Patent Docs

John Marshall Law School 56th Annual IP Law Conference

February 10, 2012

The John Marshall Law School Center for Intellectual Property Law will be holding its 56th Annual Intellectual Property Law Conference on February 24, 2012 in Chicago, IL. The conference will consist of the following sessions:

• Recent Developments in Intellectual Property Law;
• Bernard Knight, General Counsel, U.S. Patent & Trademark Office will present a luncheon keynote on "The Future Challenges of IP Litigation: A Judge's Perspective";

The conference's afternoon patent track will consist of sessions on:
• Supreme Court’s Renewed Interest in Patent Law;
• Critical Trends in 2012 from In-House Perspective;
• Monetizing IP and Generating Cash from Patents; and
• E-Discovery — Limiting the Solar System or Expanding the Universe?

Additional information about the conference, including a schedule, list of speakers, and registration form can be found here. Those interested in registering for the conference online can do so here; the registration fee is $195 (general rate), $95 (government, judicial, and academic rate), or free (JMLS students).
AstraZeneca Pharmaceuticals LP v. Apotex Corp. (Fed. Cir. 2012)

February 9, 2012

By Andrew Williams —

On Thursday, the Federal Circuit affirmed the dismissal of a § 271(e)(2) patent infringement action based on method-of-use claims because the ANDA filer was only seeking FDA approval for non-patented uses. In AstraZeneca Pharms. LP v. Apotex Corp., the Court held that alleging infringement under 35 U.S.C. § 271(e)(2) was sufficient to confer subject-matter jurisdiction on a federal district court regardless of the merits of the claim, and therefore dismissal under Rule 12(b)(1) is inappropriate in such circumstances. However, to survive a motion to dismiss for failure to state a claim upon which relief can be granted, pursuant to Rule 12(b)(6), a holder of method-of-use patents must allege that an ANDA filer is seeking approval to market its generic drug for a claimed use. If, instead, the ANDA filer is seeking approval for only non-patented indications, even if the reference listed drug is additionally approved for a claimed use, the patent holder cannot support an infringement claim pursuant to 35 U.S.C. § 271(e)(2).

The brand-name drug at issue in this case was CRESTOR®, which has as its active ingredient the cholesterol-lowering statin rosuvastatin calcium. Statins work by competitively inhibiting 3-hydroxy-3-methylglutaryl-CoA ("HMG-CoA") reductase, a key enzyme for cholesterol biosynthesis, thereby reducing circulating cholesterol. The patents-at-issue all claimed methods of using rosuvastatin calcium: U.S. Patent 6,858,618 ("the '618 patent") for the treatment of heterozygous familial hypercholesterolemia, "a genetic condition characterized by impaired cholesterol metabolism and clinically elevated blood cholesterol," and U.S. Patent 7,030,152 ("the '152 patent") with claims to using rosuvastatin calcium to lower the risk of cardiovascular disease in individuals with normal cholesterol levels but with elevated levels of circulating C-reactive protein. CRESTOR® is also approved for the unpatented treatment of homozygous familial hypercholesterolemia and hypertriglyceridemia. In order to skirt AstraZeneca's method-of-use patents, the ANDA filers in this case "carved out" the patented indications from their proposed label, only seeking approval to market the generic version for treating homozygous familial hypercholesterolemia and hypertriglyceridemia. After the conclusion of a separate ANDA litigation involving composition-of-matter patents (which expire in 2016), AstraZeneca sued the ANDA filers pursuant to 35 U.S.C. § 271(e)(2), claiming infringement of the claims of the '618 and '152 patents. The U.S. District Court for the District of Delaware dismissed the action for lack of subject matter jurisdiction and because AstraZeneca's claims were not ripe, even if the FDA may require the ANDA filers to amend their proposed label to include the patented indications at some future date.

Subject Matter Jurisdiction

On appeal, the Federal Circuit agreed with AstraZeneca that alleging that the ANDA filers infringed its method-of-use patents pursuant to § 271(e)(2) was sufficient to confer subject matter jurisdiction on the district court. Consistent with the holding in Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003), the Court concluded that, in order to establish subject matter jurisdiction pursuant to § 1338(a), nothing more than alleging infringement by the filing of an ANDA was required. This is true even if it is clear that the plaintiffs cannot succeed on their infringement claims, because the "threshold jurisdictional determination does not depend on the ultimate merits of the claims."

