Patent Docs

Conference & CLE Calendar

March 27, 2011

April 5-6, 2011 – International Patent Forum 2011 (Managing Intellectual Property) – London, UK

April 6-9, 2011 – 26th Annual Intellectual Property Law Conference (American Bar Association Section of Intellectual Property Law) – Arlington, VA

April 13-15, 2011 – Intellectual Property Counsels Committee (IPCC) Spring Conference & Meeting (Biotechnology Industry Organization) – Seattle, WA

April 15, 2011 – 2nd Annual John Marshall Law School Review of Intellectual Property Law Symposium – Chicago, IL

April 27, 2011 – 27th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

May 3-4, 2011 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Supreme Court Increases Disclosure Burdens on Pharma Companies

March 24, 2011

By Kevin E. Noonan —

As it has done in other areas of the law recently (such as Bell Atlantic Corp. v. Twombly), the Supreme Court on Tuesday addressed the requirements for pleadings sufficient to survive a motion to dismiss a complaint for securities law violations, in Matrixx Initiatives Inc. v. Siracusano. The Court's decision provides a reasoned basis for where it decided to draw the line for such pleadings. However, by engaging in its penchant for "totality of the circumstances" analyses, its decision did little to clarify the behaviors pharmaceutical companies should exhibit to avoid the kinds of liability that Matrixx will be put at risk at trial.

The case involved Zicam Cold Remedy, an over-the-counter zinc gluconate formulation used to combat the common cold that was responsible for about 70% of the company's sales. During the relevant time period, Matrixx was alleged to have become aware from several sources of a serious side effect of using Zicam, specifically anosmia or loss of the sense of smell. In 1999, a customer service representative was told by the neurological director of the Smell & Taste Treatment and Research Foundation, Ltd. that a "cluster of patients" had suffered from anosmia after using Zicam to treat their cold symptoms (and including an individual who did not have a cold when she used the product). Three years later, the company's Vice President for Research and Development contacted a scientist, Dr. Miriam Linschoten, at the University of Colorado Health Sciences Center after receiving a complaint about Zicam-induced anosmia, and the scientist recounted the results of "previous studies linking zinc sulfate [a different zinc-containing compound] to loss of smell." This scientist followed up with abstracts from these studies, dating from the 1930's and 1980's that "confirmed '[z]inc's toxicity.'" And about a year later, one of Dr. Linschoten's colleagues, Dr. Jafek, "observed 10 patients suffering from anosmia after Zicam use," and together these scientists prepared a poster for presentation at a meeting of the American Rhinologic Society. Upon hearing of these plans, the company warned the scientists that they did not have permission to use the Matrixx company name or the names of the company's products (Zicam) and the scientists deleted this information from their poster presentation. Shortly thereafter, two patients sued Matrixx in a products liability lawsuit based on Zicam-related anosmia; this number had increased to nine patients and four lawsuits by the end of the relevant time period in this case.

According to plaintiff/respondent investors, Matrixx reacted to these events with a series of public statements that were misleading and amounted to securities fraud. These statements related in large part to the company's financial prospects, including estimates that "revenues 'would be up in excess of 50%'" as well as similar predictions regarding share earnings for investors. Later, the company increased its rosy forecast to have revenues increasing by 80%. The company acknowledged the products liability suits in required SEC filings (Form 10-Q) but did not disclose that such suits had already been filed. In addition, the company responded to a Dow Jones Newswires story relating to reports of anosmia as a consequence of Zicam use (and the concomitant drop in share price by almost 12%) by releasing a statement that the company believed the allegations that Zicam use caused anosmia were "completely unfounded and misleading," further stating that:

In no clinical trial of intranasal zinc gluconate gel products has there been a single report of lost or diminished olfactory function (sense of smell). Rather, the safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established in two double-blind, placebocontrolled, randomized clinical trials. In fact, in neither study were there any reports of anosmia related to the use of this compound. The overall incidence of adverse events associated with zinc gluconate was extremely low, with no statistically significant difference between the adverse event rates for the treated and placebo subsets.

A multitude of environmental and biologic influences are known to affect the sense of smell. Chief among them is the common cold. As a result, the population most likely to use cold remedy products is already at increased risk of developing anosmia. Other common causes of olfactory dysfunction include age, nasal and sinus infections, head trauma, anatomical obstructions, and environmental irritants.

These statements resulted in an almost complete rebound of Matrixx's share price. The share price plummeted even further, however, (by over one-quarter of their value) when Good Morning America aired a segment highlighting Dr. Jafek's research results relating Zicam use to anosmia and disclosing the existence of four product liability lawsuits. Matrixx persisted in its public statements that the link between Zicam use and anosmia was without merit, and filed documents (SEC Form 8-K) that it had convened a scientific panel that had concluded that there was "insufficient scientific evidence" that Zicam affected sense of smell in users. These statements formed the basis of plaintiff/respondents' complaint.

Plaintiff/respondents brought a class action lawsuit for securities fraud under Section 10(b) of the Securities and Exchange Act of 1934, 15 U.S.C. § 78j(b), and Securities and Exchange Commission Rule 10b-5, codified at 17 C.F.R. § 240.10b.5, for actions and statements by the company made between October 22, 2003 and February 6, 2004, which were allegedly misleading based on Matrixx's knowledge of the adverse events. The District Court dismissed, based on a failure of plaintiffs to allege a "statistically significant correlation between [Zicam use] and anosmia," which made the failure to disclose the University of Colorado study insufficient to be a material omission. The District Court also held that plaintiffs did not plead scienter with sufficient specificity. The Ninth Circuit reversed, holding that the District Court erred in requiring statistical significance and that Matrixx's actions constituted a "strong inference of scienter." The Supreme Court granted certiorari and affirmed the District Court.

Writing for a unanimous Court, Justice Sotomayor started with the language of the statute, that Section 10(b), Securities and Exchange Act and SEC Rule 10b-5 made it unlawful for "any person" to "make any untrue statement of a material fact or to omit to state a material fact necessary . . . to make the statements . . . not misleading." The standard for prevailing in a complaint for securities fraud under the statute is "'(1) a material misrepresentation or omission by the defendant; (2) scienter; (3) a connection between the misrepresentation or omission and the purchase or sale of a security; (4) reliance upon the misrepresentation or omission; (5) economic loss; and (6) loss causation,'" citing Stoneridge Investment Partners, LLC v. Scientific-Atlanta, Inc., 552 U. S. 148, 157 (2008). Here, Matrixx had alleged that plaintiff/respondents had not plead the material misrepresentation/omission element and the scienter element, both based on the failure to allege that Matrixx had statistically significant evidence linking Zicam use with anosmia.

