Patent Docs

USPTO Proposes Rules Changes for Implementing AIA Provisions — Preissuance Submissions Provision

January 12, 2012

By Donald Zuhn —

Last week, the U.S. Patent and Trademark Office published four Federal Register notices as part of its efforts to implement the Leahy-Smith America Invents Act. Yesterday, we discussed the Office's notice regarding implementation of miscellaneous post patent provisions in the AIA (see "USPTO Proposes Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent Provisions"). Today, we address the Office's notice regarding implementation of the AIA's preissuance submissions provision ("Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act," 77 Fed. Reg. 448).

Section 8 of the AIA amends 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. 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 takes effect on September 16, 2012, and will apply to any patent application filed before, on, or after that date.

In implementing the preissuance submissions provision of the AIA, the Office notes that such submissions may filed in paper or electronically via the EFS-Web, but that such submissions "would not be automatically entered into the electronic image file wrapper (IFW) for an application," but instead, "would be reviewed to determine compliance with 35 U.S.C. 122(e) and new 37 CFR 1.290 before being entered into the IFW." The Office also notes that "[n]on-compliant third-party preissuance submissions would not be entered into the IFW of an application or considered and would be discarded," and further, that the Office would not provide a refund of the fee required for making a preissuance submission in the event that the submission was found to be non-compliant. The notice indicates that the Office "may attempt to notify the third party submitter of such non-compliance," if the submitter has provided an e-mail address, but that the statutory period for making the submission would not be tolled.

The notice states that "third-party submissions will not create a duty on the part of the applicant to independently file the submitted documents with the Office in an information disclosure statement (IDS)." The notice also states that examiners will "consider the documents and concise descriptions submitted in a compliant third-party preissuance submission in the same manner that the examiner considers information and concise explanations of relevance submitted as part of an IDS."

Noting that 37 C.F.R. § 1.99 currently provides for a third-party submission of up to ten documents for the fee set forth in 37 C.F.R. § 1.17(p), which is currently $180.00, and with the expectation that the processing costs of preissuance submissions under new 37 C.F.R. § 1.290 will be similar, the notice indicates that the fee set forth in 37 C.F.R. § 1.17(p) will also be applicable to third-party preissuance submissions of no more than ten documents. The fee will be waived for a preissuance submission that "lists three or fewer total documents and is the first preissuance submission submitted in an application by a third party or a party in privity with the third party." Besides noting that 35 U.S.C. 122(e) will be implemented as new rule 37 C.F.R. § 1.290, the notice also indicates that current § 1.99 will be eliminated. (The notice also indicates that the public use proceeding provisions of 37 C.F.R. § 1.292 will be eliminated because AIA § 6 makes available a post-grant review proceeding in which prior public use may be raised.)

Additional discussion of the rules changes, as well as revised versions of the affected rules, can be found in the Office's Federal Register notice (77 Fed. Reg. 448).

Comments regarding this notice can be submitted by e-mail to preissuance_submissions@uspto.gov; by regular mail addressed to: Mail Stop Comments — Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Nicole D. Haines, Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy.; or via the Federal eRulemaking Portal [http://www.regulations.gov/#!home]. The deadline for submitting comments is March 5, 2012. Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 448).
USPTO Proposes Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent Provisions

January 11, 2012

By Donald Zuhn —

Last fall, the U.S. Patent and Trademark Office announced that it would be releasing a number of a Federal Register notices in January as part of the Office's efforts to implement the Leahy-Smith America Invents Act (see "USPTO News Briefs"). On Friday, the Office issued a press release noting that four notices of proposed rulemaking regarding implementation of various provisions of the AIA had been published in the Federal Register on January 5. These four notices concern:

• Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 442);
• Changes To Implement the Preissuance Submissions by Third Parties Provision of the Leahy-Smith America Invents Act (77 Fed. Reg. 448);
• Implementation of Statute of Limitations Provisions for Office Disciplinary Proceedings (77 Fed. Reg. 457); and
• Changes To Implement the Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act (77 Fed. Reg. 982).

The Office noted that the publication of the proposed rules commenced a 60-day period for public comment. The Office also noted that proposed rules on supplemental examination, inter partes review, post-grant review, the transitional program for covered business methods, and derivation would be published later this month.

Patent Docs will discuss each of the four notices published last week, beginning with the notice to implement miscellaneous post patent provisions of the AIA. Subsequent posts will address the other notices.

In the notice entitled "Changes To Implement Miscellaneous Post Patent Provisions of the Leahy-Smith America Invents Act," the Office notes that AIA provisions result in the following changes to Title 35:

• AIA § 6(g) amends 35 U.S.C. § 301 to expand the information that can be submitted in the file of an issued patent to include written statements made by a patent owner before a Federal court or the Office regarding the scope of any claim of the patent;
• AIA § 6(a) and (d) contain provisions in new 35 U.S.C. §§ 315(e)(1) and 325(e)(1) that estop a third party requester from filing a request for ex parte reexamination where the third party requester filed a petition for inter partes review or post grant review and a final written decision under 35 U.S.C. §§ 318(a) or 328(a) has been issued;
• AIA § 6(h)(1) amends 35 U.S.C. § 303 to expressly identify the authority of the Director to initiate reexamination based on patents and publications cited in a prior reexamination request under 35 U.S.C. § 302;
• AIA § 3(i) replaces interference proceedings with derivation proceedings;
• AIA § 3(j) replaces the "Board of Patent Appeals and Interferences" with the "Patent Trial and Appeal Board" in 35 U.S.C. §§ 134, 145, 146, 154, and 305;
• AIA § 6(a) replaces inter partes reexamination with inter partes review of a patent;
• AIA § 6(d) provides for post-grant review of patents; and
• AIA § 7 amends 35 U.S.C. § 6(b) to define the duties of the Patent Trial and Appeal Board.