Failure to State a Claim

Nevertheless, the Federal Circuit affirmed the lower court's dismissal of the action based on Rule 12(b)(6) because AstraZeneca failed to state a claim on which it could ultimately succeed. The decision hinged on the language of the statute:

(e) It shall be an act of infringement to submit – (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

(emphasis added). AstraZeneca appeared to read the "or" out of the highlighted portion, resulting in following language: "It shall be an act of infringement to submit [an ANDA] for a drug . . . the use of which is claimed in a patent." The Court noted that such parsing of the statute "'eviscerated an important part of the statutory provision by conflating the first and second clauses of § 271(e)(2)(A),'" citing Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003)). Therefore, quite simply, an ANDA applicant seeking to market a drug for a non-patented indication cannot infringe under § 271(e)(2)(A).

This holding is virtually identical to the Warner-Lambert decision. AstraZeneca attempted to exploit the main difference between the two cases, namely that the NDA holder in Warner-Lambert had not obtained approval for its patented methods, and therefore in that case it was not possible for an ANDA filer to obtain approval that would infringe the claims. Here, instead, the ANDA filers chose to carve out the patented methods, although, of course, they could have sought such approval. Nevertheless, the Court found that the action of the ANDA filers did nothing to change the text of the statute, and therefore § 271(e)(2)(A) still does not apply.

This outcome does raise some real-world complications for AstraZeneca, or for that matter any other NDA holder with approved drugs indicated for non-patented uses. Regardless of what the label says, the ANDA filers in this case are seeking approval of a drug that is bioequivalent to CRESTOR®. After the generic is approved, it is very possible that doctors will prescribe the generic over the branded drug regardless of how the label reads. If that happens, the patent holder will be forced to bring suit against the ANDA filer pursuant to § 271(b) for inducement of infringement of its patents. In such a suit, however, the patent holder will have the added complication of establishing that doctors are prescribing the generic for off-label use. As a result of this outcome, generic challengers can skirt Orange Book listed method-of-use patents by carving out the patent-protected methods, provided there exists a non-patented approved indication. However, as one of the panel members noted during the oral hearing, even if the Court were sympathetic to the policy concerns expressed by AstraZeneca, there is little that it could do. Instead, as was suggested, the outcome that AstraZeneca wanted would have to be effectuated on Capitol Hill, not in the courts.

Ripeness

AstraZeneca also suggested that the FDA will require the ANDA filers to amend their label to include information related to the claimed uses. However, because this alleged amendment will occur at some unspecified point in the future, the lower court dismissed the claims as insufficiently ripe for adjudication. The Federal Circuit noted that it could not conclude that the FDA would require the ANDA filers to amend their applications in the future, in part because the Hatch-Waxman Act provides for the affirmative carving out of patented indications. Therefore, the Court also affirmed the dismissal on these grounds.

AstraZeneca Pharmaceuticals LP v. Apotex Corp. (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Lourie and Moore
Opinion by Circuit Judge Lourie
FDA Publishes Draft Guidelines for Biosimilar Product Development

February 9, 2012

By James DeGiulio —

The U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products today (see FDA press release), taking a significant step toward the utilization of § 351(k) of the Public Health Service Act (amended by the Biologics Price Competition and Innovation Act (BPCIA)). Section 351(k) creates a biologics pathway that is reminiscent of the pathway set forth by the Hatch-Waxman Act for small molecule drugs. The FDA promised that it would release the guidance materials by the end of 2011, but failed to meet this deadline, most likely due to the complexities of the many issues surrounding biosimilar products. The agency indicates that these guidance documents provide the FDA's current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products. As expected, the FDA is seeking public comment on each of draft guidance documents within 60 days of the notice of publication in the Federal Register.

