Patent Docs

Conference & CLE Calendar

January 12, 2014

January 16, 2014 – "Provisional Patent Applications: Preserving IP Rights in First-to-File System — Assessing Whether to Use — and Strategies for Leveraging — Provisional Applications Under the New Patent Regime" (Strafford) – 1:00 to 2:30 pm (EST)

January 21, 2014 – "Top Patent Law Stories of 2013" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

January 22, 2014 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (EST)

January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

January 23, 2014 – "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" (Strafford) – 1:00 to 2:30 pm (EST)

January 23-24, 2014 – IP Counsel Exchange for Biosimilar Applicants & Sponsors*** (Momentum) – New York, NY.

January 30, 2014 -"Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Litigation and Post-Grant Proceedings — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

February 18, 2014 – "Proposed Patent Reform Legislation: How It May Impact You (Especially if You Are Not Considered to be a 'Patent Troll'" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

***Patent Docs is a media partner of this conference or CLE
Webinar on Proposed Patent Reform Legislation

January 10, 2014

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Proposed Patent Reform Legislation: How It May Impact You (Especially if You Are Not Considered to be a 'Patent Troll'" on February 18, 2014 from 10:00 am to 11:15 am (CT). MBHB attorney and Patent Docs contributor Dr. Andrew W. Williams will cover the major provisions found in the Innovation Act (H.R. 3309) and various Senate patent reform bills, as well as their potential impact on the patent community. These provisions include:

• Litigation fee-shifting, including establishing a default for shifting attorneys’ fees to the prevailing party
• Heightened pleading requirements
• Changes to patent trial procedures and limitations on discovery, resulting in a decrease or elimination a district court’s discretion
• Limits on demand letters, including potentially limiting recovery for insufficient pre-suit notification
• Changes to the America Invents Act, including changes to post-issuance review of patents

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
USPTO Releases Performance and Accountability Report for FY 2013

January 9, 2014

By Donald Zuhn —

The U.S. Patent and Trademark Office recently released its Performance and Accountability Report for Fiscal Year (FY) 2013. As in last year's report, the most recent report notes that the Office's 2010-2015 Strategic Plan sets forth three strategic goals and one management goal in support of the Office's mission to foster innovation and competitiveness by providing high quality and timely examination of patent and trademark applications, guiding domestic and international intellectual property policy, and protecting intellectual property rights.

The 2010-2015 Strategic Plan specifies eleven performance outcome measures for which the Office has developed annual performance targets. According to the report, the Office met its annual performance targets for ten of the eleven performance targets. Among the patent-related performance targets that the Office met in FY 2013 were average total pendency (29.1 months versus target of 30.1 months) and patent applications filed electronically (98.1% versus target of 98.0%). The Office was slightly below the target, however, with respect to average first action pendency (18.2 months versus target of 18.0 months). Table 2 of the report provides data for the patent-related performance targets for FY 2009 to FY 2013 (click on table to expand):

The report also presents data for the following patent-related performance targets: patent average first action pendency for FY 2008 to FY 2013 (upper panel), patent average total pendency for FY 2008 to FY 2013 (middle panel), and patent applications filed electronically for FY 2008 to FY 2013 (lower panel):

The report notes that the number of applications filed increased from 565,406 in FY 2012 to 601,317 in FY 2013, which constituted a 6.4% increase in filings. This followed a 5.3% increase in application filings in FY 2012.

Despite accepting more than 500,000 patent applications for the fourth straight year, the number of applications awaiting action dropped from 633,812 in FY 2012 to 616,409 in FY 2013 (which marked the fifth consecutive year that the number of applications awaiting action has dropped). The total number of pending applications also decreased, dropping from 1,157,147 in FY 2012 to 1,148,823 in FY 2013.

Utility patent issuances were up significantly in FY 2013, rising from 246,464 in FY 2012 to 265,979 in FY 2013. It was the fourth straight year that the Office issued more than 200,000 utility patents (having issued 207,915 patents in FY 2010 and 221,350 patents in FY 2011), and the fifth straight increase.

With respect to first action and total pendency, the results in FY 2013 were mixed and the goals for FY 2014 and FY 2015 present even tougher challenges. For first action pendency, the annual performance target drops from 18.0 months for FY 2013 (which the Office failed to meet) to 17.1 months for FY 2014 and 15.1 months for FY 2015, and for total pendency, the annual performance target drops from 30.1 months in FY 2013 (which the Office did meet) to 26.1 months in FY 2014 and 25.7 months in FY 2015.

