Federal Laboratory Consortium for Technology Transfer 2012 FLC Annual Meeting Advanced Patent Training Workshop

Transcription

1 ~ Federal Laboratory Consortium for Technology Transfer 2012 FLC Annual Meeting Advanced Patent Training Workshop First-Inventor-to-File : A Patent Management Regime to Deal with the Practical Realities of New Law Patent Filings Harold C. Wegner Foley & Lardner LLP Pittsburgh April 30, 2012

2 Table of Contents Effective Date and the Bubble Year 3 The Enabled Embodiment 17 A Provisional as Step One 27 Generic Protection Model 44 7 Frequently Asked Questions 59 Three Key Solutions 75 Search Methodology 83 About the Author 87 2

3 Effective Date and the Bubble Year On March 16, 2013, a domestic first-to-file regime commences; the old first inventor system is over. 3

4 Effective Date and the Bubble Year (Cont.) Patent bubble filings will take place Winter 2013 right up through March 15, 2013, to take advantage of the old law. Applications based upon a provisional with a priority period expiring after March 15, 2013, should be filed by March 15, 2013, because of the any claim rule. 4

5 Effective Date and the Bubble Year (Cont.) Currently pending applications that will be refiled should be refiled by March 15, 2013, including any continuing or divisional application or any nonprovisional based upon a provisional application. It is dangerous to refile a case after March 15, 2013, even though one or more claims may be entitled to priority on or earlier than March 15, 2013: 5

6 Effective Date and the Bubble Year (Cont.) Even divisional applications should be filed by March 15, The statutory protection against double patenting for a divisional has nothing to do with the any claim rule. 6

7 Effective Date and the Bubble Year (Cont.) For almost every situation it will be better to file not later than March 15, 2013, to fall under the old first inventor law. First-to-file is only one of the negatives for filing under the new law: 7

8 Effective Date and the Bubble Year (Cont.) Global Prior Art: Beyond first-to-file, the new law broadens the scope of prior art to include overseas acts of public use [or] on sale, 35 USC 102(a)(1), and adds a global catchall for any public dissemination of any kind anywhere in the world, i.e., where the invention is otherwise available to the public before the effective filing date, id. 8

9 Effective Date and the Bubble Year (Cont.) Secret Prior Art: United States patents based upon a foreign priority right have a patentdefeating effect for both novelty and nonobviousness as of the foreign priority date (instead of as of the U.S. filing date under the old law), 35 USC 102(a)(2). 9

10 Effective Date and the Bubble Year (Cont.) Ariad-based Administrative Patent Revocation Trials: Perhaps even more importantly for a pioneer invention of a university or startup, the generic claim in a patent having a filing date under the first-to-file law will be subject to a post-grant challenge on any ground that could be used in litigation: 10

11 Effective Date and the Bubble Year (Cont.) This includes the right to file an Administrative Patent Revocation Trial under Post Grant Review that is based upon an Ariad challenge under 35 USC 112(a) on the basis that there is a lack of possession of the full scope of the generic invention under Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010)(en banc)(lourie, J.). 11

12 Effective Date and the Bubble Year (Cont.) Relevance of 119, 120 Priority prior to March 16, 2013 Many applications with an actual filing date before the March 16, 2013, effective date for first-to-file will have to be refiled either as a continuation, continuation-in-part or divisional under 35 USC 120. Is refiling before March 16, 2013 important? 12

13 Effective Date and the Bubble Year (Cont.) Many foreign home country or domestic provisional applications filed after March 16, 2012, will have a priority year that may extend well beyond the March 16, 2013, effective date. Is it necessary to have an actual filing date for the new application before March 16, 2013, or can the applicant rely upon a priority claim prior to that date to avoid the new law? 13

14 Effective Date and the Bubble Year (Cont.) For almost every situation given above, the prudent answer is to refile the case before March 16, 2013, to have an actual filing date under the old law: To the extent that any claim including a cancelled claim is not substantively entitled to priority, then that claim automatically invokes the new law for all claims. 14

