Fundamentals of Patent Litigation — 2025

A Course taught by Professor of Practice Ronald J. Brown, Ph.D., J.D., at the James E. Rogers College of Law, University of Arizona

Copyright 2025

  • Jan 15 (Class 1)
    • Assignment:  Introduction
      • Read Ch. 12 of Patent Law (4th ed.), pp. 303-19
        • An online version of Patent Law is available to UA law students without charge by signing in to West Academic Study Aids Collection (https://www.westacademic.com/study-aids-collection-1)
      • Read Overview
      • Read PatentTerm
  • Jan 22 (Class 2)
  • Jan 27 (Class 3)
  • Jan 29 (Class 4)
  • Feb 3 (Class 5)
    • Assignment:  Pre-suit Case Assessment – Preliminary Claim Construction
      • Read Ch. 13 of Patent Law 4th
      • Read Claim Construction and Markman (pp. 229-58)
      • Read Claim Construction
      • Read File History of US Patent 5,302,168 (only pp. NC000002-13, 31-34, 37-46, 48-55, 59-63, 66-69, 71, 73-74)
      • Read File History of US Patent 5,411,466 (only pp. NC0000248-59, 270-72, 276-78, 281-87)
      • Read File History of US Patent Re 5,411,466 (only pp. NC000096-115, 119, 136-38, 140-53, 156-60, 163-72, 176-78, 199-208, 212-15, 219-23, 230-35, 240-44)
      • Read CC Methodology
      • What do you need to think about before filing suit?
      • Which claim terms do you, as an advocate, want to be construed in the ‘168 patent, claims 1 and 6?
      • Draft for Class 7 a claims chart for the ‘168 patent, claims 1 and 6, from the perspective of your team assignment
      • Start by asking these questions:
        • If I perform claim construction of a term without reference to the accused device, what is my construction?
          • Does it produce a desired outcome for your client?
        • If not, what construction do I need to produce a desired outcome?
          • If you can’t generate a plausible argument for your needed construction, it’s time to rethink
  • Feb 5 (Class 6)
    • Assignment:  Pre-suit Case Assessment – Preliminary Claim Construction cont’d
      • Complete drafting a claims chart for the ‘168 patent, claims 1 and 6, from the perspective of your team assignment, and be ready to discuss it in class
  • Feb 10 (Class 7)
  • Feb 12 (Class 8)
    • Submission:  Infringement chart for the ‘168 patent based on your team assignment (graded)
    • Assignment:  Pre-suit Case Assessment – Preliminary Infringement Analysis cont’d.
      • Read US Patent 4,022,227
      • Google “Donald trump’s hair”
      • Be prepared to explain why/why not “the Donald’s” head infringes the ‘227 patent
  • Feb 17 (Class 9)
  • Feb 19 (Class 10)
    • Submission:  Sec. 102 prior art chart of ‘168 patent based on your team assignment (graded)
    • Assignment:  The Patent Holder’s Obligatory Pre-Suit Investigation, Rule 11, and Sec. 285
      • Read Rule 11, FRCP
      • Read Sec. 285 of the Patent Act
      • Read the following Rule 11 case:
      • Read the following Sec. 285 case
      • Warning:  the reading assignment for the next class is unusually long, so begin the reading assignment as part of today’s assignment
  • Feb 24 (Class 11)
    • Assignment:  The Patent Holder’s Recommended Pre-Suit Analysis
      • Read Ch. 16 of Patent Law 4th
      • Read articles that discuss some of the factors important in deciding whether to advise your client to proceed with the lawsuit:
      • Read articles on injunctions:
      • Read Patent Stats
      • Read Time to Trial
      • Read representative set of local patent rules
      • Facts on which you should base your Class 12 submission
        • Your analysis should be keyed to the factors that I identified as being important in deciding whether to proceed with a lawsuit on the ‘168 patent; those factors are listed in the “Recommended Pre-Suit Case Analysis” slide.
        • Assume as correct the Composite Infringement and Prior Art chart we discussed in class.  Your infringement and validity analysis should be based on that chart.
