Patent Docs

The Proper Scope of DNA (or “Gene”) Patent Claims

August 1, 2012

By Kevin E. Noonan —

One thing has become abundantly clear in the public debate about the patent-eligibility of isolated human DNA. That something is that there is a great deal of uninformed opinion extant, predominantly by well-educated people with scientific backgrounds, who believe wholeheartedly that patenting genes is pernicious because it has or will inhibit medical science and progress in the diagnosis or treatment of disease. But that doesn't appear to be the situation to those with a background in biotechnology patent law, and so exploring why the two groups have come to such diametrically opposite conclusions may be informative.

And, before we start, let's agree that we won't waste time accusing each other of being motivated by "hidden biases" or "self interest." Precious few doctors, hospitals, or medical societies have called for the practice of human genetic diagnostic methods to be performed free of charge, and it is well to remember that patenting, for all its arcane minutiae, is relatively straightforward. Protecting intellectual property in other ways, such as by trade secret, requires a great deal more cleverness, and patent lawyers are particularly adept at being clever (if you doubt this, ask Justice Breyer).

We begin, as we must, with the claims ("The name of the game is the claim," as Judge Rich famously noted). For most "gene patents," the claims have a canonical format, constructed over the last generation by the U.S. Patent and Trademark Office, on the one hand (who have been generally parsimonious in what is permitted to be patented, accusations by gene patent opponents to the contrary) and by patent applicants, who generally want claims that can be defended in a court of law when asserted against an infringer. These claims have the format:

An isolated (human) nucleic acid (or DNA molecule or gene (specified by name), encoding an amino acid sequence identified by SEQ ID NO: X.

(The portions of this claim in parentheses are optional, used in some cases but not necessary to properly recite the claimed subject matter.) Certain features of this claim merit further discussion. First, the Office has required the term "isolated" to be in the claim, for at least two reasons. First, under Diamond v. Chakrabarty, the claimed DNA must show "the hand of man" and be "markedly different." That standard was established during times where isolating a human gene was truly analogous to finding a needle in a haystack, where the needle was made of hay. While not based on a "sweat of the brow" requirement, the necessity for the "hand of man" was more evident during those times than (perhaps) it is now, when the entirety of the human genome exists (representationally at least) in computer databases worldwide. Second, a DNA molecule was required to be isolated so that the claim would not encompass ("read on" in patent geek speak) the molecule as it exists in nature. This is not a question, necessarily, of patent eligibility, but rather of novelty; the gene in nature is not novel until is isolated. This reasoning can be seen in early cases, such as Wood-Paper Patent, 90 U.S. 566 (1874), and Cochrane v. Badische Anilin Soda Fabrik, 111 U.S. 293 (1884). In the former case, the Supreme Court stated its reasoning for finding the claimed cellulose-based paper as follows:

It [the isolated cellulose] may have been in existence and in common use before the new means of obtaining it was invented, and possibly before it was known that it could be extracted from the subject to which the new process is applied. . . . If, then, the Watt & Burgess patent for a product is sustainable it must be because the product claimed, namely, "a pulp suitable for the manufacture of paper, made from wood or other vegetable substances," was unknown prior to their alleged invention. But we think it is shown satisfactorily that it had been produced and used in the manufacture of paper long before 1853, the year in which the original patent of Watt & Burgess was dated.

Similarly, in the Cochrane case the Court said:

According to the description in [the patents in suit], and the evidence, the article produced by the process described was the alizarine of madder, having the chemical formula C₁₄H₈O₄. It was an old article. While a new process for producing it was patentable, the product itself could not be patented, even though it was a product made artificially for the first time, in contradistinction to being eliminated from the madder root. Calling it artificial alizarine did not make it a new composition of matter, and patentable as such, by reason of its having been prepared artificially, for the first time, from anthracine, if it was set forth as alizarine, a well-known substance. Wood Paper Patent, 23 Wall. 566, 593. There was therefore no foundation for reissue No. 4,321, for the product, because, on the description given, no patent for the product could have been taken out originally.

The same rationale explains why isolated DNA claims cannot be read to encompass the genes in chromosomal DNA "isolated" from cells (but otherwise unchanged); Frederich Mieschner "isolated" DNA to this level of purification in the 1880's and thus, any such interpretation of the term "isolated" in isolated DNA claims would render them unpatentable for lack of novelty.

Another feature of the representative claim set forth above is that, to infringe, it requires that the entire amino acid coding sequence be produced. The reason for this limitation stems from the purpose of such claims from the dawn of the biotechnology age: to be able to produce a protein having therapeutic or other beneficial uses. If an isolated gene was to be used to produce erythropoietin, or tissue plasminogen activator, or interferon, or insulin, or blood clotting factors VIII or IX, or any of the other patented human genes, it needed to be full-length or otherwise a truncated fragment would be produced that, even if it retained biological activity could perhaps differ in biological half-life, immunogenicity, or other important properties.

One more claim feature should be mentioned, which is present in almost all but the earliest-filed claims: the nucleic acid is claimed in terms of the protein that it encodes. This represents a compromise, because although the claim thus encompasses any nucleic acid that encodes a specific protein, the claim encompasses only those DNA molecules that have the specifically recited, identified sequence. Accordingly, literal infringement does not lie even if there are conservative amino acid substitutions, meaning that a Valine to Isoleucine substitution (a difference of a single methylene group, -CH₂-) in a molecule having hundreds of amino acids does not infringe. In addition, the scope of these claims is further limited by Federal Circuit case law and PTO reactions to it, resulting in claims to unspecified "conservative" substitutions being held unpatentable under 35 U.S.C. § 112, first paragraph.