15 Effective Date and the Bubble Year (Cont.) An application filed beginning March 16, 2013, is governed entirely by the new law if any claim is not entitled to priority on or earlier than March 15, Any claim that is not entitled to such priority poisons the entire application that is then governed by the new law. Even a cancelled claim not entitled to priority poisons the entire application. 15

16 Effective Date and the Bubble Year (Cont.) An RCE may be safely filed after March 16, 2013, because the filing date is not changed. 16

17 The Enabled Embodiment An enabled embodiment of the invention, Example 1, is critical to start the patenting process. (This aspect of the presentation focuses upon patent drafting to principally cover the actually created embodiments. Some industries critically require generic protection which is the subject of the final section, Generic Protection Model.) 17

18 The Enabled Embodiment (Cont.) With an enabled embodiment disclosure, an application can be drafted overnight (if necessary) to provide basis for (a) offensive protection to provide exclusive rights for that enabled embodiment; and (b) defensive rights to block a junior-filing inventor from obtaining a claim that reads on that enabled embodiment or on any obvious variation thereof. 18

19 The Enabled Embodiment (Cont.) Without such an enabled embodiment disclosure, a corresponding application may not provide basis for offensive rights and may not provide basis for priority if the application is refiled. Without such an enabled embodiment disclosure, defensive rights may be compromised to the extent that a junior filer may argue that it is not obvious to a worker skilled in the art how to reproduce the invention so that the disclosure is not patent-defeating. 19

20 The Enabled Embodiment (Cont.) First, the enabled embodiment will enjoy priority for a claim focused on that enabled embodiment. Second, the applicant gains a patent-defeating effect to block all third parties from gaining a generic claim that would read on that enabled embodiment, keeping this area of technology free from domination by a junior filing party. 20

21 The Enabled Embodiment (Cont.) Positives for the enabled embodiment: Where the researcher provides the patent attorney with the full information for the enabled embodiment, a provisional application is ready to file for limited objectives. Provided the enabled embodiment is carried forward with a priority right into an eventually published United States or foreign patent application, then the eventual patent has two benefits: 21

22 The Enabled Embodiment (Cont.) With an enabled embodiment disclosure, an application can be drafted overnight by adding a claim that is focused on that enabled embodiment. Non-statutory elements found in some applications should not be included: 22

23 The Enabled Embodiment (Cont.) A filing should never be held up for the purpose of including the non-statutory niceties of a patent application drafted under the guidance of the Manual of Patent Examining Procedure that suggests inclusion of: 23

24 The Enabled Embodiment (Cont.) A Background of the Invention (Don t!) A Field of the Invention (Don t!) Prior art Problems and solutions (Don t!). Object of the invention (Don t!) Description of the Prior Art (Don t!) 24

25 The Enabled Embodiment (Cont.) None of this verbiage is necessary nor even desirable even for the regular (nonprovisional) application. Furthermore, the Manual of Patent Examining Procedure provides guidance that is sometimes flat out wrong. 25

26 The Enabled Embodiment (Cont.) Prior art should not be cited in the application. Of course, applicants should comply with the Duty of Disclosure by filing an Information Disclosure Statement. 26

27 Provisional as Step One Some organizations, whether corporate, academic or government, have a sometimes too lengthy review and approval procedure before filing that compromises gaining an early filing date. Here, consideration should be given to an amended system that authorizes early filing of a provisional and then review before a final filing of a non-provisional. 27

28 Provisional as Step One (Cont.) In order to effectively operate in the first-to-file world it is imperative to follow a filing strategy of first quickly filing a provisional application including an enabled embodiment and second, only later filing a more complete application meeting all formalities. The striking use of the dual filing strategy is seen by comparing provisional filing rates among different categories of applicants: 28

29 Provisional as Step One (Cont.) First-to-file becomes a reality for domestic industries for applications filed after March 15, Many applicants are already operating under first-tofile: How do they do it? How can their systems be fine tuned to be even more competitive under first-to-file? 29