        • Except for “Likelihood of infringement” and “Likelihood of validity,” your analysis should be from the perspective of Calmedica.  For the first two factors, give me your assessment from your team perspective and, if you represent Novoste, convert Novoste’s probability of success to Calmedica’s probability of success.  Your assessment on these two factors should be based on how much you had to stretch to arrive at the desired claim construction and, given that claim construction, the probability of invalidating/not invalidating the ’168 patent based on Fischell, Liprie, and Dake (assuming they are prior art).  Note that because the prevailing claim construction likely will be dispositive of infringement, the probability of a finding of infringement/non-infringement is roughly the probability of you prevailing on your claim construction.
        • For purposes of your analysis, you should make the following assumptions:
          • Calmedica markets a competing device
          • Novoste is accused of direct infringement
          • Calmedica has its offices in CA; Novoste has its offices in GA; both are DE corporations
          • Consider CA, GA, TX, and DE as possible fora for the litigation
          • There is a 50/50 chance that Fischell and Dake are prior art
          • Both the Beta-Cath and the Calmedica device are regarded by the medical community as lifesaving devices
          • Calmedica has not marked its devices
          • Each Calmedica device costs $1,000 to manufacture
          • Each Calmedica device sells for $4,000; the Beta-Cath sells for the same amount
          • Calmedica has the manufacturing capacity to sell an additional 10,000 units/year
          • The incremental profit for the additional 10,000 units/year is $2,000/unit because of the additional costs of hiring more employees
          • There are no non-infringing alternatives
          • Up to the anticipated date of trial, Novoste was selling/will sell 10,000 units/year
          • Novoste entered the market with the Beta-Cath five years prior to the anticipated date of trial
          • Devices in the field of angioplasty are typically licensed in the range of 3-5% royalty based on the sale price
          • Calmedica informed Novoste of the ‘168 patent and its reasons for believing that Novoste indirectly infringed the patent one year after Novoste entered the market
          • Novoste sought a defensive opinion shortly after Calmedica accused it of infringement
          • Shortly after Calmedica accused it of infringement, Novoste sought, but was unable to obtain, an opinion of non-infringement from its outside patent counsel
          • Instead, Novoste had its in-house counsel, who was not a patent attorney, write a defensive opinion; the opinion did not attempt to construe the claims
          • Novoste sells the Beta-Cath nationally, but its only physical presence is in Georgia
  • Feb 26 (Class 12)
    • Submission:  Prepare outline for discussion with the client (Calmedica) that addresses the factors important in deciding whether to proceed with the lawsuit on the ‘168 patent (graded)
    • Assignment:  Preparation of the Complaint and Answer
  • Mar 3 (Class 13)
      • Submission:  Turn in your team’s collective claim construction chart for exchange with your adversary
      • Assignment:  Determining Whether Art Is “Prior” Art – a Closer Look at Whether the Art Falls Within Sec. 102
        • Read Ch. 6 & pp. 145-71 of Patent Law 4th
        • Read 102 Addendum
        • Read Conception Requirements
        • Read Oesterle Decl. found in the Dake ‘939 file history
        • Based on the Dake file history, is Dake prior art?
        • What other facts would you need to establish to conclude that Dake is prior art?
        • Read Hess sec. 131 declaration:  Hess Invention Disclosure
        • Based on the Hess file history, is Fischell prior art?
        • What other facts would you need to establish to conclude that Fischell is prior art?
        • Read material on sec. 102(b) and corroboration
          • Harmon – Corroboration (read only 3.4(d)(III), pp. 168-71) 
          • RTI v. Oilmatic et. al. is an example of the role corroboration can play in a case.  RTI asserted the ‘511 patent against Oilmatic.  The ‘511 patent is directed to a bulk oil handling system that incorporates a filter for reusing cooking oil.  Oilmatic made and sold bulk oil handling systems to restaurants.  The Oilmatic system arguably infringed one or more claims of the ‘511 patent.  As one of its defenses, Oilmatic contended that there had been a prior public use under sec. 102(b).  The alleged prior art system consisted of the Sherratt Bulk oil handling system coupled with a portable filter.  The Sherratt system was identified in the ‘511 patent as a prior art system.  Oilmatic’s attorneys sought out Sherratt and, using the leads he gave them, identified a witness who testified that the Sherratt system had been used with a filter in a Wendy’s in La Habra, CA many years before the filing date for what became the ‘511 patent.  If such a system was used, it anticipated the claims of the ‘511 patent.  The thrust of RTI’s papers was that the alleged prior use under 102(b) lacked necessary corroboration.
