Patent Reform - Conference Material
Upcoming SlideShare
Loading in...5
×
 

Like this? Share it with your network

Share

Patent Reform - Conference Material

on

  • 308 views

The ongoing implementation of elements of the America Invents Act represents the biggest changes to US patent code in generations. The impact of such sweeping changes to the US patent systems will be ...

The ongoing implementation of elements of the America Invents Act represents the biggest changes to US patent code in generations. The impact of such sweeping changes to the US patent systems will be exceptionally significant for life sciences companies whose life blood is dependent on the value of their intellectual property and patents. This is the only event where you will have the opportunity to join your colleagues in an advanced think-tank discussion regarding the practical impact of patent reform on the life sciences industry.

Statistics

Views

Total Views
308
Views on SlideShare
194
Embed Views
114

Actions

Likes
1
Downloads
4
Comments
0

1 Embed 114

http://www.americanconference.com 114

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Patent Reform - Conference Material Presentation Transcript

  • 1. ~ American Conference Institute Patent Reform …The Leahy-Smith America Invents Act PATENT DRAFTING CHALLENGES UNDER THE NEW FIRST-TO-FILE LAW Harold C. Wegner Foley & Lardner LLP New York, New York January 23-24, 2013
  • 2. The Conference Paper • Section headings in this presentation are keyed to the identically styled headings in the Conference paper, Patent Drafting Challenges under the New First-To-File Law. • The contents of the Conference paper are as follows (pagination is to the conference paper):
  • 3. The Conference Paper I. II. III. IV. V. VI. VII. VIII. OVERVIEW THE PROBLEMATIC GRACE PERIOD ENABLED EMBODIMENT, DRAFTING STARTING POINT FOOLS GOLD, THE 24 MONTH “PROVISIONAL” FORMAL ELEMENTS OF THE REGULAR APPLICATION ESSENTIAL INTEGERS IN THE DRAFTING PROCESS MPEP-SUGGESTED NON-STATUTORY INTEGERS CONCLUSION 2 3 6 15 17 21 28 35 About the Author 36
  • 4. § II. THE PROBLEMATIC GRACE PERIOD • The one year grace period that continues under the new law is problematic, given the various loopholes that can destroy meaningful patent rights. • The grace period is problematic: It should never be prospectively relied upon by a patent applicant.
  • 5. § II. THE PROBLEMATIC GRACE PERIOD • But, when one is faced with the problem of an existing publication of the invention then it will, of course, be necessary to attempt to rely upon the grace period. • The grace period provides no protection for rights in the major countries of Asia and Europe where there is a publication or other prior art event before the effective filing date.
  • 6. § II. THE PROBLEMATIC GRACE PERIOD • The new grace period is not anything like the original American provision. • The new grace period only applies in the case of the inventor’s own prior work or prior commonly owned work or work published by a third party that is derived from an inventor.
  • 7. § II. THE PROBLEMATIC GRACE PERIOD • There are serious burdens placed on relying upon the grace period to avoid a third party’s publication which include the requirement for an oath or declaration for many situations to establish a right to the grace period.
  • 8. § II. THE PROBLEMATIC GRACE PERIOD • The initial Patent Office interpretation of the grace period excludes a third party’s derived disclosure obtained from the true inventor seeking reliance on the grace period if the third party’s derived disclosure is not to the “same” subject matter:
  • 9. § II. THE PROBLEMATIC GRACE PERIOD • Thus, the grace period does not apply under the Patent Office interpretation if the derived disclosure also includes “mere insubstantial changes, or only trivial or obvious variations”. • It is also unclear what proof will be needed to establish a right to the grace period. The initial Patent Office guidance published in the Federal Register:
  • 10. § II. THE PROBLEMATIC GRACE PERIOD • “Specifically, the inventor or joint inventor must establish the date and content of their earlier public disclosure. If the earlier disclosure was a printed publication, the affidavit or declaration must be accompanied by a copy of the printed publication.”
  • 11. § II. THE PROBLEMATIC GRACE PERIOD • “ If the earlier disclosure was not a printed publication, the affidavit or declaration must describe the earlier disclosure with sufficient detail and particularity to determine that the earlier disclosure is a public disclosure of the subject matter.”
  • 12. § II. THE PROBLEMATIC GRACE PERIOD “The affidavit or declaration must specifically show that the inventor or a joint inventor is the inventor of the subject matter of the earlier public disclosure and indicate the communication of the subject matter to another who disclosed the subject matter.”
  • 13. § III. ENABLED EMBODIMENT… Whether one files a provisional application as the first filing, it is essential that the priority application include an enabled embodiment of the invention and meet all the requirements of what will be 35 USC § 112(a), currently § 112, ¶ 1.
  • 14. § III. ENABLED EMBODIMENT… “Claims deserve the provisional application's earlier filing date so long as that application contains adequate written description under 35 U.S.C. § 112.… [T]he written description of the provisional application must enable one of ordinary skill in the art to practice the invention claimed in the non-provisional application.”
  • 15. § III. ENABLED EMBODIMENT… The Invention Submission Form: The normal route to filing a complete patent application starts with an Invention Submission form which, ideally, should include the full text of an enabled embodiment of the invention.