30 Provisional as Step One (Cont.) Although many American applicants even in the pharma field have operated under the first inventor system, many sophisticated companies have long operated under first-to-file as a company policy. Critical to a successful life sciences first-to-file regime is the use of a dual filing system with a first provisional filing. 30

31 Provisional as Step One (Cont.) The rise in the usage of provisional applications has been spotty, based upon the category of the domestic patent applicant. While it is understandable that pharmaceutical concerns necessarily rely upon the provisional system to gain an extra year of patent term, there are other factors at work: 31

32 Provisional as Step One (Cont.) The percentage of domestic patentee usage of the provisional system was measured for three categories of the top domestic patentees for 2010: Top 20 Domestic Patentees Domestic Chem/Bio/Pharma Domestic Universities (see Search Methodology Domestic Filings at the end of this presentation). 32

33 Provisional as Step One (Cont.) The twenty largest domestic patentees include the giants of the EE and software communities and some of the nation s largest manufacturers. None of the top five had more than 8 % usage of provisional applications, while some none of the Top 20 had more than 75 % provisional usage: 33

34 Provisional as Step One (Cont.) 34

35 Provisional as Step One (Cont.) 35

36 Provisional as Step One (Cont.) All of the companies had at least 40 % usage of provisionals. Of the nine companies that were studied that are principally in a regulated industry including pharma and biotech, the companies generally had more than 90 % usage of the provisional system. 36

37 Provisional as Step One (Cont.) 37

38 Provisional as Step One Universities Of the thirteen domestic universities in the IPO Top 300 Patentees List, the top ranked University of California filed provisionals for 100 % of all granted patents for the snapshot period that was studied. 11 of the 13 institutions used provisionals for more than 75 % of their patents: 38

39 Provisional as Step One Universities (Cont.) 39

40 Provisional as Step One (Cont.) Foreign applicants and several domestic industries have already operated under first-tofile through sequential filings keyed to either a quick home country application for Paris Convention priority in the United States or a domestic provisional in either case, followed a year later by a regular (nonprovisional) United States application. 40

41 Provisional as Step One (Cont.) The critical first step is to file first and fast which, for a domestic applicant, is a provisional. Even where a highly skilled patent attorney is involved in drafting the provisional, it is helpful for a major organization to provide its researchers with a matrix for critical information that should be provided to the patent attorney. 41

42 Provisional as Step One (Cont.) A specific patent attorney should be assigned to key researchers to train the researchers in the key information needed for a provisional: A fully enabled embodiment: A most important element for a provisional is a fully enabled A to Z embodiment. This is a cook book example that, much like a recipe, teaches how to create the embodiment starting from A materials known in the art. 42

43 Provisional as Step One (Cont.) Particularly for a chemical or biotechnology case, the fully enabled embodiment should include a statement of a specific utility for the embodiment. There should also be a disclosure of how to use the embodiment for this utility. (If there has been no actual testing, it may be sufficient to state that the embodiment is used in the manner of Example VI in U.S. Patent, 7,xxx,xxx. ) 43

44 Provisional as Step One (Cont.) Some inventions require generic coverage which is more difficult because generic claims must be included in the original application. The discussion of generic protection which follows is based upon the pharmaceutical industry model, and incorporates a dual level of filing of a first provisional followed a year later by the non-provisional 44

45 Generic Protection Model The skilled patent attorney should, however, be able to draft rings of protection, much like a pebble thrown into still water creates concentric waves. The outer ring is the initial generic claim definition which optimistically seeks protection to everything surrounding the enabled embodiment that might be both novel and just shy of novel but obvious subject matter. 45

46 Generic Protection Model (Cont.) The decreasing circles of protection the subgeneric definitions retreat little by little to provide protection for areas of likely or expected commercialization and to provide protection for likely (even though not yet made) embodiments. 46