For biotechnology and organic chemistry applications, average first action pendency continued to drop, falling from 17.8 months in FY 2012 to 13.4 months in FY 2013 (average first action pendency for these applications was 23.8 months in FY 2011). Similarly, total average pendency for biotechnology and organic chemistry applications once again improved, falling from 30.0 months in FY 2012 to 27.5 months in FY 2013 (total average pendency was 33.6 months for these applications in FY 2011). Both pendency measures for FY 2013 were below the Office's overall averages of 18.2 months and 29.1 months, respectively. No other Technology Center posted a better first action pendency than TC 1600, and only TC 2800 (semiconductor, electrical, optical systems & components) posted a better final action pendency.
FDA Approved 27 New Drugs in 2013

January 8, 2014

By Donald Zuhn —

Last month, the U.S. Food and Drug Administration (FDA) announced that the agency approved 27 new drugs and biological products in 2013. According to the FDA release, the 27 new molecular entities (NMEs) that were approved last year include:

The number of new drugs approved in 2013 fell by almost a third from the 39 new drugs approved in 2012 ("New Molecular Entity Approvals for 2012"), and was three less than the 30 new drugs approved in 2011 ("New Molecular Entity Approvals for 2011").

According to a Reuters report, the FDA attributed the drop in approvals to a drop in the number of applications filed, while noting that the 27 approvals were just under the 5-year average of 28.
NAI & IPO Release List of Top 100 Universities Receiving Patents in 2012

January 7, 2014

By Donald Zuhn —

Last month, the National Academy of Inventors (NAI) and the Intellectual Property Owners Association (IPO) published a list of the top 100 worldwide universities that received the most U.S. utility patents in 2012. The groups did not provide a detailed discussion regarding the compilation of the list, stating only that the list was based on data obtained from the U.S. Patent & Trademark Office. A comparison of the top spots on the list, however, indicates that the data is identical to that found in the IPO's annual list of the top 300 organizations receiving U.S. patents (see "IPO Releases List of Top 300 Patent Holders for 2012"). The top 20 universities on the NAI/IPO listing are as follows:

The complete list of 100 universities can be found here.

As we reported last month, the Center for Technology Innovation at the Brookings Institution asserted in a paper that by relying on a technology transfer model based on patent licensing, only a few universities have been able to generate significant revenues, and in fact, most university technology transfer offices do not generate enough income to even cover their operating expenses (see "Brookings Paper Calls for Technology Transfer Model Based on University Start-ups"). That paper suggested that the highest earners among universities had become a select club with a stable membership, with only 37 universities having reached the top 20 of licensing revenue in any given year over the last decade. A comparison of the Brookings Institution's "select club" of 37 universities with the NAI/IPO list indicates that the following universities made both lists:

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

• "Brookings Paper Calls for Technology Transfer Model Based on University Start-ups," December 12, 2013
• "IPO Releases List of Top 300 Patent Holders for 2012," June 24, 2013
• "Another Look at IPO Top 300 and Life Sciences Top 53," June 11, 2012
• "IPO Releases List of Top 300 Patent Holders for 2011," June 7, 2012
• "IPO Releases List of Top 300 Patent Holders for 2010," June 30, 2011
• "IPO Releases List of Top 300 Patent Holders for 2009," May 26, 2010
• "IPO Releases List of Top 300 Patent Holders for 2008," May 14, 2009
• "IPO Releases List of Top 300 Patent Holders," May 22, 2008
• "IPO Posts List of Top 300 Patent Holders," April 20, 2007
Court Report

January 6, 2014

By Sherri Oslick —

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

Cephalon Inc. v. Sandoz Inc.
1:13-cv-02104; filed December 31, 2013 in the District Court of Delaware

Cephalon Inc. v. Hospira Inc.
1:13-cv-02094; filed December 26, 2013 in the District Court of Delaware

Cephalon Inc. v. Accord Healthcare Inc. et al.
1:13-cv-02095; filed December 26, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Cephalon Inc. v. Sun Pharma Global FZE et al.
1:13-cv-02096; filed December 26, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the Hospira complaint here.

Helsinn Healthcare S.A. et al. v. Accord Healthcare Inc. et al.
1:13-cv-02101; filed December 27, 2013 in the District Court of Delaware

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants: Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 8,598,218 ("Liquid Pharmaceutical Formulations of Palonosetron," issued December 3, 2013) and 8,598,219 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the complaint here.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:13-cv-07884; filed December 27, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued September 11, 2012), 8,324,275 (same title, issued December 4, 2012), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), and 8,589,182 (same title, issued November 19, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.