There are several consequences of these considerations regarding these claims. First, the claims are only infringed if someone without authorization makes, uses, sells, offers to sell or imports an isolated nucleic acid encoding the specified amino acid sequence. Typically, a "gene patent" identifies a cell or tissue source (and, frequently, identifies a plurality of cell or tissue sources as part of its characterization of a gene) that natively expresses the gene. Thus, anyone who uses such a cell or tissue source to study the gene without isolating it will not infringe. Second, portions of the gene can be isolated, sequenced, and characterized and not infringe, and such portions can be changed and then introduced into the gene to produce another gene that does not infringe. (The patentability of primers and probes selected from the gene sequence are not considered here; their patentability, rather than patent eligibility, has been called into question by others; see "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims"). Third, the gene product (typically, a protein) can be isolated from the cell and studied without infringement, as can antibodies raised against the gene product. These antibodies can be used to detect under- or over-expression of the gene in cell or tissue sources for diagnostic purposes, and mutant forms of the gene product associated with disease can also be produced. All without infringing the gene claim.

Fourth, the sequence itself can be identified in individuals and compared to wildtype or disease-associated mutations without infringing unless the entire DNA is isolated intact (something that is unnecessary and unduly burdensome to do; portions can be sequenced and the entire sequence aligned in a computer). This is because (ACLU arguments to the contrary) the DNA sequence information is not protected by the patent claim. (Again, whether there can be crafted a valid method claim for making a diagnosis is not within the scope of this discussion; indeed, challenging the "gene" claims while eschewing a challenge to Myriad's several remaining method claims smacks of cynicism in an attempt to garner the most publicity rather than a honest effort to obtain genetic BRCA diagnostic testing for those women who cannot afford it.) This is also the reason why "whole genome sequencing" and other present or future genetic diagnostic methods are unaffected by the isolated DNA claims: practice of these diagnostic methods do not infringe the DNA claims.

The question remains what experiments will be impeded by the existence of claims to isolated human DNA. (It should be mentioned that there are more than 8,000 scientific research papers published in the BRCA genes since the grant dates of the patents.) Clinical testing may be one type, where a population is to be assessed for the prevalence of BRCA gene mutations, for example. Here, there are questions of whether the testing will be performed for free or whether the patients will be charged; it is difficult to defend a "study" where the research subjects pay for the privilege. But even in cases where there is a need for such a study it seems that countervailing practices should be able to reduce if not eliminate any negative effects of a gene patent claim. As discussed above, large-scale sequencing can be performed without incurring patent infringement liability as to the isolated DNA claims. Also, scientific research typically requires specialized reagents and services that are supported by grant monies. For example, there was a time when restriction endonucleases were not readily available but could be isolated from the particular bacteria that produced them, and lambda phage packaging extracts were routinely (albeit laboriously) produced from complementary cultures of mutant phage (one making the packaging protein but defective phage heads, the other making intact phage heads but not the packaging protein). The advent of commercially available preparations of more and more restriction enzymes and highly effective packaging extracts made these homemade efforts obsolete; similarly, engaging the patentee to perform the genetic testing would eliminate any risk of patent infringement liability as well as gaining for the project the reliability that such testing services provide.

Thus, there seems to be little empirical support for the contentions that "gene patents" are inhibiting research, despite the allegations from former Acting Solicitor General Neal Katyal, at this year's BIO conference, that his two weeks with NIH scientists convinced him (and, it seems, the rest of the Department of Justice) that gene patents raised such a "clear and present danger." However, because no one is infallible (here or at the NIH), it is possible that there are such instances or circumstances that have been overlooked. If so, please let us know. If not, perhaps it is time for those who argue without basis that gene patents do not "promote the progress" to make their arguments honestly, based on (legitimate) moral, religious, or political grounds. There is nothing to be ashamed of in making these types of arguments; but if that is the basis for principled opposition to patenting human DNA then perhaps the issues can be addressed in ways that can foster a solution rather than (as in so many things) mere partisanship. We welcome a response.
USPTO Issues Final Rule for Implementing Statute of Limitations Provisions for Office Disciplinary Proceedings

July 31, 2012

By Donald Zuhn —

The U.S. Patent and Trademark Office published its final rule to implement the statute of limitations provisions for office disciplinary proceedings of the Leahy-Smith America Invents Act (77 Fed. Reg. 45247). The final rule, which takes effect on August 30, 2012, is the second of several final rule notices that the Office will be publishing in order to implement AIA provisions.

As we noted when the Office published its notice of proposed rulemaking to implement the statute of limitations provisions for office disciplinary proceedings in January (see "USPTO Proposes Rules Changes for Implementing AIA Provisions — Statute of Limitations Provisions for Office Disciplinary Proceedings"), § 32 of Title 35 — prior to amendment by the AIA — read as follows:

The Director may, after notice and opportunity for a hearing, suspend or exclude, either generally or in any particular case, from further practice before the Patent and Trademark Office, any person, agent, or attorney shown to be incompetent or disreputable, or guilty of gross misconduct, or who does not comply with the regulations established under section 2(b)(2)(D) of this title, or who shall, by word, circular, letter, or advertising, with intent to defraud in any manner, deceive, mislead, or threaten any applicant or prospective applicant, or other person having immediate or prospective business before the Office. The reasons for any such suspension or exclusion shall be duly recorded. The Director shall have the discretion to designate any attorney who is an officer or employee of the United States Patent and Trademark Office to conduct the hearing required by this section. The United States District Court for the District of Columbia, under such conditions and upon such proceedings as it by its rules determines, may review the action of the Director upon the petition of the person so refused recognition or so suspended or excluded.

Section 2(b)(2)(D) of Title 35 permits the Office to require "agents, attorneys, or other persons representing applicants or other parties before the Office, . . . to show that they are of good moral character and reputation and are possessed of the necessary qualifications to render to applicants or other persons valuable service, advice, and assistance in the presentation or prosecution of their applications or other business before the Office."