  • 16. § III. ENABLED EMBODIMENT… • Effort should be made to identify, say, five recent patents drafted by quality corporate patent departments or law firms in the exact area of technology of the specific units of research. • Then, the enabled embodiment should be highlighted in yellow, as should the generic claims. • This will provide the inventors with practical guidance as to how to draft an enabled embodiment.
  • 17. § III. ENABLED EMBODIMENT… • The Invention Submission form should permit the inventor to provide a Word document that includes an enabled embodiment that can be electronically directly cut and pasted into a new application with only minimal editing. • The experiments should read like a “cook book” recipe, showing the order and amounts of adding ingredients, much like instructions to the chef show how to make a bouillabaisse or other dish.
  • 18. § III. ENABLED EMBODIMENT… • The starting point should be the use of known and available materials. (It does little good to have an example which starts from a heretofore unknown material: How is a person reading an example to carry out the invention if the starting material is unknown?) • The finishing point is to show how the product is to be used. What is the specific utility?
  • 19. § III. ENABLED EMBODIMENT… • Actual or Prophetic Enabled Embodiment: In highly competitive areas it may be possible to prophetically foresee an embodiment without actually making the invention in practice, yet a prophetic example may be all that is needed to obtain a patent. • Time is of the essence:
  • 20. § III. ENABLED EMBODIMENT… • Beyond whatever offensive patent protection that is gained by filing immediately, the ultimate publication of an application claiming priority to the early filing will have a patent defeating right. • This defensive right will bar an applicant with a junior filing date from obtaining a claim that reads on that enabled embodiment or which reads on obvious modifications of that enabled embodiment.
  • 21. § III. ENABLED EMBODIMENT… • Generic Disclosure for Later Claims: For the “upstream” pioneer invention from universities and startups that opens the door to a new field of research but where there is no specific product ready for commercialization, generic protection is the entire patenting exercise. • Conversely, for a “downstream” product that will go through the regulatory approval process which is an adjacent homolog of a compound for the same usefulness, here, the patentee is limited to species protection.
  • 22. § III. ENABLED EMBODIMENT… • For “downstream” products, species protection may be all that is needed: The epitome of the value of species protection is found in terms of commercial pharmaceutical patents such as the Plavix® patent which was worth many billions of dollars in terms of profits for a blockbuster drug, Badorc et al., U.S. Patent 4,847,265. The recently expired patent on Lipitor® generated revenues of $ 13 billion for the last year before expiration of the patent.
  • 23. § III. ENABLED EMBODIMENT… Rings of Generic Protection in the First Filing • Several generic definitions of decreasing scope should be included in the provisional application. • The broadest definition should correspond to the broadest definition compatible with the already known prior art.
  • 24. § III. ENABLED EMBODIMENT… Rings of Generic Protection (con’d) • Like concentric circles of waves formed on a pond after a pebble is thrown into the center, decreasing scope generic definitions should be provided. • At least some of these definitions should focus upon what is likely to be exploited in the industry and then what is likely to be exploited by the applicant company itself:
  • 25. § III. ENABLED EMBODIMENT… Rings of Generic Protection (con’d) • The regular (nonprovisional) application filed a year later can then include any or all the definitions of the provisional application if it turns out that the applicant’s understanding of the state of the art at the time of the provisional is unchanged at the time of the regular application.
  • 26. § III. ENABLED EMBODIMENT… Late Genus Disclosure Lacks Priority Basis: • It is important to include the generic definition in the original application. • Having a species disclosure in an original application together with a broad genus is generally insufficient to provide basis for a narrower generic definition even though reading on the originally disclosed species and within the scope of the original generic invention.
  • 27. § III. ENABLED EMBODIMENT… Late Genus Disclosure (con’d): “It is well settled that ‘the description of a single embodiment of broadly claimed subject matter constitutes a description of the invention for anticipation purposes ..., whereas the same information in a specification might not alone be enough to provide a description of that invention for purposes of adequate disclosure....’”
  • 28. § III. ENABLED EMBODIMENT… • Late Genus Disclosure (con’d): • The concept that the narrow disclosure of a parent application, repeated in a published application 18 months later, defeats a later application filed after the critical bar date is nothing more than a restatement of the the Ruscetta line of case law: • “It is now well settled law that disclosure of a species is insufficient to provide descriptive support for a generic or sub-generic claim[.]”
  • 29. § III. ENABLED EMBODIMENT… Defensive Patent Right without Generic Protection: • While offensive patent protection may be problematic with a species patent, a strong defensive patent right may be obtained through earliest filing.
  • 30. § III. ENABLED EMBODIMENT… Defensive Patent Right … (con’d): • Provided the species disclosure is carried forward into a regular (nonprovisional) application, upon publication the patentee gains a patent-defeating right retroactive to the filing date to defeat a junior applicant’s claim to either the same invention or to subject matter obvious from the species.
