause
• includes pest control

Question 24

How is ‘diagnosis’ defined for Section 4A?

Answer 24

• Includes a medical decision phase
• Practised on the body
• Assumes a medical condition (i.e. pregnancy test is not a diagnosis)

Question 25

What is the test for exclusions under section 1(2)?

Answer 25

Exclusions are limited to where the invention relates to those things 'as such'. The current test is set out in *Aerotel:* 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)