By Donald Zuhn --
Last Wednesday, Plaintiffs-Appellees SmithKline Beecham Corp., SmithKline Beecham plc, and Glaxo Group Ltd. (GSK) filed their brief in the Tafas v. Dudas appeal (see "GSK Files Brief in Tafas v. Dudas Appeal"). As we previously reported, the Plaintiffs-Appellees had until September 24th to serve and file their brief. Also filing a brief on that day was Plaintiff-Appelle Dr. Triantafyllos Tafas (see "Brief for Plaintiff-Appellee Triantafyllos Tafas").
As noted in the brief, Dr. Tafas is a founder of Ikonysis, Inc., which manufactures a robotic microscope designed to automatically read microscope slides and provide tentative diagnoses (particularly with respect to early detection of tumors). Interestingly, Dr. Tafas also owns, and is currently prosecuting, several patent applications related to energy recovery from an automobile's internal combustion engine manifold, for use in reducing carbon emissions and resultant global warming.
While the Tafas brief, which comes in at 60 pages, covers some of the same ground covered in the GSK brief, it also serves as a fine compliment to GSK's brief. Tafas begins by listing the facts set out in the Patent Office's brief with which he disagrees. Among the differences, as far as Tafas is concerned, is the Patent Office's contention that "excessive use of continuation and continuation-in-part applications . . . has contributed . . . [to] the 'large and growing backlog of unexamined patent applications.'" Tafas notes instead that one study has "clearly demonstrated, using a queuing model, that the Final Rules' limitations on continuation applications, as well as RCEs, would not reduce the USPTO's backlog." Tafas also notes that another study found that "continuation and divisional filings have remained fairly stable over the past seven years and the major cause of backlog of applications was due to the large number of non-final office rejections being issued per round of prosecution" (in a footnote, Tafas cites to Esther Kepplinger's presentation at last June's BIO International Convention, as reported in an earlier Patent Docs article). Tafas also disagrees with the Patent Office's assertion that "a continued examination filing to correct an error or 'deficiency' in the claims or disclosure constitutes misuse of continued examination practice," arguing, for example, that "there is nothing abusive about obtaining claims of narrower scope from an obstinate examiner, and then seeking broader claim scope later." Tafas further disagrees with the Patent Office's argument that the prosecution process "can continue without end," stating that "[a]s a practical matter, as any application approaches twenty years from the priority date it becomes less and less commercially viable."
As with the GSK brief, Tafas argues that Section 2(b)(2) of the Patent Act does not empower the Patent Office to restrict patent applicants' statutory rights to file multiple continuation applications or claims. In particular, Tafas states that:
Section 2(b)(2) is not an open ended license to the USPTO to re-write the Patent Act to suit its own administrative convenience under the guise of its limited procedural rulemaking authority. Rather, Section 2(b)(2)(A)-(C) merely grants the USPTO strictly procedural rulemaking authority intended to expedite and/or facilitate the processing of patent applications. It does not authorize the USPTO to engage in informal rulemaking which the USPTO admits was calculated to restrict the number of continuation applications and/or the filing of multiple claims, in contravention of numerous provisions of the Patent Act.
The brief continues:
Congress only granted the USPTO limited authority under Section 2(b) of the Patent Act to make rules concerning the processing of patent applications. Congress never delegated authority to the USPTO to re-write other provisions of the Patent Act. There is also nothing to indicate Congress intended to make the USPTO the final interpreter/arbiter, in lieu of the Federal Circuit, as to whether any of the USPTO's Final Rules enacted pursuant to Section 2(b) conflict with other parts of the Patent Act. Thus, the Final Rules, which are substantive in nature, constitute a[n] usurpation by the Executive Branch of Congressional power in violation of the Patent Clause and the constitutional principle of separation of powers.