To implement these changes, the Office proposes a number of rules changes, including the following:

• Rule 1.501 — rewritten to allow for the submission of "statements of the patent owner filed in a proceeding before a Federal court or the Office in which the patent owner took a position on the scope of any claim of a particular patent";
• Rule 1.501(f) — limits the use of statements of the patent owner and accompanying information for determining the proper meaning of a patent claim in an ex parte reexamination proceeding that has been ordered pursuant to 35 U.S.C. § 304, an inter partes review proceeding that has been instituted pursuant to 35 U.S.C. § 314, or a post grant review proceeding that has been instituted pursuant to 35 U.S.C. § 324;
• Rule 1.510(b)(6) — requires a certification that the estoppel provisions of inter partes review and post grant review do not bar the third party from requesting ex parte reexamination, as well as a statement identifying the real parties in interest to allow for a determine as to whether an inter partes review or post grant review filed subsequent to an ex parte reexamination bars the third party from maintaining a pending ex parte reexamination (the requester can remain anonymous by providing the identification and requesting that the Office seal it);
• A number of rules would be rewritten to replace "Board of Patent Appeals and Interferences" with "Patent Trial and Appeal Board," add specific references to trial proceedings before the Patent Trial and Appeal Board, and add specific references to derivation proceedings.

Additional discussion of the rules changes, as well as revised versions of the affected rules, can be found in the Office's Federal Register notice (77 Fed. Reg. 442).

Comments regarding this notice can be submitted by e-mail to post_patent_provisions@uspto.gov; by regular mail addressed to: Mail Stop Comments — Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kenneth M. Schor, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal. The deadline for submitting comments is March 5, 2012. Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 442).
Celsis In Vitro, Inc. v. Cellzdirect, Inc. (Fed. Cir. 2012)

January 10, 2012

By Kevin E. Noonan —

The effects of the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. continue to ripple unpredictably through the Federal Circuit's jurisprudence, promoting inconsistencies in obviousness determinations by the Court that seem contrary to its mandate to harmonize U.S. patent law. The most recent illustration of this effect is in Celsis In Vitro, Inc. v. Cellzdirect, Inc., where a divided panel affirmed the grant of a preliminary injunction over a dissent based, in part, on a rigid understanding of the implications of the KSR decision.

The suit by Celsis alleged infringement of U.S. Patent No. 7,604,929, specifically a method for providing cryopreserved human hepatocytes:

A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes, being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:
    (A) subjecting hepatocytes that have been  frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,
    (B) recovering the separated viable hepatocytes, and
    (C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

Thus, the claim recited three steps: subjecting frozen and thawed hepatocytes to a density gradient to separate viable from non-viable cells; recovering the viable cells, and freezing the cells again that have >70% viable cells after a second thaw without requiring density gradient step. Evidence before the District Court established that human hepatocytes are fragile and hard to cryopreserve, being very susceptible to damage when frozen and thawed and that there was an expectation in the art that repetition would make that worse, i.e., there would be even fewer viable cells after several freeze/thaw cycles. Human hepatocytes were in short supply and there was large demand, with available sources in the art being limited to fresh tissue that is rarely available. As a consequence, research was disrupted because it was dependent on sporadic availability of these cells. The opinion in the art was that hepatocytes could not be productively cryopreserved because too many non-viable cells were produced, the Court noting that "experts in this field met initial attempts to freeze hepatocytes with skepticism." The accused infringing article was a pooled multi-cryopreserved hepatocyte product allegedly produced using the claimed method (although the opinion does not give the details of the accused products "[f]or confidentiality reasons") sold in direct competition with the Celsis product (also a pooled multi-cryopreserved hepatocyte product). The District Court (Judge Milton Shadur of the Northern District of Illinois) granted the preliminary injunction.

The Federal Circuit affirmed, in an opinion by Chief Judge Rader joined by Judge Prost, with a dissent by Judge Gajarsa. The majority opinion recited the "four factors" considered with regard to a preliminary injunction: "(1) likelihood of success on the merits, (2) irreparable harm, (3) balance of hardships, and (4) public interest." Defendants challenged the District Court's decision on the first prong based on non-infringement and invalidity (for obviousness). Regarding infringement, there was a "battle of the experts" won by Celsis, perhaps in part because defendants put forward their marketing director as an expert. The Celsis expert provided testimony on the meaning of claim term "density gradient fractionation" and then "applied the term to the accused process." The District Court's decision regarding infringement was also based decision on construction of the term "not requiring" for performing a second density gradient fractionation as being inclusive of methods that actually perform a second density gradient fractionation (provided it is not "required"). The District Court expressly rejected defendants' construction that "not requiring" was equivalent to "prohibited," based on its interpretation that this construction incorporated a limitation from the specification into the claim (which the Court characterized as "hokum"). On this record, the Federal Circuit found no abuse of discretion by the District Court in deciding there was a likelihood that Celsis would succeed in its infringement claim.