The Court categorically rejected the view that a material misrepresentation/omission required this level of scientific evidence. Citing Basic Inc. v. Levinson, 485 U. S. 224, 236 (1988), the materiality requirement can be satisfied "when there is "'a substantial likelihood that the disclosure of the omitted fact would have been viewed by the reasonable investor as having significantly altered the "total mix" of information made available.'" The intention, according to the Court's opinion, was to enunciate a standard that would not encourage a company to "bury the shareholders in an avalanche of trivial information," which would presumably be just as harmful to an investor as a failure to disclose. The Court cited Basic for the proposition that materiality, which is an inherently fact-specific element, should not be decided on the basis of any "single fact or occurrence," because that approach would be "necessarily [] overinclusive or underinclusive." The Court characterized Matrixx's position as requiring a "bright-line rule" for materiality in securities fraud actions relating to adverse event reports for pharmaceuticals, i.e., to require statistically significant evidence thereof before a disclosure requirement was triggered under the securities laws. Behind this position was the idea that "reasonable investors would not consider such [adverse event] reports relevant unless they are statistically significant," because otherwise such "anecdotal" reports could not "'reflect a scientifically reliable basis for inferring a potential causal link between product use and adverse event."

The Court in rejecting this argument asserted that under such a bright-line standard information that "would otherwise be considered significant to the trading decision of a reasonable investor" would be "artificially exclude[ed]," because such a standard "rests on the premise that statistical significance is the only reliable indication of causation." "This premise is flawed," according to the Court, because there are "multiple factors" that medical researchers use to assess causation (citing the government's amicus curiae brief). In some cases, statistically significant data is simply not available, such as when an adverse event is "subtle or rare," the Court states, citing an amicus brief from the Medical Researchers, or "ethical concerns" may preclude the kinds of clinical studies necessary to establish statistical significance. The Court noted a plethora of other "relevant factors" for assessing adverse events, including "the strength of the association between the drug and the adverse effects; a temporal relationship between exposure and the adverse event; consistency across studies; biological plausibility; consideration of alternative explanations; specificity (i.e., whether the specific chemical is associated with the specific disease); the dose-response relationship; and the clinical and pathological characteristics of the event," citing defendant/petitioners and an amicus brief for the Consumer Healthcare Products Assn. et al.; these are also factors that the FDA takes into account before "taking action against pharmaceutical products" according to the Court, citing the FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment 18 (2005). Further citing FDA standards, the opinion noted that the Agency frequently takes action (such as requiring warning labels) "as soon as there is reasonable evidence of an association of a serious hazard with a drug" without requiring that causation has been established. Indeed, in this case the FDA issued a warning letter (in 2009) that "[a] significant and growing body of evidence substantiates that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who use them" based on evidence of 130 adverse event reports of anosmia as well as scientific journal articles.

In view of the fact that "medical professionals and regulators act on the basis of [scientific] evidence of causation that is not statistically significant," the Court asserted that it "stands to reason" that the reasonable investor might also be able to do so. Thus, the question of the materiality of such information, and whether it needs to be disclosed under the securities laws is "fact-specific" and requires an assessment of "the source, content and context of the reports" — in other words, the totality of the circumstances surrounding the evidence of adverse events (designated in Basic and cited here with approval as the "total mix" standard). The opinion noted that it does not intend to interpret the securities laws as "creating an affirmative duty to disclose any and all material information," including adverse event information but only that information that is necessary to make statements not misleading. "Even with respect to information that a reasonable investor might consider material, companies can control what they have to disclose under these provisions by controlling what they say to the market."

Here, the Court held that plaintiff/respondents had adequately plead materiality based on the totality of the circumstances surrounding Matrixx's statements (noting in Footnote 10 that this conclusion "accords with the views of the SEC" as evidenced by the Commission's amicus brief).

The opinion turns but briefly to the question of whether plaintiff/respondents adequately plead the scienter element, noting that Matrixx argued "in summary fashion" that the absence of statistical significance was sufficient to defeat this prong of the required pleading. The Court disagreed, stating that the inference that Matrixx acted "recklessly (or intentionally, for that matter) is at least as compelling, if not more compelling, than the inference that it simply thought the reports did not indicate anything meaningful about adverse reactions" to Zicam administration. The Court noted the company's actions both to investigate the alleged connection between Zicam and anosmia and to suppress this information, as well as its statements "suggested that studies had confirmed that Zicam does not cause anosmia when, in fact, it had not conducted any studies relating to anosmia and the scientific evidence at that time, according to the panel of scientists, was insufficient to determine whether Zicam did or did not cause anosmia." The totality of these circumstances (or "[t]hese allegations 'taken collectively'") was enough for the Court to conclude that plaintiff/respondent's allegations of scienter in their pleadings were sufficient to withstand a motion to dismiss (but "[w]hether respondents can ultimately prove their allegations and establish scienter is an altogether different question").

While not an unreasonable conclusion, the Court's decision imposes additional and unpredictable burdens on pharmaceutical companies even under conditions that may on their face appear less egregious than in this case. With regard to materiality, the "totality of the circumstances" standard replaces a scientific basis for assessing the significance of adverse events with a court's ex post facto view of what should or should not have been disclosed. There are certainly instances where the circumstances will make such a determination readily apparent, but there will also be others where some objective standard is not only necessary but also responsible if drugs are to timely come to market. While not discounting the deleterious consequences of some adverse events, it is not possible for any pharmaceutical to have no adverse events; the standard must take into account the frequency and severity of such adverse events in balancing the relative good with harm for any particular drug. Statistical significance is one but not the only standard, as the Court rightly concludes, but it has the advantage of being an objective basis that can be successfully used to distinguish from the merely anecdotal. It is foolish not to recognize that courts by necessity act well after the fact, and it is perhaps easier to assess the "totality of the circumstances" from their viewpoint. This decision does not reach the merits, but it does illustrate that eschewing scientific standards for judicial second-guessing can be fraught with unforeseen and unnecessary dangers for pharmaceutical companies and their customers alike.
Biotech/Pharma Docket

March 24, 2011

By James DeGiulio —

Apotex's Generic Provigil Found Not to Infringe Cephalon Patent

Apotex received a favorable ruling on summary judgment in its dispute with Cephalon regarding the narcolepsy drug Provigil after the U.S. District Court for the Eastern District of Pennsylvania determined that Apotex's proposed generic does not infringe one of two Cephalon patents at issue in the case. The conflict between Cephalon and Apotex arose out of an earlier dispute between Cephalon and four other generics. That earlier litigation began when Barr, Mylan, Teva, and Ranbaxy filed ANDAs seeking FDA approval to market generic versions of Provigil on December 24, 2002. In response, Cephalon filed suit against all four generic companies, alleging infringement of U.S. Patent Nos. 7,297,346 and RE37,516. Cephalon, however, reached settlements with all four defendants, giving them 180-day exclusivity to market their generics since all four companies filed their ANDAs on the same day.

