Week 6 - 10/14/03Adv.Pat.Law Seminar - rjm1 Today’s Agenda First Student Packet: David Abramowitz Another FDA/Patent Wrinkle (SmithKline Beecham v. Apotex)

Week 6 - 10/14/03Adv.Pat.Law Seminar - rjm 1

Today’s Agenda

• First Student Packet: David Abramowitz

• Another FDA/Patent Wrinkle (SmithKline Beecham v. Apotex)

• About Packets, Talks, Critiques

• Next Week


David’s Packet

• Guinea Pig Status means David is not faulted for things for which YOU will be faulted

• This is a FINE first packet, and many things David did you should strive to do, too.

• In many ways, too, it is NOT a good example for you to follow. See next slides, and the handout.


Good Writing

If you are required to write something new (that is, something on which I have not given comments), you must read your own drafts at least 5 times.

If I have made suggestions for better writing in the course of commenting on the material you did submit in draft, APPLY THEM to whatever you did NOT submit in draft, too.


Good Writing

Good writing requires good (organized, clear, sequential) thinking.

• Break down the ideas. • Try to SPEAK them.

If you have trouble writing sentences of the appropriate length, it could be because you write with your hands instead of your EARS. Use your ears!


Helping the Busy ReaderIn general, the final packet, and all

the choices of inclusion and exclusion, are YOURS.

You must be able to justify every inclusion and exclusion, if you are ever asked. See How-To.

You definitely have the right to reject explicit instructions I have given you.

…AS TO SUBSTANCE.


Hel

ping

the

Bus

y R

eade

r Imagine that I am the senior partner at your firm. I’ve asked you to brief me on a complex matter of patent law with which I am not thoroughly familiar. You have to gather source materials, edit them, steer me through them, etc. etc. I’ll have 2 hours to read the whole thing. You KNOW I think visually, like to skim, like to be able to find things again after I’ve gone through everything once. And so on. What do you do?


No footnotes, but no lies, either: The NECESSITY of giving

attributionFootnotes are an unnecessary

pretension and distraction in this context, but that does NOT permit you to pass off ideas and information that did not spring out of your own head as your own. GIVE ATTRIBUTION!


No footnotes, but no lies, either: The NECESSITY of giving

attributionExample: The story about Teddy Roosevelt and The Jungle: is that an original thought of DBA? If not, he ought to tell us whose idea it is, using a parenthesetical like one of these:

In other situations, include a BIBLIOGRAPHY to let us know how much you stood on the shoulders of giants, pygmies, ants, etc.

• (see “The FDA: A History,” at html://www.fdagov.…..)• (lecture, Prof. Eisenberg, FDA Law, U of M Law School, Winter 2003)


Abramowitz Packet

http://www-personal.umich.edu/~rjmorris/fall03/DBApacket.doc

Somewhere somebody told him that 271e2 is the ‘listing’ provision, and that it tells drug companies something relevant to the Orange Book. It must have been someone DBA believes more than he believes his own eyes. The errors in the original draft have been corrected, but the idea still lurks in his brain.

Beware of believing authority figures!This includes being wary of believing me, but it also includes reading and thinking carefully and rigorously, so you can decide for yourself who and what to believe!











CROSS-REFERENCESCross-referencing helps the busy reader. They also force YOU, as packet maker, to be more careful and more thoughtful.

In your draft, you don’t have to include the page, let alone the page and line number, but I DO expect to see where you plan to put in a cross-reference. You might write something like

{see RJM-X [where Judge X, in Case Y, shows his ignorance of Westinghouse]}

In the final, that long bracket will be replaced with a page number, or page+line number.

In your final, I expect to see EVERY cross-reference I mention in my comments, and some more that you realize are necessary after you make more changes.


CROSS-REFERENCES

In David’s packet, for example, I asked him to summarize Glaxo and Bayer: cases mentioned as if we should know about them in Warner-Lambert (e.g.DBA-9) and Allergan (e.g.DBA-15).

He wrote the summaries but omitted the cross-references entirely. They are not in the summary, and they are not in the later mentions of these precedents in the featured opinions. This, alas, somewhat defeats the purpose of including the summaries.