Novartis Pharmaceuticals Corp. v. Fresenius USA, LLC
2:13-cv-07914; filed December 27, 2013 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer). View the complaint here.

Cephalon Inc. v. Glenmark Pharmaceuticals Ltd. et al.
1:13-cv-02093; filed December 26, 2013 in the District Court of Delaware

• Plaintiff: Cephalon Inc.
• Defendants: Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics S.A.; Glenmark Generics Inc. USA

Infringement of U.S. Patent No. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the complaint here.
IPO Webinar on FTC v. Actavis

January 6, 2014

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "After Actavis: FTC Update" on January 9, 2014 beginning at 2:00 pm (ET). A panel consisting of Steven Lee of Kenyon & Kenyon LLP, Michael Perry of the Health Care Division of the Bureau of Competition at the Federal Trade Commission, and Bruce Wexler of Paul Hastings LLP will discuss the valuation of reverse payments in general, the role of ancillary agreements such as joint marketing agreements, and whether a branded company's promise not to launch an authorized generic during the generic’s exclusivity period amounts to a reverse payment.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Top Three Stories of 2013

January 5, 2014

By Donald Zuhn —

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Tuesday, Wednesday, and Thursday, we counted down stories #14 to #4, and today we count down the top three stories of 2013. As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT). Details regarding the webinar can be found here.

3. Supreme Court Decides Monsanto v. Bowman — Exhaustion Doctrine Does Not Allow Purchaser to Make New Copies of Patented Invention

In May, the Supreme Court issued its opinion in Bowman v. Monsanto Co., determining that the doctrine of patent exhaustion did not permit a farmer who buys patented seeds to reproduce them through planting and harvesting without the patent holder's permission, affirming the Federal Circuit's decision that such activities amount to the creation of a newly infringing article. Writing for a unanimous Court, Justice Kagan began a concise 10-page opinion by noting that "[u]nder the doctrine of patent exhaustion, the authorized sale of a patented article gives the purchaser, or any subsequent owner, a right to use or resell that article," but that such sale "does not allow the purchaser to make new copies of the patented invention." Although the Bowman opinion provided a (rare) favorable outcome for the life sciences sector in 2013, Justice Kagan concluded the opinion by noting that the Court's holding "is limited — addressing the situation before us, rather than every one involving a self-replicating product."

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

• "Organic Seed Growers & Trade Ass'n v. Monsanto Co. (Fed. Cir. 2013)," July 4, 2013
• "Bowman v. Monsanto Co. (2013)," May 13, 2013
• "Bowman v. Monsanto: Oral Argument," February 19, 2013
• "Parties Reiterate Arguments from Certiorari Petitions in Briefs to Supreme Court," February 18, 2013
• "Universities Urge Supreme Court to Affirm in Bowman v. Monsanto," February 18, 2013
• "WLF Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," February 7, 2013
• "U.S. Government Requests Argument Time in Bowman v. Monsanto — at Monsanto's Expense," February 5, 2013
• "It Ain't Necessarily So Down on the Farm: Not All Farmers Agree with Farmer Bowman in Bowman v. Monsanto," January 31, 2013
• "BayhDol25 Files Amicus Brief in Bowman v. Monsanto," January 30, 2013
• "Government Sticks to Its Guns in Bowman v. Monsanto Amicus Brief," January 28, 2013
• "IPO Files Amicus Brief in Support of Respondents in Bowman v. Monsanto," January 24, 2013
• "House Considers Alternative Patent Royalty Scheme for Genetically Engineered Seed," January 14, 2013