In 2006, Apotex filed against Cephalon seeking a judgment of non-infringement with respect to the '516 patent and alleging antitrust claims against Cephalon with respect to the settlements with Barr, Mylan, Teva, and Ranbaxy. Apotex later sought a judgment of non-infringement with respect to the '346 patent as well. Apotex, and other drug suppliers, alleged that Cephalon asserted patents that it knew were weak and then offered the generics payoffs to stay off the market. The plaintiffs contended that Cephalon and the other generics companies all benefited from Cephalon's alleged payoff, which amounted to an conspiracy to suppress generic Provigil.

On March 15, Judge Mitchell S. Goldberg issued an Order granting Apotex's motion for summary judgment, ruling that its generic did not infringe the '346 patent. Cephalon also moved for summary judgment, indicating that it had only asserted the RE'516 patent against Apotex's ANDA and thus that there was no controversy concerning the '346 patent. However, that motion was denied, and Cephalon conceded that Apotex's product would not infringe the '346 patent. Judge Goldberg reminded Apotex that it needed a ruling of noninfringement on both patents in order to trigger the statutory 180-day exclusivity period. The infringement trial pertaining to the '516 patent has yet to be held.

Cephalon Drops Patent Suit Against Actavis over Nuvigil Generic

Cephalon and Actavis have agreed to settle their infringement suit over the narcolepsy drug Nuvigil after Actavis made the decision not to market a generic version of armodafinil. In December 2009, Cephalon filed suit against Actavis in the U.S. District Court for the District of Delaware, claiming infringement of U.S. Patent No. 7,132,570 (see "Court Report," December 13, 2009). In December 2010, the case was consolidated with several other infringement actions over Nuvigil. Other defendants include Apotex, Teva, Mylan, Watson, Lupin, and Sandoz. While Cephalon asserted the '570 patent in all seven of the consolidated suits, it also alleged that Sandoz and Apotex infringe U.S. Patent Nos. 7,297,346 and RE37,516.

On March 16, Judge Gregory Sleet issued an Order approving the stipulation between the two parties, thus ending Cephalon's case against Actavis. According to the agreement, Actavis will wait to market its generic Nuvigil product until the expiration of the '570 patent. Actavis can also enter the market if a final, nonappealable judgment is entered finding the '570 patent invalid or unenforceable.

OSI, Genentech, and Pfizer Settle Tarceva Patent Litigation with Teva

Astellas and subsidiary OSI Pharmaceuticals, along with Roche, Genentech, and Pfizer, have ended a case against Teva covering patents for the lung cancer drug Tarceva. The case began in March 2009, when OSI sued Teva in the U.S. District Court for the District of Delaware, accusing Teva of infringing U.S. Patent Nos. 6,900,221, 7,087,613, and 5,747,498 through its ANDA filing and plans to market generic erlotinib (see "Court Report," March 29, 2009). OSI markets the drug with Genentech, and Pfizer co-owns the '498 patent with OSI. In May 2009, the Teva suit was consolidated alongside the plaintiffs' claims against Mylan. Mylan remains as the sole defendant in the litigation. On March 15, one day after beginning trial, Judge Sue L. Robinson signed off on the parties' consent order of dismissal. Details of the agreement remain confidential.
The Disappearance of Deceptive Intent in S. 23

March 23, 2011

By Kevin E. Noonan —

Nestled unobtrusively in a section of S. 23 called "Technical Amendments," S. 23 (the "America Invents Act") has done something that neither Congress nor any court has been able to do for 80 years: remove (or at least blunt) the duty of candor owed by an applicant to the U.S. Patent and Trademark Office during prosecution of a patent application. This bit of legerdemain is accomplished by removing, in almost every instance in which it appears, the requirement that an applicant act "without deceptive intent."

These instances include:

35 U.S.C. § 116 regarding joint inventorship (amended in Section 16(a))

35 U.S.C. §116 Inventors.

(a) Joint Inventions – When an invention is made by two or more persons jointly, they shall apply for patent jointly and each make the required oath, except as otherwise provided in this title. Inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.

(b) Omitted Inventor – If a joint inventor refuses to join in an application for patent or cannot be found or reached after diligent effort, the application may be made by the other inventor on behalf of himself and the omitted inventor. The Director, on proof of the pertinent facts and after such notice to the omitted inventor as he prescribes, may grant a patent to the inventor making the application, subject to the same rights which the omit- ted inventor would have had if he had been joined. The omitted inventor may subsequently join in the application.

(c) Correction of Errors in an Application – Whenever through error a person is named in an application for patent as the inventor, or through an error an inventor is not named in an application, and such error arose without any deceptive intention on his part, the Director may permit the application to be amended accordingly, under such terms as he prescribes.

35 U.S.C. § 184 regarding filing of an application in foreign country (Section 16(b)):

35 U.S.C. §184 Filing of application in foreign country

(a) Filing in Foreign Country – Except when authorized by a license obtained from the Commissioner of Patents a person shall not file or cause or authorize to be filed in any foreign country prior to six months after filing in the United States an application for patent or for the registration of a utility model, industrial design, or model in respect of an invention made in this country. A license shall not be granted with respect to an invention subject to an order issued by the Commissioner of Patents pursuant to section 181 of this title without the concurrence of the head of the departments and the chief officers of the agencies who caused the order to be issued. The license may be granted retroactively where an application has been filed abroad through error and without deceptive intent and the application does not disclose an invention within the scope of section 181 of this title.

(b) Application – The term "application" when used in this chapter includes applications and any modifications, amendments, or supplements thereto, or divisions thereof.

(c) Subsequent Modifications, Amendments, and Supplements – The scope of a license shall permit subsequent modifications, amendments, and supplements containing additional subject matter if the application upon which the request for the license is based is not, or was not, required to be made available for inspection under section 181 of this title and if such modifications, amendments, and supplements do not change the general nature of the invention in a manner which would require such application to be made available for inspection under such section 181. In any case in which a license is not, or was not, required in order to file an application in any foreign country, such subsequent modifications, amendments, and supplements may be made, without a license, to the application filed in the foreign country if the United States application was not required to be made available for inspection under section 181 and if such modifications, amendments, and supplements do not, or did not, change the general nature of the invention in a manner which would require the United States application to have been made available for inspection under such section 181.

35 U.S.C. §§ 251 and 253 regarding reissue (Section 16(d) & (e)):

35 U.S.C. §251 Reissue of defective patents.

(a) In General – Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.

(b) Multiple Reissued Patents – The Director may issue several reissued patents for distinct and separate parts of the thing patented, upon demand of the applicant, and upon payment of the required fee for a reissue for each of such reissued patents.