The second issue was non-obviousness. Evidence from both parties included a "vast proliferation of authors and articles dealing with hepatocytes and use of cryopreservation." The District Court concluded that the claimed method was non-obvious because "not a single one of that astonishingly large body of literature was devoted to the subject of multi-cryopreservation of hepatocytes" (with the District Court noting stress on "multi"). The District Court rejected testimony from defendants' expert that one of his articles disclosed multi-cryopreservation of hepatocytes, finding that the reference was limited to fetal hepatocytes, which were not the same as adult hepatocytes. Also, since fetal cells were replication-competent, District Court credited testimony from the Celsis expert that it was not possible to determine "whether the same cells were cryopreserved more than once" (which was conceded by defendants' expert). This reference not the issue on appeal, however; there was another reference that taught whether single-cryopreserved hepatocytes could substitute for fresh hepatocytes (in humans, dogs and monkeys).

In reviewing the District Court's non-obviousness determination, the majority recited the Graham v. John Deere Co. analytical framework of factual inquiries regarding: "(1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness," citing Eli Lilly & Co. v. Teva Pharm. USA, Inc., 619 F.3d 1329, 1336 (Fed. Cir. 2010). On this record, the majority found no abuse of discretion, while noting that defendants would be able to "expand upon the arguments it made at the preliminary injunction stage" at trial. The majority "does not opine on the final determination, which lays in the realm of the district court in the first instance." The opinion emphasized the unpredictability in the art, affirming the District Court's finding that "the art was a crowded field for many years and yet there was not one reference to multi-cryopreservation" and "taught away from multiple freezings." In addition, the opinion noted that the expectation in the art was that a second freezing would result in "greater loss of cells after the second cryopreservation than after the first" and relied upon this understanding as grounds for deciding the art did not render obvious the claimed invention.

In a passage noted in the dissent, the majority specifically found that the second reference relied upon in the appeal did not provide "any teaching, suggestion, or motivation . . . that multiple rounds of freezing would somehow increase rather than decrease cell viability" and criticized defendants' argument as "vague reference[] to 'market need.'" Rather, the majority said that "without more" this was evidence of the objective criteria of "long felt need" and thus was "supportive of non-obviousness." And as part of its analysis, the majority found the District Court's decision to be based in art on a (negative) assessment of defendants' witnesses' credibility, something the reviewing court gives "wide discretion" to the district court, citing Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1362-63 (Fed. Cir. 2006), Bristol- Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1236 (Fed. Cir. 2003), Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223, 1231-32 (Fed. Cir. 2007), and Agfa Corp. v. Creo Prods. Inc., 451 F.3d 1366, 1379 (Fed. Cir. 2006). Rather, the opinion states:

Not one of LTC's experts testified to actually performing the claimed process or documenting their alleged understanding before the time of the invention, despite having the financial, scientific, and professional incentive to do so. The district court found that LTC's experts did not predict the results of the claimed methods at the time of the invention, nor could they find any reference in the prior art suggesting that any other scientist had.

The Federal Circuit also found no abuse of discretion by the District Court in determining that the other prongs of the test, irreparable harm, balance of the hardships and the public interest, were satisfied. "Irreparable harm" in this case included "price erosion, damage to ongoing customer relationships, loss of customer goodwill (e.g., when an effort is later made to restore the original price), and loss of business opportunities," all of which the majority found were "valid grounds for finding irreparable harm," citing Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1362 (Fed. Cir. 2008), and Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1382-83 (Fed. Cir. 2006). The Court based its agreement on the balance of the hardships on the fact that "[defendant's] losses were the result of its own calculated risk in selling a product with knowledge of Celsis' patent," citing Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed. Cir. 2006). The public interest "favors the enforcement of Celsis' patent rights" in this case because "investment in drug research and development must be encouraged and protected by the exclusionary rights conveyed in valid patents," and does not constitute an abuse of discretion because "[t]hat incentive would be adversely affected by taking market benefits away from the patentee and giving them to the accused infringer in this case."

Judge Gajarsa's dissent illustrates how the Supreme Court's KSR decision has a tendency to tip the balance between an objective assessment of the prior art as understood by one having ordinary skill in the art and its relevance to the claimed invention in favor of a court's subjective determination that an invention is obvious (the "I know it when I see it" standard). In addition, Judge Gajarsa evinces a belief that a preliminary injunction is "an 'extraordinary and drastic' remedy" that should be denied if a defendant can raise a (presumably unrebutted) "substantial question" on the patent's validity. Here, he writes that the District Court abused its discretion by committing legal error with regard to obviousness by holding defendants "to a clear and convincing standard of proof" and "reinvigorate[ing] the pre-KSR standard for obviousness, rigidly requiring an explicit teaching, suggestion, or motivation for multi- cryopreserving hepatocytes."

