The Patent Process:New ways to Think about PatentingHealth Care TechnologiesCatherine B. Martineau, Esq.MacMillan, Sobanski & Todd, LLCmartineau@mstfirm.com
What is Intellectual Property?• Patents• Trademarks• CopyrightsU.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 inventorsthe exclusive right to their respective writings anddiscoveries.”
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 rightto exclude others from making, using, offering forsale, 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 ofmanufacture, or compositions of matter– also include improvements to existingprocesses, machines, articles of manufacture, orcompositions of matter• Design Patents– cover new, original, and ornamental designs for an articleof 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 inforeign 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 patentprotection– U.S. vs. non-US activities
Obtaining a US PatentMin 2 yrsStep 1: File a patent application with theUSPTO including: Description of the invention Drawings illustrating the invention Claims (legal boundaries)Step 2: USPTO examines theapplication, the invention must be: New Useful Non-ObviousStep 3: USPTO issues a patent
Good idea Patent FilingGeneral timeline:– Scientific research and discovery– Disclosure of the discovery to Technology andCommercialization 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 – ifdone right• Get documents in editable form(MSWord, not PDF)• Ask for all of the elements of apatent application – details!• Ask for licensing contacts• Ask patent attorneys forsuggestions on time savingmeasures at this stageA good offense isbetter than a gooddefense!Great disclosure equals
Evaluation of the disclosure by TCO• Science value• Patentability• Market valueAre interrelated but do not fully overlap.It takes “experience” tojudge 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 Questions1st - 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 inventionsuch that the natural principle is practically applied ?
1st Question for Patentability - Process ?
2nd Question for Patentability - Natural Principle?
3rd Question for Patentability – PracticalApplication?
A bare statement of a naturally occurring correlation,albeit a newly discovered natural correlation or verynarrowly confined correlationFor example,a claim to diagnosing an infection that recites the step ofcorrelating the presence of a certain bacterium in aperson‟s blood with a particular type of bacterial infectionwith the additional step of recording the diagnosis on achartAlso NOT eligible- step of recording the diagnosis on the chart is extra-solution activity that is unrelated to the correlation anddoes not integrate the correlation into the invention.What is not patentable:
Patentability Evaluation – in view of RecentSupreme Case (Mayo Clinic v Prometheus Labs)
Allowed Claims• 1. A method of decreasing expression of a transcription factor gene productfrom the Maf family, also known as protooncogene c-Maf or V-maf musculoaponeuroticfibrosarcoma oncogene homolog, (MAFB) in a subject having a cancer and/ormyeloproliferative disorder associated with an overexpression of a MAFB geneproduct, comprising• administering an effective amount of at least one miR-130a gene product oran isolated variant or biologically-active fragment thereof to the subject sufficient todecrease expression of the MAFB gene product in the subject,• wherein the cancer and/or myeloproliferative disorder is selected from the groupconsisting 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 fragmentthereof 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 systembyawarding patents to the first inventor to file anapplication with the U.S. Patent and TrademarkOffice.• Inventors of all sizes will need to file patentapplications quickly and frequently in order tostay a step ahead of their competition.
AIA – More than just a question of filing dates• Creates a „first to publish as long as you filewithin a year‟ system rather than a true first tofile system.• Should eliminate some uncertainty in thepatent system:• For priority purposes, only the date of filing willneed to be determined, not the actual date ofinvention.• It might not be the game changer that mostpeople think:– Most universities with patent programs generally fileas early as possible to preserve their options forinternational patent rights.
AIA – how it affects Universities• Protects researchers from being left behind in the race tothe patent office• Gives researchers a year after disclosing theirdiscovery, say, in a publication, to file for a patent.• Universities also retain the ability to file "provisional"patent applications that protect a discovery while TCOdecides whether it is worth the cost of pursuing a full-blown patent.• Many universities often wait to file a full application untilthey have found an investor willing to pay patentingcosts, which can reach tens of thousands of dollars.•
AIA – Will it protect researchers?• Skepticism that "safe harbor" language will protectresearchers and universities worried aboutintellectual property rights.• Any U.S. researcher seeking a foreign patent still willhave to be the first to file– other nations dont give inventors the 1-year grace period.• Could create new pressure on both scientists andTCO seeking U.S. patents to stay mum aboutpromising discoveries,– to make sure they arent "scooped" by competitors or evencollaborators.•
AIA – possible “prior user defenses”• Possible trouble for universities fromlanguage that expands so-called"prior user defenses."• Those come into play if it turns out acompany is already using a newlypatented technology under tradesecret protections.• The new law is intended to preventthe "prior user" from being forced topay royalties to the owner of the newpatent--potentially decreasing thevalue 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 banon any patents making "a claim directed to orencompassing a human organism."• New act remains vague on exactly whatconstitutes a "human organism."• Requires the patent office to deliver a studynext year on how to ensure the availability of"confirming" genetic tests.– Those tests are used to confirm diagnoses producedby other, patented tests.– The study was prompted by fears that companiesholding patents for the initial diagnostic tools couldblock the creation of confirming tests by others, orforce their owners to pay royalties on the confirmingtests.
Further Patentability Evaluation – Prior Art• What is “Prior Art?”– Determined by law, not strictly time– Anything that is publiclyknown, published, publicly used, orsold in this country– Anything published or patented here orelsewhere 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-obviousWhat do “new,” “useful” and “non-obvious” meantto an inventor?– Almost always, different from what it meansin patent law.– Their answer depends on their scientificindoctrination– Either ask the patent attorney to evaluateobviousness or file without asking.
Further Patentability Evaluation –What information will help overcome rejections?• Teaching away, long-felt need, superior results overclosest comparator, great difficulty in obtaining, etc.• Get this information during the disclosure stage(saves money!)– But watch out for admissions / statements againstinterest
Questions?Please ask!Catherine B. Martineau, Esq.MacMillan, Sobanski & Todd, LLCmartineau@mstfirm.com