Patent Docs

PatCon 3: The Patent Conference

The University of Kansas School of Law, IIT Chicago-Kent College of Law, University of San Diego School of Law, and Boston College Law School will be holding the third annual Patent Conference -- PatCon 3 -- on April 12-13, 2013 at IIT Chicago-Kent College of Law in Chicago, IL.  The conference will consist of the following sessions:

• The Changing Landscape of Patent Law: At the USPTO, the Supreme Court and the Federal Circuit? -- to be presented by The Honorable Judge Richard Linn, U.S. Court of Appeals for the Federal Circuit

• A Conversation with Industry -- panel including corporate counsel from BP America, AbbVie, Bridgestone Americas and RR Donnelley

• Plenary Session -- to be presented by Prof. Mark Lemley of Stanford Law School; Alan Marco, Acting Chief Economist at the U.S. Patent and Trademark Office; and Prof. David Abrams of the University of Pennsylvania Law School

• Debate About the Patent System -- panel including The Honorable Judge Richard Posner, U.S. Court of Appeals for the Seventh Circuit; and Prof. Richard Epstein of the New York University School of Law and University of Chicago Law School

A complete agenda for the PatCon 3 conference, including an agenda, list of speakers, and list of topics to be covered can be found here (Friday, April 12) and here (Saturday, April 13).

Additional information about the conference can be found here.  While Friday's sessions are open to anyone, Saturday's sessions are limited to academics.  Those interested in attending Friday's sessions can do so here.  The registration fee is $99 (practitioners and other members of the public) or free (full-time faculty and students).

Webinar on Impact of AIA on Claim Construction

Strafford will be offering a webinar/teleconference entitled "Advanced AIA Issues for Patent Claim Construction: Best Practices Absent Clear Court Guidance" on April 18, 2013 from 1:00 - 2:30 pm (EDT).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, Lauren L. Stevens of Foley & Lardner, and Colin G. Sandercock of Perkins Coie will provide guidance to patent counsel regarding the impact of the Leahy-Smith America Invents Act (AIA) on claim construction and offer best practices for addressing claim construction issues in light of the AIA.  The panel will review the following questions:

• What are the changes resulting from AIA and the implications for claim construction?
• What is the impact of claim construction on choice of law?
• What are the benefits of new claims in a continuation application regarding choice of law in view of transitional applications?
• Can the choice of law change when a district court judge construes the claim in such a way that the EFD changes?
• What are the benefits and dangers of new claims, depending on their claim construction, in a continuation application filed after March 15, 2013?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by March 29, 2013 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

C5 Freedom to Operate Forum

C5 (UK) will be holding its 10th International Forum on Freedom to Operate on May 15-16, 2013 in Frankfurt, Germany.  C5 faculty will offer presentations on the following topics:

• A timeline of best practice at key milestones in the development pathway to ensure you develop & execute a robust and rigorous FTO search strategy;
• Practical guidance for conducting your FTO searches more cost effectively and efficiently;
• Overcoming challenges relating to privilege: How in-house counsel should communicate their FTO findings with the board to minimise risk;
• Practical steps to take to identify & address the threat of potential blocking patents;
• Refining and repositioning your FTO strategy in light of the latest case law on SPCs;
• Update on the latest trends at the EPO: The views of the EPO and perspectives of users;
• Tailoring your FTO strategy in response to the latest developments in litigation and interim injunctions in the Netherlands, Germany and the UK;
• Tailoring your tactics for biosimilars: Analysing the regulatory risks & the impact on your FTO strategy;
• Latest US case law developments impacting your FTO analysis;
• The impact of US patent reform on European FTO analysis: What your peers are doing right now to ensure compliance;
• Freedom to operate in China and India; and
• What to do when your FTO assessment goes wrong: Key considerations relating to remedies and damages.

A pre-conference workshop, entitled "A Highly Practical and Hands-On Workshop Providing a Step by Step In-Depth Guide Through the Whole FTO Process" will be offered from 8:00 to 10:30 am on May 15, 2013, and a post-conference workshop, entitled "Reading and Analysing Claims in Patents and Patent Applications for Establishing FTO: EU and US Jurisdiction-Specific Issues," will be offered from 2:30 to 5:00 pm on May 16, 2013.

A complete brochure for this conference, including an agenda, list of speakers, detailed descriptions of conference sessions, and registration form can be downloaded here.

The registration fee is €1895 (conference), €2495 (conference and one workshop), and €2695 (conference and both workshops).  Those registering by April 19, 2013 will receive a €100 discount.  A webcast of the conference is also available for €1355 (€1155 by April 19, 2013).  Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, by faxing a registration form to +44 20 7878 6885, or by e-mailing [email protected].

Patent Docs is a media partner of C5's Freedom to Operate Forum.

C5 Pharma & Biotech Collaborations 2013 Conference

C5 (UK) will be holding its 2nd Forum on Pharma & Biotech Collaborations on May 14, 2013 in Frankfurt, Germany.  C5 faculty will offer presentations on the following topics:

• Identifying the current deal drivers and trends in deal-making: What it means for your next collaboration agreement;
• How leading pharma & biotech choose the right partner and deal structure;
• Executing robust agreements to underpin fruitful collaborations and limit the potential for future disputes and litigation;
• Successfully negotiating and drafting collaborative research agreements with academic institutions;
• Effective alliance management: Avoiding missteps and producing workable solutions for the inherent challenges of life sciences collaborations;
• Putting the end first: Defining critical termination rights from the outset;
• How much is it worth? Establishing the deal valuation; and
• Overcoming defects in IP that have the potential to derail collaborations and safeguarding your rights during negotiations.

A complete brochure for this conference, including an agenda, list of speakers, detailed descriptions of conference sessions, and registration form can be downloaded here.

