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ETMM > Pharmaceutical Inventions > Flashcards

Pharmaceutical Inventions Flashcards

1
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A
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2
Q

What is an intellectual property.

A

Rights associated with something tangible. User rights which creates a time-limited monopoly.

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3
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4
Q

What does a patent look like?

A

Front page which holds the title, summary or abstract of the invention, name of inventors, key dates-filing, List of countries patent is intended for (EU patent). Description of the pharmaceutical invention along with the claims found in the background to which details of what monopoly is being sought is stated.

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5
Q

What is the criteria for patentability (Patents are too IIner)

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6
Q

What is the criteria for patentability (Patents are too Iiner)

A

Industrial Capability.
New
Inventive

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7
Q

Define Supplementary Protection Certificate (SPC)

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10
Q

How did Finasteride become a successful re-purposed patent.

A

• At 5mg OD Finasteride (Proscar) was effective in treating benign prostate hyperplasia (BPH) but at dose of 1mg OD Finasteride was effective in the treatment of male hair loss (Propecia)- this proved to be an successful patent because of the surprising finding on hair loss against the original indication and so it received a separate patent.

• Reformulated into a five-fold lower dose.

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11
Q

Why are drugs repurposed.

A
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12
Q

How long does De novo drug discovery and development take.

A

◉10-17 years

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13
Q

What is the estimated cost of getting new drug into the market.

A

◉Over ~ $2 billion to do all the research and development.

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14
Q

How many medicine submitted for NICE approval over period 1999-2005 were reimbursed.

A

Out 71 products only ~60 products were approved for NHS reimbursement (87%).

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15
Q

When sildenafil was repurposed was was the worldwide sales in 2012.

A

$2.05 billion in sales for repurposed Sildenafil for the indication of erectile dysfunction.

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16
Q

In EU what is the regulatory approval pathway for product taken directly into phase II trials.

A

Article 10 of Directive 2001/83/EC.

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19
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20
Q

Give an example of where a drug encountered problems with becoming repurposed.

A

Auranofin

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21
Q

Give an example of where the government helped to repurpose generics.

A

Government funding agencies intervention to provide financial support for large scale clinical trials to test utility of re-purposed generics:
▻ In the USA, phase III trial of anti-diabetic drug, metformin, to test its utility in addition to standard adjuvant therapy to prevent recurrence of breast cancer (about half of the $25m costs contributed by US NCI)

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24
Q

What are the problems associated with new drug development (RELD).

A
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25
Q

How long does patent provide protection for (UK)

A

🔘 UK patent last for 20 year: Negative monopoly.

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26
Q

Patent starts from when the patent has been approved European Patent Convention (EPC).

(A) True
(B) False

A

(B) False. Patent has 20 year life from the time at which the patent application is filed.

27
Q

What is the name of the European Patent Organisation.

A

European Patent Convention.

28
Q

What can a Pharmaceutical Company Patent.

A

Patented Devices
Patented API
Patented Formulation.

29
Q

Give an example of patentable device.

A

Norvatis transdermal patch (Scopolamine/motion sickness)

30
Q

Give an example of patentable APIs

A
31
Q

Give example of patentable formulation.

A

Leo Arlamol E (non-aqueous solvent) added to disperse Calcipotriol and Betamethasone.

32
Q

A patent is granted if it meets the three criteria which is…

A

(i) Capable of being used in industry.
(ii) New
(iii) Inventive

33
Q

Describe the patent system.

A

The patent application is filed and then UKIPO do a search request within the next 6 months to gather information to determine whether the invention is new and inventive. At 12 month the application is formalised. Then at 18 months UKIPO publish the patent application, to which the applicant then has a further 6 months where UKIPO will issue an examination. The examination report is published and it is either granted or there is objections that need to be replied to. Following the applicant response patent can either be rejected or granted. After, the patent is renewed at yearly fee.

34
Q

How long is the patent application process.

A

3-4.5 years.

35
Q

What is the cost in UK for patent application process.

A

Cost (in UK): £4,000-£6,000

36
Q

Give the name for when patent is extended beyond the standard 20 years for X amount of time.

A

Supplementary Protection Certificate (SPC) providing 5 year.

37
Q

SPCs are only valid for products marketed in the UK, and are issued only to the patent holder, not to licensees or manufacturers.
(A) True
(B) False

A

(A) True.

38
Q

Give an example of where a higher life form was not patentable.

A

Havard College v. Canada (Commissioner of Patents): Wanted to patent the oncomouse.