On the subject of whether the Final Rules (sometimes referred to as the continuation and claims rules) are indeed substantive, Tafas points to a speech given by former Deputy General Counsel and Solicitor of the USPTO John Whealen, where he "confirmed the existence of the Final Rules' substantive effects" by stating that "'[w]hat we have realized is that we are an agency, and we write rules, and we can actually change policy a lot quicker by making some rules that might change the patent system." With respect to whether the District Court "disregarded its obligations under Chevron" for even determining whether the Final Rules were substantive, Tafas responds that:
[S]uch complaint is ill-founded because the District Court would be unable to even reach the question of whether a preexisting right or obligation under the statute was being affected by a rule asserted by the USPTO to be procedural under 35 U.S.C. § 2(b)(2)(A) if it was required to simply defer to the USPTO's self-serving, ipse dixit interpretation that the Final Rules are not substantive.
As in the GSK brief, Tafas reviews the substantive effect of new Rules 75, 78, and 114, which would have limited the number of claims, continuations, and RCEs that an applicant could file as of right. With respect to new Rule 78, Tafas argues that it "is substantive in nature because it removes [an applicant's right under 35 U.S.C. § 120] to obtain priority in a subsequent application if certain new conditions are not met by an applicant filing the subsequent application." Tafas also observes that the interpretation that § 120 allows for an unlimited number of continuation applications is "in accord with the interpretation of former Federal Circuit Judge Giles S. Rich, as set forth in his 1952 commentary as a member of the drafting committee that promulgated Section 120 of the Patent Act: 'Section 120 . . . on careful reading . . . [indicates] that the number of generations of the lineage is unlimited.'"
With respect to new Rule 114, Tafas argues that:
Nothing in Section 132(a) or 132(b) supports the USPTO's assertion that it has the right to set the "conditions and requirements for continued examinations." Clearly, in using the word "shall" and "at the request of the applicant," and in requiring the Director to continue examination if the "applicant persists in his claims for a patent," Congress manifested its intent that RCEs be unlimited, and that continued examination be at applicant's discretion, not the discretion of the USPTO.
Tafas also notes that the Patent Office itself acknowledged that applicants could file unlimited numbers of RCEs when the Office promulgated rules related to such filings following the creation of RCEs under the American Inventors Protection Act of 1999.
Tafas also attacks the Patent Office's arguments concerning new Rule 265, which would have forced applicants to file Examination Support Documents (ESDs) if they wished to prosecute more than five independent or 25 total claims in a single application. Calling the requirement to file an ESD "not only burdensome, but actually an insurmountable barrier for most applicants," Tafas points to the Polestar/Norseman amicus brief for support. In that brief, Dr. Richard Belzer, who served as a civil service staff economist in the Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB), calculated that if Rule 265 were to be applied to all applicable applications filed in a representative fiscal year that it "would consume the full time efforts of between 8,000 and 23,000 patent attorneys," with Tafas noting that there are only about 15,000 patent attorneys currently in practice in the United States. Tafas also points again to Mr. Whealen's speech, where he stated that "[i]f you want all your claims examined up front, you can have it done, but it's going to cost you, you're going to have to do some work, which in the current law of inequitable conduct, nobody's going to want to do."
The U.S. Patent and Trademark Office and USPTO Director Jon Dudas now have until October 15th to file their reply brief.
Patent Docs wishes to thank James Nealon of Kelley Drye & Warren LLP for kindly providing us with a copy of Dr. Tafas' brief. In addition, we offer a belated thanks to Christopher Mizzo of Kirkland & Ellis LLP for kindly providing us with a copy of GSK's brief.
For additional information regarding the appeal, please see:
• "GSK Files Brief in Tafas v. Dudas Appeal," September 25, 2008
• "Tafas v. Dudas Update," September 2, 2008
• "Public Interest Groups Back USPTO in Tafas v. Dudas Appeal," August 5, 2008
• "USPTO Files Opening Brief in Tafas v. Dudas Appeal," July 22, 2008
• "Save the Date -- Initial Scheduling of the Tafas/GSK v. Dudas Appeal," May 21, 2008
• "USPTO to Appeal Tafas/GSK v. Dudas," May 7, 2008
The U.S. Patent and Trademark Office issued a 
patent procedures and to enhance consistency in the quality of patent examination. This statement, as well as the recently announced memorandum signed with the Korean Intellectual Property Office (KIPO) (see "
In a September 25, 2008 
About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.