He also failed to note on the cover sheet that he had summarized these cases. This, too, is a foot-shooter, as well as cruel to the busy reader.


PAGE LIMITSAs between reader UNfriendliness (David’s wonderful table on page DBA-7 is a sad example; there are many others) and a longer packet, I want the longer packet.I’d rather you figured out how to EDIT to make things shorter, but whatever you do, please do NOT start deleting white space, formatting, page-breaks, etc.

I read the final version, every word. There is no way I won’t realize that your packet is wordy, insufficiently edited, etc., REGARDLESS of the number of pages. Please do not compromise usefulness by attempts at space-saving.

PLEASE BELIEVE ME ON THIS.

content appearance


STATUTES, CLAIMS, REGULATIONS

RE-FORMAT STATUTES, CLAIMS, REGULATIONS.

THIS MEANS EVERYBODY.

PLEASE DO NOT USE David’s PACKET AS A TEMPLATE.

Starting at 6 pm today, I will no longer accept drafts or finals in which hard-to-absorb language is left in its impenetrable, run-on, original state.

In almost everything I have edited. you can find examples of reformatting to enhance readability –INCLUDING statutes and claims. Look at the originals if you doubt it. If you have any questions, ASK. But please do not ignore this requirement. See How-To, page 8.


STATUTES, CLAIMS, REGULATIONS

(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

AS SHORT AS IT IS, IS MORE READABLE, MORE ABSORBABLE AT A GLANCE, IF YOU MAKE IT

(b) Whoever

actively induces infringement of a patent

shall be liable as an infringer.


(b) Filing application; contents. {NDA – DBA}

(1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such person shall submit to the Secretary as a part of the application (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; and (F) specimens of the labeling proposed to be used for such drug. The applicant shall file with the application the patent number and the

Hard to read? Hard to understand? Hard to use?

See HANDOUT!


SmithKline Beecham v. Apotex(and Warner-Lambert and Allergan)

• Does it matter to you if the PO

- couldn’t get a patent on the drug itself (and why it couldn’t)?

- has an EXPIRED patent on the drug itself

- has an EXPIRED patent on a USE that is biologically related to the USE in question?

• Who is the most likely to be INDUCING infringement of an off-label use patent: PO, AI or other?

• Why aren’t the AIs interested in fighting the induced infringement charge, or asserting double patenting or invalidity?

• De Minimis Infringement


Drugs, Uses, and 271e2 – Weekly Comments

Additional Fact *I* Want to Know: How related are C-1 and C-2 in their biology, chemistry, etc.? If they are in fact highly related (e.g. interocular pressure and nerve degeneration), that raises

(1) the possibility that there IS indeed INDUCEMENT to

infringe the C-2 patent when AI sells D for C-2, but (2) the possibility that maybe the patent claiming the

treatment of C-2 is INVALID, and(3) the main inducement may come from the PO! For

example, it may fund studies by doctors, to show that C-2 is also helped by D, that C-2 and C-1 are related, etc. so that PO can sell more D, without having to go through the expense of getting approval on C-2.


Drugs, Uses, and 271e2 – Weekly Comments

Additional Facts *I* Want to Know:

When was the first time a proprietary drug owner applied for a patent on a SECOND use for a drug? Was it before or after 1984?

When was the HWA first proposed? How different is the original proposal with regard to 271e2 v. what finally passed?

How many ‘second use’ applications were filed (or granted) in, say, 1980-1984 v. 1990-1994 and 1998-2002?

Reason: My guess is that ‘second use patents’ were VERY rare back then, notwithstanding the House Report example quoted by Lourie.


De Minimis Infringement

Why is a rule totally unnecessary?

Tautology: if someone bothers to sue, the infringement must be SERIOUS.

When does the tautology break down?


Next Week

•Dave Gaskey ’92 – Telling a good short story

•Susan Steele – 271e1

•Sharon Severance ’93 – Claim Interpretation – the littlest words

Documents

Week 6 - 10/14/03Adv.Pat.Law Seminar - rjm1 Today’s Agenda First Student Packet: David Abramowitz Another FDA/Patent Wrinkle (SmithKline Beecham v. Apotex)