Section 3(k) of the AIA amended § 32 by adding the following sentence before the last sentence:

A proceeding under this section shall be commenced not later than the earlier of either the date that is 10 years after the date on which the misconduct forming the basis for the proceeding occurred, or 1 year after the date on which the misconduct forming the basis for the proceeding is made known to an officer or employee of the Office as prescribed in the regulations established under section 2(b)(2)(D).

Prior to the AIA's amendment of § 32, disciplinary actions for violations of the USPTO Code of Professional Responsibility were generally understood to be subject to a five-year statute of limitations pursuant to 28 U.S.C. § 2462. In its proposed rulemaking, the Office noted that with passage of the AIA, "Congress provided the Office with five additional years to bring an action, thus ensuring that the Office had additional flexibility to initiate 'a [disciplinary] proceeding for the vast bulk of misconduct that is discovered, while also staying within the limits of what attorneys can reasonably be expected to remember'" (quoting the Congressional Record S1372–1373 (daily ed. March 8, 2011) (statement of Sen. Kyl)). The Office also noted that "[t]he one-year limitation period in the AIA reflects that disciplinary actions should be filed in a timely manner from the date when misconduct forming the basis of a disciplinary complaint against a practitioner is made known to 'that section of PTO charged with conducting section 32 proceedings.'"

The Office's notice of proposed rulemaking indicated that the Office can initiate disciplinary proceedings via three types of disciplinary complaints: complaints predicated on the receipt of a probable cause determination from the Committee on Discipline; complaints seeking reciprocal discipline; and complaints seeking interim suspension based on a serious crime conviction. Prior to the filing of a disciplinary complaint against a practitioner, the Office of Enrollment and Discipline (OED) Director: (1) performs a preliminary screening of the allegations made against the practitioner; (2) requests information from the practitioner about the alleged conduct; (3) conducts a thorough investigation after providing the practitioner an opportunity to respond to the allegations; and (4) submits the investigated case to the Committee on Discipline for a determination of whether there is probable cause to bring charges against the practitioner.

In the final rule notice, the Office indicates that:

[It] is adopting procedural rules which: Specify that a disciplinary complaint shall be filed within one year after the date on which the Office of Enrollment and Discipline (OED) Director receives a grievance forming the basis of the complaint, and in no event more than ten years after the date on which the misconduct forming the basis for the proceeding occurred; define grievance as a written submission from any source received by the OED Director that presents possible grounds for discipline of a specified practitioner; and clarify that the one-year time frame for filing a complaint may be tolled by written agreement.

The Office also made some changes to the proposed rules in response to comments received following publication of the Office's notice of proposed rulemaking. Although the Office had proposed that the one-year statute of limitations period for complaints predicated on the receipt of a probable cause determination from the Committee on Discipline would begin on the date on which the OED Director receives a complete, written response to a request for information and evidence from the practitioner. The final rule, however, notes that this regulation is not being adopted, and that a disciplinary proceeding will instead be commenced one year from the date the OED Director receives a grievance.

The final rule notice also indicates that the Office has adopted three new rules:

(1) A disciplinary complaint shall be filed within one year after the date on which the OED Director receives a grievance forming the basis of the complaint, and in no event more than ten years after the date on which the misconduct forming the basis for the proceeding occurred, (2) a grievance is defined as a written submission from any source received by the OED Director that presents possible grounds for discipline of a specified practitioner, and (3) the one-year period for filing a complaint may be tolled by written agreement.
Court Report

July 30, 2012

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Alcon Pharmaceuticals Ltd. et al. v. Lupin Ltd. et al.
1:12-cv-00973; filed July 24, 2012 in the District Court of Delaware

• Plaintiffs: Alcon Pharmaceuticals Ltd.; Alcon Research Ltd.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Alcon's Moxeza® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis). View the complaint here.

Alcon Pharmaceuticals Ltd. et al. v. Apotex Inc. et al.
1:12-cv-00960; filed July 20, 2012 in the District Court of Delaware

• Plaintiffs: Alcon Pharmaceuticals Ltd.; Alcon Research Ltd.
• Defendants: Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 6,716,830 ("Ophthalmic Antibiotic Compositions Containing Moxifloxacin," issued April 6, 2004) and 7,671,070 ("Method of Treating Ophthalmic Infections with Moxifloxacin Compositions," issued March 2, 2010) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Alcon's Vigamox® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis). View the complaint here.

Novartis Pharmaceuticals Corp. v. Lupin Ltd. et al.
2:12-cv-04552; filed July 20, 2012 in the District Court of New Jersey

• Plaintiff: Novartis Pharmaceuticals Corp.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 6,294,197 ("Solid Oral Dosage Forms of Valsartan," issued September 25, 2001) following a paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Novartis' Diovan HCT® (valsartan and hydrochlorothiazide, used to treat hypertension). View the complaint here.

Celgene Corp. v. Natco Pharma Ltd. et al.
2:12-cv-04571; filed July 20, 2012 in the District Court of New Jersey

• Plaintiff: Celgene Corp.
• Defendants: Natco Pharma Ltd.; Arrow International Ltd.; Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. 5,635,517 ("Method of Reducing TNFα Levels with Amino Substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines," issued June 3, 1997), 6,281,230 ("Isoindolines, Method of Use, and Pharmaceutical Compositions," issued August 28, 2001), 7,189,740 ("Methods of Using 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione for the Treatment and Management of Myelodysplastic Syndromes," issued March 13, 2007), 7,968,569 ("Methods for Treatment of Multiple Myeloma Using 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione," issued June 28, 2011), 7,977,357 ("Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione," issued July 12, 2011), and 8,193,219 (same title, issued June 5, 2012) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Celgene's Revlimid® (lenalidomide, used in the treatment of multiple myeloma patients who have received at least one prior therapy, and in the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality). View the complaint here.
USPTO Expands and Extends Patent Prosecution Highway Programs

July 30, 2012

By Donald Zuhn —

Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office had established some thirty PPH programs with more than twenty other patent offices. The USPTO recently increased the number of PPH programs (full or pilot) to thirty-three by establishing a PPH pilot program based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the Israel Patent Office (ILPO), and the number of offices with which it has PPH programs to twenty-three by establishing a PPH pilot program with the Colombian Superintendence of Industry and Commerce (SIC). In addition, the USPTO continued two other PPH programs — PCT-PPH pilot programs with IP Australia and the Nordic Patent Institute (NPI) — and fully implemented two other PPH programs — a PPH program with ILPO and a PCT-PPH program with the Korean Intellectual Property Office (KIPO).