The BPCIA and section 351(k) have been in force since March 2010. However, without any indication as to how the statute will be implemented by the FDA, the pathway has not gained much traction as an alternative to filing a full Biologics License Application (BLA) for a biologic under the PHSA (42 U.S.C. § 262). Today's guidance documents provide some direction to companies involved in biosimilar development regarding the factors the FDA will use to evaluate whether to grant a license to their biosimilar products in the United States, despite the draft status of the guidance documents. Now the biologics industry awaits public notification of the first 351(k) application filing, which under the statute, would set in motion a complex exchange of documents pertaining to the biologic, eventually progressing to litigation between the reference drug BLA holder and the 351(k) biosimilar applicant.

The FDA published the following three draft guidance documents:

1. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

The first guidance document is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a 351(k) application. As the FDA hinted last year, a stepwise approach to demonstrate biosimilarity is suggested, beginning first with structural and functional assays, and followed up with animal and clinical studies. The FDA intends to evaluate such a demonstration based on a "totality-of-the-evidence," focusing on the assessment of the effects of any differences in the products, rather than requiring an independent safety determination of the biosimilar product. Following this determination, if the differences in the two products are not "clinically meaningful," the FDA will require fewer or narrower human studies. Also discussed briefly are post-marketing safety monitoring considerations.

2. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

The second guidance document provides an overview of the analytical factors the FDA will consider when assessing biosimilarity between a 351(k) product and a reference product. Specific analytical factors include functional activities, expression systems/cell types, manufacturing processes, physicochemical and immunochemical properties, quality and quantity of impurities, stability, and drug-specific reference standards based on the scientific literature. These factors need not be identical between the biosimilar and reference product.

3. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

The third guidance document provides answers to common questions about the BPCIA, many of which were raised at the FDA's public hearings on biosimilars on November 2-3, 2010. The question and answer format addresses primarily administrative questions that may arise during biologic product development, particularly in early stages leading up to BLA or 351(k) application filings. Questions are directed to the timing and content of FDA meetings, allowable differences in the formulation/delivery from the reference product, varying scope of the FDA licenses, the types of data that a biosimilar applicant can rely on in their application, and questions regarding exclusivity under 351(k)(7).

Patent Docs will provide a more detailed analysis of each of these guidance documents in future posts.
USPTO Issues Proposed Rulemaking for Supplemental Examination Provisions of AIA

February 8, 2012

By Andrew Williams —

On January 25, 2012, the U.S. Patent and Trademark Office published its notice of proposed rulemaking to implement the supplemental examination provisions of the Leahy-Smith America Invents Act ("the AIA") (77 Fed. Reg. 3666). This is one of the ten notices that the Office plans to publish to implement the various provisions of the AIA, and specifically deals with § 12 of the Act, which amends chapter 25 of title 35, United States Code by adding new § 257 "Supplemental examinations to consider, reconsider, or correct information." We provided an overview of the supplemental examination provisions of the AIA last fall (see "AIA Overview: Supplemental Examination'). In short, this new provision permits "a patent owner to request supplemental examination of a patent by the Office to consider, reconsider, or correct information believed to be relevant to the patent." 77 Fed. Reg. 3666. The Office is required by statute to determine within three months of a request whether it raises a substantial new question of patentability, and if so, the Director is required to order an ex parte reexamination of the patent. Such a reexamination follows the same rules as a normally requested reexamination, except that the patent owner does not get the opportunity to submit a statement pursuant to section § 304 after the reexamination is ordered, and the reexamination is not limited to patents and printed publications. In addition to providing notice of rules for implementing this new procedure, the Office also proposed fees for both supplemental examination and various reexamination fees. Notably, the Office is proposes raising the cost for filing a request for ex parte reexamination to $17,750! Written comments related to these proposed rules must be received by March 26, 2012.

In general, the proposed rules track the provisions of § 12 of the AIA, but there are a few notable exceptions. The AIA did provide the Office with the authority to implement some of its own procedures, but otherwise the Office took the opportunity to interpret some sections of the AIA and propose its own rules when the AIA was silent on an issue. This report will mainly focus on the unique aspects of the Office's proposed implementation of supplemental examination, but where necessary to provide context, the provisions of § 12 of the AIA and the reasons for its enactment will be described. In addition, even though this report provides an overview of some of the more interesting aspects of the proposed rule, it is not meant to be exhaustive.

