1. Defenses & Counterclaims III Class Notes: March 27, 2003 Law 677 | Patent Law | Spring 2003 Professor Wagner

2. 03/27/032Law 677 | Spring 2003 Today’s Agenda 1.Repair versus Reconstruction 2.Restrictions on Licensing 3.Preemption 4.First Inventor Defense 5.Experimental Use

3. 03/27/033Law 677 | Spring 2003 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. 03/27/034Law 677 | Spring 2003 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 court’s 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. 03/27/035Law 677 | Spring 2003 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. 03/27/036Law 677 | Spring 2003 Preemption & Licensing Mallinckrodt (1992): Are licenses that offer less than all the rights to a patent valid? (Why or why not?)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?If the policy of the patent law required full licensing, would the result be different? What does Bowers v Baystate suggest about the Federal Circuit’s view towards preemption of license agreements? (Is this correct from a policy perspective?)What does Bowers v Baystate suggest about the Federal Circuit’s 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?)Why do courts believe that license agreements are not equivalent to IP rights? (Do you agree with this view?)

7. 03/27/037Law 677 | Spring 2003 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. 03/27/038Law 677 | Spring 2003 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?) Won’t someone eligible for the FID have had an opportunity to obtain or invalidate the patent?

9. 03/27/039Law 677 | Spring 2003 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. 03/27/0310Law 677 | Spring 2003 Experimental Use Roche v Bolar (Fed. Cir. 1984) What was the accused infringer doing?What was the accused infringer doing? Why might this argue for an experimental use exception?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?)How does the Federal Circuit define the exception? (What are the pros and cons of this approach?)

11. 03/27/0311Law 677 | Spring 2003 Experimental Use Congressional Response Hatch-Waxman Act (1984): key features 1.Limited experimental use exception 2.Automatic infringement in FDA approval process

12. 03/27/0312Law 677 | Spring 2003 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. 03/27/0313Law 677 | Spring 2003 Next Class Patent Remedies