Last week, the USPTO announced the establishment of a new Patent Prosecution Highway (PPH) pilot program with the Colombian Superintendence of Industry and Commerce (SIC). As with other PPH programs, the USPTO-SIC PPH will permit an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn. In particular, an applicant receiving a ruling from either the USPTO or SIC that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office. The USPTO-SIC PPH pilot program, which will begin on September 1, 2012, is scheduled to expire on August 31, 2013, but may be extended for up to one year or terminated earlier depending on volume of activity and other factors. The USPTO's notice regarding the USPTO-SIC PPH pilot program, including requirements for participation in the program, can be found here.

Earlier this month, the USPTO announced that it would be launching a new Patent Prosecution Highway (PPH) pilot program with the Israel Patent Office (ILPO) on August 1, 2012. The pilot program will apply to qualifying patent applications filed under the Patent Cooperation Treaty (PCT). Under the USPTO-ILPO PCT-PPH, an applicant receiving a positive written opinion or a positive international preliminary report in a PCT application where the USPTO or ILPO was the International Searching Authority or the International Preliminary Examination Authority may request that the other office fast track the examination of corresponding claims in corresponding applications. The USPTO-ILPO PPH pilot program is scheduled to expire on July 31, 2013, but may be extended for up to one year or terminated earlier depending on volume of activity and other factors. The USPTO's notice regarding the USPTO-ILPO PCT-PPH pilot program, including requirements for participation in the program, can be found here. While announcing the new PCT-PPH pilot program with the ILPO, the USPTO also announced that it was fully implementing the PPH program with the ILPO, effective July 1, 2012. The USPTO's notice regarding the USPTO-ILPO PPH program, including requirements for participation in the program, can be found here.

The USPTO also announced earlier this month the continuation of a current PPH pilot program with the ILPO (see notice) and a PPH pilot program based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the NPI (see notice). Both PPH programs have been extended indefinitely.

Finally, the USPTO announced in late June that the USPTO and KIPO had agreed to fully implement their PCT-PPH program on a permanent basis starting on June 1, 2012. The USPTO noted that "[t]he results of the [USPTO-KIPO] PCT-PPH pilot program showed that applicants have been able to expeditiously obtain a patent at an early stage by utilizing petition to make special procedures," and that "the USPTO and the KIPO have been able to reduce duplication of search efforts by exploiting the search and examination results in PCT applications to the maximum extent practicable." The USPTO's notice regarding the USPTO-KIPO PCT-PPH program, including requirements for participation in the program, can be found here.

With the addition of the above programs, the USPTO has twenty-one PPH programs (full or pilot) in place with IP Australia (IP AU), the Austrian Patent Office (APO), the Canadian Intellectual Property Office (CIPO), China's State Intellectual Property Office (SIPO), the Colombian Superintendence of Industry and Commerce (SIC), the Danish Patent and Trademark Office (DKPTO), the European Patent Office (EPO), the National Board of Patents and Registration of Finland (NBPR), the German Patent and Trade Mark Office (DPMA), the Hungarian Intellectual Property Office (HIPO), the Icelandic Patent Office (IPO), the Israel Patent Office (ILPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Mexican Institute of Industrial Property (IMPI), the Norwegian Industrial Property Office (NIPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Intellectual Property Office of Singapore (IPOS), the Spanish Patent and Trademark Office (SPTO), the Taiwan Intellectual Property Office (TIPO), and the United Kingdom Intellectual Property Office (UK IPO). The USPTO has also established twelve PCT-PPH programs with other patent offices: IP AU, APO, SIPO, EPO, NBPR, ILPO, JPO, KIPO, the Nordic Patent Institute (NPI), ROSPATENT, SPTO, and the Swedish Patent and Registration Office (PRV). Additional information regarding the various PPH and PCT-PPH programs, as well as links to the appropriate request forms to be used for each program, can be found here.
Myriad and Prometheus: Do Patents “Preempt” Follow-On Research?

July 29, 2012

By Hal Wegner —

The patent challengers in the Myriad case placed great stock in the argument that claims to "isolated DNA" (because of their alleged breadth) created a "research preemption." The argument is keyed to recent Supreme Court precedent such as Mayo v. Prometheus. In their certiorari petition a year ago in Myriad, the patent challengers argued that patents "preempt researchers . . . and pose[ ] a serious threat to scientific freedom and advancement."

The Federal Circuit today, and the Supreme Court the Next Time: While it appears that a split panel at the Federal Circuit may very well reject this argument, the more fundamental point is not addressed by the patentees that makes appellate proceedings at the merit stage at the Supreme Court problematic.

To deal with that point, the more fundamental question must be asked: Given a public right to experiment "on" a patented invention, how then does the grant of any patent "preempt" research? This issue is addressed in a new paper, Can Any Patent "Preempt" Follow-On Research?

Hal Wegner is a partner at Foley & Lardner LLP and the former Director of the Intellectual Property Law Program and Professor of Law at George Washington University Law School.

