How to Protect Your Intellectual Property

How to Protect Your Intellectual Property by Developing a Strong

Patent Por8olio

Dr. Brenda Wallach WALLACH – IP Management and ConsulBng

June 26, 2015 1

A liJle bit about me…

•  B.Sc. Biochemistry, University of California Riverside •  Ph.D. Molecular Biology, University of Copenhagen, sponsored by Novo Nordisk (the “Eli Lilly” of Europe)

•  Cooley Godward, LLP (top IP firm) •  Morrison & Foerster, LLP (top IP firm) •  Sapphire Energy, Inc. (renewable biofuels) •  CONNECT – expert domain mentor re patents

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WALLACH – IP Management and ConsulBng

A liJle bit about me… •  Founder of WALLACH – IP Management and ConsulBng

–  I recognize that there is an incredible void in the market place for entrepreneurs and scienBsts who want to protect their intellectual property, but are afraid of high legal costs and runaway bills, that ulBmately do not lead to the grant of a patent. My pracBce fills this void

•  PracBce patent law in the fields of endocrinology, biology, molecular biology, microbiology, pharmacology, virology, immunology, biochemistry, bio-‐informaBcs, biological assays, devices, renewable biofuels, and refinery pracBce.

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A few of the reasons why I pracBce patent law…

•  17 years and counBng… •  I truly LOVE science, I am a true “nerd” and proud of it! •  AWESOME clients: Stanford, U.C.S.F., Amgen, Biogen Idec,

Sapphire Energy, Illumina, and numerous startups •  REALLY COOL technology, I get to work with super smart

scienBsts and entrepreneurs •  My focus is on helping startups develop and grow their patent

por8olios so that they can get funding/partnerships, and, of course, protect their most valuable asset, their IP

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A few of the reasons that I pracBce patent law…

•  I am able to simplify the world of patent law for my clients •  I understand my clients’ drive and how their valuable

research can impact the lives of others •  I honor the incredible investment that my clients have made

scienBfically, Bme wise, and financially, when deciding to move forward to protect their intellectual property

•  I LOVE to help my clients succeed!

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What is Intellectual Property?

•  IP is intangible and propriety informaBon that you have the exclusive right to keep others from using – “the hand of man” or “creaBons of the mind”

•  The law affords different types of protecBon for different types of IP: Patents, Trademarks, Trade Secrets, and Copyrights

WALLACH – IP Management and ConsulBng 6

What is a patent? •  A right granted to the owner of the patent to stop others from making,

using, or selling the invenBon, that is the subject of the patent •  The term of a patent is 20 years from the filing of a UBlity Patent

ApplicaBon •  Timing: Provisional –> UBlity and/or PCT •  U.S. was a “first-‐to-‐invent” patent system in which the date of the

invenBon could trump the date of filing a patent applicaBon in determining patent rights. The America Invents Act (AIA) patent reform bill signed into law by President Obama in September 2011 changed this

•  Now, the U.S. is a “first-‐to-‐file” system (applicaBons with a filing date of March 16, 2013 or later) meaning the first person to the Patent Office wins!

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Examples of assets that are patentable

•  Isolated nucleic acids and polypepBdes •  Cells, cell lines, and transgenic animals •  Methods of making, using, or treaBng •  Screening and research methods •  ArBcles of manufacture •  Databases and libraries •  Computer sooware algorithms •  Business method patents

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Requirements for patentability

•  The invenBon must be statutory subject maJer (a new and useful process, machine, manufacture, or composiBon of maJer)

•  The invenBon must be useful •  The invenBon must be new (novel) •  The invenBon must be non-‐obvious, not simply the next logical step to what has already been done

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Requirements for patentability

•  The invenBon must be described (with the parBcularity required by the Patent Laws) such that a person of skill in the relevant field can understand what the invenBon is, and make it and use it without engaging in undue experimentaBon

•  The invenBon must not have been "disclosed" to the public prior to the filing of the patent applicaBon (a few excepBons exist)

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Patent Strategies •  Determine your company’s “patent space” and compare it to your compeBtors’ patent space

•  Determine which invenBons to patent, make sure that what you want to patent is aligned with the business goals of your company

•  Create an offensive patent por8olio, dominate a market

•  Create a defensive patent por8olio, allowing freedom to operate

•  Protect you “core” or pla8orm technologies

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Patent Strategies -‐ conBnued •  File broad claims in your patent applicaBon to prevent compeBtors from patenBng the technology

•  File narrower claims in your patent applicaBon to ensure that your core technology is covered by a patent

•  Use your patent por8olio to generate licensing revenue •  File a Provisional applicaBon or a UBlity patent applicaBon?

•  Carefully plan which countries, besides the U.S. to seek patent protecBon in, due to the high costs involved with filing for patent protecBon outside of the U.S.

