Patent Docs

IPO Program on Compulsory Licensing

August 19, 2011

The Intellectual Property Owners Association (IPO) will be holding a one-day CLE program entitled "Compulsory Licensing as an Emerging Global IP Issue" on September 14, 2011 in Los Angeles, CA. The one-day program follows the IPO Annual Meeting, which takes place on September 11-13. The conference will address compulsory licensing from both geographical and industry perspectives. Conference sessions directed to compulsory licensing in the United States and Asia (Japan, Taiwan, and China) will consider whether we are beginning to see a convergence in how countries apply compulsory licensing to patent enforcement and what this may mean to national and international IP rights. The conference will offer presentations and panels on the following topics:

• Introduction — Compulsory Licensing as a Global IP Issue;
• Standards and Compulsory Licensing;
• Compulsory Licensing in the Pharmaceutical Industry;
• Luncheon address by Willard Tom, General Counsel of the Federal Trade Commission;
• Compulsory Licensing in Asia; and
• Compulsory Licensing in the U.S.

Information about the one-day program, including an agenda and list of speakers, can be found in the brochure for the IPO Annual Meeting, which can be obtained here.

The registration fee for the conference is $550 for IPO members or $800 for attendees who are not IPO members. Those registering for both the conference and the 2011 Annual Meeting will receive a $50 discount off the registration fee for the conference. Those interested in registering for the meeting can do so here.
Biotech/Pharma Docket

August 18, 2011

By James DeGiulio —

Medicis and Nycomed Settle Vanos Patent Dispute

Medicis and Nycomed have reached a licensing agreement to settle a patent dispute over a generic version of the psoriasis treatment Vanos. In May 2010, Medicis filed the suit in the Southern District of New York in response to Nycomed's ANDA seeking approval from the FDA to make and sell 0.1% fluocinonide cream before the expiration of Medicis' U.S. Patent Nos. 6,765,001, 7,220,424, and 7,217,422 (see "Court Report," May 23, 2010). Nycomed's ANDA included a Paragraph IV certification asserting that the three patents would not be infringed by its generic version of Vanos. According to the complaint, Nycomed was required to amend its ANDA to provide certification relating to U.S. Patent No. 7,794,738, at issue in another Medicis-Nycomed dispute, but Medicis had yet to receive notification of any such amendment.

On August 16, U.S. District Judge Denise L. Cote signed off on a stipulation and order of dismissal dismissing the suit with prejudice after the two parties notified the Court that they had agreed on a licensing agreement. Nycomed admitted that Medicis' patents covering Vanos were valid and enforceable, and that its ANDA for a generic version of Vanos would infringe Medicis' patents outside of the licensing agreement. The Court noted the public interest in judicial economy in dismissing the suit, and both parties waived any right to appeal the stipulated order. Medicis will grant Nycomed a license to make and sell generic versions of Vanos products beginning December 15, 2013. In return, Nycomed will pay Medicis a royalty based on product sales.

Pfizer Successfully Defends Viagra Patent Against Teva

Pfizer has prevailed in its patent infringement action against Teva over a generic version of Viagra, securing a ruling that the Pfizer patent for the blockbuster drug remains valid and enforceable. On March 24, 2010, Pfizer sued Teva in U.S. District Court for the Eastern District of Virginia, challenging the generic drug maker's contention that U.S. Patent No. 6,469,012 is invalid or would not be infringed by Teva's proposed generic (see "Court Report," April 4, 2010). The '012 patent represents an important holding for Pfizer, as it does not expire until 2019. During a 12-day bench trial in July, Teva conceded that its proposed generic drug would infringe the '012 patent. However, Teva raised a series of challenges to Pfizer's patent, including the validity and enforceability of the patent, as well as Pfizer's standing to sue.

On August 15, U.S. District Judge Rebecca Beach Smith, in a lengthy opinion, found that the decision to try an orally administered version of the active ingredient, sildenafil, to treat erectile dysfunction was not obvious. Judge Smith distinguished the standard of "obvious to try" with a mere "motivation to try." She also ruled against Teva with respect to its claim of double patenting, finding the compound to be sufficiently different from a similar version protected by an earlier Pfizer patent, noting that even small changes in chemical structure could significantly affect how the drug worked in the body.

