Written Description. John B. Pegram FISH & RICHARDSON P.C. Paula K. Davis ELI LILLY AND COMPANY

Transcription

1 Written Description John B. Pegram FISH & RICHARDSON P.C. Paula K. Davis ELI LILLY AND COMPANY October,

2 The Principal Issues The International Problem Similar statutory description requirements Different interpretations The EPO requires nearly photographic identity of the description in and the claims. As we will see, US law has a broader standard. An obstacle to Harmonization & Work Sharing Policy Balancing the interests of the first discloser of broad ideas, and The disclosers of specific, commercially applied ideas 2

3 The Statute 35 U.S.C. 112, 1 states: 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. 3

4 Clarification of the Written Description Requirement Ariad Pharma. Inc. v. Eli Lilly & Co., 598 F.3d 1336 (2010) (en banc) held that written description and enablement are separate requirements. Ariad confirmed that the written description requirement applies generally, including the original application; and not limited to determining whether a later-filed application is entitled to priority. 4

5 Purpose of the Written Description Requirement The purpose is to ensure that the scope of the right to exclude, in the claims, does not overreach the scope of the inventor's contribution to the field of art as described Atlantic Research Marketing Systems, Inc. v. Troy, 659 F.3d 1345, (Fed. Cir. 2011). 5

6 The Possession Requirement Under 112, 1, claims must find sufficient support in the written description, such that the disclosure reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The specification must show that the inventor actually invented the invention claimed. Atlantic Research Marketing Systems, Inc. v. Troy, 659 F.3d 1345, (Fed. Cir. 2011). 6

7 Understandable to a Person of Ordinary Skill in the Art The patent specification should describe the invention in such a way that it is understandable to a person of ordinary skill in the art. the disclosure as originally filed does not have to provide in haec verba [exact words] support for the claimed subject matter at issue... Nonetheless, the disclosure... must convey with reasonable clarity to those skilled in the art that... [the inventor] was in possession of the invention. Pozen Inc. v. Par Pharmaceutical, Inc., 696 F.3d 1151 (Fed. Cir

8 Understandable to a Person of Ordinary Skill in the Art Because the patent specification is written for a person of skill in the art: it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed the invention Example: one skilled in the art would understand the meaning of therapeutic package and finished pharmaceutical container. Pozen Inc. v. Par Pharmaceutical, Inc., 696 F.3d 1151 (Fed. Cir. 2012). 8

9 Other Factors The level of detail required to satisfy the written description requirement depends, in large part, on the nature of the claims and the complexity of the technology. the written description requirement does not demand examples a mere wish or plan to obtain the claimed invention is not sufficient. Streck, Inc. v. Research & Diagnostic Systems, Inc., 665 F.3d 1269, 1285 (Fed. Cir. 2012). 9

10 Descriptions Saying this invention or the present invention In some cases, a patentee's consistent reference to a certain limitation or a preferred embodiment as this invention or the present invention can limit the scope of the entire invention. Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, (Fed. Cir. 2011). 10

11 Descriptions Saying this invention or the present invention On the other hand, the phrase present invention or this invention is not always so limiting, such as: Where the references to a limitation as being the invention are not uniform, Where other portions of the intrinsic evidence do not support applying the limitation to the entire patent, Where the prosecution history did not reveal such a limitation, or Where express statements in the specification clearly indicate that the feature being considered is a feature only of certain embodiments Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, (Fed. Cir. 2011). 11

12 Claim Construction [C]laim construction is inherent in any written description analysis. Atlantic Research Marketing Systems, Inc. v. Troy, 659 F.3d 1345, (Fed. Cir. 2011). 12

13 Claim Construction A written description decision often is determined almost entirely by the claim construction. Claim construction is a matter of law, reviewed de novo on appeal. Compliance with the written description requirement is a question of fact. See, e.g., Harari v. Lee, 656 F.3d 1331, (Fed. Cir. 2011) 13

14 Tightening Functional Claiming Stakeholders remain concerned about patents with overly broad claims particularly in the context of software. The PTO will provide new targeted training to its examiners on scrutiny of functional claims and develop strategies to improve claim clarity, such as by use of glossaries in patent specifications to assist examiners in the software field. Fact Sheet: White House Task Force on High-Tech Patent Issues Executive Actions, June 4,

15 Picking and choosing from lists throughout the specification While the [] application provides formal textual support for each individual limitation recited in the claims... it nowhere describes the actual functioning, thermostable alpha-amylase variants that those limitations together define. Taking each claim as we must as an integrated whole rather than as a collection of independent limitations, one searches the [] application in vain for the disclosure of even a single species that falls within the claims or for any blaze marks that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities. Novozymes A/S v. Dupont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013). 15

16 Picking and choosing from lists throughout the specification [T]he [] application lacks any indication that Novozymes had invented any thermostable alpha-amylase variants substituted at amino acid position 239 by the time of filing, much less one specifically produced from a [specific] parent. Novozymes A/S v. Dupont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013). 16

17 Practical Considerations Inventor is entitled to claim what he invents The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not attempt[s] to preempt the future before it has arrived. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc) (quoting Fiers v. Revel, 984 F.2d, 1164, 1171 (Fed. Cir. 1993)). 17

18 What makes an invention? Conception is the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention.... Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991). To prove conception, an inventor must prove that he has a mental picture of the structure or can define it by its distinguishing characteristics, but not solely by function. Hitzeman v. Rutter, 243 F.3d 1345, (Fed. Cir. 2001). 18

19 Genus claims [A] sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one skilled in the art can visualize or recognize the members of the genus. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc). Varies based on the invention, but some factors to consider: existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue. Ariad (citing Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005)). 19

20 Genus claims When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Abbott GmBh & Co. v. Centocor Ortho Biotech, Inc., 2013 U.S. Dist. LEXIS (D. Mass. 2013) (citing Carnegie Mellon Univ. v. Hoffman-La Roche Inc., 541 F.3d 1115, 1124 (Fed. Cir. 2008)). 20

21 Invention in a nascent technology Delicate balance of interests Many applicants want to claim broadly Reward for a distinct step in progress of the art Broad enough to avoid design around But also must be the complete and operative invention; must demonstrate possession Can be constructive possession Not necessarily entitled to everything invented subsequently Only what the inventor possessed at the time of invention. For example, Morse was not entitled to all uses of electro-magnetism 21

22 Invention in a nascent technology Requirements Ipsis verbis description? Not required Doesn t necessarily convey possession Enzo Biochem Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). Composition claims: Structure, or Structure plus function with correlation between them Problem is that a functional claim may simply claim a desired result, and may do so without describing species that achieve that result. Ariad, 598 F.3d at

23 Invention in a nascent technology Genus claims: Disclosure of representative number of species, or Disclosure of structural features common to the members of the genus Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1073 (Fed. Cir. 2005); LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, (Fed. Cir. 2005). Sub-genus claims not specifically listed in specification: Specification must provide blaze marks that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities. Novozymes, 723 F.3d 1336, (Fed. Cir. 2013). 23

24 Thank you John B. Pegram FISH & RICHARDSON P.C. Paula K. Davis ELI LILLY AND COMPANY 24