  • 31. § IV. FOOLS GOLD, 24 MONTH “PROVISIONAL” • On January 10, 2013, the Patent Office published a Federal Register notice, Extension of the Extended Missing Parts Pilot Program, that extends through the end of this year the “24 month provisional” scheme that is designed to permit early commercialization efforts after the provisional is filed without the expense of a detailed drafting of the application by a patent attorney:
  • 32. § IV. FOOLS GOLD, 24 MONTH “PROVISIONAL” • Then, at 24 months from the provisional filing, the full effort is provided with a regular application. • Presumably, deficiencies through the minimalistic drafting of the provisional will be cured at this stage (under the theory of this practice).
  • 33. § IV. FOOLS GOLD, 24 MONTH “PROVISIONAL” • To the extent that an applicant wants to have generic coverage based upon a limited disclosure in an application filed 24 months from the date of the provisional, this may be problematic.
  • 34. § IV. FOOLS GOLD, 24 MONTH “PROVISIONAL” • The probability is that (a) some of the commercialization efforts in the first 12 months will constitute “prior art” under the Leahy Smith America Invents Act; and (b) a generic claim broader than the original disclosure created 24 months after the provisional will not meet the strict disclosure standards of Ruscetta and New Railhead.
  • 35. § IV. FOOLS GOLD, 24 MONTH “PROVISIONAL” • The confluence of the two factors will necessarily lead to invalidity of any generic claim that may result in the eventual patent.
  • 36. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION Adding but not Deleting Definitions when Refiling • If there is a new preferred definition such as a generic numerical range, that range should be added as such but the original disclosure should be maintained. Separate claims to both ranges should be included in the application.
  • 37. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION Adding … when Refiling (con’d) • If there is no intervening prior art, then the added range may be important for enforcement purposes. • But if it develops that there is intervening prior art and that the new range is not entitled to priority, then at least a claim to the old range will remain in the case and can be relied upon.
  • 38. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION The Summary of the Invention • The Summary of the Invention should be the first section appearing after the title. Drafting the Summary… should take place immediately after drafting the claims.. • The following steps should be taken in drafting the Summary…:
  • 39. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION • The Summary of the Invention (con’d) • First, create an electronic copy of all the claims which should be the guts of the Summary…. • Identical wording should be maintained wherever possible.
  • 40. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION The Summary of the Invention (con’d) • Second, grammatical changes should be made to transform the wording of the claim (which is the object to “We claim” or “I claim” or “It is claimed that:”) into a sentence.
  • 41. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION Abstract of the Disclosure • The broadest generic claim should be used as a template for the Abstract which should then be rewritten with no change in the definition of the invention, as any difference in definitions may be used against the applicant in enforcement proceedings.
  • 42. § V. FORMAL ELEMENTS OF THE REGULAR APPLICATION Duty of Disclosure • The provisional application should never include prior art. • The regular (nonprovisional) application generally should not include a prior art discussion. • Preferably, prior art should be cited, but in a separate Information Disclosure Statement to identify but not characterize prior art known to the inventor that falls under the duty of disclosure of 37 CFR §§1.56, 57, 98.
  • 43. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting: • Claim drafting is the heart and soul of the patent drafting process and for most applications in predictable technologies is the only important part of the process where the patent attorney adds value to the process.
  • 44. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting (con’d): Claim drafting is the heart and soul of the patent drafting process and for most applications in predictable technologies is the only important part of the process where the patent attorney adds value to the process.
  • 45. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting: A Limited Number of Claims • One of the most serious mistakes made in patent drafting is to provide countless claims, perhaps dozens or scores of claims.
  • 46. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting : A Limited Number of Claims (con’d) • Creating a mindless maze of claims without thought as to commercial realities will only make it more difficult for the Examiner to go through the examination process, creating an unnecessarily hostile environment for the “judge” who decides the fate of the application. • The chance for inconsistent definitions and ambiguities under 35 USC § 112(b) also are greatly increased, proportional to the number of claims that are presented.
  • 47. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting (con’d):Disclosure versus Claiming • A handful of claims will receive far better attention and treatment by the Examiner than, say, thirty or forty claims (or more). • Where a patent-defeating disclosure is the goal of some of the possible claims, the answer, here, is to provide such disclosure, without claims.
  • 48. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting (con’d): Avoiding “Means” Claiming • “Means” claiming, if properly crafted, takes an enormous amount of time which only adds expense and delay in filing the application. This claim form should be avoided altogether, given the fact that a “means”-defined element is always narrower than the same element defined in traditional terms coupled with the highly unfavorable reception such claims have had in the case law of the Federal Circuit.