October 6-7, 2008 - 
Yesterday, we reported on the introduction of a new patent reform bill (S. 3600) in the Senate (see "
administrative challenge system" contemplated in S. 1145. Mr. Greenwood also reiterated BIO's position that the organization "remains committed to working with all Senators and Representatives, their staff, and other stakeholders to reach agreement on how best to improve our nation's patent system in a way that promotes innovation, improves patent quality and increases public participation," calling the Kyl bill " an important step forward in enacting patent reform that will benefit the American economy."
On Wednesday, SmithKline Beecham Corp., SmithKline Beecham plc, and Glaxo Group Ltd. (GSK) filed their brief in the Tafas v. Dudas appeal (see "
Last April (this time on April Fool's Day), Judge Cacheris made the injunction permanent, finding that "the [continuation and claims] Rules are substantive in nature and exceed the scope of the USPTO's rulemaking authority under 35 U.S.C. § 2(b)(2)." Judge Cacheris therefore voided the new rules. Citing 
In its opening brief, the Patent Office made two main assertions: first, that the Office acted within its rulemaking authority, and second, that the continuation and claims rules do not violate the relevant statutory provisions (see "
In its 60-page brief, GSK begins by attacking the Patent Office's claim to broad Chevron deference. According to GSK, the Patent Office takes the view that "the district court should have first cloaked the agency with Chevron deference, then deferred to the PTO’s view of the scope of its own powers, and then deferred again to the PTO’s view that the Final Rules are consistent with the Patent Act." GSK argues, however, that such a view sidesteps the Supreme Court's determination in 
During this Congress, the biotech and pharma sectors appeared to be caught flat-footed in the face of a concerted effort by information technology companies and their affiliated pressure groups (like the Coalition for Patent Fairness) to "reform" patent law out of effective existence. Not this time: 
Section 13, for example, is a provision very similar to the provision introduced into S. 1145 with some degree of haste and secrecy and a large absence of public review and commentary. The brain-child of Senator Jeff Sessions (R-AL), it purports to shield from patent infringement liability banks using an electronic check clearing technology owned by a small Texas company, DataTreasury. One of the major objections to the corresponding provision in S. 1145 is that, if passed, it would represent a "taking" of DataTreasury's property, for which the U.S. government could be liable in the Court of Claims. While paling in comparison to the magnitude of the proposed Wall Street bailout currently under consideration by Congress, the amount of the government's liability to DataTreasury could be as high as $4 billion (accruing to the benefit of the banking industry). Clearly cognizant of the political difficulties the provision created in S. 1145, Senator Kyl's bill has a savings provision: should passage of Section 13 of the bill be found to be a taking, these provisions will become "null and void."
In a 
Briefly, the Notice lists several requirements for applications to be eligible to participate in the PPH pilot program, including:
The U.S. Patent and Trademark Office (USPTO) issued a 
The memorandum seeks to promote work-sharing between the USPTO and KIPO through harmonization of patent examination processes. Particular plans include establishing a common search database, developing a standardized patent classification system, establishing common examiner training, and increasing the use of prior examination results from the other office. The two patent offices plan to have several meetings later this year to start planning the implementation of these the cooperative projects.
According to Teva's release, the company's G-CSF product, which will be marketed in Europe under the brand name TevaGrastim® beginning in 2009, is the first G-CSF biosimilar to receive a marketing authorization in the EU. The EMEA website indicates that the Filgrastim biosimilars 
Late last week, Magistrate Judge Mary Pat Thynge granted Amgen's motion of summary judgment of non-infringement as to all asserted claims in Amgen Inc. v. ARIAD Pharmaceuticals Inc., Civil Action No. 06-cv-00259 (D. Del). At issue was Amgen's Enbrel® (etanercept, a TNF blocker) product. (Another Amgen product, Kineret® -- anakinra, an IL-1 receptor antagonist -- was previously accused of infringement as well, but ARIAD later withdrew its assertion of infringement against this product).