2. First-Inventor-to-File Provisions of Leahy-Smith America Invents Act Take Effect

On March 16, 2013, the final provisions of the Leahy-Smith America Invents Act took effect, subjecting some (but not all) applications filed on or after that date to the first-inventor-to-file rules of the AIA. As part of the process of implementing the AIA, the U.S. Patent and Trademark Office began the year by publishing a final rule in the Federal Register setting and adjusting certain patent fees pursuant to the Office's fee-setting authority under § 10 of the AIA. While most of the fees changes took effect last March, the remaining changes took effect only days ago on January 1. The fees changes final rule was followed by a February 14 final rule to implement the first-inventor-to-file (FITF) provisions of the AIA. In the lengthy final rule, which numbered 160 pages in a pre-publication version released on February 13, the Office provided some interesting replies to comments submitted in response to the proposed rule. The impact of the Office's comments on post-AIA filing strategies is quite complex (readers are advised to review our February 13, 2013 report on the final rule), and we find that the subject continues to foster significant discussion. Interestingly, the change in the filing date requirements for a patent application brought about by the ratification of the Patent Law Treaty (PLT) and enactment of the Patent Law Treaties Implementation Act of 2012 (PLTIA) (see Top Story #6) have further impacted and altered post-AIA filing strategy. Finally, in April, the USPTO published two Federal Register notices to implement technical corrections to the AIA. An interim final rule revised the rules of practice to implement changes to the patent term adjustment (PTA) provisions, and a second final rule implemented changes with respect to the new (and thus far, quite popular) inter partes review proceedings.

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

• " The First IPR Decision — A Win for the Patent Challenger," November 18, 2013
• "Coalition Opposes Expansion of AIA § 18," September 13, 2013
• "Op-Eds in The Scientist Debate Impact of the AIA," September 5, 2013
• "USPTO Issues Rules to Implement AIA Technical Corrections," April 3, 2013
• "USPTO Issues First-Inventor-to-File Examination Guidelines and Final Rule," February 13, 2013
• "USPTO Publishes Final Rule Setting Patent Fees," January 21, 2013

1. Supreme Court Decides AMP v. Myriad — Naturally-Occurring, Isolated DNA Excluded from Patent Eligibility

In June, the Supreme Court issued its much anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc., holding that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but determining that cDNA is patent eligible because it is not naturally occurring. In writing for the Court, Justice Thomas provided one caveat with respect to cDNA, noting that "insofar as very short series of DNA may have no intervening introns to remove when creating cDNA," under such circumstance, "a short strand of cDNA may be indistinguishable from natural DNA," and therefore, would likely be patent ineligible. While the biotechnology industry avoided a categorical ban on patenting DNA (which was the goal of the ACLU) or, worse, on "products of nature" no matter how altered, the Court's carefully focused opinion contained enough worrisome dicta to permit plaintiffs to declare victory even though the Court expressly disclaimed any decision on genetic diagnostic methods (which, after all, was the purported basis for the litigation in the first place). While the case did not establish a categorical "product of nature" preclusion and thus should not be interpreted as mandating that other products of nature are categorically unpatentable, we warned in one of our posts that those cases are to come. In July, Consumer Watchdog attempted to pull the Myriad decision into the appeal of an inter partes reexamination involving a Wisconsin Alumni Research Foundation (WARF) stem cell patent. Reaction to the decision also led Myriad to file patent infringement suits against a number of diagnostic companies, as well as be pulled into declaratory judgment actions by some of these same companies (see Top Story #10). The Myriad decision also led Sen. Patrick Leahy (D-VT) to send a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), to urge the Director to consider using march-in rights under the Bayh-Dole Act to ensure greater access to genetic testing for breast and ovarian cancer. While the Myriad case has finally reached a conclusion, and has reclaimed the top spot on our Tops Stories list (the case was #2 in 2012, #2 in 2011, #1 in 2010, and #4 in 2009), the full impact of this case has yet to play out.