          • ‘511 Patent (read only Abstract and claim 1) 
          • RTI Undisputed Facts
          • RTI SJ Motion
          • Read materials on sec. 102(f) and corroboration
            • Hasel v. Pulpdent is an example of an attempt to invalidate a patent using sec. 102(f).  Dr. Robert Hasel invented a method for using a needle-tipped syringe containing a flowable composite to fill hollowed cavities in teeth.  Hasel was issued several patents on the technology, including the ‘567 patent (a method patent).  Hasel enforced his patents against several dental companies, including Sybron Kerr, Pentron, and Danville Materials.  Those cases ended with agreements to license the Hasel patents.  Hasel then sued Pulpdent, another manufacturer of flowable composites used to fill cavities in teeth.  That case went to trial.  Pulpdent contended, as one of its defenses, that Hasel was not the true inventor, but rather a person with whom Hasel had a prior association – Thomas Bryan – conceived the invention described and claimed in the Hasel patents.  Below is a portion of the trial cross-examination devoted to showing that Bryan had no corroboration for his claim to prior invention.  A second theme of the cross-examination was that Bryan was not responsible for the method claimed in the ’567 patent.
            • ‘567 Patent (read only Abstract and claim 1)
            • Bryan Cross-Examination
            • Bryan Cross-Examination cont’d (p. 33, l. 12 to p. 34, l. 2)
  • Mar 5 (Class 14)
    • Submission:  Complete sec. 102 prior art analysis for the ‘168 patent, focusing on Liprie, Fischell, and Dake (graded)
      • Submit in the same format as the “Prior Art Analysis” for the Vitale ‘586 Patent
      • Which of the references, if any, are prior art, and why or why not?  Confine your analysis to §§102(a), (e), g(2), and (b).
      • Assume the following:  (1) Hess’s application was filed on 9/5/91 (as shown on the face of the ‘168), but never published or in a printed publication until the patent issued; (2) the ‘168 issued on 4/12/94 (as shown on its face); (3) Hess, in his §131 declaration, claimed conception before 12/11/89 (see Hess Invention Disclosure); (4) Hess’s original disclosure is dated 3/13/89 (Hess redacted the date on the copy he submitted to the PTO – a permitted practice); (5) Hess did not RTP until his filing date of 9/5/91; (6) none of the putative prior art patent applications was published until that patent issued; and (7) none of the inventions claimed in the putative prior art patent applications appeared in a printed publication before the patent issued.
      • If you conclude that a reference is not prior art based on the information given to you, identify what additional facts you would like to establish that make the reference prior art.  Those additional facts may relate to certain activities associated with the reference as well as facts related to Hess’s ability to rely on his claimed DOI.  More specifically, in the file history you see that Hess claimed a date of conception of earlier than 12/11/89.  He did that so that the Examiner could not rely on Fischell as prior art under §102.  If Hess’s actual date of conception was earlier than 12/11/89, Fischell’s filing date and presumptive DOI, then Fischell would not be prior art.  Assume that you have done some discovery – e.g., under Rule 26, once the complaint and answer are served, Hess would have to produce a copy of his original, unredacted invention disclosure – that established his claimed date of conception as 3/13/89.  As part of your assignment, you are to look at whether Hess’s DOI can be moved to a later point in time such that more art becomes sec. 102 prior art.  Approach the assignment from Novoste’s perspective, i.e., you are looking for ways to invalidate the Hess patent.  The other avenue to explore is, rather than moving Hess’s DOI, moving the prospective prior art to an earlier point in time.  To do that, you will need to conduct some discovery related to the prospective prior art.  Tell me what you’d like to learn through discovery.
    • Assignment:  Determining Obviousness – Completing that Part of the Validity Analysis Based on Prior Art
      • Read Ch. 8 of Patent Law 4th
      • Read materials on obviousness:
      • Supplement sec. 102 prior art chart with sec. 103 analysis
        • If you are on the side of the alleged infringer, how would you argue that the combination of Bonzel and/or Liprie render claim 1 obvious?