The registration fee is €1399 (conference) or €995 (webinar).  Those registering by April 12, 2013 will receive a €200 discount.  Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, by faxing a registration form to +44 20 7878 6885, or by e-mailing [email protected].

Patent Docs is a media partner of C5's Pharma & Biotech Collaborations Forum.

Obama Administration Solicits Public Help in Preventing Foreign Trade Secret Theft

By Josh Rich --

On Tuesday, the U.S. Intellectual Property Enforcement Coordinator, Victoria Espinel, published a notice in the Federal Register "requesting any recommendations for legislative changes that would enhance enforcement against, or reduce the risk of, the misappropriation of trade secrets for the benefit of foreign competitors or foreign governments."  78 Fed. Reg. 16875 (Mar. 19, 2013).  Submissions are due by April 22, 2013.  The request for public submissions is one of the first steps in the implementation of the "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," issued on February 20, 2013 (see ""Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation").

The Administration Strategy is a five-pronged approach, coordinated by the U.S. IP Enforcement Coordinator and involving many of the executive branch departments.

First, the strategy calls for the White House to focus diplomatic efforts to protect trade secrets overseas.  Although the Administration Strategy does not expressly identify any specific countries on which it is focused, the examples of misappropriation of trade secrets for the benefit of foreign companies and countries are almost exclusively Chinese.  Consistent with this focus on China, National Security Advisor Tom Donilon later said that reports of cyber theft of confidential business information from entities in China were occurring "on a very large scale" and that the Chinese government "should take serious steps to investigate and put a stop to these activities" ("US calls for 'serious' action by China to stop cybertheft," The Washington Post, March 11, 2013).  However, a private U.S.-based cybersecurity firm had previously issued a report identifying the Chinese government (specifically, a military unit based in Shanghai) as being one of the causes of Chinese cyberattacks (see Mandiant Intelligence Center Report).  Thus, while the Strategy calls for sustained and coordinated international engagement with trading partners, such as China, it may be difficult for the Federal agencies charged with doing so (including the Departments of Commerce, Defense, Homeland Security, Justice, State, and Treasury, and the U.S. Trade Representative) to make much headway.  The Administration may find more success in the Department and PTO working with other countries through Intellectual Property Rights (IPR) working groups to fashion rules and policies to discourage trade secret theft.  The Strategy also calls for domestic law enforcement agencies to leverage international law enforcement cooperative agreements and arrangements to pursue investigations both in the U.S. and abroad.

Second, the Strategy calls for the U.S. IP Coordinator to promote voluntary best practices by private industry to protect trade secrets.  While the IP Enforcement Coordinator will work with the Departments of Justice and State (among other agencies) to encourage companies and industry groups to develop and implement voluntary best practices, the Administration Strategy expressly indicates that those best practices must be consistent with antitrust laws.  Among the areas in which the Strategy suggests focus are R&D compartmentalization, information security, physical security, and human resources policies.  But the Strategy makes it clear that compliance with best practices must be voluntary, and any identified best practices may not be suitable for all companies.

Third, the Strategy calls for the enhancement of domestic law enforcement operations.  Spearheaded by the Attorney General's Task Force on Intellectual Property and the FBI, the Department of Justice is making the investigation and prosecution of corporate and state-sponsored trade secret theft a higher priority.  The Office of the Director of National Intelligence will also coordinate the sharing of intelligence among the intelligence and law enforcement communities in order to monitor foreign government activity and prevent international trade secret misappropriation, and will also work with the private sector to warn of potential threats.

Fourth, the Strategy calls for the Administration to improve domestic legislation.  This is the prong to which the U.S. IP Coordinator's Federal Register notice is directed, and one area where there has been concrete (although incremental) progress in recent months.  The Strategy highlighted two acts passed at the conclusion of the last Congress.  First, the "Theft of Trade Secrets Clarification Act of 2012" was intended to reverse the outcome of cases like United States v. Aleynikov, 676 F.3d 71 (2d Cir. 2012), in which the defendant stole the source code for a proprietary high-frequency trading system from his former employer to provide it to a new employer, but was acquitted because the source code was intended to remain secret and therefore not "related to or included in a product that is produced for or placed in interstate or foreign commerce."  That Act modified the Economic Espionage Act (EEA) to make it cover trade secrets "related to a product or service used in or intended for use in interstate or foreign commerce."  Second, the "Foreign and Economic Espionage Penalty Act of 2012" did exactly that: increased potential sentences and fines for violations of the EEA.  The U.S. IP Enforcement Coordinator is charged with coordinating an initial review of existing Federal laws within 120 days of the release of the Administration Strategy, by June 20, 2013.

Finally, the Strategy calls for various departments in the Administration to increase efforts to develop public awareness and engage in stakeholder outreach.  For example, the FBI and Department of Commerce are to continue and expand their efforts to inform the public about the threat and cost of trade secret misappropriation, using existing public awareness programs.  In addition, the PTO will include discussion of the economic implications of trade secret misappropriation in its "road show" events.

All in all, the Administration Strategy suggests a greater focus on protection of trade secrets against foreign misappropriation, as well as a more coordinated effort than in the past.  But the next steps, both in discussions with China and shaping of Federal legislation, may be critical in determining whether that effort provides greater security for domestic companies.  We will continue to monitor developments and will report back on suggested legislative changes.