The basis for this opinion is that, in his view, the absence of "two limitations of the claimed invention" (freezing and thawing hepatocytes a second time and making the density gradient fractionation optional after the second thaw)" in the prior art did not defeat defendants' obviousness argument, because "obviousness does not require that each element of the claimed invention must be present in the prior art," citing Tegal Corp. v. Tokyo Electron Am., Inc., 257 F.3d 1331, 1349 (Fed. Cir. 2001). Indeed, in his view "all of the claimed elements were present in the prior art," including "(1) thawing cryopreserved hepatocytes; (2) using density gradient fractionation to separate viable and non-viable cells; and (3) refreezing and rethawing the hepatocytes." Taking each limitation individually (rather than considering the invention as a whole according to the plain language of the statute), the dissent notes that "[b]oth cryopreservation and density gradient fractionation were well known in the art at the time of the invention." In Judge Gajarsa's opinion, the remaining step recited in the claim was "nothing more than measuring the viability of cells thawed for a second time. If the cells have more than 70% viability, they meet this limitation; if they do not have 70% viability, they do not meet this limitation." Citing Great Atl. & Pac. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152-153 (1950), the dissent characterizes the invention as a "patent for a combination which only unites old elements with no change in their respective functions [and] obviously withdraws what already is known into the field of its monopoly." The invention in Judge Gajarsa's view of nothing more than "[r]epeating known steps to obtain a desired result" which is not inventive, citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1330-31 (Fed. Cir. 2009). The dissent also characterizes the majority's recognition that the art was unpredictable, and would have expected the claimed invention to be inoperative, as trying to "have it both ways," citing Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007), for the principle that "some degree of unpredictability" cannot render an invention non-obvious "so long as there was a reasonable expectation of success," despite the majority's reliance on evidence that there was no such reasonable expectation of success in this case.

The dissent also finds fault with the majority's citation of defendants' failure to provide evidence of any "teaching, suggestion or motivation" in the art as being contrary to the Supreme Court's KSR precedent, eliding the nuance that the Court corrected the Federal Circuit for rigid application of the test and, in fact, preserved the TSM test as being a useful analytical tool for deciding obviousness provided it was not rigidly applied.

The dissent illustrates the difficulties that arise from the Supreme Court's most quoted passage from KSR:

'When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp,' the invention is likely obvious.

The first portion of the sentence conflates the obviousness analysis from Graham v. John Deere with one of the objective indicia of non-obviousness; it is clear that grounds for finding an invention non-obviousness ("long-felt need in the art") cannot also be a basis for finding an invention obvious ("when there is a design need or market pressure to solve a problem"). Rather, it is only when the Supreme Court's statement is taken in its entirety that the two analytical frameworks can be reconciled: that in response to the need (long-felt or otherwise), and when there exists a "finite number of identified, predictable solutions" and (in a portion of the Supreme Court's teachings not recited in the dissent) "[i]f this leads to the anticipated success," then "it is likely the product not of innovation but of ordinary skill and common sense." It would appear that the required expectation of success was missing under the facts of this case.

The other basis for Judge Gajarsa's disagreement with the majority relates to the burden placed on defendant in avoiding the preliminary injunction. According to the dissenting opinion, defendants were required merely to provide evidence that the asserted claims were "vulnerable" and did not need to establish (by clear and convincing evidence) that the claims were invalid. This amounts to merely raising a "substantial question" regarding the claims' validity according to Judge Gajarsa, citing Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001); Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997), and Kimberly-Clark Worldwide, Inc. v. First Quality Baby Products, LLC, 431 Fed. Appx. 884, 886-7 (Fed. Cir. 2011). The District Court (and the majority) improperly shifted the burden to defendants, according to the dissent, and should have "simply decide[d] whether it is more likely than not that the patent will be proven invalid at trial," citing Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1379-80 (Fed. Cir. 2009).

Once again, these diverging standards for deciding questions of obviousness create a certain nostalgia for the wisdom of Judge Learned Hand in considering obviousnses:

The test laid down [in 35 U.S.C. § 103] is indeed misty enough. It directs us to surmise what was the range of ingenuity of a person "having ordinary skill" in an "art" with which we are totally unfamiliar; and we do not see how such a standard can be applied at all except by recourse to the earlier work in the art, and to the general history of the means available at the time. To judge on our own that this or that new assemblage of old factors was, or was not, "obvious" is to substitute our ignorance for the acquaintance with the subject of those who were familiar with it. Reiner v. I. Leon Co., 285 F.2d 501 (2d Cir. 1960)

Courts, made up of laymen as they must be, are likely either to underrate, or to overrate, the difficulties in making new and profitable discoveries in fields with which they cannot be familiar; and so far as it is available, they had best appraise the originality involved by the circumstance which preceded, attended and succeeded the appearance of the invention. Safety Car Heat & Light Co. v. General Electric Co., 155 F.2d 937 (2d Cir. 1946).

Celsis In Vitro, Inc. v. Cellzdirect, Inc. (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Gajarsa and Prost
Opinion by Chief Judge Rader; dissenting opinion by Circuit Judge Gajarsa
USPTO Proposes Change to PTA Provisions Regarding Appellate Review

January 9, 2012

By Donald Zuhn —

On December 28, the U.S. Patent and Trademark Office issued a notice of proposed rule making regarding certain patent term adjustment (PTA) provisions in the Federal Register (76 Fed. Reg. 81432). In particular, the Office has proposed that the period of adjustment for applications involved in appellate review begin when jurisdiction over the application passes to the Board rather than the date on which a notice of appeal to the Board is filed. According to the notice, jurisdiction of an appeal passes to the Board at the earlier of the filing of the reply brief or upon the expiration of the time in which to file a reply brief. While the Office acknowledges that "the impact of the rule change would be to reduce the amount of patent term adjustment awarded for successful appeal under 35 USC 154(b)(1)(C)(iii)," the Office also notes that in certain circumstances, "the impact may be offset by potentially increasing the amount of patent term adjustment awarded for failing to issue the patent within three years of the actual filing date in the United States under 35 USC 154(b)(1)(B)." The notice explains that one such situation could be where the examiner reopens prosecution after a notice of appeal has been filed and the patent issues thereafter.