        • If you are on the side of the patent holder, explain why claim 1 is nonobvious in view of that combination
  • Mar 17 (Class 15)
  • Mar 19 (Class 16)
    • Submission:  Claim construction chart rebutting your adversary’s constructions (graded)
    • Assignment:  Presentation of Your Claim Construction Position
      • Read A Claim Construction and Patent Law Blog – GRAY On Claims
      • Read Chart Claim Construction
      • Read Claim Construction Appeals
      • Read Appellate Standard of Review
      • Read Markman Presentation
      • Read materials from GenSci v. Osteotech.  In that case, the technology related to bone graft implants that are osteoinductive, i.e., they stimulate cells to differentiate into bone tissue.  Osteotech sued a competitor, GenSci, for infringing two Osteotech patents – one of which is found below.  The products that Osteotech claimed were infringing were those that drove the vast bulk of GenSci’s revenue.  A Markman hearing was held on the Osteotech patents during which GenSci raised numerous claim construction issues.  Those issues are summarized in the court’s Claim Construction Decision.  The Markman hearing included live testimony from each party’s expert.  Eisch Cross-Examination (below) is a portion of the cross-examination of GenSci’s expert.  Notice how the cross-examination is focused on intrinsic evidence, with additional support from extrinsic evidence.  Also notice that Eisch’s view of a POSA is not someone who worked in the field of bone graft implants, but rather is an academic chemist.
      • Read highlighted portions of ‘558 patent
      • Read highlighted portions of Eisch Cross-Examination
      • Read Claim Construction Decision to p. 17
  • Mar 24 (Class 17)
    • Assignment:  Other Defenses Not Based on Prior Art
      • Read materials on sec. 112 defenses:
      • Read materials on inventorship:
      • Read materials on estoppel and prosecution laches:
      • Read materials on failure to mark:
      • Read materials on statute of limitations:
      • Read materials on inequitable conduct:
      • Hasel v. Pulpdent:
        • Pulpdent alleged that Hasel had engaged in inequitable conduct by failing to disclose to the Patent Office the existence of clinical studies that he had conducted more than a year before his filing date.  Pulpdent argued that those studies were a public use under sec. 102(b) that gave rise to a statutory bar.  As evidence of Hasel’s inequitable conduct, Pulpdent offered the testimony and documents of Dennis Daley, a patent attorney who represented Dr. Hasel in the Patent Office.  During prosecution of the Hasel patents, a dispute arose between Hasel and Daley.  Daley then withdrew from further representation of Hasel.  He filed a notice of withdrawal with the Patent Office (Daley Ex. 23).  In that notice, Daley checked several grounds for withdrawal under 37 C.F.R. 1040 (Daley Ex. 6).  Daley also had previously written to Hasel inquiring about Hasel’s clinical studies (Daley Ex. 12).  Daley claimed that Hasel never responded to his inquiries about the clinical studies.  Pulpdent argued that one should infer from Daley’s letter and notice of withdrawal that Daley withdrew because he believed that Hasel had engaged in inequitable conduct.
        • Read Daley Ex. 12
        • Read Daley Ex. 6
        • Read Daley Ex. 23
        • Read Daley Cross-Examination
        • What was the purpose of the cross-examination?  Did it succeed?
      • What defenses (not based on prior art) should Novoste consider asserting under the following set of facts?  (For submission before Class 20):
        • Calmedica learned more than eight years ago that Novoste was planning on entering the market with the Beta-Cath but waited to file suit until now.  Seven years ago, Calmedica wrote Novoste a letter warning it that any attempt to market the Beta-Cath system would constitute infringement of the ‘168 patent.  In response to the cease-and-desist letter, Novoste promptly replied with a letter explaining why it didn’t infringe.  Six months after receiving the cease-and-desist letter, Novoste advised Calmedica that it was entering the market.  Novoste geared up to enter the market by investing heavily in a manufacturing facility for the Beta-Cath.  After the cease-and-desist letter, and until it filed suit in January 2024, Calmedica took no further action against Novoste.
        • Hess and Dr. X collaborated on the claimed invention.  As part of the collaboration arrangement, Dr. X reserved all rights to any inventions he made as part of the collaboration.  Dr. X, who worked at a CA university, had the idea during the collaboration for using the shielding shown in Figs. 1 and 5 of the ‘168 patent.  He communicated his idea to Hess.  Hess and Dr. X, prior to filing the patent application, had a falling out.  Since then, they have not spoken to each other.  Hess filed the patent application naming himself as the sole inventor.  He then assigned his rights to Calmedica, a company he owned.  Dr. X learned of the ‘168 patent after it issued.  Two months ago, Novoste asked him to assign his rights to Novoste for $10,000. Dr. X agreed and executed the assignment.