GEN Compiles List of Top Biopharma R&D Spenders

By Donald Zuhn --

Earlier this month, Genetic Engineering & Biotechnology News published its list of the top 20 best-selling prescription drugs worldwide for 2012 (see "GEN Compiles List of Top Selling Drugs for 2012").  The biotech publication has followed that effort with a list of the top 20 biopharma companies in terms of research and development spending.  GEN's latest list, which the journal released on March 12 (see "Top 20 Biopharma R&D Spenders"), was based on figures disclosed by the companies in annual reports and quarterly results press releases.  For each company making its list, GEN has provided spending totals for 2008, 2011, and 2012, R&D spending as a percentage of sales for 2008, 2011, and 2012, and the percent change in R&D spending from 2011 to 2012.  2012 R&D spending for the top 20 companies ranged from $1.156 billion to $9.332 billion.

GEN's top 20 rankings are shown below, with GEN's figures for 2012 and 2008 R&D spending.  We have also included the number of biopharm patents for which the company was listed as an assignee in 2012.  Biopharm patents were determined to be those patents designated as belonging to the following classes (each having an assigned art unit in Technology Center 1600, which encompasses biotechnology and organic chemistry):  260 (Chemistry of Carbon Compounds), 424 (Drug, Bio-Affecting and Body Treating Compositions), 435 (Chemistry: Molecular Biology and Microbiology), 436 (Chemistry: Analytical and Immunological Testing), 504 (Plant Protecting and Regulating Compositions), 506 (Combinatorial Chemistry Technology: Method, Library, Apparatus), 514 (Drug, Bio-Affecting and Body Treating Compositions), 518 (Chemistry: Fischer-Tropsch Processes; or Purification or Recovery of Products Thereof), 530 (Chemistry: Natural Resins or Derivatives; Peptides or Proteins; Lignins or Reaction Products Thereof), 532, 534, 536, 540, 546, 548, 549, 552, 554, 556, 558, 560, 562, 564, 568, 570 (Organic Compounds -- Part of the Class 532-570 Series), 730 (Data Processing: Structural Design, Modeling, Simulation, And Emulation), 800 (Multicellular Living Organisms and Unmodified Parts Thereof and Related Processes), and/or 930 (Peptide or Protein Sequence), 987 (Organic Compounds Containing a Bi, Sb, As, or P Atom or Containing a Metal Atom of the 6th to 8th Group of the Periodic System).  Note: The identification of biopharm patents in the table below may be limited in some respects.  For example, to the extent that biopharm patents were designated in some other class, such patents will be omitted from the number of biopharm patents.  In addition, to the extent that a subsidiary of a given company contributed to that company's patent count and the subsidiary had a distinct name, such patents will be omitted from the number of biopharm patents.  Moreover, if the company was not indicated on the face of the patent as an assignee, that patent will be omitted from the number of biopharm patents.

Genetic Engineering & Biotechnology News Top 20 Biopharma R&D Spenders for 2012

Genetic Engineering & Biotechnology News, "Top 20 Biopharma R&D Spenders," March 12, 2013.

IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics

By Donald Zuhn --

In an amicus brief filed last week in support of respondents Myriad Genetics, Inc. et al., the Intellectual Property Owners Association (IPO) asked the Supreme Court to affirm the Federal Circuit's decision in Association for Molecular Pathology v. Myriad Genetics, Inc. that claims to isolated human DNA are patent-eligible.  The IPO brief opens by noting that "[w]hile Petitioners and their amici provocatively refer to the subject matter at issue in this case as 'human gene patenting,' this term inaccurately characterizes the claims in Myriad's patent," and that "what is claimed is a specific sequence of isolated human DNA."

The IPO argues first that isolated human DNA constitutes patent-eligible subject matter.  Citing Diamond v. Chakrabarty, the brief reminds the Court that it "fashioned a straightforward test of whether a manufacture or composition of matter was patent-eligible: it must demonstrate the 'hand of man,' something that is 'a product of human ingenuity 'having a distinctive name, character [and] use.''"  The IPO argues that "[t]he Court's Chakrabarty test is the proper standard for patent-eligibility, not the imposition of bright line, categorical rules applying broad, categorical prohibitions such as that advanced by Plaintiffs and their amici," and thus, "[a]nything that evinces the 'hand of man' is patent-eligible" (emphasis in brief).

According to the IPO, isolated human DNA satisfies the requirement in Chakrabarty that claimed subject matter show "the hand of man," and therefore is patent-eligible.  With respect to the characteristic of being "isolated," the brief notes that "the entire genetic complement (or genome) in the cell comprises about six billion nucleotides of DNA," and that "[a]n individual gene typically comprises about 1,000 of these nucleotides."  The brief points out that "to isolate a gene requires these specific 1,000 nucleotides to be separated from the remaining (approximately) 5,999,999,000 nucleotides in the cellular genome."

The IPO next addresses the impact of other Supreme Court decisions on the Myriad case, arguing that no other precedent controverts Chakrabarty.  Noting that the Court recently addressed the issue of patent eligibility in Mayo Collaborative Services v. Prometheus Labs., Inc., the brief states that the Court's concerns about the scope of patent eligibility "arise when the claims produce no more than information (inform a relevant audience about certain laws of nature)."  Citing the Court's decisions in O'Reilly v. Morse, Gottschalk v. Benson, Parker v. Flook, and Bilski v. Kappos, the brief contends that "[i]n each of these decisions, the Court found a lack of patentable subject matter because the claimed method provided little (or nothing) more than abstract information as opposed to concrete inventions that 'promote the Progress of . . . the useful Arts.'"  Contrasting these cases with Myriad, the brief states that:

Unlike the method claims in Mayo, Benson, Flook and Bilski, Myriad's composition of matter claims at issue here are not broadly preemptive. They are both specific and concrete and as such do not implicate the policy concerns enunciated by this Court in those cases where preemption rendered claims patient-ineligible.  Rather than being directed to mere information, the claims at issue are drawn to a useful and concrete composition of matter that falls within the statutory classes of patentable subject matter defined by Congress in Section 101 of the patent statute.  Since Myriad's claimed inventions "evince the hand of man," they are directed to patentable subject matter per Chakrabarty.