As may be self-evident, one of the purposes of the new supplemental examination procedure is to help cure an application from potential future allegations of inequitable conduct. Therefore, one of the most significant differences between this procedure and ex parte reexamination is that supplemental examination is not limited to patents and printed publications. The Office recognizes that the type of information that can come from a variety of new sources, and some of these types of information may be difficult for the Office to review, especially in the view of the imposed three-month deadline. Moreover, in addition to raising issues of novelty or obviousness, the patent owner is allowed to raise issues of patentablility under 35 U.S.C. §§ 101 and 112. As a result, the Office is proposing specific rules to ensure that the determination of whether there is a substantial new question of patentability can be made within this three-month time frame. First, the Office is proposing setting a limit of ten (10) "items of information" that can be included with such a request. According to the Office, the rationale for such a number is that allegations of inequitable conduct during patent litigation typically concern fewer than ten items of information. Moreover, the Office reasons, if a patentee has more than ten items, more than one supplemental examination request can be filed at the same time. This limit on the number of items, however, is irrelevant to whether the items need to be combined, for example, where the request includes an issue of obviousness. In such a case, it is easy to see where the limit of ten items could be reached. Second, the Office is proposing an additional fee for any document submitted with the request that is in excess of 20 pages, as well as requiring a summary of the relevant portions of document over 50 pages. The Office does suggest that overly long documents can be redacted, provided that no relevant information is excluded. However, it is probably not advisable to submit a redacted portion of a document, especially if the document was responsible for the determination to file supplemental examination in the first place. Finally, the Office is proposing that the request must include (1) an identification of each issue raised by each item of information, (2) a detailed explanation for each issue, and (3) an explanation of how each item of information is relevant to each aspect of the patent to be examined and how each item raises each identified issue. It is clear that these requirements are meant to assist the Office in meeting its deadline. However, even though it might be advisable for a patent holder to alert the Office to reasoning as to why it is citing an item of information in its request, patent holders will likely be weary of providing too much information, and therefore will need to approach such a task cautiously.

And, for clarification, the proposed rules do define what an "item of information" is. For example, an item can be a document that is submitted as part of the request. Examples of these items include journal articles, patents, affidavits, declarations, and transcripts of recordings (in fact, it appears that as long as it is written, it can be an item of information). However, an item need not be a document, as documentary evidence may not be available for some issues, such as issues related to satisfying 35 U.S.C. § 101. In these cases, the Office is proposing that the "item of information" be the discussion of the issue within the body of the request. However, the proposed rules are clear that if the item is text within the request (or even another "document" reproduced in the request), the patentee still must count that item as one of the ten. And, the Office is proposing that the item of information must be in writing. As such, audio or video recordings must be submitted in the form of a written transcript.

An interesting provision of the AIA as it relates to supplemental examination involves what happens if the Director becomes aware that "material fraud" on the Office was committed in connection with a patent. In such a case, the Director is authorized to take certain actions, such as the cancellation of claims. However, the Director is required to refer the matter to the Attorney General. As a result, the Office stated clearly in the proposed rules that the standard for "material fraud" is narrower than for inequitable conduct as defined by the Federal Circuit in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011). No further explanation of how much narrower was provided, however.

The Office has proposed several other interesting rules in connection with supplemental examination. First, the patentee cannot file any amendments with the request for supplemental examination. In fact, because the patentee does not get an opportunity to submit a statement should a reexamination be declared, the first opportunity to file claim amendments is after the first Office action on the merits. The Office is also proposing a prohibition on interviews during the supplemental examination proceedings. However, this does not preclude a call to the Office to confirm receipt of a request or to discuss procedural questions. In addition, the Office is proposing a rule that prohibits third parties from participating or filing papers in a supplemental examination proceeding. Of course, this proposal isn't that surprising, because third parties are also prohibited from participating in any ex parte reexamination proceeding, should one be ordered.