        • Calmedica has prevailed on its claim construction and, as a result, the Beta-Cath system falls within the scope of claim 1 of the ‘168 patent.  In other words, the scope of clam 1 extends to the use of a catheter containing a radioactive source train that is delivered to the area of reduced stenosis by a fluid.  The court construed “radioactive dose means” as any radioactive material, whether solid, liquid, or gas.  The court construed “positioning means” as a catheter shaft, angioplasty balloons, motion wires, a canister at the end of a shaft portion, an inflatable stent delivery balloon system, and fluid that are used to position the radioactive dose means at the area of reduced stenosis.  The Court construed “containing . . . before and after exposure” in claim 6 to refer to radioactive shielding of the radioactive material at a time before and a time after the area of reduced stenosis is exposed to the radioactive material.
        • As part of the prosecution of what issued as the ‘168 patent, Hess submitted an affidavit in which he stated under oath that “work performed by me . . . relating to guide wires and catheters for use with radioactive dose means to be used for treatment and post-treatment of the stenosed regions of an artery has been ongoing in the United States from prior to December 11, 1989 through . . .” the filing date of what became the ‘168 patent.  The affidavit, submitted to establish diligence, had the effect of eliminating Fischell as a prior art reference.  The Examiner had rejected Hess’s claims based on the Fischell reference.  As a result of the affidavit, he withdrew his rejection and allowed the claims.  However, Hess’s notebooks for the period between 3/13/89 and the filing of his application disclose continuous work on selecting suitable material for the catheter wall, but no work related to radioactive materials or their shielding.  In depositions, Hess is unable to describe any work that was done prior to filing directed to the reduction to practice of a device containing radioactive material or its shielding.
        • At the time the Hess application was filed, a POSA would not have been familiar with how to remotely open and close the window of a container of radioactive material as described in the ‘168 patent.
        • Novoste has an expert witness who worked in the field of brachytherapy as of Hess’s filing date.  He is prepared to testify that, based on his review of the ‘168 patent specification, claims, and file history, he would not have thought that claim 1 was broad enough in scope to cover the use of a catheter containing a radioactive source train that is delivered to the area of reduced stenosis by a fluid.
        • Calmedica did not mark its catheter or the packaging with the ‘168 patent number.
  • Mar 26 (Class 18)
    • Mock Markman hearing (graded)
    • Assignment:
      • Finish reading the previously assigned portions of Chs. 9, 10, and 15 of Patent Law 4th (complete by Class 20)
  • Mar 31 (Class 19)
    • Mock Markman hearing (graded)
  • Ap 2(Class 20)
    • Submission:  Outline of arguments based on defenses not based on prior art (graded)
    • Assignment:  Written Patent Discovery
      • Read FRCP, Rule 26, as it relates to written discovery
      • Read In Praise of Requests to Admit
      • Read Withdrawal of Admissions, which is an excerpt of a hearing in the Osteotech case described earlier in the syllabus.  The hearing was for the dual purpose of considering (1) Osteotech’s Motion for Summary Judgment of Infringement and (2) GenSci’s Motion to Withdraw Its Admissions.  In that case, Osteotech served requests for admissions early in the case.  Two of Osteotech’s requests, and GenSci’s responses, were as follows:
        • Request for Admission No. 52:  Admit that DynaGraft Gel has new bone-growth-inducing amounts of demineralized osteogenic bone powder.
        • Response:  Admitted.
        • Request for Admission No. 53:  Admit that DynaGraft Putty has new bone-growth-inducing amounts of demineralized osteogenic bone powder.
        • Response:  Admitted.
      • The language of the requests was taken directly from claim 4 of the ‘558 patent.  Until the summary judgment motion.  GenSci had always vehemently maintained that its DynaGraft products were osteogenic.  As a result of the Markman hearing (see Class 16 assignment), it appeared that GenSci would lose Osteotech’s summary judgment motion unless it could create a fact issue.  Surprisingly, after Osteotech filed its motion, GenSci discovered a publication that cast doubt on the osteogenicity of GenSci’s DynaGraft products.  On the basis of that publication, GenSci moved to withdraw its admissions.  The above example highlights the potential value of requests for admissions.  Were it not for the two requests for admissions, summary judgment would not have been granted.