(c) Applicability of This Title – The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent.

(d) Reissue Patent Enlarging Scope of Claims – No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent.

35 U.S.C. §253 Disclaimer.

(a) In General – Whenever, without any deceptive intention, a claim of a patent is invalid the remaining claims shall not thereby be rendered invalid. A patentee, whether of the whole or any sectional interest therein, may, on payment of the fee required by law, make disclaimer of any complete claim, stating therein the extent of his interest in such patent. Such disclaimer shall be in writing and recorded in the Patent and Trademark Office, and it shall thereafter be considered as part of the original patent to the extent of the interest possessed by the disclaimant and by those claiming under him.

(b) Additional Disclaimer or Dedication – In like manner any patentee or applicant may dis- claim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted or to be granted.

35 U.S.C. § 256 regarding correcting inventorship (Section 16(f)):

35 U.S.C. §256 Correction of named inventor.

(a) Correction – Whenever through error a person is named in an issued patent as the inventor, or through error an inventor is not named in an issued patent and such error arose without any deceptive intention on his part, the Director may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.

(b) Patent Valid if Error Corrected – The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent in which such error occurred if it can be corrected as provided in this section. The court before which such matter is called in question may order correction of the patent on notice and hearing of all parties concerned and the Director shall issue a certificate accordingly.

35 U.S.C. § 288 regarding infringement litigation of a patent containing n invalid claim (Section 16(h):

35 U.S.C. §288 Action for infringement of a patent containing an invalid claim.

Whenever, without deceptive intention, a claim of a patent is invalid, an action may be maintained for the infringement of a claim of the patent which may be valid. The patentee shall recover no costs unless a disclaimer of the invalid claim has been entered at the Patent and Trademark Office before the commencement of the suit.

(The remaining subsection, 16(g), amends 35 U.S.C. § 282(a) to remove reference to obviousness under 35 U.S.C. § 103(b).)

Most of these changes may not have any effect under circumstances where any of the actions proscribed in these sections of the statute are performed with deceptive intent, since that intent is likely to preclude enforceability of any such claims obtained by deceit. It is ironic, however, that Congress has scrupulously avoided addressing inequitable conduct by statutory change in any of the various permutations of "patent reform" legislation passed in recent Congresses, while in this bill eliminating the requirement for no deceptive intent in so many statutory provisions. It may be that the intention was to "harmonize" these portions of the statute with other sections that make it an applicant, rather than an inventor, who applies for a U.S. patent. However, taken together this is in many ways a more fundamental philosophical shift than even first-inventor-to-file. In addition to focusing the statutory language on applicants rather than inventors, and granting assignees the right to file applications without the consent or perhaps even knowledge of the inventors, S. 23 changes in many ways the basis for Congressional power to grant patents: while it may be that the patent statute will still "promote the progress . . . of the Useful Arts," the grant may no longer be to the Constitutionally intended recipients: inventors. While it may be that functionally in many if not most instances this will not be a significant change (most corporate inventors are obligated to assign to their employers, for example, and the Bayh-Dole Act vests ownership to academic inventions to the university and imposes an assignment obligation on professors, students and others engaged in research), these parts of S. 23 can also be viewed as a diminution of the public's reliance interests in the patent system. Reform, indeed.

For additional information regarding thisand other related topics, please see:

• "'Reform' at the U.S. Patent and Trademark Office," March 22, 2011
• "Few 'Reform' Provisions Remain in S. 23 Relating to the Judiciary," Marech 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
“Reform” at the U.S. Patent and Trademark Office

March 22, 2011

By Kevin E. Noonan —

Senate bill S. 23 (the "America Invents Act") contains several provisions changing the statutory authority of the U.S. Patent and Trademark Office (falling short, fortunately, of giving the Office substantive rule-making authority).

The most far-reaching of these changes is contained in Section 9, which gives the Office (for the first time) the authority to set its own fees. (Anyone who remembers the proposal in the earlier part of the last decade to use significantly escalating fees to "solve" the "excess filings" problem, which has matured into the backlog problem, will be understandably skeptical of the motivations, or that the likely use of this authority will not quickly become influential to substantive rights.) The Section provides that the Director "shall have authority to set or adjust by rule any fee established, authorized, or charged under title 35, United States Code, and the Trademark Act of 1946 (15 U.S.C. 1051 et seq.), notwithstanding the fee amounts established, authorized, or charged thereunder, for all services performed by or materials furnished by, the Office . . ." (Section 9(a)(1)). This authority is limited solely in that "patent and trademark fee amounts are in the aggregate set to recover the estimated cost to the Office for processing, activities, services, and materials relating to patents and trademarks, respectively, including proportionate shares of the administrative costs of the Office." In "certain" fiscal years, the bill prescribes a role for the Patent Public Advisory Committee and the Trademark Advisory Committee (Section 9(a)(3)), wherein the Director "shall consult" with these committees "regarding the advisability of reducing any of the fees" (Section 9(a)(3)(A)) and after such consultation, the Director "may" reduce such fees (Section 9(a)(3)(B)), i.e., the Director has the authority to ignore any such recommendations. With regard to the role of these advisory committees, the Director "shall" submit any proposed fees not less than 45 days before the fees will be published in the Federal Register (Section 9(a)(4)(A)), and at least 30 days to "deliberate, consider and comment (Section 9(a)(4)(B)), wherein the committee will hold a public hearing with the assistance of the Director "including by offering the use of Office resources to notify and promote the hearing to the public and interested stakeholders" (Section 9(a)(4)(B)(i) and (ii)). The committee is required under these provisions of the bill to prepare and make public a report containing their "comments, advice and recommendations" (Section 9(a)(4)(C)). The Director is then required to "consider and analyze any comments, advice, or recommendations received from the relevant advisory committee before setting or adjusting any fee (Section 9(a)(4)(D)) and notify Congress, specifically the Chair and Ranking Member of the Judiciary Committees of the House and Senate before issuing any final rule "adjusting" the fees (Section 9(a)(4)(E)).

This Section of the bill also provides several "notice and comment" periods, triggered by publication of any rules (or, presumably, fees) "prescribed under this section" in the Federal Register (Section 9(a)(5)(A)). Such publication must include "the specific rationale and purpose for the proposal, including the possible expectations or benefits resulting from the proposed change" (Section 9(a)(5)(B)(ii)). The ensuing public comment period must last at least 45 days (Section 9(a)(5)C)). And Congress gets its own comment period, also lasting at least 45 days (Section 9(a)(6)), with no fee being effective prior to the expiration of this period.

The Section also provides for fee reductions for small entities and a new category that is a subset of the small entity population, "micro entities" (separately defined in Section 12). Fees for "filing, searching, examining, issuing, appealing, and maintaining patent applications and patents" are reduced 50% for small entities and 75% for micro entities (Section 9(a)(2)).