We thank Mr. Wegner for allowing us to provide a copy of his paper to Patent Docs readers.
Conference & CLE Calendar

July 29, 2012

July 30-31, 2012 – Freedom to Operate*** (American Conference Institute) – Philadelphia, PA

July 30 to August 1, 2012 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

August 2, 2012 – USPTO Post-Grant Proceedings: Meeting the New Requirements for Post-Grant and Inter Partes Reviews and Supplemental Examination (Strafford) – 1:00 – 2:30 pm (EDT)

September 9-11, 2012 – IPO Annual Meeting (Intellectual Property Owners Association) – San Antonio, TX

September 10-12, 2012 – Business of Biosimilars & Generic Drugs (Institute for International Research) – Boston, MA

September 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 24-25, 2012 – Biosimilars and Biobetters*** (SMi) – London, UK

September 25-26, 2012 – EU Pharma Regulatory Law*** (C5) – Brussels, Belgium

October 10-11, 2012 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) – New York, NY

October 10-11, 2012 – Biotech & Pharmaceutical Patenting*** (C5) – London, UK

***Patent Docs is a media partner of this conference or CLE
ACI Maximizing Pharmaceutical Patent Lifecycles Conference

July 27, 2012

American Conference Institute (ACI) will be holding its 13th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 10-11, 2012 in New York, NY. The conference will allow attendees to:

• Understand how the patent cliff will impact innovation and alter the industry dynamic between brand names and generics;
• Explore how generic user fees and other new and revised items under PDUFA will affect R&D and market entry;
• Demystify the provisions of the America Invents Act and learn how post-grant review, inter partes review, and institution of a global prior art regime will impact life cycle management;
• Analyze the recently issued FDA regulations on biosimilars and comprehend how the further implementation of BPCIA will affect pharmaceutical patent life cycle management strategies;
• Assess how the combined evolution of prior art obvious and obvious-type double patenting are influencing the future of secondary patents;
• Evaluate patent life cycle strategies relative to personalized medicine in light of Prometheus;
• Examine the link between inducement and divided infringement actions relative to methods of use claims for pharmaceutical patents;
• Appreciate how Caraco has affected Orange Book listings and redefined the relationship between a drug's patent, label and use code;
• Explore forfeiture rulings post-Lipitor; and
• Navigate new safe harbor dilemmas for both general screening and research tool patents.

In particular, ACI's faculty will offer presentations on the following topics:

• From product development to patent portfolio management: Patent life cycle strategies for a post-AIA world;
• An industry perspective on implementation of the AIA, new PTO proceedings, and their collective impact on life cycle management;
• Preparing for the implementation of the FDA's biosimilars pathway and its effects on life cycle planning;
• Exploring the latest regulatory conundrums affecting pharmaceutical patent life cycle strategies;
• Personalized medicine and patent life cycle considerations in light of Prometheus and other recent challenges to subject matter patentability, written description, and more;
• Employing strategies to avoid findings of obviousness: Legal analysis and practical applications for brand names and generics;
• Inequitable conduct post-Therasense and how it impacts life cycle planning;
• USPTO keynote: The brave new world of patent reform and its impact on pharmaceutical patents — to be presented by USPTO Deputy Director Teresa Stanek Rea;
• Understanding how Caraco has redefined the relationship between pharmaceutical patents, labels, and use codes;
• Analyzing method claims and the madness over recent and pending inducement and divided infringement cases;
• Exclusivities and forfeitures: New developments, controversies and related concerns;
• An update on FDA activities impacting pharmaceutical patent life cycle planning;
• Safe harbor or stormy port? Calming the legal tempest left by Proveris; and
• Understanding the importance of Rx to OTC switches to the future of pharmaceutical patent life cycle management.

Two pre-conference workshops will be offered on October 9, 2012. The first, entitled "Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Hatch-Waxman Strategies Relative to Patent Life Cycle Management" will be held from 9:00 am to 12:30 pm. The second, entitled "PTA-PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry" will be held from 2:00 pm to 5:30 pm.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference can be found here, and additional information regarding the wrokshops can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fees are $2,295 (conference only), $2,895 (conference plus one workshop), or $3,495 (conference plus two workshops). Those registering by September 10, 2012 will receive a $200 discount off the registration fee, and those registering on or before August 13, 2012 will receive a $300 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Maximizing Pharmaceutical Patent Lifecycles conference.
Biotech & Pharmaceutical Patenting Conference

July 27, 2012

C5 (UK) will be holding its 23th Annual Forum on Biotech & Pharmaceutical Patenting on October 10-11, 2012 in London, UK. The conference will allow attendees to:

• Discover competitive patent filing strategies, tactics, and implications of recent case law in Europe and the U.S.;
• Avoid infringing anti-competition laws by tailoring agreements and learning about the key factors the European Commission look for when conducting their investigations;
• Develop patent strategies to optimize patent lifecycles and extend market dominance;
• Stay one step ahead of competitors by discovering the latest trends and priorities of the EPO and national patent offices;
• Avoid patent infringement when conducting clinical trials and how to use the Bolar Exemption effectively; and
• Obtain Supplementary Protection Certificates (SPCs) to extend patent lifecycles following Novartis.

In particular, C5 faculty will offer presentations on the following topics:

• Examining what is now patentable in light of Brüstle: The implications for human embryo stem cell research;
• Optimising your SPC strategies & utilising the paediatric extension: Prolonging your patent life cycles and cementing your market position;
• Keynote presentation from the AIPPI;
• Taking advantage of the proposed EU patent court & European patent reform to streamline your IP strategy;
• Avoiding patent infringements in your clinical trials by utilising the Bolar Exemption;
• The implications of Prometheus on the patent eligibility of your gene patents;
• Gain a competitive advantage by aligning your patent strategies with the EPO's latest initiatives & priorities;
• Emerging markets focus afternoon: Successfully overcoming hurdles to the protection & management of IP assets in emerging markets;
• Overcoming regulatory & strategic hurdles to enforcement of your patents in Asia;
• Surmounting the problems arising from inconsistent provisions in Brazil's paradoxical patent law to successfully protect your IP assets;
• Tips, traps and techniques for successfully obtaining & protecting your patents in India & the implications of the first compulsory licence issued in India;
• The impact of the us patent reform on European biotech and pharma companies: Updating and strengthening your global patent strategies;
• The antibody patenting conundrum;
• Obtaining injunctive relief: Provisional enforcement of rights before trial;
• Gain a competitive edge by understanding how the new biosimilar regulatory guidelines in Europe & the U.S. will affect your patent strategy;
• Practical steps to take to protect your patent portfolio following Occlude;
• Minimise the risk of your patent strategy falling foul of anti-competition laws in the U.S. and the EU in an era of heightened regulatory scrutiny;
• Alternative models for protecting your knowhow & intellectual assets: Lessons to be learned from other technology sectors; and
• Minimising the cost of potential litigation through alternative methods of funding.

