The Written Description Requirement: How Many Invalid Patents Do You Own

1. The Written Description Requirement: How Many Invalid Patents Do You Own? Kfir Luzzatto, PhD May 25, 2011

2. Why Talk About It? In reviewing patent portfolios during DD we find many fatally faulty patents. Applicants stick their heads in the sand too often. Many problems can be cured by a little timely attention.

3. Written Description Requirement vs. Enablement Requirement) US(: Enablement requirement � The patent description should enable the skilled person in the art to make and use the invention. Written description requirement - The patent description should adequately convey the claimed invention to the skilled person in the art. The distinction between the two requirements is not always immediately evident. Similar requirements exist in various forms in every serious patent law.

4. Why Are We Doing It Wrong? Drafting in a hurry; Relying on Provisional Patent Applications to give us what they can�t give us; Postponing carrying out expensive experiments; Etc.

5. The Provisional As A Trap When used properly a provisional application can be a useful tool. However: The provisional application is often filed by an individual or business who believes that a few pages of incomplete technical description will avoid expenses and yet completely protect the invention in the United States and worldwide. Because provisional applications are never examined, the inventor remains unaware that his provisional application is fatally non-enabling or invalid due to lack of written description, until there is a challenge by a third party.

6. The Writing Is On the Wall Courts in the U.S. and in other countries are making it clear that patents lacking written description or enablement won�t fly. The bad news is that those defects are either avoided at the drafting stage, or cannot be cured later on.

8. How Centocor Lost $1.67 Billion

9. Centocor�s patent involves antibodies to human TNF-a. By exchanging the A2 mouse antibody�s mouse constant region with a known human constant region, Centocor produced a �chimeric� antibody with a mouse variable region and a human constant region. Abbott independently created the therapeutic antibody Humira�, which is a high affinity, neutralizing, fully-human antibody to human TNF-a.

10. Centocor�s Lawsuit Centocor sued Abbot, among others, on the basis of the following claim 2: 1. An isolated recombinant anti-TNF-a anti-body or antigen-binding fragment thereof, said antibody or antigen-binding fragment comprising a human constant region, wherein said antibody or antigen binding fragment (i) competitively inhibits binding of A2 (ATCC Accession No. PTA-7045) to human TNF-a, and (ii) binds to a neutralizing epitope of human TNF-a in vivo with an affinity of at least 1x10 8 liter/mole, measured as an association constant (Ka), as determined by Scatchard analysis. 2. The antibody or antigen-binding fragment of claim1, wherein the antibody or antigen binding fragment comprises a human constant region and a human variable region.

11. Written Description Reminder The written description requirement of 35 U.S.C. � 112, � 1 provides, in pertinent part, that: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

12. The Judgment ��the specification must demonstrate constructive possession, and the �775 patent�s specification fails to do so�Centocor�s asserted claims to fully-human antibodies �merely recite a description of the problem to be solved while claiming all solutions to it.� The actual inventive work of producing a human variable region was left for subsequent inventors to complete. The scope of Centocor�s right to exclude cannot �overreach the scope of [its] contribution to the field of art as described in the patent specification.� Its fully-human antibody claims are beyond the scope of its disclosure.

13. UK - Novartis and Cibavision v. Johnson & Johnson Medical The Court of Appeal has upheld Kitchin J�s decision that Novartis� patent, EP(UK) No 0 819 258 (the �Patent�), was invalid for insufficiency. The subject matter of the Patent concerned extended wear contact lenses, the claims of which were defined partly by certain desirable characteristics (such as ophthalmic compatibility, corneal health and wearer comfort), and partly by reference to physical parameters (such as oxygen transmissibility and ion permeability).� However, the Court of Appeal held that upon close inspection of the claims, the Patent claimed no more than a lens made from two types of polymers, and did not give sufficient disclosure in relation to which polymer combination might give rise to a product that works.

14. Why Should We Be Worried? The tendency of many companies, to avoid worrying too much about written description and enablement leads to irreparable damage. Patent Offices grant invalid patents with which we merrily go and try to do business. Our potential business partners are well aware of the dangers of superficially nice-looking patents.

15. Potential strategic partners and investors may think that your project is a good fit and be excited about teaming up with you�

16. Until they see what�s underneath the surface.

17. What Real Life Is Like Price Tag: $150M

18. What Real Life Is Like Price Tag: $150M Price Offered: $80M, pending DD

19. DD found WD validity issues with 2 patents Company sold for $16.5M.

20. Life Is Getting Tougher Because of the need to fight biosimilar generic products, innovators have argued that �small product or manufacturing differences in biologics can result in significant safety and/or effectiveness differences*.� Translated into simple language that means: �My patent does not sufficiently describe the invention.�

21. This argument is priming a much closer look at the written description of biotech patents, both in the US and elsewhere (particularly the EPO).

22. Conclusion Questions of Written Description must be considered at the outset and you can�t put off dealing with them. A Bad description cannot be fixed �later�. Provisional Applications lacking good description are no more than pink pills.

23. Thank you.