In a significant portion of the opinion, Judge Smith cited Therasense and chastised Teva for wasting judicial resources by trying to have the patent declared unenforceable by accusing Pfizer and one of its attorneys of engaging in inequitable conduct by not submitting information related to the Canadian version of the patent during prosecution. Judge Smith found that the material was not relevant to the prosecution of the U.S. patent because the patent examiner had already asked the company not to submit further foreign references similar to what had already been provided. Teva also lost a bid to amend its answer to flesh out inequitable conduct claims against the company and some of its attorneys. Judge Smith ruled that not only did Teva unnecessarily delay in seeking to amend its counterclaims, but that Pfizer and the accused individuals would be prejudiced by such a late change.

The Court's decision prevents Teva from receiving approval for a generic form of Viagra until October 2019. Litigation on the same patent remains pending against other generic companies, but no trials have been scheduled in those other cases.

Lilly and Hospira Settle Gemzar Patent Suit

Eli Lilly and Hospira have reached a settlement dismissing Hospira's declaratory judgment action over the patent covering the ovarian, breast, lung, and pancreatic cancer treatment Gemzar. On September 30, 2010, Hospira filed suit against Lilly in the Northern District of Illinois, seeking a declaratory judgment that its plans to sell several versions of a generic version of Gemzar, also known as gemcitabine, would not infringe Lilly's U.S. Patent No. 5,606,048, which protects a "stereoselective glycosylation process for preparing" the drug (see "Court Report," October 3, 2010). Hospira filed an ANDA seeking regulatory approval to sell three versions of the drug in late 2009, and was making preparations to sell the product immediately upon approval. Hospira asserted non-infringement of the '048 patent, but claimed reasonable apprehension that Lilly would assert the '048 patent against Hospira to block the marketing and sale of Hospira's competing product. Hospira contends that Lilly's foreign lawsuits over the drug in Denmark and the United Kingdom gave it a reasonable apprehension that Lilly intended to file a lawsuit to block a generic drug release in the U.S.

On August 10, U.S. District Judge Milton I. Shadur affirmed the parties' stipulation regarding dismissal with prejudice. The settlement brings to an end the U.S. litigation over Gemzar, which has arisen between the two parties in five different countries. Each side is to bear its own costs and attorneys' fees. Additional terms of the settlement were not immediately available.
Patent Reform News Briefs

August 17, 2011

By Donald Zuhn —

Sen. Reid's Cloture Motion Brings Senate Closer to Vote on H.R. 1249

On August 2, Sen. Harry Reid (D-NV) (at right) presented a cloture motion to bring to a close the debate on the House version of the Leahy-Smith America Invents Act (H.R. 1249) so that the Senate can proceed to vote on the bill. The Senate cloture rule (Rule XXII) provides the only process for imposing limits on further consideration of an issue, and requires that a cloture motion (or petition) be supported by at least sixteen Senators. In the case of Sen. Reid's motion, Senators Patrick Leahy (D-VT), Thomas Carper (D-DE), Joseph Lieberman (I-CT), Richard Blumenthal (D-CT), Charles Schumer (D-NY), Amy Klobuchar (D-MN), Robert Menendez (D-NJ), Jeanne Shaheen (D-NH), John Kerry (D-MA), Mark Udall (D-CO), Mark Warner (D-VA), Ben Nelson (D-NE), Jeff Bingaman (D-NM), Max Baucus (D-MT), Mark Begich (D-AK), and Robert Casey, Jr. (D-PA) joined Sen. Reid in signing the cloture petition. Sen. Reid's motion calls for a vote to invoke cloture on Tuesday, September 6, which requires a three-fifths majority of the Senate. If cloture is invoked, debate on H.R. 1249 will be limited to thirty hours, no Senator will be allowed to speak on the legislation for more than one hour, and only amendments to the bill presented prior to the cloture vote will be permitted.

