Supplementary Protection Certificates Flashcards
Do SPCs cover medical devices?
In Europe no. In USA yes.
How does the UK have the SPC regulation?
Retained UK Law
Human Medicines Regulation states:
You need a licence to sell a drug, if not that is a medical offence
Where does an SPC application have to be made?
To the UKIPO, not the EPO.
How is a medicinal product defined?
As a substance or combination of substances presented for treating or preventing disease in human beings or animals.
Includes for the diagnosis and restoration of metabolic processes.
Conditions for grant of SPC
- If the product is protected by a patent in force
- If valided authorisation has been granted
- IF THE PRODUCT HAS NOT ALREADY BEEN THE SUBJECT OF A CERTIFICATE
- They are the first authorisation to place the product on the market as a medicinal product
Uncertainties with SPCs
Combination drugs. Patent covering drug A, when marketing authorisation covers A + B.
Is SPC for Drug A, A + B or not available.
SPC interpretation
Cannot grant SPC for active ingredients which are not specified in the wording of the claims.
Claim must identify active ingredient by structural and/or functional definition.
What is explained in Yeda
An SPC may not be granted where the active ingredient in the application, although identified in the wording of the claims as an active ingredient, forms part of a combination in conjunction with another active ingredient.
Should be the subject of a claim relating to the active ingredient alone.
Which is the relevant authorisation for regulatory approval?
The member’s state. EMA for EU, MHRA for UK.
If placed on market before marketing authorisation, can you still obtain an SPC?
No. Because it was not necessary, it did not face delay per say. However, Pharmaq said that authorisation in cases of an epidemic, is not an authorisation for the purposes of the regime.
New product, not new authorisation, still can grant SPC?
No. If a former authorisation covers the active chemical compound of the former, it is important that it is a different proportion.
Impurities which only differ in percentage of purity, must be regarded as different products?
No. Same product.
Are adjuvants considered active ingredients in combination?
Not to include combination of active ingredients where only one has a therapeutic effects of its own for a specific indication, such as to make possible the therapeutic efficacy of the first substance
Covalent bonded actives
an SPC can be granted where the first active ingredient produces a pharmacological, immunological or metabolic action of its own.
Can you get more than one SPC per patented product?
No. An SPC is dependent on it patent not being already the subject of a certificate.
Reason for SPC
Basic objective is to compensate for the delay, to take into account all interests at stake.
Specificity, in terms of claiming an active ingreedient, and not a drug class, would not be a balance of interests.
Multiple patent holders
Does not preclude the grant of an SPC to each holder of a basic patent
Does an approval as a medical device count as a marketing authorisation for the purposes of obtaining an SPC?
No. LN v DPM
Can you get SPC for second medical uses
Neurim Pharmaceuticals said each medical use deserved an SPC.
Later case, Santen, stated that second medical uses are not covered. The term product, meaning that each product could get an SPC is not a decisive factor for the grant of an SPC.
Can an SPC be granted if the effect of the active ingredient is not covered by the therapeutic indication of the market authorisation?
No
When must an SPC application be made?
Within 6 months of the first marketing authorisation being granted, or if later, within 6 months of the grant of the basic patent.
Does an SPC cover things other than that covered by the marketing authorisation?
No. SPC invalid to the extent it is broader than the product (or indication) covered by the marketing authorisation
What does the SPC manufacturing waiver allow?
It allows EU-based companies to manufacture SPC-protected medicines for export or EU market entry after SPC expiry.
What conditions must be met for manufacturing under the waiver?
The medicine must be for export or stockpiling.
Acts strictly necessary for production/export/storage are allowed. Compliance with notification and labelling requirements.
When does the SPC waiver apply?
Only to SPCs applied for on or after July 1, 2019, and effective from July 2, 2022.
What protection does an SPC provide
The same as the patent before the expiry of the patent. Can prevent sale of a medicinal product if it contains the protected ingredient via SPC.
What is the duration of the SPC
Up to 5 years
How is the SPC duration calculated?
Time elapsed between date of application for a basic patent and the date of the first authorisation - 5 years.
So if patent in 2010, market authorisation in 2017, SPC is for 2 years.
Pediatric extensions
If you hold an SPC for pediatric extensions you are entitled to an additional six months of protection.
You can be at 4 years and 10 months, and be at ‘negative territory’ for SPC, but 6 months makes you positive at +4 months.
SPC invalidity when:
- it did not satisfy the requirements of grant
- The basic patent lapses before its lawful term ends
- The basic patent is revoked or such grounds exist