One of the more shocking aspects of the proposed rules is the size of the proposed fees for both requesting supplemental examination and for filing a request for ex parte reexamination. Currently, the fee of the reexamination request is $2,520. However, the Office is proposing that this fee be raised to $17,750, with a subset of the fee refunded should the request be refused. In addition, the proposed fee for a supplemental examination request is $5,180, but such a request must also include the fee for reexamination should it be ordered, in this case $16,120. Therefore, provided there are no documents over 20 pages submitted with the request (because documents over 20 pages require an additional fee), the fee that must accompany a request for supplemental examination is $21,300. The Patent Office acknowledges that it is not following the provisions of the AIA that set out the process for setting or adjusting fees, allegedly because it is not feasible to have these fees in place by September 16, 2012 under that scheme. Therefore, the Office is relying on 35 U.S.C. § 41(d)(2) for its authority, which allows the Office to set fees to recover the estimated average cost to the Office of processing, services, or materials. The notice does discuss the analysis of how these estimated numbers were derived, and refers the reader to the Patent Office website. Still, considering the onerous requirements that the AIA placed on the Office in relation to supplemental examination (for example, requiring a decision within three months), one can't help but wonder whether the Office is proposing these new fees as a way to deter patent holders from filing such a request, rather than an effort to recoup their ultimate costs.

Similar to the other notices of rulemaking, comments can be submitted by e-mail to supplemental_examination@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 Cynthia L. Nessler, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Associate Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal. Again, the deadline for submitting comments is March 26, 2012. Additional information regarding the submission of comments can be found in the Office's Federal Register notice (77 Fed. Reg. 3666).

For information regarding the Office's implementation of other AIA provisions, please see:

• "USPTO Proposes Rules Changes for Implementing AIA Provisions — Oath or Declaration Provisions," January 30, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions — Statute of Limitations Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions — Preissuance Submissions Provision," January 12, 2012
• "USPTO Proposes Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent Provisions," January 11, 2012
Adair v. Carter (Fed. Cir. 2012)

February 7, 2012

By Donald Zuhn —

Today, the Federal Circuit affirmed a decision by the Board of Patent Appeals and Interferences holding that claim 24 of Appellants' application, which was involved in an interference with Appellees' patent, was barred under 35 U.S.C. § 135(b)(1). That section states that:

A claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.

Appellants John Robert Adair, Diljeet Singh Athwal, and John Spencer Emtage filed U.S. Application No. 11/284,261 on November 21, 2005, along with a preliminary amendment requesting an interference based on U.S. Patent No. 6,407,213, which was issued to Appellees Paul J. Carter and Leonard G. Presta on June 18, 2002. The Board declared an interference, identifying claims 30, 31, 60, 62, 63, 66, 67, 70, 73, 77-81 of Appellees' '213 patent and claim 24 of Appellants' '261 application to be involved in the count.

Claim 24 of the '261 application recites:

24. A humanised antibody comprising a heavy chain variable domain comprising non-human complementarity determining region amino acid residues which bind an antigen and a human framework region wherein said framework region comprises a non-human amino acid substitution at a residue selected from the group consisting of 23, 24, 49, 71, 73, and 78, and combinations thereof, as numbered according to Kabat.

Claim 66 of the '213 patent, which is representative of the claims in the count, recites:

66. A humanized antibody heavy chain variable domain comprising non-human Complementarity Determining Region (CDR) amino acid residues which bind antigen incorporated into a human antibody variable domain, and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of: 24H, 73H, 76H, 78H, and 93H, utilizing the numbering system set forth in Kabat.

Because claim 24 was not presented to the USPTO prior to June 18, 2003 (i.e., one year from the date on which the '213 patent issued) — the critical date — Appellants attempted to rely on claims 1 and 16 of their International application and corresponding national stage application, which were presented prior to the critical date, and which Appellants' contended provided pre-critical date support for claim 24 of the '261 application. Appellants' claims 1 and 16 recite:

1. A CDR-grafted antibody heavy chain having a variable region domain comprising acceptor framework and donor antigen binding regions wherein the framework comprises donor residues at at least one of positions 6, 23 and/or 24, 48 and/or 49, 71 and/or 73, 75 and/or 76 and/or 78 and 88 and/or 91.