Section 9(a)(7) may, like remarriage, be the triumph of hope over experience. This rule provides that "[n]o rule prescribed under this subsection [i.e., prescribing fees] may diminish (A) an applicant's rights under title 35, United States Code, or the Trademark Act of 1946, or (B) any rights under a ratified treaty."

The Section also has a number of conforming amendments to several laws regulating USPTO fees, including an amendment to 35 U.S.C. § 41(d) deleting the provision that the Director cannot increase any fee after Congress sets a fee schedule (Section 9(b)(e)). This section of the bill also contains a provision for encouraging electronic filing (Section 9(h)), imposing an additional fee of $400 for any "application for original patent, except for a design, plant or provisional application," that is not filed electronically (subject to reductions for small and micro entities), this "surcharge" to become effective 60 days after the bill is enacted into law (Section 9(h)(2)). In addition, the bill provides for a 50% reduction in fees to small entities for "prioritized examination" (Section 9(i)). Except for the provisions of Section 9(h), these provisions of the bill will become effective on the day the bill becomes law.

The definition of "micro entities" in Section 12 is contained in new 35 U.S.C. § 123, wherein the applicant can certify (and must certify) that they qualify as a small entity (§ 123(a)(1)), has not been named on 5 or more previously filed applications, including U.S. provisional applications, international applications "for which the basic national fee has not been paid," or applications filed "in a foreign country" (§ 123(a)(2)), did not in the prior calendar year have a gross income . . . exceeding 3 times the most recently reported median household income" (§ 123(a)(3)), and "has not assigned, granted, conveyed, and is not under an obligation by contract or law to assign, grant, or convey, a license or other ownership interest in the particular application to an entity that had a gross income . . . exceeding 3 times the most recently reported median household income . . . other than an entity of higher education where the applicant is not an employee, a relative of an employee, or have any affiliation with the entity of higher education" (§ 123(a)(4)). These latter provisions may encompass some sole inventors, and whether they are likely to be beneficial to traditional small entities that make significant contributions to innovation such as universities will depend on how the "other than" provision of § 123(a)(4) is interpreted.

There are a few exceptions to these limitations. Applications "resulting from prior employment" (i.e., when the applicant is named on earlier patents or applications where she had an obligation to assign her rights) do not "count" within the 5 application limit of § 123(a)(2) (§ 123(b)), and state (but not private) institutions of higher learning are included under the designation of a micro entity (§ 123(d)(1)), provided that the applicant has assigned her rights to the State institution of higher education ((§ 123(d)(1)(B)). The Director is given the authority to "impose income limits, annual filing limits, or other limits on who may qualify as a micro entity" provided that the Director "determines that such additional limits are reasonably necessary to avoid an undue impact on other patent applicants or owners or are otherwise reasonably necessary and appropriate" (Section 12(a)(2)). The Director is obligated under these circumstances to notify Congress, through the Judiciary Committees of both Houses, at least three months prior to imposing any such limits.

Section 19(a) provides the Office with the authority to provide funds for "subsistence expenses and travel-related expenses, including per diem, lodging costs, and transportation costs, of non-federal employees attending" programs, studies, or exchanges of items or services regarding domestic and international intellectual property law and the effectiveness of intellectual property protection domestically and throughout the world, and provides the Director with the authority to set administrative patent judges pay (Section 19(b)).

Section 20 of the bill relates to fee diversion and efforts to prevent Congress from continuing to raid USPTO coffers to fund general expenses. This is done by establishing a new repository for USPTO fees, called the "United States Patent and Trademark Office Public Enterprise Fund" (Section 20(b)(1)(A)) and by revising 35 U.S.C. § 42 to provide that the fees collected by the Office "shall be collected by the Director and shall be available until expended," i.e., the monies are solely available for use by the Director in directing the performance of the duties of the Office (Section 20(b)(1)(B)(ii)). The effective date of these provisions are a date certain, either October 1, 2011 or "the first day of the first fiscal year that begins after the date of the enactment of this Act" (Section 20(b)(2)(A) and (B)).

Section 20 also provides a "USPTO Revolving Fund" (Section 20(c)) that is "available for use by the Director without fiscal year limitation," i.e., the monies will not revert to the general fund if not expended in any particular fiscal year. All patent and trademark fees are to be deposited into this Fund (Section 20(c)(2)) (except the paper application surcharge of Section 9(h) or trademark surcharges) and will be available to cover "all administrative and operating expenses, determined in the discretion of the Under Secretary to be ordinary and reasonable, incurred by the Under Secretary and the Director for the continued operation of all services, programs, activities, and duties of the Office relating to patents and trademarks, as such services, programs, activities, and duties are described under" the patent or trademark laws (Section 20(c)(3)). This section also imposes on the Director an obligation to submit to Congress a report setting forth information on the "operations of the Office" including finances and staff levels for the past fiscal year (Section 20(d)(1)); providing an "operating plan" for the coming fiscal year (Section 20(d)(2)); describing plans for Office modernization (Section 20(d)(3)) and details on progress of such modernization plans (Section 20(d)(4)); and audit results for the Office (Section 20(d)(5)). This section also imposes the obligation that the Director notify the Appropriations Committees of both Houses of Congress with regard to "the plan for the obligation and expenditure of the total amount of the funds for that fiscal year" (Section 20(e)). Such a report must contain a summary of Office operations and a detailed operating plan for the current fiscal year (Section 20(e)(2)). There are also audit (Section 20(f)) and budget (Section 20(g)) requirements, evincing a desire by Congress to retain oversight over the new-found fiscal authority of the Office.

Less urgently, the bill provides for the establishment of "3 or more satellite [Patent] offices in the U.S." (Section 21(a)), for the general purpose of improving the Office's performance and outreach and to attract and retain more examiners (Section 21(b)). There are "required considerations" for choosing the locations of these satellite offices (Section 20(c)), including "geographic diversity," and such offices are to be "phased in" over a three-year period beginning on the date of enactment of the bill into law (Section 20(d)). This section also includes a requirement for a Report to Congress describing the "rationale" for choosing the sites for satellite offices, the progress made in doing so, and whether establishing these offices fulfills the statutory mandate (Section 20(e)). The first of these satellite offices is to be established in Detroit (Section 24), and to be named the "Elijah J. McCoy United States Patent and Trademark Office" (Section 24(a)).

There are two other sections of the bill that relate to U.S. Patent and Trademark Office practices. Section 22 authorizes the Director to establish, "subject to available resources," a Patent Ombudsman Program, to "provid[e] support and services relating to patent filings to small business concerns." Section 23 provides "priority examination for technologies important to American competitiveness," amending 35 U.S.C. § 2(b)(2) by adding subparagraph (G):

(G) may, subject to any conditions prescribed by the Director and at the request of the patent applicant, provide for prioritization of examination of applications for products, processes, or technologies that are important to the national economy or national competitiveness without recovering the aggregate extra cost of providing such prioritization, notwithstanding section 41 or any other provision of law.

