The Patent Process: New ways to Think about Patenting

Health Care Technologies

Catherine B. Martineau, Esq.MacMillan, Sobanski & Todd, LLC

martineau@mstfirm.com

What is Intellectual Property?

• Patents

• Trademarks

• Copyrights

U.S. Constitution - Article I, Section 8, Clause 8: “The Congress shall have power…

to promote the progress of science and useful arts, by securing for a limited time to authors and inventors the exclusive right to their respective writings and discoveries.”

US Patents – Keep in mind

• A patent is issued by the U.S. Patent and Trademark Office (part of the Department of Commerce)

• A patent provides the patent owner with the exclusive right to exclude others from making, using, offering for sale, selling or importing an invention

• A patent has a term of up to 20 years

Types of Patents in the US

• Utility Patents – cover new and useful processes, machines, articles of

manufacture, or compositions of matter– also include improvements to existing processes,

machines, articles of manufacture, or compositions of matter

• Design Patents – cover new, original, and ornamental designs for an article

of manufacture

• Plant Patents – cover new plant varieties

Patent Cooperation Treaty (PCT)

• PCT is an international agreement for filing patent application• Has effect in many countries around the world• Does not provide for the grant of “an international patent”• Simplifies the process of filing patent applications• Delays the expenses associated with applying for patent protection in

foreign countries ($15-50+K, per country)• Allows TCO more time to assess the commercial viability of invention• Under the PCT, an inventor can file

• a single international patent application • in one language • with one patent office • in order to simultaneously seek protection • for an invention in the PCT member countries.

Overview of US and PCT Patenting Process

• Patentability rules: technical and unforgiving

• Dates are critical

• Delay is a significant risk– Prior art– Barring events

• Activities of inventor may foreclose patent protection

– U.S. vs. non-US activities

Obtaining a US Patent

Min 2 yrs

Step 1: File a patent application with the USPTO including:

Description of the invention Drawings illustrating the invention Claims (legal boundaries)

Step 2: USPTO examines the application, the invention must be:

New Useful Non-Obvious

Step 3: USPTO issues a patent

Good idea Patent Filing

General timeline:– Scientific research and discovery– Disclosure of the discovery to Technology and

Commercialization Office (TCO)– Evaluation of the disclosure by TCO– Filing provisional or PCT or national application

Scientific research and discovery

• Funding – If US funded, need to state in patent

• Record keeping – Sign and countersign, date

• Reporting – Not usually a tech transfer function (grants &

contracts admin)

Disclosure of the discovery to TCO

• This is a money-saving stage – if done right

• Get documents in editable form (MSWord, not PDF)

• Ask for all of the elements of a patent application – details!

• Ask for licensing contacts

• Ask patent attorneys for suggestions on time saving measures at this stage

A good offense is better than a good defense!

Great disclosure equals

Evaluation of the disclosure by TCO

• Science value• Patentability• Market value

Are interrelated but do not fully overlap.

It takes “experience” to judge market value!

Evaluation of the disclosure by TCO

• Don’t be misled by who is talking– Scientists value science– Patent attorneys are sometimes scientist-thinking– Patent attorneys are often noncommittal on the law– First adopters love everything– Risk adverse people hate everything

• Most important: actual value in today’s market– Licensable, profitable scope– Social-only valuation is legitimate for US universities

(Bayh-Dole – “for the benefit of the public”)

How to evaluate Health Care Technology Inventions(in view of recent Supreme Court Mayo Clinic vs Prometheus Labs Case):

3 Questions

1st - It is a Process ?

2nd - Is the process a Natural principle ?

3rd - Are there additional elements/steps

(or a combination of elements/steps)

that integrate the natural principle into the invention

such that the natural principle is practically applied ?

1st Question for Patentability - Process ?

2nd Question for Patentability - Natural Principle?

3rd Question for Patentability – Practical Application?

A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation

For example, a claim to diagnosing an infection that recites the step of correlating the presence of a certain bacterium in a person’s blood with a particular type of bacterial infection with the additional step of recording the diagnosis on a chart Also NOT eligible

- step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation and does not integrate the correlation into the invention.

What is not patentable:

Patentability Evaluation – in view of Recent Supreme Case (Mayo Clinic v Prometheus Labs)

Allowed Claims• 1. A method of decreasing expression of a transcription factor gene

product from the Maf family, also known as protooncogene c-Maf or V-maf musculoaponeurotic fibrosarcoma oncogene homolog, (MAFB) in a subject having a cancer and/or myeloproliferative disorder associated with an overexpression of a MAFB gene product, comprising

• administering an effective amount of at least one miR-130a gene product or an isolated variant or biologically-active fragment thereof to the subject sufficient to decrease expression of the MAFB gene product in the subject,

• wherein the cancer and/or myeloproliferative disorder is selected from the group consisting of: acute myeloid leukemia (AML), acute megakaryoblastic leukemia (AMKL), multiple myeloma (MM), and chronic myelogenous leukemia (CML).

