Blockbuster Drugs and Lifecycle Management

Question 1

What is a patent? Give 2 things

Answer 1

1) A license granted by a government body that guarantees exclusive exploitation rights to intellectual property
2) Prevents others from making, using and selling the invention claimed during the life of the patent

Question 2

What must the investor do in return for the patent?

Answer 2

Publish full details of the invention to stimulate further innovation

Question 3

Give 4 reasons why it is beneficial to patent.

Answer 3

1) encourages exploitation on inventions
2) increases scientific and technical knowledge
3) encourage transfer of technology
4) means market excusivity

Question 4

What do you have the right to do if your patent is infringed?

Answer 4

Sue

Question 5

How long does a patent last?

Answer 5

20 years

Question 6

What are generics?

Answer 6

Drugs produced which are very similar to the original

Question 7

What happens to the price of the drug once the patent expires and why?

Answer 7

Decreases as market forces drive it down

Question 8

When does the patent start?

Answer 8

From the date of filing

Question 9

What is there a balance between?

Answer 9

Filing early enough to protect your data but getting good return of investment (ROI)

Question 10

What can you patent?

Answer 10

An invention that is non-obvious or include an inventive step to a person ordinarily skilled in the art. can also claim analogues of the drug. Don’t have to have made every compound included in the patent but some of them.

Question 11

What can happen if you claim too many or too little prophetic compounds?

Answer 11

The patent examiner may reject the application. Leave yourself open to competitors

Question 12

Name some things we can patent.

Answer 12

Drug substance and analogues, crystalline form/polymorphs, formulation, manufacturing process, intermediates, use of product/associated devices, potentially genes

Question 13

How much cheaper are lower price generics and what proportion of the market share can they take up?

Answer 13

30% cheaper and 90%

Question 14

What is the patent cliff?

Answer 14

Concerns about lack of new products in the pipeline. In 2016 lots of patents expired so lots of generic versions expected

Question 15

Explain what the desired life cycle management is.

Answer 15

To reduce the cost of investment. start selling earlier, sell more during the return period and sell for longer during the return period after patent expiry.

Question 16

What 4 things must generics certify?

Answer 16

1) has not been patented
2) patent has expired
3) patent will expire on a given date
4) patent is not invalid or not infringed

Question 17

What can a generics company file in the US and the UK/EU?

Answer 17

ANDA, abridged application

Question 18

What must a generic drug contain?

Answer 18

Same active ingredient

Question 19

What is useful about having identical/ bioequivalent compound?

Answer 19

Don’t need to go through testing as the pharmacokinetics/dynamics will be the same

Question 20

What is beneficial about a generic for the company?

Answer 20

lower cost as no drug discovery or clinical trials

Question 21

When can you get a patent extension?

Answer 21

When take into account the time is took to do the paper work etc.

Question 22

What is evergreening?

Answer 22

producers extend their patents over products that are about to expire by taking out new patents or finding a way to extend the patent

Question 23

What is good about new formulations’ patents?

Answer 23

might show advantages eg increased compliance, efficacy, few side effects. shorter apprival process if similar to original drug. eg metformin hydrochloride diabetes drug.

Question 24

Give an example of a new formulation that changed delivery mechanism.

Answer 24

Sumatriptan (Imitrex) migraine treatment by GSK. 5-HT agonist causing vasoconstriction of cranial arteries. 2006-injection, 2009-tablets, 2011-nasal spray

Question 25

What happens with enantiomers?

Answer 25

One often has increased efficacy and reduced side effects

Question 26

What is chiral switching?

Answer 26

Replacing racemic drugs with single enantiomer drugs in the market

Question 27

Give an example of a chiral drug.

Answer 27

Omeprazole by AZ in 1998 for acid reflux treatment. S enantiomer shows improved potency and bioavailability

Question 28

What is the S enantiomer of omeprazole called?

Answer 28

Esomeprazole (Nexium)

Question 29

What sales in the first 5 years did Esomeprazole make? and when did patent expire?

Answer 29

over $14b and 2014

Question 30

Give an example of a drug that found a new use

Answer 30

Atomoxetine antidepressant by Eli Lilly is a selective noradrenaline reuptake inhibitor but was approved for use to treat ADHD in 2002 called Strattera

Question 31

How many prescriptions of Strattera in the first 9 months?

Answer 31

over 2 million

Question 32

Why are combinations useful and give an example?

Answer 32

Already proven to be safe and effective eg HIV treatments - AZT (Retrovir)

Question 33

What does Fluoxetine (Prozac) do?

Answer 33

Antidepressant drug by Eli Lilly blocks the carrier protein responsible for serotonin uptake (SSRI) from nerve synapses forcing it to hang around for longer.

Question 34

What was Prozac patented?

Answer 34

Between 1977 and 1986 - 4 patents

Question 35

What happened when Barr challenged Prozac’s patent as an example of double patenting?

Answer 35

The first patent was valid, the rest weren’t so expired in 2001

Question 36

Why was an extra 6 months granted to Prozac? How much revenue dod this get them?

Answer 36

For paediatric testing. $1b

Question 37

How many companies were given 180 exclusivity to generics? Give an example

Answer 37

5. Barr Laboratories

Question 38

What combination is available for fluoxetine and how many sales?

Answer 38

combo with Zyprexa (1 capsule) for treatment of bi polar disorder (2003) and treatmetn resistant depression (2009). $82m annual US sales.