Patents and intellectual property issues.

Phil 133 – Ethics in ScienceSan José State University

Norm of communismNorm of communism

• Scientific knowledge as shared resource for whole scientific community.

• Individual ownership – intellectual property.

Who owns what’s in your head?Who owns what’s in your head?

• You own it, at least until you disclose it in some way.

• Depending upon how it gets into your head, it may become a trade secret.

Who owns what’s in your head?Who owns what’s in your head?

• “Work-for-hire”: Your employer may have a claim to own all that’s in your head, even what you think of on your own time.

(Not in California, but in some other states – and California law may protect CA residents who are employed in states where the laws favor employers.)

Who owns what’s in your head?Who owns what’s in your head?

• Not unusual for universities to make their employees, students sign patent agreements.

If you discover something patentable, university gets the patent, not you.

SJSU’s policy is more complicated …http://www.sjsu.edu/senate/f98-3.htm

SJSU policy on intellectual and SJSU policy on intellectual and creative property:creative property:

“SJSU recognizes that ownership rights in intellectual property should remain with the creator whenever possible. At the same time, the University also recognizes there are situations where the University has a vested interest in certain intellectual property rights due to the nature of the creation of the work, use and cost of facilities and/or equipment available to someone because of their relationship with SJSU, or specific contractual agreements.”

Patents: what are they?Patents: what are they?

Vandana Shiva notes three historical uses, not neatly separated in law:

• Patents for conquests• Patents for inventions• Patents for imports

Used to establish colonies, import monopolies, not just reward invention.

Patents: what are they?Patents: what are they?

• A patent gives the holder a limited right to a monopoly (i.e., to exclude others from making, using, or selling the subject matter of the patented claims).

• After the term of the patent (in U.S., 17 years from issue or 20 years from first filed application), the knowledge becomes a public good.

What can you patent?What can you patent?

• A process• A machine• A manufacture• A composition of matter• Any improvement thereof

Recent court decision on BRCA1/BRCA2 patents.

What’s an improvement?What’s an improvement?

Rogaine (minoxidil) was originally developed as an oral medication to treat high blood pressure.

Hair growth was a side effect.

Reformulated for topical use, filed for (and received) patent as hair growth treatment.

What’s an improvement?What’s an improvement?

Prozac (fluoxetine) patented for treatment of depression.

Near when patent was to expire (in 2001), Eli Lilly changed package insert and secured a new patent (under the name Sarafem) for fluoxetine as treatment of premenstrual dysphoric disorder (PMDD).

Is new package insert improvement enough?

Who can claim patent rights?Who can claim patent rights?

In the U.S.:• First to invent (not file)• One year grace period for filingRest of world: • Absolute novelty (so no communication

beforehand)• No grace period

To be patentable, must be:To be patentable, must be:

• NEW• USEFUL• UNOBVIOUS

To be patentable, must be:To be patentable, must be:

• NEWHow did a Texas company get a patent on Basmati rice (around for thousands of years)?

• USEFULWhat about new allergy meds that are better than placebo but not existing meds?

• UNOBVIOUSTo whom? (Software algorithms obvious to programmers but not Patent Office)

To be patentable:To be patentable:

• Need to be able to explain the process, machine, manufacture, composition of matter, or improvement thereof in terms someone else can repeat.

To be patentable:To be patentable:

• Need to disclose “best mode” – can’t keep back the best of the invention for yourself.

If you know it, it has to go into the patent application!

Witnessed and signed notebooks Witnessed and signed notebooks as legal documents:as legal documents:

• To document “best mode” as you know it when filing patent application.

• In establishing date of invention (which, under U.S. law, determines who gets the patent in case of conflict).

Vandana Shiva points out some Vandana Shiva points out some problems:problems:

‘We have among us men of great genius, apt to invent and discover ingenious devices. … Now, if provisions were made for the works and devices discovered by such persons, so that others who may see them could not build them and take the inventors’ honour away, more men would then apply their genius, would discover, and would build devices of great utility for our common wealth.’ (14)

Vandana Shiva points out some Vandana Shiva points out some problems:problems:

• Do patent rights encourage innovation – or theft?

Patents issues on the basis that there is “no prior art” in this jurisdiction.

Vandana Shiva points out some Vandana Shiva points out some problems:problems:

“The assumption of ‘ignorance of invention’ is enshrined in the US Patent Act of 1952. Section 102 of the Act talks of use in the US, not use in foreign countries, as prior art. The US Patent Act, which was designed to make the country an independent industrial power, was thus deliberately designed to deny prior art and hence treat ignorance of prior innovation as the grounds for invention.” (18)

Vandana Shiva points out some Vandana Shiva points out some problems:problems:

• Lack of uniform rules internationally.

Push to enforce U.S. intellectual property laws in other jurisdictions (or face economic sanctions).

Vandana Shiva points out some Vandana Shiva points out some problems:problems:

• Biopiracy – patenting products of local innovation (or of nature), then selling them back to the population that depends on them.

In the social contract, what does this approach to patents do to increase the general welfare?

BRCA1/BRCA2 caseBRCA1/BRCA2 case

• Myriad Labs first sequenced these genes, associated with breast cancer.

• Patented genes, had monopoly on testing for them.

• Other labs argued that Myriad’s testing was not as advanced or accurate as what they had developed but could not offer to patients, because of Myriad’s patents.

BRCA1/BRCA2 caseBRCA1/BRCA2 case

• Do patents for genes impede research by impeding sharing of information?

• Human Genome Project (significant federal funding) – aimed to make information about the genome freely available.Did HGP set groundwork for BRCA1/2 discovery?

BRCA1/BRCA2 caseBRCA1/BRCA2 case

“Myriad has sent cease and desist letters in connection with the patents-in-suit and … Myriad prohibits clinical testing of the BRCA1/2 genes.”

AMP vs. USPTO Opinion, p. 72.

BRCA1/BRCA2 caseBRCA1/BRCA2 case

“Myriad also does not permit researchers to tell patients involved in research the results of their BRCA1/2 testing, leading physicians involved in breast cancer care and research unable to meet their ethical obligations to provide genetic test results to research subjects, when requested.”

AMP vs. USPTO Opinion, p. 72.

BRCA1/BRCA2 caseBRCA1/BRCA2 case

Myriad argued that patents were essential to attract private money to develop clinical tests.

Private money invested in BRCA1/BRCA2 commercialization significantly greater than public money invested in early stages of research.

BRCA1/BRCA2 caseBRCA1/BRCA2 case

“[P]roducts of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.”

AMP vs. USPTO Opinion, p. 107.

What happened to the What happened to the norm of communism?norm of communism?

• If scientists are supposed to treat scientific knowledge as a shared resource that belongs to the whole community, doesn’t this conflict with the idea of “intellectual property”?

What happened to the What happened to the norm of communism?norm of communism?

• Secrecy required leading up to patent application (to establish “new” and “unobvious”).Choice between publishing or patenting.

• Use of knowledge during term of patent is restricted.

What’s the public’s stake?What’s the public’s stake?

• Economic growth -> good for everyone?• How much did the patentable invention

depend on resources funded with public moneys?

Do patents convert public resources to private profits?Will knowledge provide actual benefit when patent expires?

What’s the public’s stake?What’s the public’s stake?

• How much does profit motive drive the direction of scientific research (and/or quality of scientific evidence generated)?

What’s the public’s stake?What’s the public’s stake?

• How much does profit motive drive the direction of scientific research (and/or quality of scientific evidence generated)?

Is this the best driver?