Freedom to Operate and Selected Issues

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Freedom to Operate and Selected Issues March 9, 2010 Presented by: Cary A. Levitt

My principal business consists of giving commercial value to the brilliant, but misdirected, ideas of others... Accordingly, I never pick up an item without thinking of how I might improve it. - Thomas Edison

Freedom-to-Operate vs. Patentability Freedom-to-Operate (i.e., non-infringement) is quite different from patentability. Patents give the patent owner the right to exclude others from making, using and selling (i.e., practicing) the patented invention, not the right to practice the patented invention. Thus, while an invention may be patentable and result in an issued patent, the practice of the invention may still infringe a prior patent.

Reviewing Patents/Publications Freedom-to-Operate vs. Patentability Example 1 (Non-infringement/Not Patentable): Claim Limitations A B C D E Prior Art X X X X Inventio n X X X The prior patent requires limitation A, which the invention does not have. Thus, the invention does not infringe the prior patent. However, because the prior art discloses all of the limitations of the invention (e.g., B, C, and D limitations), the invention is not patentable.

Reviewing Patents/Publications Freedom-to-Operate vs. Patentability Example 2 (Infringement/Patentable): Claim Limitations A B C D E Prior Art X X X Invention X X X X The prior patent fails to disclose limitation E, limitation, which is part of the invention requires. The invention is thus patentable. But the invention also includes each of the limitations of the patented claim (e.g., limitations B, C, and D. Thus practice of the invention infringes the prior patent.

Reviewing Patents/Publications Freedom-to-Operate vs. Patentability Example 3 (Non-infringement/Patentable): Limitations A B C D E Prior Art X X X X Invention X X X X The prior patent fails to disclose limitation E. The invention is thus patentable over the prior patent. The invention does not include limitation A. Thus, the practice of the invention does not infringe the prior patent.

Why is Freedom to Operate Important? When introducing a new product or process When introducing a reformulated product or redesigned process When purchasing a business or product line When considering technology offered in a license

Why is a Freedom to Operate Analysis Conducted? To inform of the risks attendant to making, using and/or selling a product To develop a strategy to avoid third party patents and minimize risk of litigation (possible reexamination) To try to insulate client from a finding of willful infringement To provide a possible tool for negotiations with the patentee

Who Should be Involved in Analyzing Freedom to Operate? Multi-functional process The author of an FTO opinion should be Knowledgeable, Independent, Potential good witness Law firm vs. In-house Conducting the Investigation Gather all the factual information required to render the opinion Interview knowledgeable technical personnel Obtain detailed description of product/process to be commercialized Review product/process specification and literature If possible, observe the product/process in operation Determine when and where the product or process will be commercialized

Conducting The Search For Potentially Interfering or Dominating Patents Define the subject matter of the search Define the search parameters U.S. Patents / published applications Foreign Patents / published applications

Performing the Infringement Analysis Claim construction Review written description and claim language Review file history statements that resolve ambiguity in claim language principal cited prior art, with attention to examiner s rejections and amendments drawn to overcome art, i.e., file wrapper estoppel investigate terms of art where necessary Literal infringement Doctrine of equivalents definitions in specification, dictionaries and technical treatises using claim charts, evaluate whether there is an identical or equivalent element in the product or process for each claim element consider effect of amendments and arguments made during prosecution Consult with technical personnel, if necessary, to confirm that opinion is factually accurate and that any assumptions made are true or at least realistic Develop noninfringement position(s)

Reviewing Patents/Publications Freedom-to-Operate To infringe the claim of another patent, the invention (composition/method/use/apparatus) must include each and every limitation of the claim, or an equivalent thereof; The claim must be valid; and The patent must not be expired.

Reviewing Patents/Publications Freedom-to-Operate Comparison of invention with independent claim of patent/ publication. 1) Does the invention being practiced literally include each and every limitation of the independent claim? 2) If no, are one or more elements of the practice invention equivalent to those elements of the claim that are not literally being practiced? If the answer to 1) and 2) is no, the independent claim is not infringed. If an independent claim is not infringed, all dependent claims depending from the independent claims are also not infringed.

Reviewing Patents/Publications Freedom-to-Operate General thoughts regarding validity/patentability Just because an independent claim is invalid or unpatentable, this does not mean the entire patent is invalid or unpatentable. A dependent claim narrows the independent claim and may still be valid/patentable. It is therefore good practice to review the relevance of the dependent claims to the practiced invention. For example, a complete assessment might result in independent claim 1 and dependent claims 2-4, 8 and 12 raising a potential freedom-to-operate issue, with the remaining dependent claims raising no issues.

Preparing the Freedom To Practice Opinion Opinion is preferably in writing, not oral, and should rest on a strong legal and factual foundation Confirm accuracy of facts and assumptions regarding product/process Generate element-by-element claim chart for each claim, separately for infringement and validity analyses Opinion should state that it is based on the patent, its file history, the prior art of record, any additional prior art and provide a description of product/process provided by client Provide infringement/validity analysis (consider doing one or both) Incorporate pertinent current Federal Circuit and District Court case law and statutory authority Provide substantive analysis, not conclusory assertions Identify probability of success, risks and recommended course of action Discard drafts of opinion (but maybe not during litigation) Limit distribution of opinion to preserve claim of privilege

Ongoing Considerations Freedom to Operate should be reviewed periodically to ensure that a supplemental analysis is not required due to intervening circumstances, such as: publication of patent application modification of product/process issuance of reissue patent or reexamination certificate subsequent discovery of more relevant prior art than that considered in original opinion additional evidence relevant to secondary considerations of nonobviousness becomes available

FTO - Summary of Best Practices Conduct analysis / Prepare opinion as soon as possibility of infringing activity becomes apparent Acquire all of the factual information required to render a fully competent opinion Include thorough legal and factual analysis, preferably based upon claim charts for both validity and infringement Provide a realistic assessment of the risk, identifying any uncertain complex technological issues and any areas of unsettled law Select the recipient of the opinion wisely

Licensing Due Diligence How does a licensee evaluate a patent / patent application? Do I need the license? If I take a license, will I be able to use what I am getting? What is a license worth? What IP exists? Who owns the relevant IP? Are there any Warts? What third party IP right may affect the IP portfolio? From the licensor s perspective evaluate the potential problems before taking the IP to market.

Licensing Due Diligence (continued) Managing Licensing Due Diligence Budget for the exercise Evaluate potential design around opportunities Multi-functional approach R&D, marketing, legal, finance Scope and strength of the patents being licensed Potential blocking patent Design around Validity Commercial Terms Exclusive vs. Non-exclusive Rights Granted Royalty payments; minimum royalty payments Field of Use Termination Rights ** Ultimate goal = arrive at fair commercial terms **