  • 49. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Claim Drafting (con’d): Claims to Stimulate a Restriction Requirement • It is understandable that alternate forms of claiming protection may be desirable. • Thus, if there is a new product and also a new use for that product, two sets of claims may be desirable with the understanding this may stimulate a restriction requirement.
  • 50. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Supporting Disclosure -- Alternate Enabled Embodiments • Some of the case law of the Federal Circuit has given a negative reception to the idea of a broad interpretation of generic claims supported by only a single example. • Whether this is a trend in the law or not, the patent attorney can mitigate the problem by providing alternate prophetic examples to complement a limited disclosure of actual working examples.
  • 51. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Defensive Patent Matrix: A prime value for early disclosure of a species is that this will create a patent-defeating effect against a junior applicant’s generic claim inclusive of that species. • But, this often is insufficient because the road may be clear for the competitor to gain a claim to an important subgeneric definition mutually exclusive from this one species.
  • 52. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Defensive Patent Matrix (con’d): Here, a defensive matrix should be set forth in the disclosure: • Imagine a genus as being comparable to the nine squares of a tic-tac-toe board, and the enabled species occupies a space within one of these squares. • If a competitor files a subgeneric claim to any of the unoccupied squares and establishes a patentable difference versus the disclosed species, then that competitor may gain a dominant claim to that tic-tactoe square.
  • 53. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS Defensive Patent Matrix (con’d): • A goal of defensive patenting should be to block the entire tic-tac-toe board: An enabled species should be specifically named for each square. • In this way, a patent-defeating right is established to block all squares of the tic-tac-toe board.
  • 54. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS IDS to Cite Prior Art • Prior art should never be cited in a provisional application and generally should not be cited in a patent application. But, an Information Disclosure Statement should be filed at the time of the regular (nonprovisional) application or shortly thereafter.
  • 55. § VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS IDS to Cite Prior Art (con’d) • The object of the IDS is to identify prior art known to the inventor that falls under the duty of disclosure of 37 CFR §§1.56, 57, 98. • The IDS need only identify the prior art; it should not characterize the prior art.’
  • 56. § VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS • A great deal of wasted effort goes into drafting a patent application by following the guidance of the Manual of Patent Examining Procedure. • The statutorily unnecessary bells and whistles of the Manual of Patent Examining Procedure are costly in terms of the greatly increased time it takes to draft the patent application both which adds greater costs and delays filing. • This is an untenable proposition in an era of first-tofile, but, just as important, creates technical traps in terms of claim interpretation and arguments for unpatentability or invalidity based upon KSR.
  • 57. § VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS Summary of the Invention • The proper drafting of a Summary… is a formal matter that should never deviate from the definition in the claims. • The Manual says otherwise:
  • 58. § VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS Summary of the Invention (con’d) • “The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.”
  • 59. § VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS Background of the Invention • The Manual states that the Background of the Invention should include “[a] description of the related art known to the applicant and [ ], if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant's invention. …”
  • 60. § VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS Background of the Invention (con’d): • But, beyond the additional time and expense needed to craft such a Background of the Invention, under KSR it is also very dangerous to make “references to specific related art and problems involved in the prior art which are solved by the applicant's invention.”
  • 61. § VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS • “Most Attorneys Follow the Manual” This is not true as to some non-statutory provisions of the MPEP. • While the MPEP says that an “object” or “gist” of the invention should be recited, fewer than 20 % percent set forth an “object” of the invention and only 0.25 % express a “gist” of the invention.
  • 62. Thank you for your attention! ~ Questions? hwegner@foley.com
  • 63. HAROLD C. WEGNER continues his patent practice as a partner at Foley & Lardner LLP. Prof. Wegner retains his affiliation with the George Washington University Law School where he had been Director of the Intellectual Property Law Program and Professor of Law. His involvement with other academic institutions has included service as a Visiting Professor at Tokyo University. Prof. Wegner’s patent career commenced with service at the U.S. Department of Commerce as a Patent Examiner. He spent three years at the Max-Planck-Institut für Geistiges Eigentum in Munich where he was a Wissenschaftliche Mitarbeiter. He then became a Kenshuin at the Kyoto University Law Faculty under Dr. Kitagawa. contact: hwegner@foley.com hwegner@foley.com 63