Turning to Petitioners' argument that isolated human DNA is patent ineligible because it constitutes a product of nature, the IPO counters that "[t]his contention is incorrect as a matter of law and as a matter of fact."  The brief explains that:

The claimed isolated human BCRA1 and BCRA2 DNA are not "products of nature" because, as claimed, they are not found in nature.  These isolated human DNAs are never found "isolated" in nature.  First, they are not merely associated with contaminants (like the "intracellular material" contaminating cellulose in the Wood Paper Patent Cases); they are intrinsically (and covalently) attached to and are a part of the physical and chemical structure of the chromosomal DNA, and their isolation requires them to be separated from this DNA, i.e., to be present in an entirely new chemical structure.  . . .  [I]n other (cDNA) embodiments the claimed isolated human DNA is also not merely "isolated" but chemically changed in the process, first by the cell in making mRNA, and again by the inventor in converting the mRNA into cDNA.  Thus, the claimed subject matter is different, physically and chemically, from the DNA present in nature.

The brief continues by arguing that:

[Another] line of reasoning, enunciated by the Court in Funk Brothers and recited with approval in Chakrabarty and more recently in Mayo, is that claims cannot encompass a "natural law" or "phenomenon of nature."  Myriad's claims to isolated human DNA do neither.  These claims recite man-made manufactures or compositions of matter, not phenomena.  They are tangible, physical compounds, having particular and specific structures capable of being elucidated and described.  They do not foreclose anything other than making, using, selling, offering to sell, or importing these specific and particular chemical compounds.

The IPO also takes the Petitioners to task for "wrongly equat[ing]" the patenting of isolated human DNA with the patenting genetic information.  While acknowledging that "[t]here is no dispute that genetic information, standing alone, is not patentable subject matter and does not belong to one of the statutory categories required for patent-eligibility," the IPO argues that "[p]atent claims to isolated DNA only cover the isolated DNA itself, and not the genetic information per se."  The brief also argues that:

The dichotomy between patent-eligible isolated human DNA and patent-ineligible genetic information is consistent with precedent.  For example, in O'Reilly v. Morse, 56 U.S. 62, 63 (1853), the ability to use electricity for communication was found to be patent-ineligible, but the specific telegraph invented by Morse was determined to be patent-eligible.  Algorithms per se have also been held to be patent-ineligible, Parker v. Flook, 437 U.S. 584, 585 (1978); Gottschalk v. Benson, 409 U.S. 63, 64 (1972), while the use of an algorithm (an equation) in a patented process has been found to be patent-eligible, Diamond v. Diehr, 450 U.S. 175, 177 (1981).

The brief next discusses the adverse impact that a ban on isolated human DNA patenting would have on the development of biologic drugs and personalized medicine.  The brief also suggests that "[a]bsent patent protection, and under the circumstances of multigenic causation (or at least association) of common diseases, the impetus will be to develop and protect this nascent technology using, inter alia, trade secret protection."  The brief predicts that "[u]nder these circumstances, innovation in genetic-based diagnostics would be severely limited, since there would be no incentive (indeed, there would be strong disincentives) to disclose the genetic basis of the diagnostic assay," and that as a result, genetic information "as a trade secret, could be kept out of the public domain indefinitely."

The brief concludes by arguing that isolated human DNA patenting does not impede research.  In support of this conclusion, the brief cites a study performed by the American Association for the Advancement of Science on the effects of isolated human DNA patenting on basic research in the U.S., Germany, the U.K, and Japan, the study finding that "intellectual property rights had little negative impact on the practice of science."  Suggesting that "[p]erhaps the best measure of [research] activity is the number of research reports in public databases that reflect ongoing basic scientific research in peer-reviewed scientific journals," the brief notes that "[w]hile reported estimates differ depending on the search term used, a simple search of 'brca1 or brca2' resulted in 10,652 publications [in the scientific literature]."  The brief then adds that:

If [Myriad's] patents had a chilling effect on basic research, the expectation would be that the number of scientific research reports would have declined in the face of these patents.  On the contrary, the number of such publications has steadily increased each year, which is precisely what would be expected if these patents had no significant effect on basic scientific research.

What these patents do, of course, is prevent commercial activity -- using the patented isolated human DNA or performing the patented methods for profit.  This is a legitimate exercise of the patent grant.

Note: the IPO brief was co-authored by Patent Docs author Dr. Kevin Noonan.

USPTO News Briefs

By Donald Zuhn --

USPTO Extends Comment Period on Notice Regarding Preparation of Patent Applications

In January, the U.S. Patent and Trademark Office published a notice in the Federal Register (78 Fed. Reg. 2960) requesting public comment regarding potential practices that applicants can employ in the drafting of patent applications to facilitate examination and bring more certainty to the scope of issued patents.  The notice set forth a list of nine "potential practice changes that applicants can employ to augment the quality of issued patents" and sought input as to whether any of the practices should be used by applicants during the preparation of an application to place the application in a better condition for examination.

On March 15, the Office published a new notice in the Federal Register (78 Fed. Reg. 16474) extending the comment period by one month from March 15, 2013 (when many application drafters were likely preoccupied with a more significant deadline) to April 15, 2013.  Comments can be sent by e-mail to [email protected], or by regular mail addressed to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Nicole D. Haines.

In the Office's initial notice, the potential practice changes were divided into two groups, one group related to clarifying the scope of the claims and one group related to clarifying the meaning of claim terms in the specification.  The first group of potential practices included:

1.  Presenting claims in a multi-part format by way of a standardized template that places each claim component in separate, clearly marked, and designated fields (e.g., preamble, transitional phrase, and individual claim limitations).