Rep. Rogers: Fees Collected by USPTO "Reserved Only for Use By the PTO"

On June 22, the day before the House passed H.R. 1249, Rep. Harold Rogers (R-KY) (at right), the Chairman of the House Committee on Appropriations, sent a letter to the Speaker of the House and the House Majority Leader addressing the USPTO funding provisions of H.R. 1249. Rep. Rogers, along with Rep. Paul Ryan (R-WI), the Chairman of the House Committee on the Budget, was primarily responsible for convincing the House to change the USPTO funding provisions of H.R. 1249 so that the Patent Office would require Congressional approval in order to spend all of the fees it collects. In his letter, Rep. Rogers notes that (emphasis added):

The language [in H.R. 1249] ensures: the PTO budget remains part of the annual appropriations process; all PTO collected fees will be available only for PTO services and activities in support of the fee paying community; and finally, this important agency will continue to be subject to oversight and accountability by the Congress on an annual basis.

To assure that all fees collected for PTO remain available for PTO services, H.R. 1249 provides that if the actual fees collected by the PTO exceed its appropriation for that fiscal year, the amount would continue to be reserved only for use by the PTO and will be held in a "Patent Trademark Fee Reserve Fund".

At the same time, consistent with the language included in H.R. 1249, the Committee on Appropriations will also carry language that will ensure that all fees collected by PTO in excess of its annual appropriated level will be available until expended only to PTO for support services and activities in support of the fee paying community, subject to normal Appropriations Committee oversight and review.

However, the resolution to the debt ceiling crisis may make it difficult (if not impossible) for Rep. Rogers to keep his promise. Under the legislation that raised the debt ceiling, which was signed into law on August 2, a joint committee of Congress will have to produce debt reduction legislation with at least $1.2 trillion in cuts by November 23, 2011 or face across-the-board cuts of spending, equally split between defense and non-defense programs. How the joint committee's proposal (or automatic spending cuts) will ultimately impact the funding provisions of H.R. 1249 (if passed by the Senate in September and signed by the President) is yet to be determined.

Washington Post Supports Patent Reform Legislation

In an op-ed piece appearing in Sunday's Washington Post, the newspaper says that President Obama is right when he states that patent reform will allow inventors and entrepreneurs to "cut the red tape" that prevents them from "quickly turning new ideas into thriving businesses." Arguing that "the patent system has become creaky" since the 1952 Patent Act was passed, the article contends that the Patent Office "struggles under an enormous backlog, takes far too long to approve legitimate patents, and paradoxically at times blesses weak ones that undermine serious innovation and expose legitimate inventors to costly damages after their products have gone to market." According to the Post, the Leahy-Smith America Invents Act will "go a long way toward curing these problems." While conceding that H.R. 1249 "unfortunately weakens an important funding change that would have ensured needed resources for the perennially beleaguered U.S. Patent and Trademark Office," the Post says "[t]he change is unfortunate, but it is a small price to pay for passage of a broad package of changes that should lift burdens that for far too long have stood in the way of innovation and economic growth."
GOP Candidates Unified in Opposition to Embryonic Stem Cell Research

August 16, 2011

By Donald Zuhn —

On Saturday, the GOP kicked off the 2012 presidential election cycle with Iowa Republicans gathering in Ames, Iowa to participate in the Ames Straw Poll. Minnesota Rep. Michele Bachmann picked up 4,823 votes (28.6%) of the 16,892 votes cast in the straw poll to edge out Texas Rep. Ron Paul, who received 4,671 votes (27.7%). Texas Gov. Rick Perry collected 718 write-in votes after announcing his candidacy in South Carolina on the day of the Ames Straw Poll, and former Massachusetts governor Mitt Romney picked up 567 votes after deciding to skip the straw poll in June.

