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IP Chat Channel – Biotech/Pharmaceutical

Webinars are listed in chronological order with the most recent at the top of the page.
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Obviousness After Apple v. Samsung

Webinar Date: 11/02/2016

The early October en banc decision in a smartphone patent dispute between Apple and Samsung has revealed a startling disagreement on the Federal Circuit about obviousness – a concept viewed by many experts as the central issue in patent law. Judge Dyk, a member of the original three-judge panel that was overruled by the eight-judges majority, said in a dissent that the majority opinion created “profound changes in the law of obviousness” by turning the legal question into a factual one, contrary to KSR. The majority, in contrast, insisted their opinion involved simply “apply[ing] the existing obviousness to the facts of this case.” The majority and the original panel disagree in this case about what weight to give the jury verdict of non-obviousness. While the original panel found little to support the jury’s finding, the majority found that there was the “substantial evidence” required by law, and that the appellate court needed to show the appropriate deference.

Our panel will discuss the likely impact of this case, as well as of the recent Federal Circuit opinion in Arendi v. Apple, where the court overruled the PTAB invalidation of of Arendi’s patents, stressing that “common sense” critiques of an invention must be supported by substantial evidence and explained with sufficient reasoning. Lessons will also be drawn from the recent PTAB decision Innopharma v. Senju Pharmceutical, where after institution the patentee was able to prove to the PTAB both unexpected technical effects and the nexus between those technical effects and commercial success.

Speakers:

  • Robert Asher, Sunstein Kann Murphy & Timbers
  • Kenneth Corsello, IBM Corp.
  • Justin Hasford, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP



Life Sciences & Section 101: The Way Ahead

Webinar Date: 08/11/2016

The U.S. Supreme Court’s recent decision not to grant certiorari in Ariosa v. Sequenom was a sharp disappointment to many inventors and patent owners who had hoped the Court would revisit and clarify its views on patent eligibility after its decisions in Mayo and Alice. But that was not to be. As a result, the two industries most wounded by Mayo and Alice — life sciences and computer software — must look for paths ahead without any reprieve from the Justices. Recent Section 101 cases from the U.S. Federal Circuit and ex parte PTAB decisions can serve as signposts for both the life sciences and software industries. Our industry-specific panel is made up of a technically-savvy in-house counsel and two top law firm patent prosecutors. They will discuss cases such as:

  • Rapid Litigation v. CellzDirect, where in early July, the U.S. Federal Circuit panel reversed a district court’s holding that claims to a method of isolating and preserving liver cells were patent-ineligible. The appellate court held that the claims did not encompass a judicial exception (step one of the Mayo/Alice analysis). The same kind of analysis helped save patents involving self-referential software databases in Enfish v. Microsoft this spring.
  • Bascom v. AT&T, where in June the U.S. Federal Circuit reversed a district court’s finding that Bascom’s patent for filtering internet content failed step two of the Mayo/Alice The U.S. Federal Circuit stated that “the inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . an inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.” Life science experts believe this finding can also help life science patents.

Our panelists will give specific tips for drafting and prosecuting patents in their industries to avoid Section 101 rejections, resulting in patents that will withstand patent-eligibility attacks in litigation. The life science webinar will include discussion of both therapeutics and diagnostics, and the software webinar will include discussion of several recent useful ex parte PTAB decisions that overturned examiners Section 101 rejections.

Speakers:

Deborah Martin, Pfizer Inc.
Christopher Jeffers, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Warren Woessner, Schwegman, Lundberg & Woessner, P.A.




Life Science and Section 101: USPTO New Examiner Guideline

Webinar Date: 05/25/2016

A senior lawyer at the USPTO and two experienced life science patent prosecutors will use this webinar to probe deeply into the new examples published this month that show how claims for life science inventions should be examined by the agency for subject-matter patent eligibility. They will look in detail at the first four examples, two centering on diagnostics and two on inventions that involve a product of nature. Attendees will benefit most if they are already familiar with the examples and have a printed copy of the examples available to refer to during the webinar. The examples are available on the USPTO website.

The panelists will crystallize the examples into “dos and don’t” for patent prosecutors in life science matters relating to Subject 101. They will also discuss pending litigation and how the guidelines will have to change if the U.S. Supreme Court denies certiorari in the Sequenom case. The two diagnostic examples do not apply the 2015 Federal Circuit decision in Sequenom.

Speakers:

Raul Tamayo, USPTO
Courtenay Brinckerhoff, Foley & Lardner
Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP




USPTO and Section 101: New Examiner Guidelines

Webinar Date: 05/18/2016

The USPTO is trying to put an end to the “I know it when I see it” era of subject-matter ineligibility decisions by patent examiners. This month the agency published a new package of guidance to examiners that includes, among other things, instructions on formulating detailed subject-matter eligibility rejections and responses to applicant’s replies, and a new set of life science examples.

Our webinar on Wednesday, May 18 will focus on the patent prosecution process and Section 101 rejections in light of the new guidance. The panel features the USPTO’s Deputy Commissioner of Patent Examination Policy. In discussion with two law firm patent prosecutors, he will explain the agency’s new policies and how the agency will encourage examiners to follow them. The panel will also review the recent Federal Circuit decision in Enfish v. Microsoft and other pending decisions that may cause the USPTO to further adjust its policies.

Another upcoming webinar (date to be announced shortly) will feature a USPTO life sciences expert who will hone in on the new life science examples in discussion with two life science patent prosecutors. Despite the welcome new insights provided to patent applicants by the latest USPTO examples, some experts point out that hard questions remain. For example, what is the likely eligibility of a claim directed to a mixture of an efficacious amount of a naturally-occurring product?