2.  Identifying corresponding support in the specification for each of the claim limitations (e.g., using a claim chart).

3. Indicating whether examples in the specification are intended to be limiting or merely illustrative.

4.  Identifying whether the claim preamble is intended to be a limitation on claim scope.

5.  Expressly identifying clauses within particular claim limitations for which the inventor intends to invoke 35 U.S.C. § 112(f) (which pertains to means-plus-function limitations for applications filed on or after September 16, 2012) and pointing out where in the specification corresponding structures, materials, or acts are disclosed that are linked to the identified § 112(f) claim limitations.

6.  Using textual and graphical notation systems known in the art to disclose algorithms in support of computer-implemented claim limitations, such as C-like pseudo-code or XML-like schemas for textual notation and Unified Modeling Language (UML) for graphical notation.

The second group of practices included:

1.  Indicating whether terms of degree -- such as substantially, approximately, about, essentially -- have a lay or technical meaning and explaining the scope of such terms.

2.  Including in the specification a glossary of potentially ambiguous, distinctive, and specialized terms used in the specification and/or claims.

3.  Designating, at the time of filing the application, a default dictionary or dictionaries to be used in ascertaining the meaning of the claim terms.

USPTO Implements PCT-PPH with IPOPHL

On March 5, the U.S. Patent and Trademark Office announced that it was establishing a patent prosecution highway (PPH) pilot program based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the Intellectual Property Office of the Philippines (IPOPHL).  Under the new pilot program, which went into effect on January 29, an applicant receiving a written opinion or international preliminary examination report in a PCT application that indicates at least one claim in the PCT application has novelty, inventive step, and industrial applicability, where the USPTO was the International Searching Authority or the International Preliminary Examining Authority, may request that the IPOPHL fast track the examination of corresponding claims in an application filed with the IPOPHL.  The USPTO- IPOPHL PCT-PPH pilot program is scheduled to expire on January 28, 2014, but may be extended if necessary to adequately assess the feasibility of the program.

USPTO Upgrades to PPH 2.0 with IPOPHL

On the same day that the U.S. Patent and Trademark Office announced the implementation of a PCT-PPH with the IPOPHL, the USPTO announced that it was upgrading its PPH with the IPOPHL to a PPH 2.0 program, with the upgrade commencing on January 29.  The PPH 2.0 program with IPOPHL supersedes the prior PPH program with that office.  The upgrade with the IPOPHL brings the number of PPH 2.0 participating offices to twelve, including the USPTO, Canadian Intellectual Property Office (CIPO), European Patent Office (EPO), Japan Patent Office (JPO), IP Australia (IPAU), Korean Intellectual Property Office (KIPO), National Board of Patents and Registration of Finland (NBPR), Portugal National Institute of Industrial Property (INPI-PT), Federal Service on Intellectual Property, Patents & Trademarks of Russia (Rospatent), Spanish Patent and Trademark Office (SPTO), and United Kingdom Intellectual Property Office (UKIPO).

In order to participate in any of the PPH 2.0 programs in the USPTO, applicants must satisfy the following requirements:

1.  One of the other PPH 2.0 participating offices has determined that at least one claim is allowable/patentable (under the PPH 2.0 program, applicants no longer need to submit a copy of the allowed claim or any English translation thereof).

2.  The application before the PPH 2.0 participating office (i.e., containing the allowable/patentable claim) and the U.S. application for which participation in the PPH 2.0 program is being requested must have the same priority/filing date (the Annex to the USPTO's notice on the PPH 2.0 program provides fifteen schematics outlining situations in which this requirement would be satisfied).

3.  All claims on file, as originally filed, or as amended in the U.S. application must sufficiently correspond to one or more of the claims indicated as allowable in the application filed in the PPH 2.0 participating office (the USPTO notice states that "[a] claim is considered to 'sufficiently correspond' where, accounting for differences due to translations and claim format, the claim in the U.S. application is of the same or similar scope as a claim indicated as allowable in the application filed in the PPH 2.0 participating office").  Under the PPH 2.0 program, applicants must submit a claims correspondence table (in English), indicating how all the claims in the U.S. application correspond to the allowable/patentable claims in the application filed in the PPH 2.0 participating office.

4.  Examination of the U.S. application for which participation in the PPH 2.0 program is being requested has not yet begun.

5.  The applicant has filed a request to participate in the PPH 2.0 program.

6.  The applicant must submit a copy of the office action issued just prior to the "Decision to Grant a Patent" (along with an English translation, which may be a machine translation) for the application before the PPH 2.0 participating office (under the PPH 2.0 program, applicants no longer need to submit a statement that the English translation is accurate).

7.  The applicant must submit an information disclosure statement listing all documents cited in the office action of the PPH 2.0 participating office.

8.  All of the documents described above must be filed via the EFS-Web and indexed using the document description:  "Petition to make special under Patent Pros Hwy."

Additional information regarding the PPH 2.0 program with the IPOPHL can be found here.

USPTO Continues PPH with SIPO

Earlier this month, the U.S. Patent and Trademark Office announced the continuation of the PPH pilot program with the State Intellectual Property Office of the People's Republic of China (SIPO).  As with other PPH programs, the USPTO-SIPO PPH permits an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either the USPTO or SIPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.  The USPTO-SIPO PPH pilot program is now scheduled to expire on November 30, 2013, but may be extended thereafter.

Court Report

By Sherri Oslick --

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

Apotex, Inc. et al. v. Teva Pharmaceutical Industries, Ltd. et al.
0:13-cv-60601; filed March 14, 2013 in the Southern District of Florida

• Plaintiffs:  Apotex, Inc.; Apotex Corp.
• Defendants:  Teva Pharmaceutical Industries, Ltd.; Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 6,531,486 ("Pharmaceutical Compositions Comprising Quinapril Magnesium," issued March 11, 2003) based on Teva's manufacture of generic quinapril hydrochloride products (used to treat hypertension).  View the complaint here.