In addition, two pre-conference workshops will be held on October 9, 2012. The first, entitled "IP Due Diligence Procedure: Comprehensive Practical Guide to Best Practice," will be offered from 9:00 am to 12:00 pm, and will provide in-depth, critical insights into the often overlooked aspect of the procedure for conducting IP due diligence in M&A, joint venture, and licensing transactions. The second, entitled "Matters to Be Aware of When Reviewing Patent Settlement Agreements & Distribution Agreements to Minimise the Risk of Infringing Anti-Competition Laws," will be offered from 1:30 to 4:00 pm, and will guide attendees through settlement agreements and provide practical and strategic tips for drafting and reviewing these agreements to ensure you do not fall foul of anti-competition laws in the U.S. or the EU.

A complete brochure for the Biotech & Pharmaceutical Patenting conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is £1595 (conference alone), £2095 (conference plus one workshop), or £2495 (conference and both workshops). Those registering on or before September 12, 2012 will receive a £100 discount. Those interested in registering for the conference can do so here, by e-mailing registrations@C5-Online.com, by calling +44 20 7878 6888, or by faxing a registration form to +44 20 7878 6885.

Patent Docs is a media partner of the C5 Biotech & Pharmaceutical Patenting conference.
European Court of Justice Rules Supplementary Protection Certificates Available for “New Medical Use”

July 26, 2012

By Kevin E. Noonan —

Again in only the span of a few months, the views of the Advocate General of the European Court of Justice (ECJ) have been adopted by Court. Previously, this pattern resulted in a ban on patenting human embryonic stem cells (see "European Court of Justice Renders Stem Cell Decision"). Last Thursday, the Court agreed with the AG that Supplementary Protection Certificates (SPCs) should be made available for new pharmaceutical uses for known products, providing innovator drug companies with an additional five years of patent protection under circumstances where patent term had been running during the time taken for regulatory approval.

The case came to the ECJ from the UK Court of Appeals, after the Intellectual Property Office (IPO) rejected grant of an SPC to Neurim Pharmaceuticals Ltd., which had developed a formulation of melatonin for treating insomnia. (Melatonin, produced in the pineal gland, has long been known to be involved in maintaining circadian rhythms in animals including humans.) In this case, the grounds for the IPO's denial of SPC protection was a previous approval of a different melatonin formulation for use in sheep breeding; under the IPO's interpretation of the law, the sheep use constituted a "first medical use" of the compound, thus precluding grant of an SPC on the insomnia formulation to Neurim.

Five Questions were Presented to the ECJ from the UK Court of Appeals:

1. In interpreting Article 3 of Regulation 469/2009 ("the SPC Regulation") when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4?

2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, "the first authorisation to place the product on the market in the Community" needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?

3. Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication?

4. Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8 (3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)?

5. Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?

In May, Advocate General Verica Trstenjak promulgated an Opinion on the matter, concluding that a proper interpretation of the law would entitle Neurim to an SPC on its insomnia formulation. The Opinion was set forth as a response to a request for clarification of the law from the UK IPO. The Opinion cast the inquiry as whether "authorisation to place the product on the market as a medicinal product within the meaning of letter (b) must be the first authorisation to place that product on the market as a medicinal product." The Opinion also set forth the relevant provisions of the law:

Article 1 of Regulation No 1768/92, which is entitled 'Definitions', provides:

'For the purposes of this Regulation:

(a)    "medicinal product" means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

(b)    "product" means the active ingredient or combination of active ingredients of a medicinal product;

(c)    "basic patent" means a patent which protects a product as defined in (b) as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;

(d)    "certificate" means the supplementary protection certificate;

3.    Articles 3 to 5 of Regulation No 1768/92 read as follows:

'Article 3 – Conditions for obtaining a certificate

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a)    the product is protected by a basic patent in force;

(b)    a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;

(c)    the product has not already been the subject of a certificate;

(d)    the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.

Article 4 – Subject-matter of protection

Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.

Article 5 – Effects of the certificate

Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.'

4.    Article 7 of Regulation No 1768/92, which is entitled 'Application for a certificate', provides:

'1.    The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted.

2.    Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.

5.    Article 13 of Regulation No 1768/92, which is entitled 'Duration of the certificate', provides:

'1.    The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community reduced by a period of five years.

2.    Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.

In its synopsis of the facts, the Opinion sets forth the claim of Neurim's European Patent for which the SPC was requested:

A pharmaceutical formulation, for use in correcting a melatonin deficiency or distortion in the plasma melatonin level and profile in a human subject, which comprises melatonin in combination with at least one pharmaceutical carrier, diluent or coating, wherein the melatonin is present in the formulation in controlled-release form adapted to release melatonin following administration to a human patient, over substantially the whole of a single nocturnal period of at least about 9 hours, such that melatonin release occurs according to a profile which, taking into account the existing nocturnal profile, simulates a normal human endogenous melatonin nocturnal profile in plasma, in that administration of the formulation at the beginning of said at least about 9 hour single nocturnal period causes melatonin to be detectable in the plasma in an amount which increases to a peak in the course of said period and subsequently decreases to a post-peak minimum essentially at the end of said period.