16. A CDR-grafted antibody heavy or light chain or molecule according to any one of the preceding claims comprising human acceptor residues and non-human donor residues.

In response to rejections of claims 1 and 16 during national stage under §§ 101, 102(b), 103, and 112, first and second paragraphs, Appellants cancelled those claims.

The Board rejected Appellants' argument that claims 1 and 16 provided pre-critical date support for claim 24, determining in part that Appellants added limitations to overcome the rejection of those claims during national stage, and as a result, material differences presumptively existed between claim 24 (the post-critical date claim) and claims 1 and 16 (the pre-critical date claims).

On appeal, Appellants argued that the Board erred by failing to assess material differences in view of the claim being copied from Appellees' patent. Appellees countered that the question of whether there is a sufficient degree of identity between pre- and post-critical date claims for compliance with § 135(b) is an inquiry that is distinct and independent from any comparison with the patent claims copied. In siding with the Appellees, the Federal Circuit cited Corbett v. Chisholm, 568 F.2d 759 (CCPA 1977), stating that:

In Corbett . . . this court compared the "copied claim" with the pre-critical date claims and affirmed the Board's finding that material differences precluded Corbett from relying on any of the pre-critical date claims to overcome the § 135(b) bar. Id. at 765-66. In identifying certain limitations of Chisholm patent claim 1 as "material," the court was simply noting the material differences that existed between that claim as copied by Corbett after the critical date and those pre-critical date claims Corbett was relying on to overcome the § 135(b) bar. The court did not establish any rule requiring some sort of threshold assessment of which limitations of the copied patent claim are material before determining whether material differences exist between post- and pre-critical date claims.

Pointing to In re Berger, 279 F.3d 975 (Fed. Cir. 2002), the opinion noted that:

[T]he court in Berger referenced the issued Muller patent claim 1 only because the post-critical date claim, claim 7, was a direct copy of the patent claim. Id. at 981-83. This court affirmed the Board's analysis based only on the material differences between the post- and pre-critical date claims. Id. at 983 ("Because Berger's original claims 1-6 [the pre-critical date claims] do not include a material limitation of Berger claim 7 [the post-critical date claim], copied claim 7 is not entitled to the earlier effective date of those original claims for purposes of satisfying § 135(b)." (emphasis added)).

The opinion also notes that in Regents of the University of California v. University of Iowa Research Foundation, 455 F.3d 1371 (Fed. Cir. 2006), "this court expressly approved an analysis of material differences based solely on a comparison of the post- and pre-critical date claims in order to obtain the benefit of the earlier filing date." Citing Corbett, Berger, and Regents, the Court therefore concluded that:

[T]o overcome a § 135(b) bar for a post-critical date claim, an applicant must show that such claim is not materially different from a pre-critical date claim present in the application or any predecessor thereto in order to obtain the benefit of the earlier filing date. Any claims filed within the critical period, whether or not later cancelled, may provide pre-critical date support for the later filed patent claim(s), so long as the pre-critical date claims are not materially different from the later filed claim(s).

Applying its holding to the instant interference, the panel determined that because the Board found material differences between claim 24 (the post-critical date claim) and claims 1 and 16 (the pre-critical date claims), and an assessment of claim 66 of Appellees' patent was not necessary, the Board did not err by failing to assess material differences in view of the claim being copied from Appellees' patent.

Appellants also argued that the Board erred by applying Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), in the context of an interference in order to conclude that a limitation added to a claim in response to a rejection that results in allowance is presumed to be necessary to patentability and therefore material. With respect to this argument, the panel again sided with Appellees, stating that:

When an applicant adds limitations in response to an examiner's rejection, and those limitations result in allowance, there exists a well established presumption that those limitations are necessary to patentability and thus material. See Festo, 535 U.S. at 734; Corbett, 568 F.2d at 765. This presumption applies with equal force in the interference context.