Bayer Intellectual Property GmbH et al. v. Rea
1:13-cv-00324; filed March 12, 2013 in the Eastern District of Virginia

• Plaintiffs:  Bayer Intellectual Property GmbH; Bayer Pharma Aktiengesellschaft
• Defendant:  Hon. Teresa Stanek Rea

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,273,876 ("Medicaments Containing Vardenafil Hydrochloride Trihydrate," issued September 25, 2012).  View the complaint here.

Janssen Products, L.P. et al. v. Hetero Drugs, Ltd. et al.
2:13-cv-01444; filed March 8, 2013 in the District Court of New Jersey

• Plaintiffs:  Janssen Products, L.P.; Janssen R&D Ireland
• Defendants:  Hetero Drugs, Ltd.; Unit III; Invagen Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 7,126,015 ("Method for the Preparation of Hexahydro-furo-[2,3-b]furan-3-ol," issued October 24, 2006) and 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Alvogen Pine Brook Inc. et al.
1:13-cv-00370; filed March 7, 2013 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendants:  Alvogen Pine Brook Inc.; Alvogen Group Inc.

Novartis Pharmaceuticals Corp. et al. v. Actavis Inc. et al.
1:13-cv-00371; filed March 7, 2013 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendants:  Actavis Inc.; Watson Pharmaceuticals Inc.; Watson Laboratories Inc.; Watson Pharma Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the Alvogen complaint here.

Merck, Sharp & Dohme Corp. et al. v. Hetero USA Inc. et al.
1:13-cv-01402; filed March 7, 2013 in the District Court of New Jersey

• Plaintiffs:  Merck, Sharp & Dohme Corp.; Bristol-Myers Squibb Co.; Bristol-Myers Squibb Pharma Co.
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd. Unit-III

Infringement of U.S. Patent Nos. 6,639,071 ("Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one," issued October 28, 2003) 6,939,964 (same title, issued September 6, 2005), and 6,673,372 ("Crystalline Efavirenz," filed January 6, 2004) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of BMS' Sustiva® (efavirenz, used to treat HIV infection).  View the complaint here.

Conference & CLE Calendar

March 18-19, 2013 - 7th Annual Patent Law Institute (Practising Law Institute) - San Francisco, CA

March 19-20, 2013 - FDA Boot Camp*** (American Conference Institute) - New York, NY

March 20, 2013 - Improving the Success of Appeals to the Patent Trial and Appeal Board (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 - 11:15 am (CT)

March 20, 2013 - Patent Claim Drafting and Construction in 2013: Crafting Claims to Withstand Scrutiny and Avoiding Claim Limitation Attack (Strafford) - 1:00 - 2:30 pm (EST)

March 25-27, 2013 - 2013 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) - San Diego, CA

April 3-5, 2013 - 28th Annual Intellectual Property Law Conference (American Bar Association (ABA) Section of Intellectual Property Law) - Arlington, VA

April 4, 2013 - Double Patenting: Defeating Rejections and Avoiding Terminal Disclaimers (Strafford) - 1:00 - 2:30 pm (EDT)

April 15-16, 2013 - China IP Counsel Forum (American Conference Institute) - Shanghai, China

April 16, 2013 - 29th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) - New York, NY

April 16, 2013 - Optimizing the Discovery Process: Home and Abroad (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

April 22-25, 2013 - 2013 BIO International Convention (Biotechnology Industry Organization) - Chicago, IL

May 7-8, 2013 - Paragraph IV Disputes (American Conference Institute) - New York, NY

May 21-23, 2013 - Pharma Legal Affairs (IBC Life Sciences) - Shanghai, China

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

Pharma Legal Affairs Asia 2013

IBC Life Sciences will be holding its 2nd annual Pharma Legal Affairs conference on May 21-23, 2013 in Shanghai, China.  IBC faculty will offer presentations on the following topics:

• India: Latest change toward "the public good" regime;
• Overcoming the hurdles of obtaining drug approvals in the China market;
• South East Asia: Understanding the legal barriers in entering Asia's emerging markets;
• Leveraging patents in competition with generics in China;
• Identifying cost effective patent litigation strategy;
• How much protection is provided by the current legal framework in China?
• The legal battle over biosimilars;
• Learning strategies to counter "employee's theft of trade secrets" in pharma-biotech;
• Mastering your manufacturing and distribution agreements in Asia;
• Improving negotiation skills in collaboration and licensing contracts;
• Strategic collaboration agreements and successful commercialization of product in biopharmaceuticals;
• Mergers and acquisitions: The cure to rejuvenate big pharma?
• US FCPA and its implication on evolving legislation in Asia;
• Reviewing recent pharmaceutical FCPA violation cases in Asia;
• Reaping the benefits of effective anti-corruption programs; and
• Managing and enforcing corruption compliance across Asia.

In addition, two post-conference workshops will be offered on May 23, 2013.  The first, entitled "Due Diligence for Pharma-Biotech Collaboration and R&D Agreement," will be held from 9:00 am to 12:30 pm, and the second, entitled "Anti Bribery and Corruption Compliance for Pharmaceutical Companies," will be held from 1:30 to 5:00 pm.

The agenda for the Pharma Legal Affairs conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $1,995 (conference alone), $2,295 (conference and one workshop), or $2,595 (conference and both workshops).  Those registering by April 12, 2013 will receive a $100 discount.  Those interested in registering for the conference can do so here, by e-mailing [email protected], by calling +65 6508 2401, or by faxing a registration form to +65 6508 2407.