Market authorization in Europe was granted in 2007 for Neurim's product (Circadin), 15 years after Neurim filed its patent application thus leaving only five years of term for its patent.

The Opinion also described the parties submitting written observations and oral argument before the ECJ: Neurim Pharmaceuticals, the United Kingdom Government, the Portuguese Government, and the European Commission. The Commission and Neurim argued that Article 3d does not preclude grant of an SPC on a "medicinal product comprising an active ingredient where an earlier marketing authorisation (A) has been granted which is for a different medicinal product comprising that active ingredient" (with the caveat that the "limits of the protection" from the "basic patent" would not "extend to the medicinal product the subject of the earlier marketing authorization" and all other requirements of Article 3 are met). The UK and Portuguese governments took the position that a "second" SPC should not be granted on a medicinal product where the active ingredient had previously been the subject of an SPC.

Advocate General Trstenjak addressed the first question by considering a "literal interpretation" of the language of the regulation, and then assessing the result to determine whether it is consistent with "the schemes and objectives" of the SPC regulations to come to her conclusion as to the first Question Presented. In this analysis, the AG determined that the literal meaning of the words of the regulation would preclude grant of a subsequent SPC where a previous SPC had been granted on a medicinal product containing the same active ingredient. However, the AG then determined that such a result would be contrary to the "schemes and objectives" of the regulation. Specifically, the AG noted that is was certainly the case that the same active ingredient could be the subject of patent protection for different formulations and uses, as was the case here: Neurim had a patent for its Circadin insomnia forumation and Hoechst had a patent for its Regulin product for use in sheep breeding (which had expired in 2007). As a consequence, the AG's Opinion states that "[i]t must therefore be assumed that, in principle, Article 3(a) permits the grant of more than one supplementary protection certificate for a product." The AG reached the same conclusion with regard to Article 3(b), because that Article provides for market approval for, inter alia, human and veterinary uses. The AG's Opinion thus concludes that "Article 3(b) also permits, in principle, multiple supplementary protection certificates for products which are used as active ingredients in different medicinal products." While Article 3(c) by its plain wording would seem to preclude grant of a subsequent SPC on an active ingredient that had received a prior SPC, the AG concluded that "requirement may not be construed as meaning that only one supplementary protection certificate could be granted for a patented active ingredient or for a patented combination of active ingredients" in view of the ECJ's case law. Because there is thus a "common feature" of Articles 3(a), (b) and (c), the AG concluded that "the schematic context" of Article 3(d) also suggests that this Article would also permit grant of more than one SPC.

The AG then discussed "teleological" considerations, that is, directed at a consideration of the purpose of the SPC regulations. Here, the AG noted that "the aim of granting supplementary protection certificates for medicinal products is essentially to extend the term of patent protection for active ingredients used in medicinal products." Recognizing that protracted regulatory approval proceedings can seriously reduce the patent term remaining when regulatory approval is finally achieved. The AG appreciates the "view of the European Union legislature" to be that SPCs are needed and granted to remedy the insufficiencies in patent protection occasioned by these long delays in regulatory approval. Thus:

Those rules [i.e., the SPC Regulations] are intended to achieve a balance between the various interests at stake in the pharmaceutical sector. Those interests include, on the one hand, the interests of the undertakings and institutions, some of which pursue very cost-intensive research in the pharmaceutical sector and therefore favour an extension of the term of protection for their inventions in order to be able to balance out the investment costs. On the other hand, there are the interests of the producers of generic medicines who, as a consequence of the extension of the term of protection of the active ingredients under patent protection, are precluded from producing and marketing generic medicines. It is also relevant in this connection that, in general, the marketing of generic medicinal products has the effect of lowering the prices of the relevant medicinal products. Against that background, the interests of patients lie between the interests of the undertakings and institutions conducting research and those of the producers of generic medicines. That is because patients have an interest, on the one hand, in the development of new active ingredients for medicinal products, but, on the other, they also have an interest in those products then being offered for sale as cheaply as possible. The same applies to State health systems in general which, in addition, have a particular interest in preventing old active ingredients from being brought onto the market in slightly modified form under the protection of certificates but without genuine innovation and thereby artificially driving up expenditure in the health sector.

Applying these factors to the case before the Court, the AG recommended that the "absolute preclusive effect" resulting from a prohibition of a subsequent SPC to Neurim for its Circadin product "would be not compatible with the objectives of [the SPC] Regulation[]." Conversely, granting an SPC under these circumstances is consistent with Article 54(5) of the European Patent Convention (EPC), which "expressly recognises the patentability of 'second and further medical uses' of substances whose use in other medical processes already forms part of the state of the art." In the AG's view, "it would therefore be contrary to the aims of Regulation No 1768/92 if, in a case like the main proceedings, an application for a supplementary protection certificate would inevitably be unsuccessful because the patented active ingredient has already been placed on the market in another medicinal product." The AG emphasizes that the prohibitions of Article 3(c) remain, that "prohibit the grant of more than one certificate for each basic patent" (emphasis in original).

The AG then recognized that while her Opinion is consistent with one line of cases in the ECJ (including Medeva, Georgetown Unversity and Others, and AHP Maufacturing), it is inconsistent with other cases where the ECJ has interpreted the law more stringently. These cases include Synthon, and Generics (UK), but the AG appears to believe that the Opinion is more consistent with the "first line" of ECJ cases and thus is a sound legal representation.

The AG rendered a recommendation on Questions 2 through 5 more summarily, stating that the term of the SPC for the subsequent approved use is to be made using the same rubrics and limitations as any other SPC. Question No. 3 the AG answered in the negative, because the "crucial question" is that the product seeking a subsequent SPC does not fall under the scope of any "basic patent" for which a previous SPC was awarded. Similarly, the fourth and fifth questions were not deemed particularly relevant in view of the AG's recommendations on the first three Questions.