According to the notice, the proposed rule making is based on comments the Office received in response to a Federal Register notice the Office published in April 2011 (see "USPTO Proposes Changes to PTA and PTE Provisions"). In particular, the Office noted that several comments suggested that the appellate review period should be treated as beginning when jurisdiction passes to the BPAI, rather than on the date a notice of appeal to the BPAI was filed, so that applicants could obtain patent term adjustment under 35 U.S.C. 154(b)(1)(B) (i.e., delay arising from the USPTO's failure to issue a patent within three years of an application's actual filing date). Currently, "B" delay does not include the period of appellate review by the BPAI or a Federal court, and the period of appellate review begins with the filing of a notice of appeal. The Office's notice provides a detailed explanation as to how the Office arrived at the new interpretation of the start of the appellate review period (see page 81434).

Comments regarding the proposed change should be sent e-mail to AC63.comments@uspto.gov; by regular mail to Mail Stop Comments — Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kery A. Fries, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal. The deadline for submitting comments is January 27, 2012.
Court Report

January 8, 2012

By Sherri Oslick —

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

Takeda Pharmaceutical Co. et al. v. Mylan, Inc. et al.
1:12-cv-00024; filed January 3, 2011 in the Southern District of New York

• Plaintiffs: Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.; Takeda Global Research and Development Center, Inc.; Watson Pharmaceuticals, Inc.; Andrx Labs, LLC
• Defendants: Mylan, Inc.; Mylan Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,099,859 ("Controlled Release Oral Tablet Having a Unitary Core," issued August 8, 2000), 6,495,162 (same title, issued December 17, 2002), 6,790,459 ("Methods for Treating Diabetes Via Administration of Controlled Release Metformin," issued September 14, 2004), 6,866,866 ("Controlled Release Metformin Compositions," issued March 15, 2005), 7,785,627 ("Pharmaceutical Formulation Containing a Biguanide and a Thiazolidinedione Derivative," issued August 31, 2010), 7,919,116 ("Controlled Release Metformin Composition," issued April 5, 2011), and 7,959,946 ("Pharmaceutical Formulation Containing a Biguanide and a Thiazolidinedione Derivative," issued June 14, 2011) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Takeda's ACTOplus met® (pioglitazone and metformin, used an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes). View the complaint here.

Allergan, Inc. v. Lupin Ltd. et al.
2:11-cv-00530; filed December 30, 2011 in the Eastern District of Texas

• Plaintiff: Allergan, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,008,338 (""Ketorolac Tromethamine Compositions for Treating or Preventing Ocular Pain," issued August 30, 2011) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Allergan's Acular LS® (ketorolac tromethamine ophthalmic solution, 0.4%, used for the reduction of ocular pain and burning/stinging following corneal refractive surgery). View the complaint here.
Conference & CLE Calendar

January 8, 2012

January 11, 2012 – Biotechnology European Patent Case Law (D Young & Co.) – 7:00 – 7:45 am and 12:00 – 12:45 pm (EST)

January 20, 2012 – Prosecution Strategies: Tackling USPTO Obviousness Rejections (American Bar Association) – 1:00 – 2:30 pm (Eastern)

January 25-26, 2012 – Biosimilars Forum 2012 (C5) – London, UK

January 26, 2012 – Life Under AIA: Anticipating and Surviving Post Grant Challenges (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

January 31, 2012 – Obviousness Standard for Patents: Approaches to Withstand USPTO Obviousness Rejections and Attacks on Patent Validity (Strafford) – 1:00 – 2:30 pm (EST)

January 31 – February 1, 2012 – Patent Reform for Life Sciences Companies*** (American Conference Institute) – New York, NY

January 31 – February 1, 2012 – Pharma & Biotech Patent Litigation (C5) – Amsterdam, The Netherlands

February 13-14, 2012 – China IP Counsel Forum (C5) – Shanghai, China

February 21-22, 2012 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

February 22-23, 2012 – EU Pharma Law & Regulation*** (C5) – London, England

February 22-24, 2012 – Intensive Patent Law Training Seminar (Chisum Patent Academy) – New York, NY

February 27-29, 2012 – Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – New York, NY

February 28-29, 2012 – Medical Device Patents*** (American Conference Institute) – Boston, MA

March 14-15, 2012 – Biotech Patenting (C5) – Munich, Germany

***Patent Docs is a media partner of this conference or CLE
European Biotech Patent Law Update

January 8, 2012

D Young & Co. will be offering a live webinar on "Biotechnology European Patent Case Law" on January 11, 2012. The 45-minute webinar will be offered at two times: 7:00 am (EST) and 12:00 pm (EST). Robert Dempster and Simon O'Brien will provide an essential update and live Q&A on European biotechnology case law.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
ABA Webinar on Tackling Obviousness Rejections

January 8, 2012

The American Bar Association (ABA) Section of Intellectual Property Law, Young Lawyers Division, ABA-IPL Young Lawyers Action Group, and Center for Continuing Legal Education will be offering a live webinar entitled "Prosecution Strategies: Tackling USPTO Obviousness Rejections" on January 20, 2012 from 1:00 – 2:30 pm (Eastern). Dr. Janet S. Hendrickson (moderator) of Senniger Powers LLP, Gregory L. Hillyer of Feldman Gale, Michelle E. O'Brien of O'Brien Jones PLLC, and Zachary S. Stern of Oblon, Spivak, McClelland, Maier & Neustadt, LLP will explore how the standards from KSR v. Teleflex have been applied in various technology areas and provide guidance for effective avenues of argument based on the technology area, as well as discuss various arguments that may be effective, but may also narrow the scope of arguments that can be made during litigation.

