What a chemist needs to know about patent law

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What a chemist needs to know about patent law

• Committee On Patents and Related Matters
• Galina YakovlevaValerie L. McDevitt
• Marc A. McKithen

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Constitutional Authority

• The Congress shall have Power.....To promote the
  Progress of Science and useful Arts, by securing
  for limited Times to Authors and Inventors the
  exclusive Right to their respective Writings and
  Discoveries . . . (Article 1, section 8, clause
  8)

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Right to Exclude

• A United States patent provides its owner with
  the legal right to prevent unauthorized making,
  using, selling, offering for sale in the U. S.
  and the importation into the U.S., of the
  invention set forth and claimed in the patent

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Not a Right to Practice

• But this right to exclude does not grant the
  right to practice the invention (e.g., government
  regulation may interfere)

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Reasons for Acquiring Patents

• Protect market
• Prevent competitor from copying
• Maintain product differentiation
• Erect barriers for entry into a market
• Develop reputation as innovator/prestige
• Revenue through licensing/assignment
• Helps with credibility/advertising

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Patentable Inventions

• Whoever invents or discovers any new and useful
  process, machine, manufacture, or composition of
  matter, or any new and useful improvement
  therefore, may obtain a patent therefore. 35
  U.S.C. 101
• Utility and plants patents 20 year term from
  earliest claimed U.S. filing date
• Design patents 14 years from grant date

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Patentable Subject Matter

• Composition of matter includes chemical
  compounds or processes, altered or isolated
  genetic material, mechanical or physical
  mixtures, alloys and compositions, and unions of
  several ingredients
• Plants Limited to plants that are asexually
  reproduced other than a tuber propagated plant or
  a plant found in an uncultivated state

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Non-patentable Subject Matter

• Laws of Nature and Scientific Principles
• Discovery of new principle, force or law of
  operating on matter are not patentable, but their
  application usually is patentable
• Abstract Ideas or Theories

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Patents - Capturing Inventions

• The first-to-invent system in U.S.
• The first to conceive and reduce to practice an
  invention is entitled the patent rights
• The first to conceive and diligently pursue his
  or her invention is entitled to patent rights
  even if the last to reduce to practice

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Requirements for Patentability

• Novelty
• Non-obviousness
• Usefulness
• Requirements that should be satisfied before
  application is filed

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Novelty

• Applicant for patent must believe he or she is
  first person to discover the invention
• The invention must not have been published
  anywhere and must not have been in public use or
  on sale in the U.S. more than one year before the
  filing of the application
• Inventor actions can bar a patent on his or her
  own invention
• Absolute novelty required in most countries
• One (1) Grace Year in U.S.

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Non-Obviousness

• Must not have been obvious
• Prior art discloses an invention that is so
  similar to the alleged invention that it would
  have been obvious to one of ordinary skill in the
  art based on the knowledge of the prior art
• The court determines obviousness by examining the
  differences between the prior art and the claimed
  invention in view of what would be readily
  understood by one of ordinary skill in the art

A B
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Non-Obviousness

• Objective evidence of non-obviousness
• Commercial success attributable to the invention
• Long felt but unsatisfied need for the invention
• Copying by competitors
• Acclaim by the industry, etc.

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Non-Obviousness

• Generally non-obviousness is established by
  showing
• the advantages of the invention
• a lack of motivation for modifying prior art to
  result in the invention
• the prior art actually suggests not making the
  modification (teaching away)

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Usefulness

• Generally it is easy to meet this criteria
• Now mostly used to deny patents for perpetual
  motion machines and other things that seem to
  violate the laws of nature or otherwise lack
  credibility
• Also used to deny patents where real world
  utility of a DNA sequence is not clear

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Pre-Filing Procedure

• Document the invention
• Collect relevant prior art duty of disclosure
  owed by applicant
• Evaluate economic significance of the invention
• Do not publish invention anywhere or use or offer
  to sell it in U.S.

