Patents - Short Answer Qs

Question 1

What is excluded from patentability under Article 6 of the Biotechnology Directive?

Answer 1

• Processes for cloning human beings
• Processes for modifying the germ line genetic identity of human beings
• Uses of human embryos for industrial or commercial purposes
• Process for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes

Question 2

What is prescribed as for the “services of the Crown” in relation to Crown use?

Answer 2

For the services of crown is prescribed in PA1977 s56 as including:

• the supply of anything for foreign defence purposes
• the production or supply of specified drugs and medicines; and
• such purposes relating to the production or use of atomic energy or research into matters connected therewith as the Secretary of State thinks necessary or expedient;

and use for the services of crown shall be construed accordingly.

Question 3

When is commercial success relevant to inventive step?

Answer 3

• Pfizer Ltd. Patent: Commercial success comes into its own as an indicator of inventiveness where the relevant prior art has been available and the need for a solution to a known problem has been sought for a long time. Failure to make step indicates that step is not as obvious as it first appears
• Samuel Parkes v Cocker Bros: Where problem has awaited a solution for many years and solution has huge sucess then may be indiciative
• Small company without sales team, commercial success more likely to suggest inventiveness than huge company (EPO: Commercial Success/WATER TAP)
• It is necessary to exclude success being due to other factors such as market monopoly, advertising or better selling techinque (EPO: Pulley System/AUBECQ)

Question 4

On what issues in relation to a patent is it possible to get an Intellectual Property Office opinion?

Answer 4

Any person may request an opinion on:
- whether a particular act constitutes, or (if done) would constitute, an infringement of the patent;

• whether the patent is valid because it is not a patentable invention, matter has been added or insufficiency
• whether an SPC is invalid.

Opinion is non-binding (PA1977 s74A)

If an opinion finds a patent to be invalid, the comptroller may revoke the patent after giving the proprietor the opportunity to apply for a review of an opinion, and no such review is applied for within a specified period or a review is applied for and upholds the comprtroller’s decision.

Comptroller must give proprietor chance to amend/make observiations before revocation. (PA1977 s73)

Question 5

What are the four steps of the Aerotel/Macrossan test?

Answer 5

• Properly construe the claim
• identify the actual contribution
• ask whether it falls solely within the excluded subject-matter
• check whether the actual or alleged contribution is actually technical in nature

Question 6

What is the “trinity” applied for determining equivalents for the purposes of US claim construction?

Answer 6

• Trinity is legal test from Warner-Jenkinson Co. v. Hilton Davis Chem. Co. to determine whether difference between feature in accused device and claim is insubstantial
• The difference is insubtantial if the feature in the accused device:
  
  • performs substantially the same function
  • in substantially the same way
  • to obtain the same result

Question 7

What are the requirements under Article 3 of Regulation (EC) No. 469/2009 for granting a supplementary protection certificate?

Answer 7

• The product is protected by a basic patent in force
• A valid authorization to place the product on the market as a medicinal product has been granted
• The product has not already been the subject of a certificate
• The authorization referred to above is the first authorization to place the product on the market

Question 8

Describe the differences between Absolute Novely, Relative Novelty and Local Novelty

Answer 8

• Absolute novelty means that the state of the art used to assess novelty comprises all disclosures (including oral disclosures, publication and public use) made anywhere in the world before the priority date
• Relative Novelty - Public use outside the jurisdiction is not part of the state of the art but all publications still are
• Local novelty means that the state of the art only comprises disclosures within the jurisdiction in question

Question 9

In what circumstances can a reference be made to the Enlarged Board of Appeal of the EPO by a Technical Board of Appeal?

Answer 9

Article 112 EPC

In order to ensure uniform application of the law, or if a point of law of fundamental importance arises:

a)the Board of Appeal shall, during proceedings on a case and either of its own motion or following a request from a party to the appeal, refer any question to the Enlarged Board of Appeal if it considers that a decision is required for the above purposes. If the Board of Appeal rejects the request, it shall give the reasons in its final decision.

Question 10

Under US law, what is proscution file wrapper estoppel?