The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public (for group fee options, please visit the event website). Those interested in registering for the webinar, can do so here or by calling 800-285-2221.
Top Stories of 2011: #3 to #1

January 5, 2012

By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories. For 2011, we identified a dozen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Monday and Tuesday, we counted down stories #12 to #10 and #9 to #7, and yesterday, we covered stories #6 to #4. Today, we present the top three stories for 2011. As with our other lists (2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

3. Federal Circuit Issues Standards for Establishing Inequitable Conduct Defense

In May, the Federal Circuit delivered its en banc opinion on inequitable conduct in Therasense, Inc. v. Becton, Dickinson & Co. The majority determined that (a) an omitted reference is a material reference only if "but for" its exclusion, the claim or patent would not have issued; (b) a finding of inequitable conduct requires clear and convincing evidence of a specific intent to deceive by the applicant; (c) a court cannot use a "sliding scale" to find inequitable conduct, i.e., it cannot use a strong showing of materiality to overcome a weak showing of intent; (d) both materiality and intent to deceive must be supported by clear and convincing evidence; and (f) courts should apply equity to ensure that the remedy of unenforceability is not imposed for misconduct that was "immaterial to the issuance of the patent." The opinion was authored by Chief Judge Rader and joined in full by Judges Newman, Lourie, Linn, Moore, and Reyna. Judge O'Malley joined in part, and Judge Bryson authored a dissenting opinion and was joined by Judges Gajarsa, Dyk, and Prost. The dissent differed from the majority with regard to the standard for assessing materiality, arguing that the best measure of a material reference is the one used by the U.S. Patent and Trademark Office and codified as PTO Rule 56 (37 C.F.R. § 1.56). Shortly after the Federal Circuit handed down its decision in Therasense, the USPTO published a notice in the Federal Register proposing to change the Office's definition of materiality in Rule 56 to be consistent with the materiality standard enunciated in Therasense, and seeking comments regarding the proposed change.

For information regarding this and other related topics, please see:

• "Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2011)," September 15, 2011
• "USPTO Proposes Change in Duty of Disclosure," July 21, 2011
• "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc): Judge O'Malley's Opinion," May 30, 2011
• "USPTO Studying Therasense Decision, Will Issue Guidance Soon," May 26, 2011
• "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc): The Dissenting Opinion," May 26, 2011
• "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc)," May 25, 2011

2. Federal Circuit Issues Decision in AMP v. USPTO

Two months after giving the patent community some clarity with respect to inequitable conduct, the Federal Circuit issued its decision in Association for Molecular Pathology v. United States Patent and Trademark Office — the Myriad gene patenting case. The decision, however, was somewhat fractured, with Judge Lourie writing for the majority; Judge Moore authoring a concurring opinion, joining certain parts of the "majority" opinion and for other parts, concurring with the result; and Judge Bryson concurring-in-part and dissenting-in-part. On the substantive issues, the majority reversed the District Court's finding that "isolated DNA" was not patent-eligible under the "products of nature" "exception," affirmed the District Court on the diagnostic method claims under the Bilski "machine or transformation test," and reversed on the sole screening method claim at issue. Biotech practitioners and applicants no doubt breathed a sigh of relief as to the Court's finding of patent-eligibility for the composition of matter ("gene") claims. Following the decision, the Federal Circuit denied petitions for panel rehearing filed by both Plaintiffs/Appellees and Defendants/Appellants. Last month, counsel for Plaintiffs/Appellees (the American Civil Liberties Union (ACLU) and Public Patent Foundation (PubPat)) filed a petition for certiorari with the Supreme Court, ensuring that the case will likely be on next year's Top Stories list.

While the Federal Circuit was addressing the gene patenting issue in the United States, the Australian Senate was addressing the issue Down Under. In September, the Legal and Constitutional Affairs Legislation Committee of the Australian Senate issued a recommendation that the Senate not pass The Patent Amendment (Human Genes and Biological Materials) Bill 2010, which would have prevented the patenting of biological materials that are identical or substantially identical to materials as they exist in nature (such as genes and proteins).

For information regarding this and other related topics, please see:

• "Plaintiffs File Petition for Certiorari in AMP v. USPTO," December 8, 2011
• "News from Abroad: The Gene Patents Debate in Australia — An Update," December 1, 2011
• "Like Two Ships Passing in the Night: U.S. and Europe Consider Patent Eligibility of Biological Materials," November 22, 2011
• "Australian Senate Committee Issues Recommendation on Gene Patenting Bill," October 6, 2011
• "Federal Circuit Denies Petition for Rehearing in AMP v. USPTO," September 18, 2011
• "Federal Circuit Denies Plaintiff(s)' Petition for Rehearing in AMP v. USPTO," September 14, 2011
• "Defendants File Petition for Rehearing in AMP v. USPTO," August 30, 2011
• "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO," August 29, 2011
• "Plaintiff(s) File Petition for Rehearing in AMP v. USPTO," August 28, 2011
• "CyberSource and the Tragedy of Bad Analogies," August 24, 2011
• "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?" August 23, 2011
• "WFU Law Professor Says Federal Circuit Failed as 'Keeper of the Constitution' in AMP v. USPTO," August 22, 2011
• "AMP v. USPTO: Standing," August 4, 2011
• "AMP v. USPTO: Judge Bryson's Opinion," August 3, 2011
• "AMP v. USPTO: Judge Moore's Concurring Opinion," August 2, 2011
• "Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2011)," August 1, 2011
• "Standing in AMP v. USPTO: The Plot Thickens," July 29, 2011
• "Federal Circuit Issues Decision in AMP v. USPTO," July 29, 2011
• "Myriad Writes to Federal Circuit on Standing Issue," July 28, 2011
• "AMP v. USPTO: Oral Argument at the Federal Circuit," April 7, 2011
• "Federal Circuit to Hear Argument in AMP v. USPTO," April 3, 2011
• "Curiouser and Curiouser," February 16, 2011
• "AMP v. USPTO — Briefing Update III," February 8, 2011
• "Amicus Briefs in AMP v. USPTO: AARP," January 27, 2011
• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "BIO Survey Shows Support for DNA-Based Patents Despite Some Reservations," January 9, 2011

