The The The The New New New New US Patent Law US Patent Law US Patent Law US Patent Law Medical Device & Manufacturing Medical Device & Manufacturing Medical Device & Manufacturing Medical Device & Manufacturing – – – Florida 2013 Florida 2013 Florida 2013 Florida 2013 Clark Wilson Clark Wilson Clark Wilson Clark Wilson [email protected][email protected][email protected][email protected]www.gardnergroff.com 2018 Powers Ferry Road Suite 800 Atlanta, GA 30339 770-984-2300 www.gardnergroff.com [email protected][email protected][email protected][email protected]
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The New US Patent Law - From a Medical Device Perspective
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The The The The NewNewNewNew US Patent LawUS Patent LawUS Patent LawUS Patent LawMedical Device & Manufacturing Medical Device & Manufacturing Medical Device & Manufacturing Medical Device & Manufacturing –––– Florida 2013Florida 2013Florida 2013Florida 2013
• Registered Patent Attorney & Partner at IP Law Firm (see website)
• Board Certified in IP Law by the Florida Bar Association
• Licensed Attorney in Florida & Georgia
• Master’s Degree in Bioengineering (May, 2013)
• Previously In-house Patent Attorney at Medical Device Company
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• Previously In-house Patent Attorney at Medical Device Company
• Clients Include Medical Device: Startups � Multinationals
• US & Global Patent + Trademark Application Prep/Prosecution
• Freedom-to-Operate & Non-Infringement Opinions
• Patent + Trademark Infringement Litigation
• www.linkedin.com/in/clarkadwilson
Recent Med Device Patent InfringementRecent Med Device Patent InfringementRecent Med Device Patent InfringementRecent Med Device Patent Infringement
• Stent, $1.73 billion (part of the “Stent Wars”)
• Translateral Spinal Implant, $101.2 million
• Valve Prothesis for Implanation, $74 million
• So, it’s not just smart phones!
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General Patent TerminologyGeneral Patent TerminologyGeneral Patent TerminologyGeneral Patent Terminology
• Patentable subject matter: what is allowed to be patented
• Prior art: information relevant to the invention & available to the public before patent application filed
• Novelty: the claimed invention is not disclosed in a single prior art reference
• Non-obviousness: the claimed invention could not be readily be deduced from prior art by a person of ordinary skill in the art
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from prior art by a person of ordinary skill in the art
• 12 month grace period: allows exactly 12 months to file a patent application after a first public disclosure/use/sale of the invention.
• Provisional patent application: temporary application for patent lasting 12 months (non-extendable) from the filing date. The 12-month pendency period cannot be extended.
• Freedom-to-Operate: opinion provided by a patent attorney that a proposed product or process does or does not infringe a patent
NewNewNewNew USA Patent LawUSA Patent LawUSA Patent LawUSA Patent Law
• September 16, 2011-President Obama Signs America-Invents-Act (AIA)
– First major overhaul in over 50 years
– Most measures already in effect
– All measures to be in full effect by March 19, 2013
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US Patent Law US Patent Law US Patent Law US Patent Law postpostpostpost----AIAAIAAIAAIA(of particular importance to Med Device Industry)(of particular importance to Med Device Industry)(of particular importance to Med Device Industry)(of particular importance to Med Device Industry)
• § 102(b)(2) — A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if —
– (A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor;
– (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been
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– (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or
– (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.
– The patent owner may request a supplemental examination for a patent so that the Office can consider, reconsider, or correct information believed to be relevant to the patent.
– Filing fee of $21,260, but $16,120 is refunded if no re-examination
– The patent owner can immunize the patent against allegations of
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– The patent owner can immunize the patent against allegations of inequitable conduct by completing a supplemental examination.
• PRACTICAL TIP:
– If you become aware of information relevant to your patent after issuance, consider filing a supplemental examination to clear up doubts
– If you discover prior art relevant to a competitor’s patent, consider whether or not to disclose it to them because they might file a S.E. and make their patent stronger
Increase in Fees + Micro Entity DiscountIncrease in Fees + Micro Entity DiscountIncrease in Fees + Micro Entity DiscountIncrease in Fees + Micro Entity Discount
• Fee Changes
– Total filing fees: ↑ $1,260 to $1,600 (50% Small EnQty Discount)
– Issue Fees: ↓
– Maintenance Fees: ↑
– Many other fees have either ↑ or ↓
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• Micro-Entity Discount
– USPTO will reduce certain fees by 75% if either:
• Small entity status + < 4 previous patent application filings, income
limits (< 3x average national household income) + and no
assignment/licensing/conveyance obligations to a large entity; or
• Employment by assignment/licensing/conveyance obligations to
an institution of higher education
Obtaining Advice of CounselObtaining Advice of CounselObtaining Advice of CounselObtaining Advice of Counsel
• Codification of case law, §298
– The failure of an infringer to obtain the advice of counsel with respect
to any allegedly infringed patent, or the failure of the infringer to
present such advice to the court or jury, may not be used to prove that
the accused infringer willfully infringed the patent…
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• PRACTICAL TIP:
– If you are planning to make/use/sell a new product or process, have an
independent patent attorney conduct a Freedom-to-Operate patent
search/opinion before you begin. This can only benefit you:
• If infringing, do not have to provide it to court
• If not infringing, show to court to prove not willful or intentional
Prior User RightsPrior User RightsPrior User RightsPrior User Rights
• Defense to allegations of patent infringement
– Based on earlier commercial use of the patented technology in the
U.S. by the alleged infringer
– Can only be asserted by the person who performs, or directs the
performance of, the allegedly infringing acts
– Prior use must be at least 1 year prior to earlier of first effective filing
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– Prior use must be at least 1 year prior to earlier of first effective filing
date of patent or first exception-based publication
– Exceptions: if the patent was owned by a University or Govt. funded
• PRACTICAL TIP:
– If you are alleged to have infringed a patent, determine the date of
your earliest commercial use of the subject matter in the patent
Virtual Marking of Product/PackagingVirtual Marking of Product/PackagingVirtual Marking of Product/PackagingVirtual Marking of Product/Packaging
• Into the 21st century
– Constructive notice of patent protection can be made by marking
“patented” on the article in combination with a web address
• The website includes information about the patent and the
product
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• PRACTICAL TIP:
– Make sure your product or packaging has adequate patent markings,