Section 14 of the bill bans patents on tax strategies, by providing that they are deemed to be "within the prior art." Tax strategy patents are defined as claiming "any strategy for reducing, avoiding, or deferring tax liability, whether known or unknown at the time of the invention or application for patent" (Section 14(a)), where "tax liability" is defined as "any liability for a tax under any Federal, State, or local law, or the law of any foreign jurisdiction, including any statute, rule, regulation, or ordinance that levies, imposes, or assesses such tax liability" (Section 14(b)). The bill provides (Section 14(c)) that these provisions are not to "be construed to imply that other business methods are patentable or that other business-method patents are valid," reacting no doubt to such arguments made by Bilski and amici in Bilski v. Kappos regarding provisions of the American Inventors Protection Act (1999). The bill specifically excludes any invention that is "a method, apparatus, computer program product, or system, that is used solely for preparing a tax or information return or other tax filing, including one that records, transmits, transfers, or organizes data related to such filing" (Section 14(e)), and that the effective date of these provisions is the "date of enactment of this Act and shall apply to any patent application pending and any patent issued on or after that date" (Section 14(d)).

Finally, Section 25 provides that, unless otherwise provided in this Act," the provisions of the bill will become effective one year after enactment and will apply "to any patent issued on or after that effective date," i.e., will be retroactive to all pending applications.

For additional information regarding thisand other related topics, please see:

• "Few 'Reform' Provisions Remain in S. 23 Relating to the Judiciary," Marech 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
Biotech Industry Losing Interest in the Therapeutic Potential of RNAi

March 21, 2011

By James DeGiulio —

When Andrew Fire and Craig Mello (at right) unraveled the mechanism of RNA interference (RNAi) and were awarded the Nobel Prize in 2006 for their efforts, RNAi was predicted to become the next great source of new therapeutics. Pharmaceutical companies moved quickly to devote research funding and personnel to developing what appeared to be a novel way to target nearly any protein involved in nearly any disease. However, five years — and billions of dollars in research and development — later, it appears that RNAi is falling out of favor in the industry, which is moving away from investing in potential RNAi therapeutics, according to a recent New York Times article ("Drugmakers’ Fever for the Power of RNA Interference Has Cooled"). Despite the nearly universal belief that at a certain point RNAi will make it to the market, the efficiency of RNAi delivery has thus far limited its therapeutic potential. Industry executives claim that alternatives to RNAi that are closer to producing marketable drugs have taken priority, including conventional drugs, monoclonal antibodies, and even older antisense gene silencing technology.

RNAi was first discovered in 1998 in the nematode worm Caenorhabditis elegans and later found in a wide variety of organisms, including mammals. Research development moved quickly, and by 2005, three drugs were ready for clinical trials. Since then, however, two of the three trials have already been dropped due to inefficient delivery. The third, targeting respiratory infection, has shown some signs of effectiveness, but conclusive trials are only now under way. Achieving efficient delivery of RNAi molecules has been the largest obstacle to realizing the therapeutic potential of RNAi, an obstacle that has also limited gene therapy applications. Drugs working through the RNAi mechanism have been shown to successfully silence genes, but it has been difficult to deliver these drugs to the cells where they are needed. One major problem is that RNA is quickly degraded in the bloodstream, and even if the RNA can reach the target cells in the body, it has trouble entering the cells. Yet another obstacle is the immune response that double-stranded RNA particles can provoke. To address these issues, scientists have developed RNA chemical modifications which prevent degradation in the bloodstream and avoid immune responses, but achieving efficient and reliable delivery of RNAi remains elusive.

Within the past year, some big players in the biotech industry have pulled the plug on development of RNAi therapeutics. In November 2010, Roche announced the end of its efforts to develop drugs using RNAi, after it had invested half a billion dollars in the field over four years. In January 2011, Pfizer decided to shut down its 100-person unit working on RNAi and related technologies. Abbott Laboratories has also ended its RNAi drug development work. Partnerships have also decreased, as big pharma companies have been increasingly hesitant to invest capital in smaller companies that specialize in RNAi. Alnylam Pharmaceuticals, widely considered the leader among these companies, cut a quarter of its work force late last year after Novartis decided against partnership.

History may indicate that the RNAi hype is just dying down, and more realistic expectations are now taking hold. It is not unusual for the initial enthusiasm for a new technology to wane as the technology slowly is perfected. A prime example is monoclonal antibodies, which took twenty years to translate into blockbuster drugs like Avastin and Humira. Indeed, regardless of the decisions of big pharma, interest in RNAi technology still remains. In early February, two midsize European drug companies signed small deals to explore development of RNAi drugs. Also, despite no clear proof that a drug using RNAi can effectively treat a human disease, about a dozen RNAi drugs in clinical trials are currently pending, which is more than ever before.
Few “Reform” Provisions Remain in S. 23 Relating to the Judiciary

March 21, 2011

By Kevin E. Noonan —

Seante bill S. 23 (the "America Invents Act"), as passed on March 13, 2011, contains few provisions related to aspects of patent law administered by the judiciary. This is ironic, in view of the extent to which calls for reform of damages, venue, willfulness, and other issues provided a major impetus to the persistent calls for reform that originally motivated such legislation (see, e.g., "Tech Companies Send Letter on Patent Reform to Secretary Locke"; "Draft Report on Senate Patent Reform Bill Circulated"; "Draft Report on Senate Patent Reform Bill: Damages"; "Senate Leadership Unveils Details of Patent Reform Agreement"). Decisions by the Supreme Court (eBay, KSR, Bilski, Lucent, Uniloc, TS Tech, Seagate, and the prospect of Microsoft v. i4i) may have blunted the force of these arguments (mostly by the "high tech" industry), but it is noteworthy that S. 23 contains nothing relating to the "grand compromise" worked out by Judiciary Committee Chairman Senator Leahy (D-VT), Senator Feinstein (D-CA), and Senator Specter (R-, then D-PA) in the prior bill, S. 515, which was reported out of committee in 2010 but never brought to a vote on the Senate floor.

The only provisions regarding venue, Section 8 of S. 23, relate to what the bill terms "technical amendments," wherein §§ 32, 145, 146, 154(b)(4)(A), and 293 of 35 U.S.C. and § 21(b)(4) of the Lanham Act are revised by replacing the U.S. District Court for the District of Columbia with the U.S. District Court for the Eastern District of Virginia, in recognition that the U.S. Patent and Trademark Office has moved to Arlington, Virginia. This change will be effective on the enactment date of the Act.