1. Leahy-Smith America Invents Act Signed Into Law

On September 8, the Senate voted 89 to 9 in favor of H.R. 1249, the House version of the Leahy-Smith America Invents Act (AIA). The House had passed the bill by a 304-117 margin on June 23. Eight days following Senate passage, on September 16, President Obama signed the Leahy-Smith America Invents Act into law. Certain provisions of the AIA took effect within days of enactment (e.g., prioritized examination and a 15% fee surcharge); some provisions will take effect on September 16, 2012 — one year after enactment (e.g., supplemental examination and inter partes review); and the remaining changes will take effect on March 16, 2013 — 18 months after enactment (e.g., first-inventor-to-file and derivation provisions). The effective date provisions of § 3(n) of the AIA, however, will force patent practitioners and applicants to deal with two distinct regimes — the old first-to-invent and the new first-inventor-to-file — for years and decades to come.

For information regarding this and other related topics, please see:

• "AIA Overview: Changes in Requirements for the Inventor's Oath or Declaration," October 27, 2011
• "AIA Overview: Supplemental Examination," October 26, 2011
• "AIA Overview: Changes to Provisions Relating to Third Party Submissions of Prior Art," October 24, 2011
• "AIA Overview: Changes to Inter Partes Re-examination," October 23, 2011
• "AIA Overview: Post-grant Review Provisions," October 20, 2011
• "AIA Overview: Prior User Rights Defense," October 19, 2011
• "AIA Overview: First-Inventor-to-File Provisions," October 11, 2011
• "USPTO Seeking Comment on AIA Mandated Studies," October 10, 2011
• "USPTO Implements AIA Changes to Inter Partes Reexamination," September 28, 2011
• "USPTO Updates Fee Schedule, But Does Not Yet Offer Micro Entity Discount," September 27, 2011
• "USPTO Implements Prioritized Examination Track under AIA," September 26, 2011
• "President Signs AIA into Law; USPTO Begins Implementation of Act," September 20, 2011
• "Reaction to Senate Passage of H.R. 1249," September 11, 2011
• "Senate Passes H.R. 1249," September 8, 2011
• "Senate Votes to Invoke Cloture on H.R. 1249," September 6, 2011
• "Senate Cloture Vote on H.R. 1249 Scheduled for Tuesday," September 5, 2011
• "Patent Reform News Briefs," August 17, 2011
• "USPTO Seeks Input on Implementation of Leahy-Smith America Invents Act," August 8, 2011
• "Patent Reform News Briefs," July 12, 2011
• "House Passes H.R. 1249," June 23, 2011
• "Patent Reform Update II," June 21, 2011
• "Patent Reform Update," June 20, 2011
• "Is the End of Fee Diversion Dead in the Leahy-Smith America Invents Act?" June 19, 2011
• "AMA, ACLU and Their Friends Oppose (Leahy-Smith) America Invents Act," June 16, 2011
• "Manager's Amendment (and Others) to H.R. 1249 — Human Patenting," June 15, 2011
• "Debate over H.R. 1249 Continues," June 15, 2011
• "Manager's Amendment (and Others) to H.R. 1249 — Second Opinions in Genetic Diagnostic Testing," June 14, 2011
• "Patent Reform News Briefs," June 13, 2011
• "America Invents Act: Quo Vadis?" June 8, 2011
• "Patent Reform News Briefs," June 7, 2011
• "Not Necessarily Patent 'Reform,'" June 2, 2011
• "Commerce Secretary Provides Administration's Views on America Invents Act," May 31, 2011
• "Patent Reform News Briefs," May 11, 2011
• "Boundy Issues Call to Arms on America Invents Act," April 21, 2011
• "More Reaction to H.R. 1249," April 18, 2011
• "House Judiciary Committee Approves H.R. 1249," April 14, 2011
• "Reaction to Manager's Amendment to House Patent Reform Bill," April 13, 2011
• "House Judiciary Chairman Releases Manager's Amendment to H.R. 1249," April 12, 2011
• "Reaction to House Patent Reform Bill," March 31, 2011
• "House Introduces Its Version of 'America Invents Act,'" March 30, 2011
• "Patent Reform Discussion Moves to House," March 29, 2011
• "The Disappearance of Deceptive Intent in S. 23," March 23, 2011
• "'Reform' at the U.S. Patent and Trademark Office," March 22, 2011
• "Few 'Reform' Provisions Remain in S. 23 Relating to the Judiciary," March 21, 2011
• "Additional Opportunities for Pre- and Post-grant Review, and Brand New Patent Trial and Appeal Board in S. 23," March 17, 2011
• "Post-grant Review Provisions of S. 23," March 16, 2011
• "Inventor's Interests, If Not Rights, Limited by S. 23," March 15, 2011
• "What Are the Provisions of the Proposed "First-Inventor-to-File" System in S. 23?" March 14, 2011
• "Obama Administration Supports S. 23," March 9, 2011
• "Reaction to Senate Passage of S. 23," March 8, 2011
• "Senate Passes S. 23," March 8, 2011
• "Senator Feinstein Opposes First-to-File Provisions of Patent Reform Bill (S. 23)," March 3, 2011
• "Patent Reform Bill (S. 23) Debated and Amended on Senate Floor," March 2, 2011
• "More Reaction to Senate Patent Reform Legislation," February 24, 2011
• "Patent Reform Legislation Moves to Senate Floor," February 22, 2011
• "Reaction to Senate Patent Reform Bill (S. 23)," February 9, 2011
• "Judiciary Committee Votes on Patent Reform Bill," February 3, 2011
• "Here We Go Again," January 20, 2011
• "Rep. Latta Reintroduces False Marking Bill in the House," January 18, 2011
Top Stories of 2011: #6 to #4

