The New US Patent Law - From a Medical Device Perspective
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The New US Patent Law - From a Medical Device Perspective

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The New US Patent Law - From a Medical Device Perspective The New US Patent Law - From a Medical Device Perspective Presentation Transcript

  • The New US Patent Law Medical Device & Manufacturing – Florida 2013 Clark Wilson cwilson@gardnergroff.com 2018 Powers Ferry Road Suite 800 Atlanta, GA 30339 770-984-2300www.gardnergroff.com www.gardnergroff.com
  • Clark Wilson • 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 • 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/clarkadwilsonwww.gardnergroff.com
  • Recent 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!www.gardnergroff.com
  • General 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 • 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 patentwww.gardnergroff.com
  • New USA 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, 2013www.gardnergroff.com
  • US Patent Law post-AIA post- (of particular importance to Med Device Industry) • Subject Matter Eligibility • What is “Prior Art” • First Inventor to File • Derivation Proceedings • Prioritized Examinations • Pre-issuance Submissions • Post-Issuance Procedures • Increase in Fees + Micro Entity Discount • Obtaining Advice of Counsel • Prior User Rights • Virtual Marking of Products/Packaging • Alternative Design Patent Strategieswww.gardnergroff.com
  • Subject Matter Eligibility • Eligible under 35 USC § 101 – “A” patent – only one patent granted for each “invention.” (MPEP 804) – “Useful” – a specific, substantial, and credible utility. (MPEP 2107) – “Process, Machine, Manufacture, Composition of Matter” • Not Eligible – Laws of nature, abstract ideas, naturally occurring phenomena, mental processes, and mathematical algorithms – Claims directed to or encompassing a human organism • If a human organism is a claimed element of the invention – Natural Principle (see next slide) • The handiwork of nature that occurs without the hand of manwww.gardnergroff.com
  • Subject Matter Eligibility, cont’d… • Natural Principle – Ex: the relationship between blood glucose levels and diabetes – Examples of methods that focus on natural principles: • Diagnosing a condition based on a naturally occurring correlation of levels of a substance produced in the body when a condition is present • Identifying a disease using a naturally occurring relationship between the presence of a substance in the body and incidence of disease – TIP to make the claim eligible: • Integrate the natural principle into the claimed invention such that the natural principle is practically applied, and ensure that the claim amounts to significantly more than the natural principle itselfwww.gardnergroff.com
  • Subject Matter Eligibility, cont’d... • Natural Principle – Example outlined by USPTO: • A claim that uses the natural disinfecting properties of sunlight would require additional steps beyond merely exposing an item requiring disinfection to sunlight to be eligible. • Must limit its reach to a particular, inventive application of the law • The additional steps to make it eligible could involve: – Constructing a sanitizing device that uses ultraviolet light for disinfection with steps that integrate the ultraviolet light into the device and are sufficient to confine the use of the ultraviolet light to a particular application (not so broad as to cover all practical ways of applying ultraviolet light).www.gardnergroff.com
  • What is now “Prior Art” • Prior Art: – Information used against you during patent application examination – Assists a defense of invalidity in allegations of patent infringement • So, what is it? – For applications filed before March 16, 2013 • Printed publications as of their publication date; ex: patents/applications (global) – Ok if own pub. within 12 month grace period (US pat. only) • Public use or sale of the invention (only within the USA) – If your own use/sale, ok within 12 month grace period – Ok if use is for experimental purposes (strict guidelines) • USA patents or patent applications as of their filing datewww.gardnergroff.com
  • What is now “Prior Art” • For applications filed on/after March 16, 2013 – Printed publications as of their publication date (global) • Exceptions: • Own pub. within 12 month grace period (US pat. only) • Can anticipate third party publication with your own publication – Public use or sale of the invention (now global) • Exceptions: • Own use/sale within 12 month grace period (US pat. only) • Can anticipate third party use/sale with your own use/sale – US patents/applications with foreign priority as of foreign filing date • Includes PCT international applicationswww.