Patent Docs is a media partner of IBC's Pharma Legal Affairs conference.

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

By Kevin E. Noonan --

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 504, the "Fair and Immediate Release of Generic Drugs Act."  Like many of its predecessors, it is aimed at banning settlement agreements of ANDA litigation between innovator drug companies and generic drug manufacturers.

The bill contains provisions that preclude the 180-day exclusivity period granted to the first ANDA filer from any party that has entered into a "disqualifying agreement."  Another provision limits agreements on deferring commercial marketing, which are defined as being between a first ANDA filer and NDA holder (or owner of an Orange Book listed patent that was the subject of a Paragraph IV certification) and wherein the first filer agrees "not to seek an approval of its application that is made effective on the earliest possible date" or "not to begin the commercial marketing of its drug on the earliest possible date after receiving an approval of its application" or both.  More specifically:

An agreement described in this subclause is an agreement between an applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the 180-day exclusivity period whereby that applicant agrees, directly or indirectly, not to seek an approval of its application or not to begin the commercial marketing of its drug until a date that is after the expiration of the 180-day exclusivity period awarded to another applicant with respect to such drug (without regard to whether such 180-day exclusivity period is awarded before or after the date of the agreement).

If there is more than one possible date where an applicant can either "seek an approval of its application or begin the commercial marketing of its drug," then the ANDA applicant can seek approval or begin commercial marketing on the earlier of the latest date set forth in the agreement or 180 days after "another first applicant" begins commercial marketing.  That latest date in an agreement "shall be the date used to determine whether an applicant is disqualified from first applicant status."

The bill also contains a notice provision to the FDA that requires that the "text" of any agreement "that has been reduced to writing" (or a "written detailed description" of any agreement not reduced to writing) be submitted to the Secretary of HHS "not more than 10 business days after execution of the agreement."  And the bill contains a confidentiality clause providing that "[a]ny information or documentary material filed with the Secretary pursuant to this paragraph shall be exempt from disclosure []and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding (although another provision states that there is "nothing" to prevent disclosure to either body of the Congress or to any duly authorized committee or subcommittee of the Congress).

35 U.S.C. § 271(e) is also amended to recite:

(7) The exclusive remedy under this section for an infringement of a patent for which the Secretary of Health and Human Services has published information pursuant to subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act shall be an action brought under this subsection within the 45-day period described in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal Food, Drug, and Cosmetic Act.

Application of these provisions is limited to agreements subject to the amendments made by the Medicare Prescription Drug, Improvement and Modernization Act of 2003.

It is the responsibility of the prevailing party in the litigation to notify the FDA.

For those keeping track, the Supreme Court will decide FTC v. Activis this term, perhaps rendering the bill moot.  The proximity of the bill and the Court's deliberations suggest that these Senators may be expressing their displeasure with "pay for delay" agreements and that they recognize the political capital that can be garnered by taking this stance.

AIPLA Submits Amicus Brief to Supreme Court in AMP v. Myriad Genetics

By Kevin E. Noonan --

There is a great cultural divide that has been illuminated by the Myriad case (AMP v. Myriad Genetics), between producers of technology and its consumers, governments and non-government organizations such as patient groups who are goal-driven to reduce present costs (especially in healthcare) regardless of future disadvantages, and the more general schism between those who understand science and technology and those who don't.  There is also the problem of bright, educated, ambitious, and motivated graduates of America's best colleges and universities who have the natural propensity of their class and age to think they have better answers than their elders who have actually tackled the problems of investment and commercialization.  This becomes a problem, of course, when many of these folks go into government, resulting in the Justice Department's "magic microscope" as but one example.

Another consequence is that briefs for both sides of the "gene patenting" question repeat the same arguments based on the same policy rationales to come to the same conclusions.  The AIPLA's amicus brief in the Myriad case illustrates the issue.  The brief sets forth the following propositions:

I. MYRIAD'S CLAIMED DNA MOLECULES ARE NOT PRODUCTS OF NATURE
    A. Human DNA Is Complex in Both Structure and Function
    B. Myriad Claims Isolated DNA Molecules, Not Found in Humans, That Can Perform New Functions
II. THE FEDERAL CIRCUIT APPLIED THE CORRECT TEST
    A. Patent Eligibility of Isolated DNA Molecules, Which Are Compositions of Matter, Must Be Analyzed Under the Applicable Precedents
    B. Prometheus Applies to Method Claims, Not to the Isolated DNA Molecule Claims at Issue Here
    C. Myriad's Claims May Not Be Patentable, But That Does Not Make Them Patent-Ineligible Under Section 101
III. PATENT PREEMPTION DOES NOT PRECLUDE THE PATENTABILITY OF THE CLAIMED SUBJECT MATTER
    A. The Importance of Broad Patent Eligibility
    B. The Experimental Use Exception Allows For Some Uses of the Claimed DNA Molecules
IV. CONGRESS HAS RECOGNIZED THE PATENT ELIGIBILITY OF ISOLATED DNA MOLECULES
    A. Moral and Ethical Considerations Are for Congress, Not the Courts

There is not an incorrect statement of the law in any of this, nor the science.  (There are a few aspects that bear closer scrutiny, as set forth below.)  But it is true that the science of DNA does not resemble either the pointedly incorrect analogies set forth by the petitioners (DNA as a kidney, or a leaf, or a mineral) or the equally inapt analogies by courts (such as the distinctions between a tree and a baseball bat or a statue and a piece of marble).  Ignoring the facts makes it easy to misapply the law; indeed, the old aphorism may need to be updated to read "Bad analogies make bad law."  The distinctions set forth in Section I of the AIPLA's brief are not news to anyone who understands the scientific basis of isolated DNA.  But generalist lawyers and judges can be understood (if not forgiven) to have believed that the ways scientists have tried to explain DNA (as a library or a book or a code or software) are in fact what DNA actually is.  "A gene is but a chemical compound, albeit a complex one" is the proper measure of what is encompassed in claims to isolated DNA, and the conflation of the patent-eligible molecule for the patent-ineligible sequence has made it easier for petitioners to convince some judges and the public that patents for human genes are a bad idea.