The bill also contains Section 11, which applies to the residency requirement for judges on the Court of Appeals for the Federal Circuit. Under current law, Federal Circuit judges are required to reside within 50 miles of the District of Columbia (also known as the "Baldwin Rule"), a requirement that precludes them from travelling from the residences to the court as needed (much like former Deputy PTO Director Sharon Barner was able to do during her term in the Office). Section 11 provides that 28 U.S.C. § 44(c) be amended to read:

(c) Except in the District of Columbia, each circuit judge shall be a resident of the circuit for which appointed at the time of his appointment and thereafter while in active service.

While in active service, each circuit judge of the Federal judicial circuit appointed after the effective date of the Federal Courts Improvement Act of 1982, and the chief judge of the Federal judicial circuit, whenever appointed, shall reside within fifty miles of the District of Columbia.

In each circuit (other than the Federal judicial circuit) there shall be at least one circuit judge in regular active service appointed from the residents of each state . . . in that circuit.

On the other hand, Section 11(b) provides that repeal of the residency requirement for Federal Circuit judges "shall not be construed to authorize the provision of any court facilities or administrative support services outside of the District of Columbia," which immediately reduces the likelihood that any member of the court will be able to live outside the District. These provisions will be effective on the date the bill is enacted into law.

Section 15 of the bill removes the best mode requirement as way of proving invalidity under 35 U.S.C. § 282 or for alleging a defect to a patent for reissue under 35 U.S.C. § 251. The requirement is also deleted (Section 15(b)) from the requirements for claiming priority under 35 U.S.C. § 119(e)(1) or 35 U.S.C. § 120. These provisions will be effective on the date the bill is enacted into law "and shall apply to proceedings commenced on or after that date."

Section 17 "clarifies jurisdiction" of federal courts over patenting matters, amending 28 U.S.C. § 1338(a) to affirmatively recite that "[n]o State court shall have jurisdiction over any claim for relief arising under any Act of Congress relating to patents, plant variety protection, or copyrights" (Section 11(b)). In a similar vein, the bill (Section 17(c)) amends 28 U.S.C. § 1295(a)(1) to recite that the Federal Circuit has jurisdiction for ". . . an appeal from a final decision of a district court of the United States, the District Court of Guam, the District Court of the Virgin Islands, or the District Court of the Northern Mariana Islands, in any civil action arising under, or in any civil action in which a party has asserted a compulsory counterclaim arising under, any Act of Congress relating to patents or plant variety protection" (Section 17(c)(1)). Removal of a state action to Federal Court is provided in Section 17(d) of the bill, amending 28 U.S.C. § 89 by adding new section 1454:

Sec. 1454. Patent, plant variety protection, and copyright cases

(a) In General- A civil action in which any party asserts a claim for relief arising under any Act of Congress relating to patents, plant variety protection, or copyrights may be removed to the district court of the United States for the district and division embracing the place where such action is pending.

(b) Special Rules- The removal of an action under this section shall be made in accordance with section 1446 of this chapter, except that if the removal is based solely on this section—

(1) the action may be removed by any party; and

(2) the time limitations contained in section 1446(b) may be extended at any time for cause shown.

(c) Derivative Jurisdiction Not Required- The court to which a civil action is removed under this section is not precluded from hearing and determining any claim in such civil action because the State court from which such civil action is removed did not have jurisdiction over that claim.

(d) Remand- If a civil action is removed solely under this section, the district court—

(1) shall remand all claims that are neither a basis for removal under subsection (a) nor within the original or supplemental jurisdiction of the district court under any Act of Congress; and

(2) may, under the circumstances specified in section 1367(c), remand any claims within the supplemental jurisdiction of the district court under section 1367.

Similarly, the bill (Section 17(e)) amends 28 U.S.C. § 89 by adding new section 1632:

Sec. 1632. Transfer by the Court of Appeals for the Federal Circuit

When a case is appealed to the Court of Appeals for the Federal Circuit under section 1295(a)(1), and no claim for relief arising under any Act of Congress relating to patents or plant variety protection is the subject of the appeal by any party, the Court of Appeals for the Federal Circuit shall transfer the appeal to the court of appeals for the regional circuit embracing the district from which the appeal has been taken.

The effective date of these amendments made will apply to "any civil action commenced on or after the date of the enactment of this Act."

For additional information regarding thisand other related topics, please see:

• "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
USPTO Offers Relief to Japanese Applicants

March 20, 2011

By Donald Zuhn —

Last week, the U.S. Patent and Trademark Office announced that it would be offering relief to persons affected by the 9.0-magnitude earthquake that struck about 250 miles northeast of Tokyo on March 11 and the resulting tsunami. In particular, the Office stated that it would withdraw and reissue any outstanding Office notice in a patent application or reexamination proceeding having one or more inventors, an assignee, or a correspondence address in areas of Japan affected by the earthquake and tsunami.

In a notice published in the Official Gazette, the Office said it considered the effects of the earthquake and tsunami to be an "extraordinary situation" within the meaning of 37 C.F.R. § 1.183 and 37 C.F.R. § 2.146 for affected applicants. Saying that the Office's "thoughts and prayers are with the people of Japan who continue to suffer from the effects of the earthquake and resulting tsunami," USPTO Director David Kappos noted that the Office was "offering assistance in the form of flexibility on deadlines to the full extent allowable under our laws to Japanese applicants."

The relief applies to situations "in which a reply or response to an Office action (final, non-final, or other), a notice of allowance, or other Office notice . . . is outstanding, and for which the statutory or non-statutory time period set for response has not yet expired." The notice states that the Office will withdraw and reissue such notices upon an applicant's or reexamination party's request, to be made using Form PTO/SB/425 (or by including a copy of the Office's notice regarding the relief) "prior to expiration of the statutory or non-statutory time period set for response and within sufficient time so that withdrawal and reissuance of the Office communication occur prior to expiration of the statutory or non-statutory time period."

The Office also noted that it will waive the surcharge under 37 C.F.R. § 1.20(h) or (i) for affected patentees who were unable to timely pay a maintenance fee that was due on or after March 11. In addition, the Office will waive the surcharge under 37 C.F.R. § 1.16(f) for affected applicants who did not file an oath or declaration, or basic filing fee, search fee, and/or examination fee when filing a nonprovisional application on or after March 11. To obtain the above relief, applicants must use Form PTO/SB/425 or include a copy of the Office's notice regarding the relief.