39
Q

What is the name of patent brought against the idea of novelty of Enzalutamide.

A

Lack of novelty: US patent 6087509 was used as prior art document, disclosed in the form if Markush representation. Both compounds were similar in chemical structure.

40
Q

Why did India revoke the patent for COPD drug Boehringer Ingelheim (what was the patent law).

A

Salt, ethers, polymorphs and esters of known molecules cannot be patented under Section 3(d) of the Indian Patent Act.

41
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A
42
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43
Q

Give an example of registered trade-mark.

A
44
Q

Give an example of registered design.

A

Viagra, the diamond-shaped, blue-coloured tablets manufactured by Pfizer

45
Q

Give an example of copyright patent in pharmaceutical.

A

Product information leaflet and summary of product characteristic, which may be literary works. GSK did that with Priorix PIL.

46
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A
47
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48
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49
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50
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51
Q

“Skinny labelling” refers to the practice of (a) drug (b) seeking (c) for some but not (d) indications for which the (e) drug has been (f).

A

(a) Follow on
(b) manufacturer
(c) approval
(d) all
(e) branded
(f) approved

52
Q

In 1997, USA regulators approved (a) (b) to treat (c), congestive heart failure (CHF) and (d) following a heart attack. GSK met with (e) in their initial patent filling but in 2008 successfully secured patent for (a) but the patent pertained only to the treatment of (f).

(g) sough approval for a generic version of (a) that would hold a ‘(h)’ for just the other X indications. But doctors were prescribing (g) version of the drug for all (i) regardless of the label.

GSK brought a court case against Teva ( (j) ) but the judge ruled (k) them- and (g) avoided having to pay GSK Y million in (L) and (M).

A

(a) Coreg
(b) Carvedilol
(c) hypertension
(d) Left ventricular dysfunction
(e) difficulties
(f) CHF
(g) TEVA
(h) Skinny labelling
X: 2
(i) indications
(j) induced infringement
(k) against
(Y) $235 million
(L) profits
(M) royalties

53
Q

A trade mark is a type of (a) consisting of recognisable (b), (c), or (d), which (e) the product or services of a particular (f) from those of (g).

A

(a) intellectual property
(b) sign
(c) design
(d) expression
(e) identifies
(f) source
(g) others

54
Q

How can you identify a product has a trademark. Give an example of trademark.

A

Product that is trademark has r with encircled. Example: Viagra is the trademark for Sildenafil.

55
Q

Design patent is form of (a) that is concerned with the (b) of the invention, the way it (c), how it is (d).

A

(a) intellectual property
(b) appearance
(c) looks
(d) ornamented.

56
Q

Give an example of design patent and describe it.

A

Pfizer’s Blue Viagra tablet.

57
Q

Briefly describe a dispute concerning registered design.

A

Pfizer initiated litigations against many generic producers of Viagra. Generic manufacturers were using brand names such as Penegra, and adopted a similar blue colour and packaging. One of the main concerns expressed by Pfizer was that consumers would buy generic product like Penegra thinking it to be Viagra’s equivalent that was manufactured by Pfizer in India. BUT Pfizer did not hold a trademark registration in India and was not marketed in India at the time. Therefore the Court ruled that there was no misrepresentation but did say that generic company could not use the blue colour used by Pfizer.

58
Q

Copyright is the (a) right given to the (b) of a (c) work to reproduce the work, usually for a limited (d). The (c) work may be (e), artistic, (f), or (g).

A

(a) exclusive
(b) creator
(c) creative
(d) time
(e) literary
(f) educational
(g) musical

59
Q

Give an example of Copyright.

A

Priorix by GSK Patient information leaflet.

60
Q

Give all the type of intellectual properties.

A
  1. Molecule/Formulation/Device patent: Protect invention
  2. Trade-marks
  3. Design patent
  4. Others: confidential and trade secrets, copyrights, customs protection, counterfeiting protection.
61
Q

How many times can trade-mark be renewed. What type of monopoly is it.

A

Capable of indefinite renewal (every 10 years)—> perpetual monopoly.

62
Q

SPC compensates the patent holder for the delay in bringing the (a) (b) to market until (c) (d) is obtained, in the form of an (e) (f).

A

(a) medical
(b) product
(c) regulatory
(d) approval
(e) marketing
(f) authorisation

63
Q

Give an example of SPC granted to API.

A

Trastuzumab sold by Roche as Herceptin were it was granted SPC extending exclusivity a further 2 years.

ETMM (13 decks)

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