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File • What applications are still under pre-AIA First-to-Invent system – Claim scope with priority to application filed before March 16, 2013 – Ex: New applications based on provisional; continuation; divisional • What applications are under the new First-Inventor-To-File System – Applications with claim scope beyond any pre-March 16, 2013 priority – New applications; Continuation-in-Part Applications; etc.www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • So, going forward in the AIA system: • A person shall be entitled to a patent unless— – § 102(a)(1) —the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention (i.e., PRIOR ART); or – § 102(a)(2) —the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • In other words, you can have a patent unless another entity does one of these before you file an application: • File a US patent application describing the invention – If priority to foreign application, then as of that filing date • Publish something describing the invention – Article, Patent, Patent Application (anywhere in the world) • Use the invention in public (anywhere in the world) • Put a product (including the invention) on sale (anywhere in the world)www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • Exceptions to the § 102 provisions above: • § 102(b)(1) —A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if – (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or – (B) the subject matter disclosed had, before such disclosure, 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.www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • Exceptions to the § 102 provisions above: • § 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 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.www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • In other words, it will not be “prior art” against you if: • The disclosure was made by the inventor, or was derived directly or indirectly from the inventor • The inventor publicly disclosed before the third-party disclosure (within grace period) • The subject matter disclosed and the invention, at the application’s effective filing date, were co-owned or subject to an obligation of assignment to the same owner • However, this will exclude foreign patent protection – Note: Derivation proceedings in slide belowwww.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... B’s grace period May 1, 2013 May 1, 2014 B publishes Y B files patent application claiming Y • B’s publication is prior art under 102 (a)(1), but knocked out by the exception in 102(b)(1) as a grace period inventor disclosure.www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... B’s grace period May 1, 2013 May 1, 2014 B publishes Y C publishes Y B files patent application claiming Y • B’s publication is prior art under 102 (a)(1), but knocked out by the exception in 102(a)(2)(A) as a grace period inventor disclosure. • C’s publication is prior art under 102(a)(1), but knocked out by the exception in 102(a)(2)(B) as a grace period intervening disclosurewww.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... A’s grace period May 1, 2013 May 1, 2014 B publishes Y C publishes B files patent Y and Z application claiming Y • B’s publication is prior art under 102 (a)(1), but knocked out by the exception in 102(a)(2)(A) as a grace period inventor disclosure. • C’s publication is prior art under 102(a)(1), but knocked out by the exception in 102(a)(2)(B) as a grace period intervening disclosure as to subject matter Y only; C’s publication is prior art as to subject matter Z per proposed rule.www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • PRACTICAL TIP: – File Provisional Applications Early and Often • Ongoing piggybacking provisional applications for design changes – Improve the invention disclosure process • Incorporate IP focus into product development life cycles • Schedule regular IP review meetings • Strive to improve quality/completeness of invention disclosures – Detailed disclosures improve patent attorney efficiency – Review patent filing processes and strategies • Can your patent attorney(s) complete high quality applications reasonably quickly? – If not, my email address is cwilson@gardnergroff.com and phone number is (770) 984-2300 ☺www.gardnergroff.com
  • First-Inventor-To- First-Inventor-To-File, cont’d... • PRACTICAL TIP: – The 12 month grace period is not a strategy, but a last option • Educate inventors to file patent applications (e.g., provisional) prior to publicly disclosing the invention • If the invention is publicly disclosed, you may still be able to obtain US patent protection if within grace period (US only) – Public disclosure must fully support the claimed invention in order to be entitled to anticipatory priority – If no patent protection is desired, publish often and quickly • Might prevent 3rd parties from gaining patentswww.gardnergroff.com
  • Derivation Proceedings • Ensures the person obtaining a patent is a true inventor and did not derive the invention from another. – Dispute between two applicants to determine who is the true inventor – May only be requested by an inventor who has filed a patent application claiming the same or substantially the same invention as another applicant. • PRACTICAL TIP: – Maintain an inventor’s journal with dates and witnesses • This could provide evidence that you are the true inventorwww.gardnergroff.com
  • Prioritized Examinations • Procedure for expedited review of a patent application – Goal to provide a final disposition within 12 months of prioritized status being granted – Maximum of 10k Priority applications per year will be granted – Eligible at the time of filing an original (non-provisional) or RCE if: • Application contains a limited number of claims • Application is filed electronically with the Request Form • Payment of $4800 fee (50% reduction for small entity) • PRACTICAL TIP: – Consider filing for Prioritized Examination for high-priority applications • Ex: If infringer is identifiedwww.gardnergroff.com