The AG thus concluded that:

[A] supplementary protection certificate for a product which is protected by a basic patent in force may be granted only on the basis of the first authorisation which permits that product to be placed on the market as a medicinal product which is within the scope of protection conferred by the basic patent in the Member State for which the application is made. The fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the Member State for which the application is made does not preclude the grant of a supplementary protection certificate based on a later authorisation to place that product on the market as a new medicinal product, provided the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent.

The ECJ's decision to follow the AG's recommendation, while coming as no surprise, certainly changes the landscape for the better for pharmaceutical patents and products in Europe. It is frequently the case that new uses can be found for old, well-established and characterized drug compounds, and extending the benefit of SPC protection can be expected to shift the investment scales to encourage such new uses. In a world where the drug pipeline from traditional pharmaceutical companies has dwindled, these considerations may prove crucial to addressing previously unmet medical needs.
USPTO Issues Final Rule for Preissuance Submissions

July 25, 2012

By Donald Zuhn —

Last week, the U.S. Patent and Trademark Office published its final rule to implement the preissuance submissions by third parties provision of the Leahy-Smith America Invents Act (77 Fed. Reg. 42150). The final rule concerning preissuance submissions is the first of many final rule notices that the Office is expected to publish in order to implement AIA provisions that, like the preissuance submissions provision, will take effect on September 16, 2012.

As we noted when the Office published its notice of proposed rulemaking on the preissuance submissions provision in January, § 8 of the AIA amended 35 U.S.C. 122 by adding 35 U.S.C. 122(e), which lists certain conditions that apply to a third-party preissuance submission to the Office in a patent application (see "USPTO Proposes Rules Changes for Implementing AIA Provisions — Preissuance Submissions Provision"). In particular, AIA § 8 permits any third party to submit for the Office's consideration and inclusion in an application's file "any patent, published patent application, or other printed publication of potential relevance to the examination of the application," provided that the submission is made:

before the earlier of —

(A) the date a notice of allowance under section 151 is given or mailed in the application for patent; or

(B) the later of —

(i) 6 months after the date on which the application for patent is first published under section 122 by the Office, or

(ii) the date of the first rejection under section 132 of any claim by the examiner during the examination of the application for patent.

The submission must also "set forth a concise description of the asserted relevance of each submitted document." This provision of the AIA, which takes effect on September 16, 2012, applies to any patent application filed before, on, or after that effective date.

The final rule specifies the requirements for a preissuance submission, which must be timely filed (as described above), be in writing, and contain:

(1) a list identifying the items being submitted;

(2) a concise description of the relevance of each item listed;

(3) a legible copy of each non-U.S. patent document listed;

(4) an English language translation of any non-English language item listed;

(5) a statement by the party making the submission that the submission complies with the statute and the rule; and

(6) the required fee.

The final rule notes that the statutory time period for making a third-party submission will not be tolled by an initial non-compliant submission. In addition, the Office will not set a time period for a third party to file a corrected third-party submission or accept amendments to a non-compliant submission that was previously filed. Moreover, the Office will not refund the required fee in the event that a third-party submission is determined to be noncompliant. With respect to the required fee, the final rule notes that the fee set forth in 37 C.F.R. § 1.17(p), which is currently $180, will apply to third-party submissions containing up to ten documents. For every ten additional documents, submitters will have to pay an additional fee under § 1.17(p). The Office will provide an exemption from the fee requirement for third-party submissions listing three or fewer documents, when the submission is the first third-party submission by a third party (or a party in privity with the third party) in a given application.

The final rule also cautions that third parties must use the dedicated Web-based interface for preissuance submissions when electronically filing such submissions. This can be done by selecting the "Third-Party Preissuance Submission under 37 CFR 1.290" option on the EFS-Web.

With respect to the impact of preissuance submissions on applicants (other than the consideration of relevant art during prosecution of a given application), the final rule notes that third-party submissions will not create a requirement on the part of the applicant to independently file submitted documents with the Office in an Information Disclosure Statement.

In addition to setting forth rules for implementing the preissuance submission provision of the AIA, the final rule also eliminates 37 C.F.R. § 1.99 ("Third-party submission in published application"), which permitted a third party to submit patents or publications relevant to a pending published application and have such submissions entered in the application file, but did not permit the third party to submit an accompanying concise description of the relevance of each submitted document, and limited the time period for such submissions to two months after the date of the patent application publication or the mailing of a notice of allowance, whichever was earlier. The final rule also eliminates 37 C.F.R. § 1.292, which provided for public use proceedings. The Office noted in the final rule notice that such proceedings were no longer necessary in view of post-grant review proceedings, provided by § 6 of the AIA, in which prior public use may be raised.

The Office made several changes to the proposed rules on preissuance submissions in response to comments received following publication of the Office's notice of proposed rulemaking. Among the changes are the following:

• The Office had proposed allowing third-party submissions in reissue applications, but in view of public comments it received decided not to adopt its previously proposed position. The final rule notice explains that because a reissue application is a post-issuance proceeding, a preissuance submission should not be permitted in a reissue application. The Office recommended that third parties seeking to submit information in a reissue application should use the protest provisions of 37 C.F.R. § 1.291 instead.

• The Office had also proposed amendments to § 1.291 to make the requirements for submitting protests clearer and more consistent with the requirements for submitting preissuance submissions under new § 1.290, but in view of comments it received decided to limit its efforts to harmonize § 1.290 and § 1.291. The final rule notice explains that the Office's proposed attempt to harmonize these sections may have resulted in some confusion.

• As a result of numerous comments it received regarding third party notification, the Office has decided that it will notify a third party of a non-compliant submission and inform the submitter of the reasons for non-compliance, provided that the third party provides an e-mail address with its submission (whether filed electronically or on paper).

• As a result of numerous comments it received regarding applicant notification, the Office has also decided that it will notify applicants upon entry of a compliant third-party submission, provided that the applicant participates in the e-Office Action program.

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