      • Read Powerful Pleadings
      • Read Composting Files
      • Review your infringement and prior art charts as well as your §102 prior art analysis
        • Assume you represent Novoste.  What facts are needed to add or solidify Novoste’s defenses?
  • Ap 7 (Class 21)
  • Ap 9 (Class 22)
    • Submission:  Draft Novoste interrogatories (3), document requests (3), requests for admissions (3) to Calmedica, and a subpoena duces tecum to a third party of your choice with document requests (3).  You are free to assume the facts set forth in the fact pattern for the Class 20 submission (found in the Class 17 assignment).  Do not, however, ignore the prior art defenses when formulating your discovery requests.  Make use of the knowledge you gained from your infringement and prior art analyses.  Explain the rationale for each discovery request.  (graded)
    • Assignment:  Taking and Defending a Deposition
  • Ap 14 (Class 23)
  • Ap 16 (Class 24)
    • Submission:  Outline of deposition questions for Hess (if you represent Novoste) or Ron Waksman (if you represent Calmedica) (graded).  Ron Waksman is a co-inventor of the Beta-Cath and Novoste’s Chief Scientific Officer.  He is familiar with the development of the Beta-Cath, Novoste’s knowledge of the Calmedica ‘168 Patent, uses of the Beta-Cath, and Novoste’s costs and sales of the Beta-Cath.  If you are deposing Hess, focus on prior art and non-prior art defenses.  If you are deposing Waksman, focus on establishing direct and indirect infringement, damages, and undermining Novoste’s non-prior art defenses and its defenses to the claim of willful infringement.
      • Organize the outlines by topics.  Under each topic, list bullet points that provide a mental trigger for the questions you want to ask, and for each bullet point, provide a parenthetical explanation for what questions you want to ask and why you want to ask those questions.  
    • Assignment:  None
  • Ap 21 (Class 25)
    • Mock depositions (graded)
      • If you represent Novoste, you will depose Hess.  If you represent Calmedica, you will depose Ron Waksman, a co-inventor of the Beta-Cath and an officer of Novoste.
      • Assumptions you are to make for purposes of the depositions:
        • The ‘168 patent has not expired
        • The Markman hearing has not yet been held
        • Hess’s notebooks for the period between 3/13/89 and the filing of his application disclose continuous work on selecting suitable material for the catheter wall, but no work related to radioactive materials or their shielding
        • Calmedica has produced all of Hess’s lab notebooks.  Hess’s invention disclosure (part of his section 131 declaration) contained in his lab notebook is dated 3/13/89.
        • Waksman informed Calmedica more than 8 years ago that Novoste was planning on entering the market with the Beta-Cath, but Calmedica didn’t sue until January of this year.
        • Seven years ago, Calmedica wrote Novoste a letter warning it that any attempt to market the Beta-Cath system would constitute infringement of the ‘168 patent.  In response to the cease-and-desist letter, Novoste promptly replied with a letter explaining why it didn’t infringe.
        • Six months after receiving the cease-and-desist letter, Novoste advised Calmedica that it was entering the market
        • After the cease-and-desist letter, and until it filed suit, Calmedica took no further action against Novoste.
        • Novoste has produced and is relying on a defensive opinion of non-infringement from its in-house counsel
        • Hess and Dr. X collaborated on the claimed invention
        • Waksman has knowledge of the sales figures for the Beta-Cath
      • You should make use of deposition exhibits.  If you are taking Hess’s deposition, consider using his sec. 131 declaration and 3/13/89 invention disclosure; if you are taking Waksman’s deposition, consider using some of the Novoste documents depicting the operation of the Beta-Cath.  Have the exhibits ready to share on-line.
      • Your grade will depend on (1) your ability to ask clear, open-ended questions, (2) your ability to listen carefully and use the answers of the witness to generate your next question, (3) the extent to which your questions are designed to uncover facts central to the key issues in the case, and (4) the material that you are able to cover in the time available.
  • Ap 23 (Class 26)
  • Ap 28 (Class 27)
  • Ap 30 (Class 28)