Judge Thynge's ruling was based primarily on the testimony of ARIAD's expert in view of the claim construction of the term "reducing NF-kB activity in [the] cells." The Court construed this claim limitation, in accordance with Amgen's proposal, as meaning "taking action inside cells to directly inhibit (interfere or block) an NF-kB activity." Relying on testimony by ARIAD's expert that Enbrel® acts only extracellularly, and that she could not think of an infringement argument in the event the Court adopted Amgen's claim construction, Judge Thynge concluded that there was no issue of material fact concerning ARIAD's infringement claims against Amgen.
Last week, Forbes.com 
can get products to market more quickly." Forbes.com also noted that Obama similarly supported making the exclusivity period as short as possible for biotech drugs. In addition, Obama's health care advisor Dora Hughes noted that the Illinois Senator intends to put an end to the "reverse payment" practice, in which innovators pay generic drug manufacturers to delay introduction of generic drugs.
BioWorld 
The Intellectual Property Owners Association (IPO), which just concluded its 2008 Annual Meeting in San Diego, 
After several years of having its decisions reversed by the Supreme Court -- including 
The Federal Circuit reversed, in an opinion written by Judge Linn and joined by Judges Newman and Bryson. The Court based its decision on statutory construction, specifically whether 35 U.S.C. § 282 was sufficient to include within its auspices IGT's novel "improper revival" defense. In concluding it did not, the Court construed the provisions of 35 U.S.C. § 282(2) relating to "any ground specified in part II of this title as a condition for patentabity." The "conditions for patentability," according to the opinion, were those recited in §§ 101, 102, and 103, and they specifically do not include § 133 that contains the six-month deadline for prosecuting an application. In doing so the court drew a distinction between these "conditions for patentability" and sections such as § 112, which it characterized as "merely requirements for obtaining a valid patent." The opinion supports its interpretation with reference to § 282(3), which expressly recites failure to comply with §§ 112 or 251; according to the opinion, IGT's interpretation (and the District Court's) would render this portion of the statute redundant, an outcome contrary to the principles of statutory construction. The CAFC similarly dismissed IGT's contention, and the District Court's reliance thereupon, that the "catch-all" provisions of § 282(4) was a sound basis for its decision. The Federal Circuit stated that this argument "pretermits the fundamental requirement of the subsection -- namely, that the act or fact is 'made' a defense by the title." If followed, the District Court's interpretation of § 282(4) would eliminate the need for § 282(1) through (3); if Congress had "intended to permit any provision of title 35 to constitute a defense in an action involving the validity or infringement of a patent, it could have simply said, in one paragraph rather than four, that a defense lies in 'any section of this title.'"
It is important to note that the emergency interruption provisions are applicable only to postal interruptions (e.g., post office closed or suspended Express Mail service) and does not provide for the granting of a filing date to correspondence that is not timely filed because of other circumstances (e.g., closing of buildings other than a Post Office). Petitions to accord a filing date in light of the weather related emergencies can be made under 37 C.F.R. § 1.10(i). Additional questions regarding this interruption can be directed to Eugenia Jones, Senior Legal Advisor in the OPLA, by phone 571-272-7701 or by e-mail at PatentPractice@uspto.gov.
Visiongain will be holding its 4th Biosimilars conference on November 11-13, 2008 in Philadelphia, PA. The conference is intended to help attendees:
In addition, a pre-conference interactive biosimilars workshop will be offered on November 11. The agenda for the Biosimilars conference can be found 
On Wednesday, 
Earlier this month, eGenomics, Inc. 
Dr. Barry Kreiswirth (at left), who founded eGenomics with Steve Naidich, believes that the system "should be a major component of every hospitals' effort to monitor and prevent methycillin-resistant strains of Staphylococcus aureus (MRSA) infections," and noted that eGenomics was in the process of expanding its system to track other common 