In determining that the Board did not err by applying Festo, the panel noted that:

[B]ecause [Appellants] cancelled claims 1 and 16 of the PCT Application in response to the examiner's rejections, and added limitations into what eventually became claim 24 of the '261 Application to secure allowance, the Board properly presumed material differences between [Appellants'] post- and pre-critical date claims.

The panel, therefore, affirmed the Board's decision that claim 24 of Appellants' application was barred under 35 U.S.C. § 135(b)(1).

Adair v. Carter (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Linn and Moore
Opinion by Circuit Judge Linn
USPTO Extends PCT-PPH Programs with EPO & JPO

February 6, 2012

By Donald Zuhn —

Last month, the U.S. Patent and Trademark Office announced that it was extending its Patent Prosecution Highway (PPH) pilot program based on Patent Cooperation Treaty (PCT) work products (i.e., PCT-PPH pilot program) with the European Patent Office for two more years. The USPTO similarly announced that it was extending the PCT-PPH pilot program with the Japan Patent Office for two more years. Both pilot programs are now scheduled to end on January 12, 2014, although either program may be further extended past that date.

Under the PCT-PPH framework, an applicant receiving a positive written opinion or a positive international preliminary examination report in a PCT application where the EPO or JPO was the International Searching Authority (ISA) or the International Preliminary Examination Authority (IPEA) may request that the USPTO fast track the examination of corresponding claims in the corresponding U.S. application. A positive written opinion or IPER is one in which at least one claim in an International application is determined to have novelty, inventive step, and industrial applicability. Both programs were extended in order to collect more information before any formal decision on the programs is made.

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 has established a total of twenty PPH programs with other patent offices. Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), and the Israel Patent Office (ILPO), the Taiwan Intellectual Property Office (TIPO), the Norwegian Industrial Property Office (NIPO), China's State Intellectual Property Office (SIPO), and the Icelandic Patent Office (IPO). The USPTO has also established eleven PCT-PPH programs with other patent offices: IP Australia, APO, SIPO, EPO, NBPR, 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 can be found here.
Court Report

February 5, 2012

By Sherri Oslick —

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

Abbott Laboratories et al. v. Sandoz Inc.
1:12-cv-00103; filed January 30, 2012 in the District Court of Delaware

• Plaintiffs: Abbott Laboratories; Abbott Respiratory LLC
• Defendant: Sandoz Inc.

Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Sandoz's filing of an amended ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia). View the complaint here.

Enzo Life Sciences Inc. v. Gen-Probe Inc.
1:12-cv-00104; filed January 30, 2012 in the District Court of Delaware

Enzo Life Sciences Inc. v. Life Technologies Corp.
1:12-cv-00105; filed January 30, 2012 in the District Court of Delaware

Enzo Life Sciences Inc. v. Roche Molecular Systems Inc. et al.
1:12-cv-00106; filed January 30, 2012 in the District Court of Delaware

• Plaintiff: Enzo Life Sciences Inc.
• Defendants: Roche Molecular Systems Inc.; Roche Diagnostics Corp.; Roche Diagnostics Operations Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,922,180 ("Oligo- Or Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides," issued January 31, 2006) based on defendants' manufacture and sale of certain nucleic acid probe products. View the Gen-Probe complaint here.

Bayer Healthcare LLC v. Pfizer Inc.
1:12-cv-00630; filed January 30, 2012 in the Northern District of Illinois

Infringement of U.S. Patent No. 5,756,506 ("Single High Dose Fluoroquinolone Treatment" issued May 26, 1998) based on Pfizer's planned launch of ADVOCIN™ (single high dose fluoroquinolone, used to treat bovine respiratory disease). View the complaint here.

Takeda Pharmaceutical Co., Ltd. et al v. Sandoz, Inc.
5:12-cv-00446; filed January 27, 2012 in the Northern District of California

• Plaintiffs: Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals LLC; Takeda Pharmaceuticals America, Inc.
• Defendant: Sandoz, Inc.