• 2. The method of Claim 1, wherein the at least one miR-130a gene product or isolated variant or biologically-active fragment thereof comprises a nucleotide sequence that is complementary to a nucleotide sequence in the MAFB gene product.

•  4. The method of Claim 1, wherein the cancer and/or myeloproliferative disorder is a leukemia.•  5. The method of Claim 4 wherein the leukemia is acute myeloid leukemia.•  6. The method of Claim 5, wherein the acute myeloid leukemia is acute megakaryoblastic leukemia.•  7. The method of Claim 3, wherein the cancer is multiple myeloma.•  8. The method of Claim 1, wherein the cancer and/or myeloproliferative disorder is chronic myelogenous leukemia (CML).•  10. The method of Claim 1, wherein the subject is a human.

Leahy-Smith America Invents Act (AIA)

• Fundamentally changes the U.S. patent system

by

awarding patents to the first inventor to file an application with the U.S. Patent and Trademark Office.

• Inventors of all sizes will need to file patent applications quickly and frequently in order to stay a step ahead of their competition.

AIA – More than just a question of filing dates

• Creates a ‘first to publish as long as you file within a year’ system rather than a true first to file system.

• Should eliminate some uncertainty in the patent system:

• For priority purposes, only the date of filing will need to be determined, not the actual date of invention.

• It might not be the game changer that most people think:– Most universities with patent programs generally file

as early as possible to preserve their options for international patent rights.

AIA – how it affects Universities

• Protects researchers from being left behind in the race to the patent office

• Gives researchers a year after disclosing their discovery, say, in a publication, to file for a patent.

• Universities also retain the ability to file "provisional" patent applications that protect a discovery while TCO decides whether it is worth the cost of pursuing a full-blown patent.

• Many universities often wait to file a full application until they have found an investor willing to pay patenting costs, which can reach tens of thousands of dollars.

•  

AIA – Will it protect researchers?

• Skepticism that "safe harbor" language will protect researchers and universities worried about intellectual property rights.

• Any U.S. researcher seeking a foreign patent still will have to be the first to file– other nations don't give inventors the 1-year grace period.

• Could create new pressure on both scientists and TCO seeking U.S. patents to stay mum about promising discoveries, – to make sure they aren't "scooped" by competitors or even

collaborators.

•  

AIA – possible “prior user defenses”

• Possible trouble for universities from language that expands so-called "prior user defenses."

• Those come into play if it turns out a company is already using a newly patented technology under trade secret protections.

• The new law is intended to prevent the "prior user" from being forced to pay royalties to the owner of the new patent--potentially decreasing the value of the patent.

• (*chart from Patentlyo blog dated 2-1-12)

AIA - Other provisions that could affect the researchers:

• Contains language meant to strengthen a ban on any patents making "a claim directed to or encompassing a human organism."

• New act remains vague on exactly what constitutes a "human organism."

• Requires the patent office to deliver a study next year on how to ensure the availability of "confirming" genetic tests. – Those tests are used to confirm diagnoses produced

by other, patented tests. – The study was prompted by fears that companies

holding patents for the initial diagnostic tools could block the creation of confirming tests by others, or force their owners to pay royalties on the confirming tests.

Further Patentability Evaluation – Prior Art

• What is “Prior Art?”

– Determined by law, not strictly time

– Anything that is publicly known, published, publicly used, or sold in this country

– Anything published or patented here or elsewhere in the world

– That came BEFORE your invention (applies to both above)

DANGER: Using the term “prior art” is an admission / statement against legal interest!

Get in the habit of saying “reference” or “disclosure”

Further Patentability Evaluation - Timing

• Things the inventor does

– What starts the “clock” ticking?• 4 “triggering events”

– Public Disclosures– Public Use– Sale– Offers for Sale

• Fact Specific Inquiry

– Once the clock starts, it can’t be stopped!

Further Patentability Evaluation – New, Useful and Non-obvious

What do “new,” “useful” and “non-obvious” meant to an inventor?– Almost always, different from what it means

in patent law.– Their answer depends on their scientific

indoctrination– Either ask the patent attorney to evaluate

obviousness or file without asking.

Further Patentability Evaluation – What information will help overcome rejections?

• Teaching away, long-felt need, superior results over closest comparator, great difficulty in obtaining, etc.

• Get this information during the disclosure stage (saves money!)– But watch out for admissions / statements against

interest

Questions?

Please ask!

Catherine B. Martineau, Esq.MacMillan, Sobanski & Todd, LLC

martineau@mstfirm.com