The notice explains that the Office cannot grant waivers or extensions of dates or requirements set by statute, and therefore, cannot extend the following time periods:

(1) the period set forth in 35 U.S.C. 119(a)-(d) to file a nonprovisional patent application claiming the benefit of a prior-filed foreign application; (2) the twelve-month time period set forth in 35 U.S.C. 119(e) during which a nonprovisional application claiming the benefit of a prior filed provisional application must be filed in order to obtain benefit of the provisional application's filing date; (3) the copendency requirement of 35 U.S.C. 120 between a parent application which issues as a patent and a later filed child application, which requires that the child application be filed prior to issuance of the parent application; (4) the three-month time period to pay the issue fee set forth in 35 U.S.C. 151; (5) the 35 U.S.C. 304 two-month time period from the date of patentee service, for a requester to file, in an ex parte reexamination, a reply to a statement filed by the patentee; and (6) the 35 U.S.C. 314(b)(2) thirty-day time period from the date of service, for a requester to file, in an inter partes reexamination, written comments addressing issues raised by an Office action or the patentee's response to the action.

Thus, the Office's notice does not apply to these statutory dates or requirements.

Additional details for obtaining the relief being offered to affected applicants by the USPTO can be found in the Office's notice. The notice also provides information about relief that is being offered to affected trademark applicants.
Court Report

March 20, 2011

By Sherri Oslick —

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

Glycobiosciences, Inc. v. Nycomed US, Inc. et al.
2:11-cv-01280; filed March 17, 2011 in the Eastern District of New York

• Plaintiff: Glycobiosciences, Inc.
• Defendants: Nycomed US, Inc.; Pharmaderm; Jagotec AG

Infringement of U.S. Patent Nos. 5,897,880 ("Topical Drug Preparations," issued April 27, 1999) and 6,723,345 (same title, issued April 20, 2004) based on defendants' manufacture and sale of Solaraze® (diclofenac sodium, used to actinic keratosis). View the complaint here.

Braintree Laboratories, Inc. v. Amrutham, Inc.
2:11-cv-01854; filed March 16, 2011 in the Eastern District of Pennsylvania

Infringement of U.S. Patent No. 6,946,149 ("Salt Solution for Colon Cleansing," issued September 20, 2005) following a Paragraph IV certification as part of Amrutham's filing of an ANDA to manufacture a generic version of Braintree's Suprep® (sodium sulfate, potassium sulfate and magnesium sulfate osmotic laxative, used for bowel cleansing prior to an adult patient having a colonoscopy procedure). View the complaint here.

United States of America et al. v. Teva Pharmaceuticals USA, Inc.
2:11-cv-01461; filed March 15, 2011 in the District Court of New Jersey

• Plaintiffs: United States of America; Board of Trustees of the University of Illinois
• Defendants: Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 7,470,506 ("Fitness Assay and Associated Method," issued December 30, 2008), licensed to Tibotec, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Tibotec's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.

Gilead Sciences, Inc. et al. v. Natco Pharma Ltd. et al.
2:11-cv-01455; filed March 15, 2011 in the District Court of New Jersey

• Plaintiffs: Gilead Sciences, Inc.; Hoffmann-La Roche Inc.; F. Hoffmann-La Roche Ltd.; Genentech, Inc.
• Defendants: Natco Pharma Ltd.; Natco Pharma Inc.

Gilead Sciences Inc. et al. v. Natco Pharma Ltd. et al.
1:11-cv-00221; filed March 14, 2011 in the District Court of Delaware

• Plaintiffs: Gilead Sciences Inc.; Hoffmann-La Roche Inc.; F. Hoffmann-La Roche Ltd.; Genentech Inc.
• Defendants: Natco Pharma Ltd.; Natco Pharma Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,763,483 ("Carbocyclic Compounds," issued June 9, 1998) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Genentech's Tamiflu® (oseltamivir phosphate, used to treat uncomplicated acute illness due to influenza infection in patients one year or older who have been symptomatic for no more than two days and for the prophylaxis of influenza in patients one year or older). View the Delaware complaint here.

Affymetrix, Inc. et al. v. Illumina, Inc.
3:11-cv-00184; filed March 14, 2011 in the Western District of Wisconsin

• Plaintiffs: Affymetrix, Inc.; Gregory L. Kirk
• Defendant: Illumina, Inc.

Correction of inventorship of U.S. Patent Nos. 7,510,841 ("Methods of Making and Using Composite Arrays for the Detection of a Plurality of Target Analytes," issued March 31, 2009) and 7,612,020 ("Composite Arrays Utilizing Microspheres with a Hybridization Chamber," issued November 3, 2009) to name Dr. Gregory L. Kirk as an inventor. View the complaint here.

Endo Pharmaceuticals Inc. v. Mylan Technologies Inc. et al.
1:11-cv-00220; filed March 14, 2011 in the District Court of Delaware

• Plaintiff: Endo Pharmaceuticals Inc.
• Defendants: Mylan Technologies Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.

Declaration that Mylan's Paragraph IV notice is null, void, and without legal effect and that Mylan's notice did not trigger the 45-day period for filing an infringement action under the Hatch-Waxman Act. Also, infringement of U.S. Patent No. 5,741,510 ("Adhesive Patch for Applying Analgesic Medication to the Skin," issued April 21, 1998), licensed to Endo, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Endo's Lidoderm® (lidocaine patch, used to treat after-shingles pain). View the complaint here.

Hoffman-La Roche, Inc. et al. v. Kappos
1:11-cv-00516; filed March 10, 2011 in the District Court of the District of Columbia

• Plaintiffs: Hoffman-La Roche, Inc.; Morphosys AG
• Defendant: David J. Kappos

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,794,719 ("Anti-Amyloid β Antibodies," issued September 4, 2010). View the complaint here.

Abbott Laboratories et al. v. Sandoz Inc.
2:11-cv-01415; filed March 10, 2011 in the District Court of New Jersey

• Plaintiffs: Abbott Laboratories; Fournier Laboratories Ireland Ltd.
• Defendant: Sandoz Inc.

Infringement of U.S. Patent No. 7,259,186 ("Salts of Fenofibric Acid and Pharmaceutical Formulations Thereof," issued August 21, 2007) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Abbott's Trilipix® (choline fenofibrate delayedrelease, used to treat increased triglyceride levels). View the complaint here.
Conference & CLE Calendar

March 20, 2011

March 23, 2011 – Antibody Patents after Centocor (Intellectual Property Owners Association) – 2:00 PM (ET)

April 5-6, 2011 – International Patent Forum 2011 (Managing Intellectual Property) – London, UK

April 6-9, 2011 – 26th Annual Intellectual Property Law Conference (American Bar Association Section of Intellectual Property Law) – Arlington, VA

April 13-15, 2011 – Intellectual Property Counsels Committee (IPCC) Spring Conference & Meeting (Biotechnology Industry Organization) – Seattle, WA

April 15, 2011 – 2nd Annual John Marshall Law School Review of Intellectual Property Law Symposium – Chicago, IL

April 27, 2011 – 27th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

May 3-4, 2011 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE

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