In an article published in The Boston Globe prior to the Ames Straw Poll, the positions of the Republican presidential candidates on embryonic stem (ES) cells was examined ("Most in GOP field would scale back stem cell funding"). The Globe reported that "[n]early all of the Republican presidential candidates would put the brakes on President Obama's efforts to broaden federal spending on embryonic stem cell research." In March 2009, President Obama issued Executive Order 13505, entitled "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells," which reversed limits imposed by the Bush administration on taxpayer support of ES cell research (see "President Obama to Lift Stem Cell Limits on Monday" and "President Obama Reaffirms Faith in Science").

The Globe noted that most of the candidates responded to the newspaper's survey of their positions on federal funding of ES cell research "with vague statements and dodged questions about whether they would endorse Bush's position of allowing funding for research on a limited number of existing stem cell lines to continue." However, the article points out that the socially conservative Susan B. Anthony (SBA) List has suggested that Rep. Bachmann, Rep. Paul, former senator Rick Santorum, former House speaker Newt Gingrich, and Rep. Thaddeus McCotter (MI) would oppose further expansion of federal funding of ES cell research. (The SBA List also indicated that former Minnesota governor Tim Pawlenty would also oppose further expansion of federal funding of ES cell research, but after his third-place finish on Saturday, Mr. Pawlenty withdrew from the Republican presidential race on Sunday.) Mr. Romney told the Globe that he would not allow federal funding of ES cell research, but "would make an examination of the science and speak with experts in the field" before deciding whether to follow the Bush administration's example by permitting research to be conducted on existing ES cell lines.

According to a report in Salon, Gov. Perry (at left), who had not officially entered the race when the Globe article was published, would appear to side with the other Republican candidates, having declared that stem cell research has "turn[ed] the remains of unborn children into nothing more than raw material" ("Gov. Rick Perry underwent stem cell therapy"). While not inconsistent with Gov. Perry's position on ES cell research, the Salon article noted (with some surprise) that the Texas governor underwent an experimental spinal fusion procedure last month in which he was injected with adult stem cells to treat a back injury. As a result of the procedure, which the Perry campaign called a success, the Texas governor is a strong proponent of adult stem cell research ("Perry's Surgery Included Experimental Stem Cell Therapy").

Interestingly, in opposing ES cell research and federal funding of such research, the Republican presidential candidates side with a minority of Americans — a Gallup 2011 poll indicated that 62% of Americans believe ES cell research is morally acceptable, and a Pew Research Center poll showed that 58% of Americans support federal funding of ES cell research.
Legislators Urge President to Include 12-Year Data Exclusivity Period in Free Trade Agreement

August 15, 2011

By Donald Zuhn —

On August 4, Rep. Henry Waxman (D-CA) led a group of seven House Democrats in asking President Obama to exclude the 12-year data exclusivity period provided by the biosimilar approval pathway of the Patient Protection and Affordable Care Act (PPACA) from the intellectual property provisions of the Trans-Pacific Partnership (TPP) agreement (see "House Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade Agreement"). One week earlier, however, a bipartisan group of forty Representatives sent their own letter to the President, indicating their support for the President's "continued efforts to ensure that intellectual property standards in the Trans-Pacific Partnership ("TPP") trade agreement are consistent with U.S. law, protect U.S. interests and sustain and help grow U.S. jobs."

The TTP, or Trans-Pacific Strategic Economic Partnership Agreement, is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam (Canada, Japan, the Philippines, South Korea, and Taiwan have also expressed interest in participating in the agreement). The seventh round of TTP negotiations was held in Ho Chi Minh City, Vietnam, in June, and two more rounds of negotiations are scheduled to take place in September (in the United States) and in October (in Peru). The nine TPP members have set a goal of reaching the outlines of an agreement by November of this year.

In their July 27 letter, the forty-member House coalition states that "[c]ritical to increasing U.S. companies' ability to export and contribute to U.S. GDP growth is ensuring that our government does all it can to help provide a level playing field for U.S. companies globally and advocate for intellectual property rights that provide certainty for America's innovative companies in the biosciences and other sectors." The letter adds that "[s]etting strong standards allows our companies to secure the capital investments needed to generate tomorrow's new treatments and potential cures and make them available to patients around the world."