47 Generic Protection Model (Cont.) Refining Generic Protection a Year Later: At the time of the regular filing one year later, the true state of the art will be better known. The commercial realities will be better known by input from business persons and international experts. 47

48 Generic Protection Model (Cont.) Based upon the realities of the actual state of the art and the practical domestic and business concerns it is quite possible that the scope of protection for the original generic definition should be abandoned while the generic protection should be limited to one of the narrower rings of protection in the original application. 48

49 Generic Protection Model (Cont.) The new generic claim for the regular application is thus one of the original subgeneric claims of the provisional: Because there is verbatim support in the provisional, the new generic (old subgeneric) definition will be entitled to priority as of the original provisional filing date. 49

50 Generic Protection Model (Cont.) Alternate Embodiments in the Provisional: Particularly for a biotechnology invention, a highly skilled Ph.D. who has actually worked in the very industry of a new innovation may provide priceless help in drafting the provisional: 50

51 Generic Protection Model (Cont.) Based upon the single enabled embodiment provided by the inventor, the Ph.D. patent attorney should be able to prophetically create several alternate embodiments that flesh out the full scope of the generic definition of the invention. 51

52 Generic Protection Model (Cont.) Without such alternate embodiments, priority to the provisional may be problematic as to generic protection even if literally supported in the provisional. This is due to the Ariad problem where a single embodiment may be deemed insufficient to support the generic definition. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir.2010) (en banc). 52

53 Generic Protection Model (Cont.) Prophetic Species in the Provisional: Based upon the single enabled embodiment provided by the inventor, it should be possible to envision several (or many) other species that can be made following the same procedures that are used for the enabled embodiment. 53

54 Generic Protection Model (Cont.) A list of such species should be included in a table that specifically names each species. If some modification to the procedures used to make the enabled embodiment are necessary, they should be set forth. 54

55 Generic Protection Model (Cont.) If the generic invention encompasses a broad swath of new technology, several species should be included which are each representative of various parts of the overall swath of new technology. A matrix of species should be included in the application to cover all subgeneric areas within this broad swath: 55

56 Generic Protection Model (Cont.) To the extent that a junior applicant seeks to carve out protection for a subgeneric definition that is very different from the enabled embodiment provided by the inventor but which reads on one of the species provided in this matrix, then the junior competitor s generic claim should be barred. 56

57 Generic Protection Model (Cont.) The Role of Multiple Provisionals: Of course, information for the regular (nonprovisional) application may supplement the provisional. But a year of lost priority for new matter first introduced in the regular application may be a dangerous loss of priority. Here is where a second provisional enters the picture: 57

58 Generic Protection Model (Cont.) In an ideal world, the various subgeneric definitions, alternate prophetic examples and lists of species would all be included in the provisional. But, this should not hold up the filing of the provisional in a highly competitive area: Instead, the single enabled embodiment should be filed immediately and then the other information included in a second provisional filed as soon as possible thereafter. 58

59 7 Frequently Asked Questions 1. What is the Difference between First- Inventor-to-File and First-to-File? None, in fact. The difference was one of political nomenclature that was extremely important as a matter of lobbying, but which no longer serves any useful purpose. 59

60 7 Frequently Asked Questions (Cont.) One of the most critical aspects in gaining enactment of first-to-file was to understand the difficulty of the knee jerk reaction to first-to-file as being against the true inventor. Robert A. Armitage created the terminology first-inventorto-file to confirm that the American flavor of first-to-file protects inventors rights. The Armitage contribution was perhaps the single most important lobbying move to persuade many in the first inventor camp to switch sides. 60

61 7 Frequently Asked Questions (Cont.) In fact, the American system is a true first-tofile system, where the difference is in the form of a grace period unique, to be sure, but nevertheless a grace period difference from most first-to-file systems. 61

62 7 Frequently Asked Questions (Cont.) There is nothing inconsistent with having both a first-to-file system and a grace period system. In fact, Germany since the late nineteenth century had both first-to-file and a grace period. Germany only abandoned the grace period as a necessity to conform to the Strasbourg and European Patent Conventions in the latter twentieth century. 62

