IP IN PHARMACEUTICAL

INDUSTRY
Shenbagapandiyan B
I year, ME (Engineering Design),
Department of Mechanical Engineering
 IP INTRODUCTION
• IP any original creation of the human intellect such as arstistic, literary,
technical or scientific creation.
• IPR legal rights given to the inventor or creator to protect his IP for a
certain period of time.

TYPES OF IP PATENTS

TRADEMARKS

COPYRIGHT

GEOGRAPHICAL
INDICATION
 IP IN BIO-TECH & PHARMA
• Bio-Tech & Pharma are ruling the IP world.
• Though they both find ways to improve the living organism’s health
and both produce medicines, pharma companies have more narrow
focus on healthcare.
• Bio-tech develop products using live material.
• Pharma develops products using chemical compounds.
 TYPES OF PATENT IN
PHARMA
• for new chemical entity created.
Product patent • with these rights, no manufacturer can create/devlop the
same product.

• for a certain process of creating the product.

Process patent • But one may produce the same product with some other
process.

Formulation • pharmaceutical dosage form on the drug.

• quantity of the key ingredients.
patent
Method of use • use of the drug to treat a disease.
patent
 IP IN PHARMA - WHAT WAS
INTENDED
Protecting • patent is robust because a drug cannot be reverse-
engineered as in the case of trade secrets.
medical invention

Drives economic • because investor is the exclusive owner of the

product.
growth

Consumer • ensures a standard by guaranteeing quality which

builids a dependable and efficient public health
protection infrastructure.

Incentives for • offer incentives for developing novel concepts into

potential new medicines.
global solution
 IP IN PHARMA - WHAT IS
HAPPENING
1. INCREASES THE PRICE OF THE PRODUCTS.
– Companies repackage old science or make minor modifications to their existing
products to keep their patents indefinitely.
– Tahir Amin, co-director of the Initiative for Medicines, Access and Knowledge (I-
MAK) contested the patents on Hepatitis C drug called sofosbuvir that in many
places costs $1,000 (₹83,329) per pill.
– Amin argues that in early 2000s, the world saw the power of generic drugs to
exponentially expand the availability of HIV medicines. This had saved the
millions of lives.
– Now, with 7,00,000 people dying each year from Hepatitis C worldwide, we must
once again prevent spurious patents from standing between patients and their
right to healthy, productive lives.
2. BLOCKS THE GENERIC DRUGS TO JOIN THE WORLD
3. PREVENTS THE INNOVATION AND DEVELOPMENT OF MEDICINE
 SCALE OF PHARMA PATENT
MANIPULATION
• Between 2005 to 2015, Feldman’s research tells that 78% of drugs
associated with new patents are not new drugs, but existing ones.
• More than 70% of the 100 best selling drugs between 2005 and 2015 had
their protection extended at lease once, with almost 50% receiving more
than one exclusivity extension.
• As per I-MAK’s 2018 report, among the 12 best selling drugs, it is found
that the drugs have an average of 38 years of exclusivity - almost doubble
the 20 year original patent protection and an average of 125 patent
applicaitons.
 TAKE AWAYS
• Developing drugs is expensive and patents are important and it is a
reward for that investment.
• But it is manipulated by extending the patent period by slight
modifications to the existing products without further R&D.
• Drug development must be one-and-done approach in which each drug
invention receives one and only one period of exclusivity.