In contrast with Rep. Waxman's letter, the letter from the forty legislators specifically seeks to have the 12-year data exclusivity period provided by the PPACA included in the TTP. In fact, the legislators state that:

In the course of the TPP negotiations on intellectual property rights issues, we urge you to support current U.S. law on biologics, which provides for 12 years of protection. The U.S.-led biopharmaceutical industry would be disadvantaged if the U.S. does not ensure consistency with U.S. law as part of the TPP, because foreign countries do not provide the same type of protection rules. The current protections for biologic drugs were debated extensively and received strong bipartisan support in both the House and the Senate. This provision is critical to keeping and expanding high-value U.S. jobs offered by America's biotech sector and spurring the R&D investment needed to seize extraordinary opportunities for medical advances to combat our most costly and challenging diseases. Continued R&D investment is needed to ensure that the cures and treatments the biotechnology sector delivers today will continue and allow more patients to access to these revolutionary therapies.

The July 27 letter was signed by Representatives Ron Kind (D-WI), Erik Paulsen (R-MN), Joseph Crowley (D-NY), Vern Buchanan (R-FL), Richard Neal (D-MA), Aaron Schock (R-IL), Mike Thompson (D-MS), Wally Herger (R-CA), John Larson (D-CT), Devin Nunes (R-CA), Bill Pascrell, Jr. (D-NJ), Dave Reichert (R-WA), John Carney (D-DE), Charles Boustany, Jr. (R-LA), Gerald Connolly (D-VA), Adrian Smith (R-NE), Susan Davis (D-CA), Lynn Jenkins (R-KA), Anna Eshoo (C-DA), Rick Berg (R-ND), Martin Heinrich (D-NM), Diane Black (R-TN), James Himes (D-CT), Marsha Blackburn (R-TN), Rush Holt (D-NJ), Michael Burgess (R-TX), Michael Honda (D-CA), David Dreier (R-CA), Rick Larsen (D-WA), Brett Guthrie (R-KY), Gregory Meeks (D-NY), Tom Latham (R-IA), Loretta Sanchez (D-CA), Cathy McMorris Rodgers (R-WA), Allyson Schwartz (D-PA), Joseph Pitts (R-PA), Adam Smith (D-WA), John Sullivan (R-OK), Edolphus Towns (D-NY), and Lee Terry (R-NE). One of the letter's signatories, Rep. Anna Eshoo, was primarily responsible for the inclusion of the biosimilar approval pathway and the 12-year data exclusivity period in the PPACA, having introduced an amendment to the House health care reform bill in June 2009 along with Rep. Jay Inslee (D-WA) and Rep. Joe Barton (R-TX) (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period").

TTP members – original four members in orange and additional five members in green.
ABA Journal Accepting Nominations for 5th Annual Blawg 100

August 15, 2011

Last week, the ABA Journal began work on its 5th annual list of the 100 best legal blogs (or blawgs) and announced that it is seeking the advice of its readers, via the ABAJournal.com website, on which blawgs and practice areas to include on this year's Blawg 100. Readers interested in nominating a particular blog or practice area should use the blawg 100 amici form provided on the ABA Journal website. Additional information about the Blawg 100 can also be found on the blawg 100 amici form. The form requires that anyone making a nomination provide a name, employer or law school, city, and e-mail address. Nominations must be submitted no later than Friday, September 9.
Court Report

August 14, 2011

By Sherri Oslick —

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

Avanir Pharmaceuticals Inc. et al. v. Par Pharmaceutical Inc. et al.
1:11-cv-00705; filed August 10, 2011 in the District Court of Delaware

• Plaintiffs: Avanir Pharmaceuticals Inc.; Avanir Holding Company; Center for Neurologic Study
• Defendants: Par Pharmaceutical Inc.; Par Pharmaceutical Companies Inc.