63 7 Frequently Asked Questions (Cont.) 2. How is first to file interpreted and applied in the European Patent Office in comparison to the first-to-file provisions in the America Invents Act? One statutory difference concerns the patent-defeating effect for an earlier-filed later-granted patent: In the United States, the first-to-file has a patent-defeating effect for both novelty and nonobviousness, while in Europe the first-to-file has a patent-defeating effect as of the filing date for novelty only. 63

64 7 Frequently Asked Questions (Cont.) 3. Are Inventor Notebooks from the first inventor system important? Even though notebooks and other record keeping under the first inventor law is now obsolete, nevertheless record keeping will still be important but with a different focus. It will remain important to record details of who is the inventor of each of various aspects of a large project because including a person as a joint inventor may have significance in avoiding prior art. 64

65 7 Frequently Asked Questions (Cont.) Daily record keeping to show continuous diligence toward a reduction to practice will no longer be of great importance. Instead, record keeping should continue to show when the concept of the invention was made (and hopefully to include records of when and with whom such conception was shared). Records of when the invention was completed should also be maintained. 65

66 7 Frequently Asked Questions (Cont.) Records should be kept of s and conferences and any discussions of the invention with others to be able to show, years later, that the inventor or joint inventor had disclosed the subject matter to others. 66

67 7 Frequently Asked Questions (Cont.) This may well turn out to be critical to establish that a third party learned of the invention under one of the eight scenarios painted in 35 USC 102(b)(1) for public disclosures or 35 USC 102(b)(2) for disclosures in an earlier-filed later-published application. 67

68 7 Frequently Asked Questions (Cont.) 4. Is one first to file even if the filing wasn t effective or disclosures inadequate under 35 USC 112(a)? Yes, but by failing to meet 112(a) he does not get a patent. Neither does the second-to-file merely because 112(a) was not met by the first-to-file: 68

69 7 Frequently Asked Questions (Cont.) The standard for enablement of a prior art reference for purposes of anticipation under section 102 differs from the enablement standard under 35 U.S.C SRI Intern., Inc. v. Internet Sec. Systems, Inc., 511 F.3d 1186, 1192 (Fed. Cir. 2008)(quoting Novo Nordisk Pharm., Inc. v. BioTechnology Gen. Corp., 424 F.3d 1347, 1355(Fed.Cir.2005); see also In re Hafner, 410 F.2d 1403, (CCPA 1969)(Rich, J.). 69

70 7 Frequently Asked Questions (Cont.) [A]nticipation does not require actual performance of suggestions in a disclosure. Rather, anticipation only requires that those suggestions be enabled to one of skill in the art. SRI Intern., Inc. v. Internet Sec. Systems, Inc., 511 F.3d 1186, 1192 (Fed. Cir. 2008)(quoting Novo Nordisk Pharm., Inc. v. BioTechnology Gen. Corp., 424 F.3d 1347, 1355 (Fed.Cir.2005), quoting Bristol-Myers Squibb Co. v. Ben Venue Labs. Inc., 246 F.3d 1368, 1379 (Fed.Cir.2001) ). 70

71 7 Frequently Asked Questions (Cont.) 5. What arguments can be made against the patent being first to file based on ineffective disclosures or lack of specificity in description? The first-to-file is always first-to-file whether he is entitled to a patent or not. The second-to-file can obtain a patent by proving that the disclosure is non-enabling under LeGrice: 71

72 7 Frequently Asked Questions (Cont.) A reference anticipates a claim if it discloses the claimed invention such that a skilled artisan could take its teachings in combination with his own knowledge of the particular art and be in possession of the invention. In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995)(quoting In re LeGrice, 301 F.2d 929, 936 (CCPA 1962)(original emphasis)). 72