Nor is the brief incorrect on the law, setting forth the "applicable precedents" of Chakrabarty, Funk Bros., and J.E.M. Ag Supply to support the proposition that isolated human DNA satisfies the requirements for the "hand of man" and new utilities of isolated natural products.  Unfortunately, the matter is before the Court because the patent eligibility of isolated human DNA has not been decided before, despite the 30 years and thousands of patents in this area.  And the brief is also correct that the principles enunciated in Benson, Flook, Diehr, Bilski, and Mayo do not directly apply, as those were method claims embodying laws of nature, not composition or manufacture claims directed to isolated "products of nature."  The brief goes somewhat astray in making this argument categorically, i.e., based on the statutory category of invention rather than, for example, on the differences in scope of the two types of claims.  This is nicely illustrated by the Myriad claims at issue, which are limited to DNA molecules that encode a specific amino acid sequence.  Unlike the broad reach of claims to a "law of nature," Myriad's claims are extremely narrow.  Think:  if a putatively infringing DNA molecule encodes a protein that differs by even a single amino acid, that DNA molecule does not literally infringe.  This point is even sharper when it is recognized that the one amino acid difference could be a valine to isoleucine change, which is equivalent to the addition or subtraction of a single methylene group – (-CH₂-) –  in a protein molecule comprising 60,000-100,000 atoms.  Never has so small a change had so large an effect on claim scope, and yet the AIPLA misses the opportunity to inform the Court that petitioners' claims about the scope of preemption occasioned by permitting isolated human DNA to be patented are grossly exaggerated.  Also in this section of the brief the AIPLA appears to agree that Myriad's claims may not even be patentable, a curious position for a brief in favor of patent eligibility.  Mayo showed clearly that the Court believes that its Section 101 jurisprudence is "well established" and a better vehicle for preventing patenting of claims that should not be patented -- why give them a reason to think that Myriad's claims might not be worth the effort?

The brief's section on preemption is where questions are raised about the focus of the brief and its potential vel non for persuasiveness.  First, rather than addressing the argument, the brief takes the position that "broad patent eligibility" is necessary, thereby to a degree conceding to petitioners the point that these claims broadly preempt use of human genes for research.  The brief then posits the existence of an "experimental use exception" for basic research that, frankly, does not exist.  While there are some 19th Century district court cases that support the proposition, for most, the Federal Circuit's decision in Madey v. Duke Univ., 307 F.3d 1351, 1361-62 (Fed. Cir. 2002), foreclosed any such broad protection against patent infringement liability for university research.  This is because the Federal Circuit recognized that university research was not for "philosophical experiments" or "gratifying a philosophical taste, or curiosity, or for mere amusement."  The brief correctly identifies the "safe harbor" provisions of the Hatch-Waxman Act, codified under 35 U.S.C. § 271(e)(1), but while broadly interpreted by the Supreme Court (Medtronic v. Eli Lilly & Co., Merck v. Integra) this is of limited usefulness for most inventions including isolated human DNA.  And the brief's citation of In re Rosuvastatin Calcium Patent Litig., __ F.3d___, 2012 WL 6217356, at *12 (Fed. Cir. Dec. 14, 2012), misses the mark because while "patenting does not deprive the public of the right to experiment with and improve upon the patented subject matter" and "[i]t is not necessary to wait for the patent to expire before the knowledge contained in the patent can be touched," the case does not stand for the proposition that a three-judge panel of the Court sua sponte created a research exception sufficient to protect university research on isolated, patented human DNA.  (It is somewhat amusing that one of the citations set forth in the brief to support the existence of a experimental use exception is L.C. Bruzzone, The Research Exemption: A Proposal, 21 AIPLA Q.J. 52 (1993), which is, on its face, a proposal.)  The better argument, of course, is that there has never been patent infringement litigation against basic research, even by Myriad:  indeed, more than 10,000 research papers have been published since the BRCA gene patents were granted.  This statistic is much more persuasive than an argument that bolsters the proposition that basic science research is at risk of patent infringement liability but for the tenuous existence of a experimental use/research exemption.

Finally, as has been discussed in previous posts, it is a waste of paper to argue to this Court deference to Congress on such matters, particularly when it is inaction, rather than affirmative action, that is the basis for the argument.

Oral argument is set for April 15th, and Patent Docs will be posting on additional amicus briefs in the interim and oral argument in due course.

GEN Compiles List of Top Selling Drugs for 2012

By Donald Zuhn --

Genetic Engineering & Biotechnology News has compiled a list of the top 20 best-selling prescription drugs worldwide for 2012.  GEN's list, which the journal released on March 5 (see "Top 20 Best-Selling Drugs of 2012"), was based on sales figures obtained from biopharma company press announcements, annual reports, and conference calls during 2012 and 2011.  For each drug on its list, GEN has provided 2011 and 2012 sales, percent change from 2011 to 2012, and Q4 sales and percent change for both 2011 and 2012.  2012 sales for the top 20 drugs range from $3.81 billion to $9.265 billion.  GEN's top 20 rankings are shown below, with the additional designation of small molecule or biologic for each drug that made GEN's list.

Genetic Engineering & Biotechnology News Top 20 Best-Selling Drugs of 2012

Genetic Engineering & Biotechnology News, "Top 20 Best-Selling Drugs of 2012," March 5, 2013.