Avanir Pharmaceuticals Inc. et al. v. Actavis South Atlantic LLC et al.
1:11-cv-00704; filed August 10, 2011 in the District Court of Delaware

• Plaintiffs: Avanir Pharmaceuticals Inc.; Avanir Holding Company; Center for Neurologic Study
• Defendants: Actavis South Atlantic LLC; Actavis Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,659,282 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued February 9, 2010) and RE38,115 ("Dextromethorphan and an Oxidase Inhibitor for Treating Intractable Conditions," issued May 6, 2003) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Avanir's Nuedexta® (dextromethorphan hydrobromide/quinidine sulfate, used to treat pseudobulbar affect). View the Par complaint here.

Purdue Pharmaceutical Products L.P. et al. v. Hikma (Maple) Ltd. et al.
1:11-cv-00695; filed August 8, 2011 in the District Court of Delaware

• Plaintiffs: Purdue Pharmaceutical Products L.P.; Purdue Pharma L.P.; Purdue Pharma Technologies Inc.
• Defendants: Hikma (Maple) Ltd.; West-Ward Pharmaceuticals Corp.

Infringement of U.S. Patent No. 6,589,960 ("Hydromorphone And Hydrocodone Compositions And Methods For Their Synthesis," issued July 8, 2003) following a Paragraph IV certification as part of Hikma's filing of an ANDA to manufacture a generic version of Purdue Pharma's Dilaudid® (hydromorphone hydrochloride for injection, used to treat moderate to severe pain). View the complaint here.

Braintree Laboratories, Inc. v. Paddock Laboratories, Inc.
3:11-cv-04568; filed August 8, 2011 in the District Court of New Jersey

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 Paddock'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.

ViiV Healthcare UK Ltd. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:11-cv-00688; filed August 5, 2011 in the District Court of Delaware

• Plaintiffs: ViiV Healthcare UK Ltd.; ViiV Healthcare Co.
• Defendants: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 6,417,191 ("Synergistic Combinations of Zidovudine, 1592U89 and 3TC," issued July 9, 2002) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Viiv's Epzicom® (abacavir sulfate and lamivudine, used to HIV infection in humans). View the complaint here.
Conference & CLE Calendar

August 14, 2011

August 15-19, 2011 – Intellectual Property Law Summer School 2011 (IBC Legal) – Cambridge, UK

August 16-18, 2011 – The Bilski Impact: Procuring & Enforcing Software, Business Methods & Bioinformatics Patents (Patent Resources Group) – Alexandria, VA and Southfield, MI

September 6-7, 2011 – Pharmaceutical Law Academy (IBC Legal Conferences) – London, UK

September 8, 2011 – Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly (Strafford) – 1:00 – 2:30 PM (EDT)

September 11-13, 2011 – 2011 Annual Meeting (Intellectual Property Owners Association) – Los Angeles, CA

September 14-16, 2011 – 85th Annual Meeting (Intellectual Property Institute of Canada) – Chicago, IL

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa*** (South African Department of Science and Technology) – Cape Town, South Africa

September 19-20, 2011 – Tech Transfer Summit Europe*** (Tech Transfer Summit Ltd.) – Paris, France

September 19-21, 2011 – Business of Biosimilars & Biobetters*** (Institute for International Research) – Boston, MA

September 21-22, 2011 – Forum on European Pharmaceutical Regulatory Law*** (C5) – Brussels, Belgium

September 22-23, 2011 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 26-27, 2011 – Biosimilars and Biobetters*** (SMi Group) – London, UK

September 26-27, 2011 – Life Sciences Business Development & Acquisitions in Emerging Markets (American Conference Institute) – New York, NYNew York, NY

October 3-4, 2011 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – Bethesda, MD

October 4-5, 2011 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) –

October 5-6, 2011 – Biotech Patenting*** (C5) – London, UK

October 24-26, 2011 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, UK

October 25-26, 2011 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

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

August 12, 2011

Tech Transfer Summit Ltd. will be holding the European and North American stops of its Tech Transfer Summit on September 19-20, 2011 in Paris, France and on October 3-4, 2011 at the National Institutes of Health (NIH) in Bethesda, MD. The Summit focuses on dialogue, partnering, licensing and technology transfer between public sector research technology transfer offices and senior industry licensing and business development executives, and serves as an international think-tank for technology transfer professionals, researchers, business angels, Government funding bodies, venture capitalists, financiers and financial service providers, and the legal profession in the biotechnology and life sciences sectors.