73 7 Frequently Asked Questions (Cont.) 6. What activities are patent-defeating on sale events? It remains uncertain whether a secret commercialization as in Metallizing Engineering Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516 (2d Cir.1946)(L. Hand, J.), remains an on sale event something the courts will need to decide. 73

74 7 Frequently Asked Questions (Cont.) 7. Is an on sale event covered by the grace period? Whether an on sale event is a saved by the grace period depends upon whether an on sale event is considered a disclosure of the invention under 35 USC 102(b)(1) something the courts will need to decide. 74

75 Three Key Solutions No. (1) The Inventor Must Provide an Enabled Embodiment to Start the Process. Ideally, the inventor will provide a Wordreadable cook book example showing how an embodiment of the invention is carried out and/or 75

76 Three Key Solutions No. (1) (Cont.) The Inventor should provide the closest prior art that was the starting point for his invention and point out the specific feature that is different from the prior art. 76

77 Three Key Solutions No. (1) (Cont.) The Drafting Process must be simple and focused on the statutory requirements. Every effort should be made to have a complete enabled embodiment. 77

78 Three Key Solutions No. (2) No Background of the Invention No Field of the Invention No Prior art Problems and solutions No Object of the invention No Description of the Prior Art (but do cite prior art in an Information Disclosure Statement that can be submitted after filing) 78

79 Three Key Solutions No. (2) (Cont.) Particularly for chemical and biotechnology inventions, a focus must be placed on claims of varying scope. (This procedure is not needed unless offensive, generic coverage is necessary). 79

80 Three Key Solutions No. (3) Consider a Provisional Application before Starting the Agency approval process: The regular application should be filed as a provisional application before the Agency approval process begins, if that procedure is time consuming. 80

81 Three Key Solutions No. (3) (Cont.) Then, the regular application can be filed within 12 months without losing priority rights. A complete, enabled embodiment must be part of the provisional filing 81

82 Three Key Solutions No. (3) (Cont.) If filing the regular is delayed because of the use of this system, it is imperative that the provisional have a complete disclosure of an enabled embodiment (and, for chemical and biotechnology cases, a complete set of generic and subgeneric disclosures). 82

83 Search Methodology Application Origins 83

84 Search Methodology Crouch Study Professor Dennis Crouch, Priority Claims in Issued Patents, Patently O (July 26, 2009): [M]ost issued patents now claim priority to at least one prior patent filing. I created a database of all priority claims for non-reissue utility patents issued February 14, 2006 February 17, 2009 (Pat. Nos. 7,000,000 7,493662). In fact, only 31% of the patents have no listed priority claims. I looked at the earliest listed priority date (one for each patent) and then categorized those according to the type of priority claim. 40% of the earliest claims were to foreign patent filings, and 18% claimed earliest priority to a provisional patent application. The remaining 11% earliest priorities reached back via US continuations, divisionals, and continuations-in-part (CIPs). 84

85 Search Methodology Domestic Filings Top 20 Domestic Patentees: Rankings were based upon the number of patents granted in the year 2010 according to the Intellectual Property Owners Top 300 list for Domestic Chem/Bio/Pharma: The top nine companies from the same IPO list were selected, together with four other organizations based upon the prominence of patents to their financial success. Domestic Universities: University patentees from the same IPO list were selected. For each organization a snapshot was taken of patent activity in late 2011 according to the following methodology to give the percentage of patents which claimed priority to at least one provisional application. 85

86 Search Methodology Domestic Filings 86

87 About the Author HAROLD C. WEGNER practices intellectual property law at Foley & Lardner LLP where he has a special interest in patent appellate matters at the Federal Circuit and inter partes patent challenges at the Patent Office. Professor Wegner commenced his patent career at the U.S. Department of Commerce as a Patent Examiner. For twenty years beginning in 1991 Prof. Wegner was involved with the George Washington University Law School where he had been Director of the Intellectual Property Law Program and Professor of Law. This presentation represents the work of the author and does not necessarily reflect the views of any colleague, organization or client thereof. contact: hwegner@foley.com 87