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

• " In Defense of Patenting," December 19, 2013
• "Genes and Information: The Problem of Disease-specific Databases," October 15, 2013
• "Authors of Genome Medicine Article Form Genetic Testing Company," August 12, 2013
• "NCI Researchers Generate Largest Database of Cancer-specific Genetic Variations," August 6, 2013
• "Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101," August 1, 2013
• "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "After Myriad: A Herd of Elephants in the Room," July 3, 2013
• "Consortium Launches Public Database of BRCA Data," July 2, 2013
• "Reaction to Supreme Court's Decision in AMP v. Myriad," July 1, 2013
• "Does the Myriad Decision Presage a Golden Age of Patent-Free Personalized Medicine?" June 19, 2013
• "AMP v. Myriad: A Bad Day At Black Rock," June 16, 2013
• "The Supreme Court's Myriad Decision: Where Does It Leave the 'Inventive Concept' Test?" June 16, 2013
• "Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)," June 13, 2013
• "USPTO Issues Memo on AMP v. Myriad to Examining Corps," June 13, 2013
• "Supreme Court Issues Decision in AMP v. Myriad," June 13, 2013
• "The Myriad Case and "Gene" Patents: Much Ado about Nothing?" May 14, 2013
• "A Perspective on the Cost of the Myriad BRCA Gene Test," May 2, 2013
• "What We May Learn from the Myriad Oral Argument," April 18, 2013
• "PBS NewsHour Examines Oral Argument in AMP v. Myriad — Patent Docs Author Kevin Noonan Appears on Program," April 16, 2013
• "Myriad Genetic Database Under Siege," April 15, 2013
• "A Response to Dr. Mason's "Rebuttal" to Criticisms of His Genomics Medicine Article," April 11, 2013
• "A Primer on Claim Construction — Comments on Dr. Mason's Response," April 11, 2013
• "Dr. Chris Mason Responds to Blog Posts on Genome Medicine Article — Updated," April 10, 2013
• "Revisiting Genome Medicine Article on 'Pervasive Sequence Patents' That 'Cover the Entire Human Genome'," April 8, 2013
• "Genome Medicine Article Calls for Limits on Patenting of Existing Nucleotide Sequences," April 2, 2013
• "Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?" March 26, 2013
• "IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics," March 19, 2013
• "AIPLA Submits Amicus Brief to Supreme Court in AMP v. Myriad Genetics," March 13, 2013
• "Myriad Sets Forth Its Case to the Supreme Court," March 11, 2013
• "News from Abroad: Federal Court of Australia Affirms Patentability of Isolated Nucleic Acids," February 17, 2013
• "News from Abroad: Australian Federal Court Upholds Myriad's BRCA1 Gene Patents," February 17, 2013
• "United States Asks Supreme Court to Affirm on cDNA, Reverse on Isolated, Unmodified DNA," February 12, 2013
• "Is It Time for Myriad to Concede in AMP v. Myriad for the Good of the Biotechnology Industry?" January 23, 2013
Conference & CLE Calendar

January 5, 2014

January 8-12, 2014 – National CLE Conference (Law Education Institute, Inc.) – Vail, CO

January 16, 2014 – "Provisional Patent Applications: Preserving IP Rights in First-to-File System — Assessing Whether to Use — and Strategies for Leveraging — Provisional Applications Under the New Patent Regime" (Strafford) – 1:00 to 2:30 pm (EST)

January 21, 2014 – "Top Patent Law Stories of 2013" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

January 22, 2014 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (EST)

January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

January 23, 2014 – "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" (Strafford) – 1:00 to 2:30 pm (EST)

January 23-24, 2014 – IP Counsel Exchange for Biosimilar Applicants & Sponsors*** (Momentum) – New York, NY.

January 30, 2014 -"Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Litigation and Post-Grant Proceedings — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

***Patent Docs is a media partner of this conference or CLE
IP Counsel Exchange for Biosimilar Applicants & Sponsors

January 3, 2014

Momentum will be holding an IP Counsel Exchange for Biosimilar Applicants & Sponsors January 23-24, 2014 in New York, NY. Developed to provide a forum for IP counsel within the pharmaceutical, biopharmaceutical and biotechnology space, the IP Counsel Biosimilars Exchange will focus on providing participants with best practices and proven strategies for best positioning biosimilar/biobetter products to obtain market exclusivity.

In particular, Momentum's faculty will offer presentations on the following topics:

• Patent Caselaw Year in Review
• Orange Book Withdrawal
• So You Think You Can Patent Dance?
• Dissecting the Divergent Litigation Pathways of Small vs. Large Molecule Products and What Steps Your Company Should Take Now to Prepare Your Future Litigation Strategy
• The Evolving Biosimilar Landscape
• Addressing the Potential Use of Trade Secrets (Or Not) in Connection with the FDA's Review of Biosimilar Applications Citing a Reference Product and BLA That Predates the BPCIA
• Understanding the Biosimilar Landscape: Addressing Emerging Regulatory and Legal Issues
• To Collaborate or Not to Collaborate?
• Global IP Considerations, Challenges, Risks and Opportunities for Biosimilar Applicants and Sponsors When Filing Patent Applications Abroad
• Interactive Roundtable Discussions

In addition, attendees can pick from one of two workshops to be held on January 23, 2014. The workshops are entitled "Dissecting the European Biosimilars Experience" (Workshop A) and "Navigating the Patent Application Process" (Workshop B).

An agenda for the conference and workshops 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 downloaded here.

The registration fee for the conference is $1,395. Those interested in registering for the conference can do so here.

Patent Docs is a media partner of the IP Counsel Exchange for Biosimilar Applicants & Sponsors.

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