Week 9- Intellectual Property and Patents

Intellectual property

A work or invention that is the result of creativity, such as a manuscript or a design, to which one has rights and for which one may apply for a patent, copyright, or trademark.

Bayh-Dole Act

Allows universities and other small businesses to control intellectual property resulting from federally funded research.

Martin Shkreli

Bought a drug called Daraprim and raised its price from less than $20 a tablet to $750.

Trade Secrets

Confidential information that has economic value (formulas, customer lists, and manufacturing processes)

The Patent Act

Defines what is patentable,in order to be patentable the invention must be novel, useful, and non-obvious.

Governments rights to patents for inventions

Developed under federally funded R&D at privately owned business organizations are determined by the terms of the procurement contract. These procurement regulations required to be used by most government agencies closely parallel the provisions used for universities, nonprofit corporations and small business organizations.

Copyrights

Expressions of ideas (writings, music, art works)

Exclusivity

FDA can grant exclusivity if certain requirements are met. Designed to promote a balance between new drug innovation and generic drug competition. Orphan drug- 7 years New chemical- 5 years Other- 3 years Pediatric- 6 months added to existing patents/exclusivity

Ariosa

Fetal blood test to determine genetic abnormalities and sex of child. Discovered that maternal cffDNA is found in mother's blood stream. Method claims found not directed towards patentable subject matter because the blood was always in the mother and is natural.

Government funded work

Funds almost 50% of the national R&D effort. Fed gov has the most US patent rights (30,000 patents), and has rights to nonexclusive royalty-free licenses in thousands of patents.

Myriad case May 12, 2009

Group of plaintiffs led by the American Civil Liberties Union filed a lawsuit against Myriad Genetics. Alleged that the 2 human genes associated with breast and ovarian cancer were invalid and unconstitutional. Supreme court ruled the gene is natural, so shouldn't be patentable.

Provisional patent

Holds spot in line which then needs to be converted to the common utility patent within a year.

Theranos

Holmes constantly scared off investors b/c she refused to explain to investors how her technology worked. Never responded to Google Ventures, and was found to not be doing proper blood drawing procedures.

PCT

If you would like to file patents across the world. Can file one application and you have 30 months to decide which countries you want the patent in.

Biological patents

In the US up until 2013, natural biological substances themselves could have been patented if they were sufficiently isolated from their naturally occurring states.

Patents

Inventions (processes/methods and machines/devices). Gives right to have that protection, and gives reward for invention. Grants the patentee right to exclude others from using or making the invention.

Obviousness

Is measured by what one of ordinary skill in the subject area of the patent would have known at the time of the invention.

Utility patent

Issued for the invention of a new and useful process, machine, manufacture, or composition of matter, or a new and useful improvement thereof.

What to know as an investor

Keep accurate and complete records of all research or concept design efforts, do not publicly disclose your invention until talking with a patent attorney or without having them sign anon disclosure or confidentiality agreement, if your invention is created with the scope of your employment you may have to assign rights to employer, stay away from invention promotion firms.

Patent timeline

Last 20 years from the filing date/ 17 years from the issue date

Government rights

March in rights, rights to require the owner to license others, rights to require licensing of background patents, rights to approve assignments, rights to limit terms of license agreements and revisionary ownership rights

Improvement patent

Most patents granted today are improvement. They protect the differences between a new product and previously existing products and services of the same kind. Can be further broken down into addition or substitution inventions.

Mylan- Epipen

Mylan dominates the market so can price whatever they want. In 2007 Epipens were $50, but now ever since they bought Epipens they now cost $600 for a 2 pack.

What can not be patented?

Natural works, laws and theorems of nature, discoveries or suggestions, and abstract ideas.

Can a product be re-patented?

No, but you may be able to obtain a patent on how to use the product.

Patent office guidelines

Patent office has issued guidelines for what is patentable subject matter. Strategy- find an example similar to patent application you are writing.

Publishing a patent

People will know how you do what you do, this is different from a trade secret.

Patent acquisition

Prepare and file--> examination by examiner--> issuance after awarded patent by examiner--> post-issuance challenges if someone feels there is a reason they shouldn't have been issued the patent

Trademarks

Source indicators like the Nike Swoosh

Novel

The invention is new and is non identical to the previous work of others

Non-obvious

The invention must not be an obvious extension or combination of the previous work of others.

Patent trolls

Uses patents as legal weapons, instead of actually creating any new products or coming up with new ideas. In the business of litigation or even just threatening litigation. They will buy patents cheap and send threatening letters to anyone who infringes.

Patent attorney

Write applications, preform office actions/prosecutions, evaluate technology/searches, patent strategies, licensing, and litigation