  • Pre- Pre-issuance Submission • Third parties’ right to submit prior art for consideration in another’s patent application examination: – Must be filed before the earlier of: (1) a Notice of Allowance or (2) the Later of 6 months after publication or the date of first rejection – Any member of the public may file a third-party submission, including private persons and corporate entities – A third party may file any patents, published patent applications, or other printed publications of potential relevance – A fee of $180 unless qualify for the exception • PRACTICAL TIP – Offense: monitoring competitor’s applications & file submissions – Defense: consider expediting examination to beat any submissionswww.gardnergroff.com
  • Post- Post-issuance Procedures • POST GRANT REVIEW – Third party right to challenge the validity of a patent application within 9 months after it is granted • Only available for patents subject to First-Inventor-to-File • Can request to cancel one or more claims of a patent on any ground relating to invalidity (i.e., novelty, obviousness, written description, enablement, indefiniteness, but not best mode). • Filing fee at least $35,800. Non-refundable if petition denied • Warning: Once final disposition, cannot raise same issue again in USPTO or in court • PRACTICAL TIP: If your competitor just received an issued patent, this can be an alternative to litigation if your chances of success are highwww.gardnergroff.com
  • Post- Post-issuance Procedures, cont’d... • INTER PARTES REVIEW – Third party right to request to cancel one or more claims of the patent only on the grounds of novelty or obviousness based on prior art patents or publications • Must not have previously filed a civil action challenging the validity of a claim of the patent • Cannot be filed until after the later of 9 months after patent is issued or the date of termination of a post-grant review • Filing fee of at least $27,000. Non-refundable if petition denied • Warning: Once final disposition, cannot raise same issue again in USPTO or in court • PRACTICAL TIP: If your competitor is asserting some old patents against you, this may be an alternative to litigation if your changes are high.www.gardnergroff.com
  • Post- Post-issuance Procedures, cont’d... • SUPPLEMENTAL EXAMINATION – 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 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 strongerwww.gardnergroff.com
  • Increase 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 ↓ • 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 educationwww.gardnergroff.com
  • Obtaining 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… • 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 intentionalwww.gardnergroff.com
  • Prior 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 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 patentwww.gardnergroff.com
  • Virtual 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 • PRACTICAL TIP: – Make sure your product or packaging has adequate patent markings, so that you maximize your rightswww.gardnergroff.com
  • Alternative Design Patent Strategy • Design Patents – Protects the way something looks, not functions • Ex: A new design shape of an old lancet product – Consider whether unique design elements are equally important to a product’s identity and market-share. • If so, consider securing design patent protection. • Combination of filing for both utility and design patent protection will serve the purpose of protecting not only the functional aspects of your products but their unique appearances as well. • Design patents provide good protection now and are no longer considered weaker alternatives to utility patentswww.gardnergroff.com
  • Some Hypothetical Scenarios • A Medical Device Designer/Manufacturer (MDDM) – The MDDM makes/sells, or is proposing, one or several products • If not yet making/selling, have counsel perform Freedom-to-Operate • If already making/selling, have counsel perform Freedom-to-Operate – If you find a competitor’s patent that covers your product: • Use Freedom-to-Operate to attempt to design-around the patent • Conduct invalidity search for the competitor’s patent – If you identify prior art that invalidates competitor’s patent • Evaluate the benefits/pitfalls of staying quiet until contacted • If within 9 months from issuance, consider Post Grant Review • If beyond 9 months from issuance, consider Inter Partes Review • If contacted, consider filing Declaratory Judgment Actionwww.gardnergroff.com
  • Some Hypothetical Scenarios, cont’d... • You Own A Patent for Technology that is not Being Used Anymore – Consider seeking a third party to license the patent – Make sure that the patent is not invalid • Conduct an invalidity search of your patent • If you find some potentially damaging prior art: – Evaluate leaving it alone vs. Supplemental Examination • The analysis is similar for preparing to file a lawsuit against an infringer – If the infringer provides you with damaging prior art • Leave it alone and sue or Supplemental Examination?www.gardnergroff.com
  • Some Hypothetical Scenarios, cont’d... • The Careless Inventor – Inventor describes the invention at a trade show on May 1, 2013 – Competitor files patent app. describing the invention on July 1, 2013 – Inventor files patent app. for invention on September 1, 2013 – You discover the competitor application on December 1, 2013 – What do you do? • Find out if the competitor learned of the invention at the May 1 trade show. If so, Derivation Proceeding – If not, provide evidence to Patent Office of May 1 disclosure • Final Tip: If/when you invent, start considering patent issues early, at least before you plan to publicly disclose the inventionwww.gardnergroff.com
  • Congrats! You made it through! Thank You! Clark Wilson cwilson@gardnergroff.com 2018 Powers Ferry Road Suite 800 Atlanta, GA 30339 770-984-2300www.gardnergroff.com www.gardnergroff.com