Defenses

1
Defenses Counterclaims III

• Class Notes March 27, 2003
• Law 677 Patent Law Spring 2003
• Professor Wagner

2
Todays Agenda

• Repair versus Reconstruction
• Restrictions on Licensing
• Preemption
• First Inventor Defense
• Experimental Use

3
Implied License / Repair Reconstruction

• Implied license arises from equitable estoppel
• Typically requires inferred consent to use the
  patented invention
• Repair versus Reconstruction
• Repair okay
• Reconstruction not okay (Why?)
• Key issue how to determine repair/reconstruction
  distinction

4
Limitations on Licensing

• Brulotte v Thys (1964)
• What was the challenged behavior here? (What
  does the court think is improper?)
• Consider the middle on page 1144. Is this
  correct as a matter of economics? Of logic?
• Aronson v Quick Point Pencil (1979)
• What was the challenged behavior here? (Can the
  courts reasoning be squared with Brulotte?)
• Is there a meaningful distinction between
• Negotiating under the guise of an issued patent
• Negotiating under the guise of a patent
  application

5
Limitations on Licensing

• Note 35 USC 271(d)(5)
• No patent owner otherwise entitled to relief for
  infringement or contributory infringement of a
  patent shall be denied relief or deemed guilty of
  misuse or illegal extension of the patent right
  by reason of his having done one or more of the
  following . . . .
• refused to license or use any rights to the
  patent or
• conditioned the license of any rights to the
  patent or the sale of the patented product on the
  acquisition of a license to rights in another
  patent or purchase of a separate product, unless,
  in view of the circumstances, the patent owner
  has market power in the relevant market for the
  patent or patented product on which the license
  or sale is conditioned.

6
Preemption Licensing

• Mallinckrodt (1992)
• Are licenses that offer less than all the rights
  to a patent valid? (Why or why not?)
• If the policy of the patent law required full
  licensing, would the result be different?
• What does Bowers v Baystate suggest about the
  Federal Circuits view towards preemption of
  license agreements? (Is this correct from a
  policy perspective?)
• Why do courts believe that license agreements are
  not equivalent to IP rights? (Do you agree with
  this view?)

7
The First Inventor Defense (FID)

• How does the FID differ from the requirement that
  all patents be novel?
• The FID has important restrictions
• Covers only claims to a method of doing or
  conducting business
• Requires actual reduction to practice one year
  prior to the effective filing date of the patent
• Requires commercial use of the invention prior to
  the effective filing date

8
The First Inventor Defense (FID)

• What if you sell a product/service under your
  right to the FID is your purchaser likewise
  protected?
• You transfer your rights to the FID to a 3rd
  party. Any problem?
• What do you think is the theory behind this
  provision? (Is this a good way to address the
  problem is seems to target?)
• Wont someone eligible for the FID have had an
  opportunity to obtain or invalidate the patent?

9
Experimental Use

• 35 U.S.C. 271(a)
• . . .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 therefore infringes the
  patent.
• Why have an experimental use exception? (In
  what cases would you find an exception to
  infringement?)

10
Experimental Use

• Roche v Bolar (Fed. Cir. 1984)
• What was the accused infringer doing?
• Why might this argue for an experimental use
  exception?
• How does the Federal Circuit define the
  exception? (What are the pros and cons of this
  approach?)

11
Experimental Use

• Congressional Response
• Hatch-Waxman Act (1984) key features
• Limited experimental use exception
• Automatic infringement in FDA approval process

12
Experimental Use

• Experimental Use (271(e)(1)) reasonably related
  to the development and submission of information
  under Food Drug laws
• What if you infringe to develop a new drug or
  medical product, but also demonstrate the
  (infringing product) at shows, etc.
• Automatic Infringement (271(e)(2))
• What is an ANDA? (Why have it?)
• Why make the filing of an ANDA an infringement?
• What is important about the automatic stay of
  processing by the FDA upon filing a lawsuit
  related to an ANDA application?

13

• Next Class
• Patent Remedies