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Patent Prosecution

• Prosecution is the term given to the
  back-and-forth between the Patent Office (PTO)
  and the Applicant or his attorney/agent

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Types of Applications

• Provisional A place holder
• No claims required
• Not examined
• Duration is 12 months, maximum
• Needs only a Specification, and drawings (if
  needed)
• Regular application - Requires Specification,
  drawings (if needed), and claims

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Application Order of Sections

• Title
• Cross-Reference to Related Application(s)
• Background of the Invention
• Brief Summary of the Invention
• Brief Description of the Drawings
• Detailed Description of the Invention
• Claim(s)
• Abstract

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Procedure for Obtaining Patents

• Prepare a patent application
• Disclose enough to enable one skilled in the art
  to make and use the invention
• Disclose best mode of carrying out the
  invention (that is, if the inventor has the
  subjective belief there is a best way to carry
  out the invention)
• If possible, disclose more than required
• Formalities

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Procedure for Obtaining Patents

• Prepare a patent application
• Disclose all alternative embodiments
• Interferes with others attempts to obtain
  improvement patents or designing around the
  patent
• Broadens possible scope of protection and
  provides retreat positions for claiming invention
• Applications lacking in detail sometimes get
  broader interpretations, but are easier to
  invalidate

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Procedure for Obtaining Patents

• Prepare claims for a patent application
• Define the scope of the invention
• Must be clear
• Must not read on the prior art
• Must define a novel, non-obvious and useful
  invention
• Provides notice to the public

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Procedure for Obtaining Patents

• Patentability searches
• Searches made to determine whether there is
  enough protection available to go forward
• Identifies the prior art
• Identifies extent protection available over prior
  art
• Also helps with drafting process
• Draft claims to reflect existing prior art
• Identifies customary level of disclosure for a
  particular art

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Procedure for Obtaining Patents

• Responses to an Examiners actions can occur
  through interviews, written arguments,
  amendments to the text of the application
  including claims, and affidavits or other
  documentary evidence supporting patentability
• Generally present arguments twice for each office
  action fee

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Procedure for Obtaining Patents

• If USPTO denies application patent, a patent
  applicant may appeal to the USPTO Board of three
  Administrative Patent Judges, then onto either
  District Court to present more evidence or
  directly to the Court of Appeals for the Federal
  Circuit
• Allowance of claims and issuance upon payment of
  issue fee and now an application publication fee

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18 Month Publication of U.S. applications

• Provide for provisional rights
• No injunctions, but can get monetary award
  (reasonable royalty) if issued claims are
  substantially identical to the claims in the
  published application
• Must provide actual notice to infringer
• Voluntary publication possible but generally
  application published as filed
• May cause competitors apprehension
• Can block others from getting similar rights

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Granted Patents

• Patent can be licensed for money or in exchange
  for anothers IP rights
• fight patents with patents

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Technology Transfer Of A Patented Invention
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The Value of An Invention is in the Using of It

• Modified from Thomas Alva Edison

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Criteria and Considerations For Technology
Transfer

• Commercial potential
• Ability to define product
• Ability to identify customer/end user
• Perceived industry value/need
• Market size
• Prospective licensee(s) identified
• Prospective licensee(s) expressed interest
• Competing technologies
• Predisposition of industry to licensing
• Regulatory and liability commercialization
  hurdles
• Development status-time to milestones
• Established industry channels to commercialize

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Why not pursue

• Commercial market too small.
• Patent breadth limited due to earlier public
  disclosures.
• Patent would be difficult or impossible to
  police.
• No commercial advantages or economic cost-savings
  apparent to encourage companies to take a
  license.
• Research funding complications.
• Sponsorship agreement may give rights to funding
  organization.
• Often, intellectual property complications can be
  negotiated out of research agreements.

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The Technology Transfer Decision

• Decision
• Does reflect the likelihood that the technology
  will be able to generate commercial royalties
  greater than patent costs.
• Does not reflect a judgment of the quality of the
  science nor the scientific importance of the
  discovery.

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Targeted Strategic Marketing

• E-mail
• Snail mail
• Newsletter
• Web site
• Symposia
• Venture forums
• Road trips to Corporations

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Marketing Technology

• Non-confidential summary
• Confidential summary
• Letter of intent
• An option
• License

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Major Steps in Tech Transfer

• Disclosure of Inventions
• Record Keeping and Management
• Evaluation and Marketing
• Patent Prosecution
• Negotiation and drafting of license agreements
• Management of active licenses

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Factors governing license fees and royalties

• Type of technology
• Stage of development
• Size of potential market
• Profit margin for product
• Amount of perceived risk
• Strength of patents
• Costs of bringing product to market

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Elements of the Agreement

• RD sponsorship
• Initiation Fee
• Maintenance fees
• Milestone payments
• Royalties
• Equity vs. Cash
• Endowed Fellowships and Chairs
• Incentives and Penalties
• Sponsorship of Awards , Symposi

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Patent Infringement Litigation

• A form of civil litigation where a patent-holder
  (patentee) sues a defendant for infringing a
  patent.