A full program for the European and North American legs of the Tech Transfer Summit, including an agenda of each event's sessions and list of speakers can be obtained here (Europe) or here (North America).

The registration fee for the Tech Transfer Summit Europe is €499 (academia, start-up, and government rate) or €799 (industry, legal, financial, and advisory rate). Details regarding registration for the European event can be found here. The registration fee for the Tech Transfer Summit North America is $549 (academia, start-up, and government rate) or $899 (industry, legal, financial, and advisory rate). Details regarding registration for the North American event can be found here.

Patent Docs is a partner of the Tech Transfer Summit.
IQPC Developing IP Strategies for Crystalline Forms Conference

August 12, 2011

International Quality & Productivity Center (IQPC) will be holding its 7th Annual Developing IP Strategies for Crystalline Forms conference from October 24-26, 2011 in London, UK. The conference will allow attendees to:

• Receive clarification of the application submission criteria directly from the examiners;
• Make informed decisions before designing and drafting robust crystalline form patents;
• Understand the required levels of data disclosure;
• Save time and speed approval through successful examples of patent prosecution highways in practice;
• Understand and overcome the challenges of demonstrating true innovation in crystalline forms;
• Implement effective strategies to enforce and protect your polymorph patent;
• Discover strategies to defend against litigation and extend market exclusivity;
• Analyze the latest patent strategies, case laws, and judicial decisions to ensure a successful drafting and litigation strategy;
• Benchmark patent protection strategies with leading experts in the field; and
• Connect with colleagues and peers in dedicated interactive networking and discussion sessions.

In particular, the conference will offer presentations on the following topics:

• Drafting and designing a robust and meaningful crystalline form patent: The EPO perspective;
• USPTO: Your guide to examination of crystalline forms in the U.S. and the impact of these on your patent application;
• Are crystalline forms patentable in India? Understanding what is and what isn't eligible for submission and approval;
• International panel discussion — chance to ask specific questions and get answers needed to ensure successful global crystalline form patent applications;
• Fast tracking your application using the patent prosecution highways and accelerated examination;
• Strategically strengthening your patent application;
• Understanding the value and reasons for patenting crystalline forms;
• Differentiating your polymorph from prior art: How do you demonstrate true innovation and prove novelty and inventive step?
• Computational prediction of crystal structures;
• Enforcing and protecting your polymorph patent;
• Understanding the Orange Book requirements to avoid litigation;
• Maximizing your patent lifecycle to extend market exclusivity;
• Breakout roundtable discussions: (a) supplementary protection certificates; (b) designing and drafting a robust patent application; and (c) preparing for litigation;
• Uncovering the available technologies to differentiate competitor samples from reference samples: Beyond x-ray diffraction;
• European judicial update;
• Update on the community/EU patent and unified litigation system;
• Unraveling multinational approaches to avoid exploitation: Strategies for obtaining a preliminary injunction; and
• Identifying and exploiting vulnerable patents: The generics perspective.

An additional pre-conference workshop will be offered on October 24, 2011. The workshop will offer presentations on the following topics:

• Overview of current opportunities and requirements for SPC/PTE applications;
• SPCs at the interface between patent and pharmaceutical law;
• Extending patents via pediatric exclusivity in Europe and the U.S.; and
• SPC judicial case law update.

The agenda for the Developing IP Strategies for Crystalline Forms conference can be found here (Day 1), here (Day 2), and here (pre-conference workshops). A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

Pricing for the conference and workshops can be found here. Those registering by September 9, 2011 will receive a discount of between £100 and £250 off the registration fee, and those registering for the conference and workshop by September 30, 2011 will receive a discount of £150 off the registration fee. Those interested in registering for the conference can do so here.

Patent Docs is a media partner of the Developing IP Strategies for Crystalline Forms conference.

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