January 4, 2012

By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories. For 2011, we identified a dozen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Monday, we counted down stories #12 to #10, and yesterday, we covered stories #9 to #7. Today, we present stories #6 to #4. As with our other lists (2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

6. Supreme Court Hears Prometheus & Federal Circuit Decides Classen

Last month, the U.S. Supreme Court heard oral argument in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which involves the patent-eligibility of claims directed to methods for determining whether an effective amount of a drug is being administered to a patient. A decision in Prometheus should come some two years after the Court issued its opinion on the patent-eligibility of (business) method claims in Bilski v. Kappos. Shortly after handing down its decision in Bilski in 2010, the Court granted certiorari, vacated the Federal Circuit opinion, and remanded both Prometheus and Classen Immunotherapies, Inc. v. Biogen IDEC. The Federal Circuit decided Prometheus on remand in December 2010, and last June, the Court again granted certiorari. The Federal Circuit revisited Classen in August, finding that the claims of one patent in suit were not patent-eligible under § 101, and that the claims of two other patents were patent-eligible, because the latter recite methods that include "the physical step of immunization on [a] determined schedule" and thus are "directed to a specific, tangible application."

For information regarding this and other related topics, please see:

• "Mayo Collaborative Services v. Prometheus Laboratories at the Supreme Court: Oral Argument Tomorrow," December 6, 2011
• "Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen," September 20, 2011
• "Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) — Additional Views from Chief Judge Rader," September 8, 2011
• "Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) — Judge Moore's Dissent," September 6, 2011
• "Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)," August 31, 2011
• "Another Academic with Solutions to Problems that Don't Exist," January 31, 2011

5. Supreme Court Interest in Patent Law on the Rise

In little more than a week last spring, the Supreme Court was in the unusual position of issuing opinions on three separate patent cases. On May 31, the Court in Global-Tech Appliances, Inc. v. SEB S.A. affirmed a Federal Circuit decision upholding a jury verdict that defendants were liable for inducing infringement, finding that willful blindness requires not only the existence of a known risk but a high probability of that risk that is appreciated by the defendant, coupled with active efforts by the defendant to avoid knowing that the induced activities are infringing. On June 6, in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., the Court rejected the idea that employment is enough, absent an agreement, to vest ownership of a patented invention. Finally, on June 9, the Court in Microsoft Corp. v. i4i Limited Partnership held that 35 U.S.C. § 282 requires an invalidity defense to be proved by clear and convincing evidence. With the Prometheus decision on tap, and AMP v. USPTO possibly coming before the Court, 2012 will bring even more Supreme Court decisions on important patent law issues.

For information regarding this and other related topics, please see:

• "Microsoft Corp. v. i4i Limited Partnership (2011)," June 9, 2011
• "Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)," June 6, 2011
• "Global-Tech Appliances, Inc. v. SEB S.A. (2011)," May 31, 2011

4. Embryonic Stem Cell Patenting Suffers Setback in Europe

In a blow to human embryonic stem cell (hESC) research in Europe, the European Court of Justice (ECJ) determined in October that hESCs are not patent-eligible subject matter. The decision evoked Europe's "moral" position against biotech patenting some 30 years ago, which allowed the rest of the world (and predominantly the U.S.) to develop an entirely new industry with little European competition. With regard to the stem cell decision, the question remains whether the ruling will foster or hinder innovation, and it will take perhaps a generation to understand the full extent of the ban. While not related to the ECJ decision, California-based stem cell pioneer Geron Corporation announced in November that it was discontinuing further development of its human embryonic stem cell (hESC) programs and would be seeking partners for each of the programs, with the company focusing on its oncology programs instead.

For information regarding this and other related topics, please see:

• "Geron Discontinues hESC Programs," November 16, 2011
• "Comparative Study on Patenting of Human Embryonic Stem Cells," November 16, 2011
• "Let the Experiment Begin: Impact of ECJ Stem Cell Ruling on Synthetic Blood Development," November 15, 2011
• "No More Patents for Cells Derived from Human Embryos in EU," October 18, 2011
• "European Court of Justice Renders Stem Cell Decision," October 18, 2011
• "GOP Candidates Unified in Opposition to Embryonic Stem Cell Research," August 16, 2011
• "European Court of Justice Considers Embryonic Stem Cell Ban," May 11, 2011
• "The Hinxton Group Foresees Stem Cell Issues and Proposes Solutions," April 4, 2011