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Infringement

• What is infringement?
• Direct infringement - 35 U.S.C. 271(a)
• Infringement by Inducement - 35 U.S.C. 271(b)
• Contributory infringement - 35 U.S.C. 271(c)
• Test for infringement
• A product infringes if it falls within the scope
  of the patent claims, not if it copies the patent
  holders product

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Direct Infringement

• Whoever without authority makes, uses, offers to
  sell, or sells any patented invention, within the
  United States or imports into the United States
  any patented invention during the term of the
  patent therefor, infringes the patent. (35
  U.S.C. 271(a))

Dear Sir or Madam You are hereby notified that
your new adhesive branded asviolates U.S.
Patentand you are hereby directed to cease and
desist immediately or we will be forced
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Infringement by Inducement

• Whoever actively induces infringement of a
  patent shall be liable as an infringer. (35
  U.S.C. 271(b))

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Contributory Infringement

• Whoever offers to sell or sells with the United
  States or imports into the United States a
  component of a patented machine, manufacture,
  combination or composition, or a material or
  apparatus for use in practicing a patented
  process, constituting a material part of the
  invention, knowing the same to be especially made
  or especially adapted for use in an infringement
  of such patent, and not a staple article or
  commodity of commerce suitable for substantial
  non-infringing use, shall be liable as a
  contributory infringer. (35 U.S.C 271(c))

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Challenges To Patent

• Validity
• Enforceability

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Validity

• A patent is valid only if the following
  requirements for patentability are satisfied,
  including
• Useful
• Novel i.e., it is not anticipated
• Nonobvious
• NB A patent is presumed valid

35 U.S.C. 282 Presumption of validity
defenses. A patent shall be presumed valid. Each
claim of a patent (whether in independent,
dependent, or multiple dependent form) shall be
presumed valid independently of the validity of
other claims dependent or multiple dependent
claims shall be presumed valid even though
dependent upon an invalid claim
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Validity

• Other validity requirements include
• Definiteness
• Written description
• Enablement
• Best mode
• Requirements that should be satisfied before
  patentissues

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Enforceability

• A patent is not enforceable when there is
• Patent misuse - Patentee uses patent as leverage
  to obtain more market power than Congress
  intended to convey through the grant of a patent
• Inequitable conduct - Patentee intentionally
  made a misrepresentation or withheld material
  information about the patentability of the
  invention during the patent application process

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How does the court decide these issues?

• Judge v. Jury
• Under Markman, the scope of the claims of the
  patent - what the patent covers - is thus
  decided by a Judge
• The jury decides facts - whether the patent is
  valid and enforceable, whether there is actual
  infringement, and whether that infringement was
  willful

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What are the stages of litigation?

• Pleadings
• Discovery
• Pretrial motions
• Markman hearing
• Trial

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The Stages of Litigation

• Pleadings
• Complaint
• Answer
• Discovery
• Production of documents - Lab notebooks, memos,
  emails, computer files, etc.
• Written discovery - interrogatories and document
  responses
• Oral discovery (in and out of court) -
  depositions and questioning of witnesses

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The Stages of Litigation

• Discovery (Cont.)
• Experts - retained by both sides to review the
  patent, the allegedly infringing product, and
  related documents
• Non-testifying experts are retained as
  consultants
• Testifying experts write a report giving their
  expert opinion as to material issues such as
  infringement, validity and enforceability
• They are usually deposed by the opposing
  counsel before trial and testify at trial

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The Stages of Litigation

• Pretrial motions
• Summary judgment - judge may rule on issues where
  the facts are not in dispute
• Motion in limine - motion to exclude evidence
• Markman hearing
• Judge determines the scope of the claims of the
  patent, or what the patent covers

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The Stages of Litigation

• Trial - the opposing sides present evidence (both
  documentary and testimony) before a jury, who
  determines if the patent is valid and
  enforceable, if there was infringement, if the
  infringement was willful, and what the
  appropriate relief is
• NB In a bench trial, there is no jury and the
  Judge decides the case

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Relief

• Damages (money)
• Actual damages
• Lost profits
• Reasonable royalty
• Willful infringement? double or treble damages
• Injunctive relief the court forces the defendant
  to stop infringing
• Permanent v. preliminary relief

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In what ways can YOU be involved in a patent
litigation?

• Produce documents
• Deposed during discovery
• Fact witness at trial
• As an expert witness

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