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Provisional vs. UBlity •  Provisional applicaBon – Not examined – No costs for prosecuBon of the patent applicaBon with the USPTO during the first year, only a small filing fee

– Serves as a priority document (re first to file) – Preserves rights for 1 year, must file either a UBlity patent applicaBon and/or a PCT applicaBon (internaBonal) applicaBon aoer 1 year

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Provisional applicaBon – cont.

– Able to file addiBonal provisional applicaBons and combine their contents into the UBlity applicaBon or PCT that is filed at the 1 year date

– Allows Bme to develop technology, obtain data, get funding/partners

– File a provisional BEFORE you publically present, publish, use, or sell your invenBon

– Allows a product covered by the provisional applicaBon to be labeled as “patent pending”

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Provisional applicaBon – cont.

•  My pracBce is to prepare a very solid provisional so that, inter alia, every aspect of the invenBon is described, the invenBon is fully enabled, there is good wriJen support, mulBple different embodiments are provided, and there are mulBple layers and types of claims

•  Too ooen a provisional is draoed that is not well prepared and then although it, in theory, provides a priority date, it only does so in regards to the subject maJer that is clearly described therein. Therefore, it is CRUCIAL to write a really good provisional

•  A well wriJen provisional applicaBon will serve as a strong starBng point for wriBng the UBlity applicaBon, someBmes liJle addiBonal data or descripBon is added prior to filing of the UBlity applicaBon

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UBlity ApplicaBons

•  Examined at the USPTO •  Earlier examinaBon, important in fast-‐developing technology

•  Earlier issuance •  From date of filing the UBlity patent applicaBon to patent grant is approximately 3-‐4 years

•  Fast Track program with the USPTO allows a final disposiBon within approximately one year

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ProsecuBon of a UBlity ApplicaBon before the USPTO

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•  InformaBon disclosure requirement (IDS) •  RestricBon Requirement, divisionals •  Non-‐final Office AcBon(s) •  Final Office AcBon •  Interview(s) with the Examiner •  Appeal or request to conBnue prosecuBon •  Upon grant, keep an applicaBon “alive”

Who is the inventor?

•  An inventor is an individual(s) involved in the “concepBon” and (someBmes) “reducBon to pracBce” of the claimed invenBon

•  ConcepBon is the formaBon in the mind of the inventor of a definite and permanent idea of the complete and operaBve invenBon

•  The invenBon is complete only if ordinary skill is needed to reduce the invenBon to pracBce

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A Joint inventor?

•  A joint inventor must: –  contribute in some significant manner to the concepBon or reducBon to pracBce

– make a contribuBon to the invenBon that is not insignificant in quality, when that contribuBon is measured against the dimensions of the full invenBon

–  do more than merely explain to co-‐inventor(s) well-‐known concepts or the current state of the art

–  contribute to the subject maJer of at least one claim in the patent applicaBon

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The importance of laboratory notebooks

•  The pracBce of keeping and witnessing a laboratory notebook is important even in light of the U.S. becoming a first-‐to-‐file system

•  Laboratory notebooks are sBll relevant to patentability because they are ooen a means of proving that you are the true inventor –  In the U.S., because you will sBll be able to pre-‐date an earlier filed applicant who obtained your invenBon from you, it will be important to keep a lab notebook because it can show that you invented the invenBon first and possibly how the other filer obtained the invenBon from you

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Laboratory Notebooks – cont.

•  Laboratory notebooks remains relevant for determining inventorship and correcBng errors in inventorship

•  Laboratory notebooks remain relevant during prosecuBon of the patent applicaBon when it may be necessary to supplement the specificaBon with arguments and/or data from the inventors such as in a declaraBon

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How should a notebook be set up?

•  A bound hard copy with page numbers, and an electronic copy, if possible

•  Signed and witnessed on a regular basis •  No loose papers, permanently affix any loose papers (including photos) into notebook

•  IdenBfy data with a specific project •  All entries consecuBvely dated

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Notebook set up – cont.

•  Each invesBgator should have her own notebook, no shared notebooks

•  Permanent ink •  Avoid derogatory remarks •  Don’t change entries, make a new entry •  Include sketches, diagrams, etc. •  Clearly idenBfy figures, data, etc. 23


Our Bme is running out and there is sBll so much to cover…

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•  Patent law is a complex and fascinaBon intersecBon of law and science

•  There are many things to consider when deciding to patent your invenBon

•  A well wriJen patent applicaBon is criBcal in protecBng your IP

•  I would welcome the opportunity to assist your company in developing and protecBng its IP


There is so much more…

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•  Please feel free to contact me with any quesBons that you might have

•  (858) 336-‐9584

Thank you for your 0me and a3en0on!

How to Protect Your Intellectual Property

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