Answer 10

Festu v Shoketsu

A presumption that prosecution history estoppel bars the application as to the amended claim element where:
1. The amendment was made to overcome the prior art;
2. The amendment was to bring the claim within patentable subject
matter

3. The amendment was to satisfy the non-obviousness requirement;
4. The amendment was to provide sufficient disclosure

but the presumption can be rebutted where:

1. The equivalent was unforseeable at the time of the application
2. The reason for the amendment only a tangential relation to the equivalent in question.
3. There is some other reason suggesting the patentee could not reasonably be expected to describe the equivalent.

Question 11

What is required to establish a date of filing under the PCT?

Answer 11

Article 11(1)
The receiving Office shall accord as the international
filing date the date of receipt of the international application, provided that that Office has found that, at the time of receipt:
 (i) the applicant does not obviously lack, for reasons of residence or nationality, the right to file an international application with the receiving Office,
 (ii) the international application is in the prescribed language,

(iii) the international application contains at least the following elements:
(a) an indication that it is intended as an international application,

(b) the designation of at least one Contracting State,
(c) the name of the applicant, as prescribed,
(d) a part which on the face of it appears to be a description,
e) a part which on the face of it appears to be a claim or claims.

Question 12

When does the international phase end under the PCT? And what must be done to enter the national phase in the UK?

Answer 12

• The international phase lasts a minimum of 30 months from the priority date
• At the UK IPO and EPO, it lasts 31 months from the priority date
• To enter the national the phase in the UK:
  
  • a form must be file and an appropriate fee paid
  • the necessary translations must be filed, i.e. a translation into English or Welsh, if English was not the language of the PCT publication

Question 13

When can the term of a Japanese patent be extended?

Answer 13

• Under Article 67(2) the term of the patent may be extended by up to 5 years, where the patent invention cannot be worked because the relevant approval has not yet been obtained.
• Such extensions must be applied for in writing before the patent right expires and within 3 months of any approval being granted.
• where the approval is not likely to be granted before expiry of the patent term, the patentee can write within the last 6 months of term to indicate that a request will be filed in due course.
• If the patentee does this can file the approval after expiry, and possibly still extend the term

If there are joint proprietors, the extension application must also be made jointly

Question 14

What are the criteria for granting an SPC under Art. 3 of SPC Regulation?

Answer 14

• the product is protected by a basic patent in force
• a valid authorisation to place the product on the market as a medicinal product has been granted
• the product has not already been the subject of a certificate
• the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product

Question 15

Duration of SPC

Answer 15

The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.

i.e. (time for first authorisation to palce product on the market in the community - 5) years, up to 5 years (or 5.5 with paediatric extension)

Question 16

Coco v Clark test

Answer 16

• Information must be of a confidential nature (hence capable of being protected)
• Information must have been communicated in circumstances importing an obligation of confidence
• Must be unauthorized use of the information to the deteriment of the person communicating it.

Question 17

What are grounds for revocation of a patent?

Answer 17

PA1977 S72

• the invention is not a patentable invention
• the patent was granted to a person who was not entitled to be granted that patent
• the specification of the patent does not disclose the invention clearly and completely enough for it to be performed by a person skilled in the art (sufficiency)
• the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent as filed
• the protection conferred by the patent has been extended by an amendment which should not have been allowed

Question 18

What is required to obtain a date of filing under the EPC?

Answer 18

EPC Rule 40

• Documents filed by the applicant must contain:
  
  • an indication that a European patent is sought
  • information identifying the applicant or allowing the applicant to be contacted; and
  • a description or reference to a previous filed application

Question 19

What criteria are needed to obtain a date of filing at UK IPO?

Answer 19

Documents must:

• indicate that a patent is sought
• the documents must identify the person applying for a patent or contain information sufficient to enable that person to be contacted by the Patent Office; and
• must contain either:
  
  • something which is or appears to be a description of the invention for which the patent is sought
  • a reference to an earlier relvant application made by the applicant or a predecessor in title of his

Question 20

When and what conditions are there on the reinstatement of a UK application?

Answer 20

• An additional reinstatement fee must be paid and an application for reinstatement made
• Application must be made by 12 months from the day after the application lapsed
• Applicant must show that failure was unintentional