HMM304 Therapeutic Development - IP, Patents, Regulation, Marketing, and Post-market (Week 6)

Question and Answer flashcards covering IP basics, patents, regulations, marketing, and post-market considerations from the lecture notes.

What is Intellectual Property (IP)?

IP is the application of the mind to create something new or original and can exist as inventions (patents), brands, designs, or artistic works; it is a strategic asset that should be managed.

Name common forms of intellectual property.

Patents, trademarks, registered designs, copyright, trade secrets, and Plant Breeder's Rights.

What does a trademark do?

Identifies the goods or services of a trader as distinct from those of others (e.g., Qantas®, Lonely Planet®).

What is a patent and what does it protect?

A patent protects how an invention works or functions; it is issued by country authorities and prevents others from commercialising the invention during the patent term, but it does not automatically give the right to practice the invention.

What does copyright protect?

The owner's original expression of ideas, not the ideas themselves (examples include typefaces and fonts).

What does a registered design protect?

The visual appearance of a product, not how it works (e.g., iPod, kitchen appliances, footwear, fashion items).

What are trade secrets?

Confidential information that gives a competitive edge (e.g., Coca-Cola’s formula).

What are Plant Breeder's Rights?

Protection of the commercial rights of new plant varieties.

Why are patents essential for drug development?

Drugs require large discovery and development costs; publishing the structure could enable others to copy, so patents help recoup costs and keep the business viable.

What does a patent application include?

Bibliographic details, description of the invention, and claims; typically 10 to over 100 pages; must provide enough detail to understand the invention but not necessarily prove it works.

What can be patented?

Products (physical things like drugs) and processes (methods to make or use something, including surgical procedures); must be novel, involve an inventive step, and be industrially applicable; country rules may differ.

What is the Paris Convention’s 12-month period?

After the first filing, there is a 12-month window to file in other countries for patent protection (foreign filing).

What is the standard duration of a drug patent, and can it be extended?

Typically 20 years; extensions of up to 5 years may be available under certain circumstances.

When should a drug patent be pursued in the development timeline?

Patents are ideally filed toward the end of discovery and just before drug development begins; early patents may expire sooner.

What do IND and NDA stand for and what are their roles?

IND = Investigational New Drug approval to permit clinical trials; NDA = New Drug Approval to market the drug after demonstrating safety and efficacy.

What is the role of the Australian TGA?

The Therapeutic Goods Administration regulates therapeutic goods in Australia, maintains the ARTG, and ensures safety, effectiveness, and quality of medicines, devices, and related products.

What is ARTG?

The Australian Register of Therapeutic Goods.

How is a ‘medicine’ differentiated from ‘food’ in regulatory terms?

A clove of garlic is considered food, while concentrated garlic in capsules with health claims is treated as a complementary medicine.

Is direct-to-consumer advertising of prescription drugs generally allowed?

In most countries, prescription drugs cannot be directly advertised; DTCA is allowed in the USA and New Zealand, but it can bias patient reporting and has regulatory implications.

What are the two key marketing considerations for pharma products?

1) Features of the product (clinical trial findings, endpoints, safety, post-market studies, labeling) and 2) Identifying the market (market research, labeling, focus groups, target audiences).

What is a ‘freedom of pricing’ environment in pharma?

Companies can set drug prices in many countries; regulated pricing involves government negotiations and may involve standardized costs or bulk/ performance-based discounts.

What is Continuing Medical Education (CME) in pharmaceutical marketing?

Ongoing education for medical professionals, often run by independent organizations but sometimes funded by drug companies, which can introduce bias.

Why is post-market monitoring needed?

To detect very rare adverse effects, long-term safety issues, and to expand knowledge of beneficial effects and indications.

What is Phase IIIb in drug development?

Peri-approval phase conducted between NDA submission and decision; may include additional long-term safety data or testing an additional indication before final data.

What is Phase IV in drug development?

Post-approval phase involving large, multi-site studies to collect ongoing safety and efficacy information.

What are the three core patentability requirements?

Novelty (not disclosed before), inventive step (not obvious and not to public detriment), and industrial applicability (functional utility).

What is the purpose of patent foreign filing?

To extend patent protection to other countries; decision on which jurisdictions to file in is made during the 12-month period after the initial filing (Paris Convention).

What is the difference between CAM and prescription medicine in Australia’s regulatory framework?

Medicines require regulation for safety and efficacy; complementary medicines may be regulated differently and may have less stringent claims.