Infringement of U.S. Patent Nos. 6,462,058 ("Benzimidazole Compound Crystal," issued October 8, 2002), 6,664,276 (same title, issued December 16, 2003), 6,939,971 (same title, issued September 6, 2005), 7,285,668 ("Process for the Crystallization of (R)- or (S)-Lansoprazole," issued October 23, 2007), and 7,790,755 ("Controlled Release Preparation," issued September 7, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease). View the complaint here.

Allergan, Inc. v. Hi-Tech Pharmacal Co.
6:12-cv-00043; filed January 27, 2012 in the Eastern District of Texas

Infringement of U.S. Patent No. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.01% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension). View the complaint here.

Exelixis, Inc. v. Kappos
1:12-cv-00096; filed January 27, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,989,622 ("Phosphatidylinositol 3-kinase Inhibitors and Methods of Their Use," issued August 2, 2011). View the complaint here.

Valeant International (Barbados) SRL et al. v. Spear Pharmaceuticals, Inc.
2:12-cv-00043; filed January 26, 2012 in the Middle District of Florida

• Plaintiffs: Valeant International (Barbados) SRL; A.P. Pharma, Inc.
• Defendant: Spear Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Spear's filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp). View the complaint here.

Astrazeneca AB et al. v. Torrent Pharmaceuticals Ltd. et al.
3:12-cv-00506; filed January 26, 2012 in the District Court of New Jersey

• Plaintiffs: Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
• Defendants: Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 5,877,192 ("Method for the Treatment of Gastric Acid-Related Diseases and Production of Medication Using (-)Enantiomer of Omeprazole," issued March 2, 1999), and 6,875,872 ("Compounds," issued April 5, 2005), following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Conference & CLE Calendar

February 5, 2012

February 8, 2012 – Corporate Intellectual Property Law Conference (Law Bulletin Publishing Co.) – Chicago, IL

February 14, 2012 – New Supplemental Examination: USPTO Outlines New Rules (Strafford) – 1:00 – 2:30 pm (EST)

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

February 15, 2012 – Effects of the AIA on Valuation, Licensing & Acquisitions (American Intellectual Property Law Association) – 12:30 – 1:30 pm (Eastern)

February 17, 2012 – Invention Disclosures and the America Invents Act (Intellectual Property Law Association of Chicago) – Chicago, IL

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 23, 2012 – Gene Patenting in the U.S. after Myriad (Navigant) – Chicago, IL

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

March 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – New York, NY

March 26-27, 2012 – PTO Procedures under the America Invents Act*** (American Conference Institute) – New York, NY

March 28-30, 2012 – 27th Annual Intellectual Property Law Conference (American Bar Association (ABA) Section of Intellectual Property Law) – Arlington, VA

***Patent Docs is a media partner of this conference or CLE
IP Roundtable on Gene Patenting after Myriad

February 3, 2012

Navigant will be hosting a IP roundtable on the "Gene Patenting in the U.S. after Myriad" on February 23, 2012 from 12:00 to 1:30 pm at Navigant's offices in Chicago, IL. The roundtable will be moderated by Thomas J. Filarski of Steptoe & Johnson LLP. There is no registration fee for the roundtable, but those interested in registering for the roundtable can do so here. To encourage maximum interaction, enrollment will be limited to 25 persons. Additional information regarding the roundtable can be found here.
Webinar on Supplemental Examination

February 3, 2012

Strafford will be offering a webinar entitled "New Supplemental Examination: USPTO Outlines New Rules" on February 14, 2012 from 1:00 – 2:30 pm (EST). Scott A. McKeown of Oblon Spivak McClelland Maier & Neustadt and Professor Lisa A. Dolak of Syracuse University College of Law will discuss the new supplemental examination proceeding, the mechanics of the procedure and the considerations that may govern decisions to use it over other post grant options. The panel will also examine the ethics implications, including questions that must await USPTO and judicial developments relating to supplemental examination. The webinar will review the following questions:

• What are the mechanics of using the supplemental examination process?
• What are the primary factors for deciding whether to use supplemental examination to consider, reconsider, or correct information relevant to a patent?
• What are the ethical risks that can arise in the supplemental examination process — and how can counsel avoid ethics violations?

An interactive Q&A session will follow the presentation.

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the webinar, can do so here.

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