Speakers:

Robert Bahr, USPTO
Bart Eppenauer, Shook, Hardy & Bacon L.L.P.
Michelle Holoubek, Sterne Kessler Goldstein and Fox




Settling ANDA Litigation: Options and Risks

Webinar Date: 03/23/2016

The recent First Circuit opinion in the In Re Loestrin reverse-payment litigation appears to have clarified that non-cash payments to a generic company from a branded pharmaceutical company can be targeted as anti-competitive under the U.S. Supreme Court 2013 decision in FTC v. Actavis. But many other antitrust-related issues about settling Hatch-Waxman litigation remain open, such as:

  • How big must a reverse payment be to count as a “large and unjustified” under Actavis?
  • Does the promise of “no authorized generic” amount to an unlawful reverse payment?
  • May side deals that are profitable for the generic manufacturer and reflect commercially reasonable arm’s-length terms be freely entered into by settling parties
  • What role will arguments about patent strength play if a reverse-payments antitrust case goes to trial?

Our panel, which will discuss these and other issues, features an attorney at the Federal Trade Commission, and two law firm litigators, one from each side of the innovator/generic divide.

Speakers:
Daniel Butrymowicz, Federal Trade Commission
Kevin Nelson, Duane Morris
Bruce Wexler, Paul Hastings



Double-Patenting: Tech Patents, Double Patenting, and Ex Parte Reexam

Webinar Date: 01/08/2016

This panel will examine how double patenting arises in tech company patent portfolios, how ex parte reexam differs from other post-grant proceedings vis a vis double patenting, and how it can be used to invalidate vulnerable patents. Our panel includes both an in-house tech company lawyer and a law firm lawyer with relevant first-hand experience, and a law firm attorney who was former head of the USPTO’s Central Reexamination Unit.

The Federal Circuit decision twenty months ago in Gilead v. Natco arose out of ANDA litigation over patents on anti-viral drugs, and tremors from that decision – which expanded the universe of patents vulnerable to charges of double patenting — are being widely felt in the pharma and biotech industry. But life sciences companies are not the only ones to find themselves with Gilead’s problem: after asserting a patent in litigation, some high-tech companies have discovered that the defendant can use one of the plaintiff’s later issued but earlier expiring patents to knock out a patent that was issued earlier but expires later. Like drugmakers, some tech companies may come to regret relying heavily on continuations in their patent prosecution, using a “more is more” strategy to grow large patent families. Ex parte reexamination has emerged as the proceeding of choice for tech patent challengers with at least a dozen patents invalidated by the USPTO’s Central Reexamination Unit for double patenting since Gilead.

Speakers:

Barry Bretschneider , BakerHostetler
Jeffrey Hohenshell , Medtronic
Lissi Mojica, Dentons US LLP




Double-Patenting: Impact of Gilead on Bio and Pharma

Webinar Date: 01/07/2016

The Federal Circuit decision twenty months ago in Gilead v. Natco arose out of ANDA litigation over patents on anti-viral drugs, and it is widely seen as expanding the universe of patents vulnerable to charges of double patenting in the pharma and biotech industry. However, life sciences companies are not the only ones to find themselves with Gilead’s problem. After asserting a patent in litigation, some high-tech companies have discovered that the defendant can use one of the plaintiff’s later issued, but earlier expiring patents, to knock out a patent that was issued earlier but expires later.

Like drugmakers, some tech companies may come to regret relying heavily on continuations in their patent prosecution, using a “more is more” strategy to grow large patent families. Ex parte reexamination has emerged as the proceeding of choice for tech patent challengers, with at least a dozen patents invalidated by the USPTO’s Central Reexamination Unit for double patenting since Gilead.

This panel will focus on tips for patent prosecution after Gilead, as well as the litigation outlook with a particular focus on biosimilars. Because many branded pharma companies are entering the biosimilar market, they are finding themselves combing the portfolios of competitors for double patenting weakness, much as generic companies are doing. Our panel features the lawyer who argued for Natco at the Federal Circuit, a law firm biotech lawyer who is an expert on patent term adjustment, and the vice president of IP at a drug development company.

 

Speakers:

Tim Babcock, Akros Pharma Inc.
Jack Brennan, Fish & Richardson
Jeremy Lowe, Axinn Veltrop




USPTO's After Final Consideration Pilot: Tips to Reach Allowance

Webinar Date: 11/19/2015

The USPTO recently announced that it is extending the After Final Consideration Pilot (AFCP), a compact prosecution initiative that authorizes additional time for examiners to search and to consider responses from a patent applicant after final rejection. Many applicants remain leery of this program that dates in its current form to 2013. But that skepticism may be misplaced. According to the USPTO, about 27% of the 122,882 AFCP requests since then have directly resulted in allowances, a result made possible by the fact that an applicant must file a non-broadening amendment to at least one independent claim to be eligible for the program. More than 60% of applicants in a recent USPTO survey said that using the AFCP reduced the likelihood a Request for Continued Examination (RCE) being filed. The applicants who fail to get an application allowed during AFCP are less likely to appeal. Appeal briefs are only submitted in 2.4% of AFCP applications, compared to 6% of cases with traditional after-final submissions.

Our panel features the group director of a USPTO Technology Center who practices in and helped develop the program, and two law-firm patent prosecutors, one specializing in electronics and the other in the life sciences. They will discuss which cases are best suited to the AFCP and which are not, giving real-life examples of successful cases that passed through the program and others that failed. They will also discuss another recently-extended USPTO program aimed at the later stages of prosecution, the Quick Path Information Disclosure Statement (QPIDS) program, which can let an applicant file an IDS after the issue fee is paid without paying for reopening prosecution through an RCE.

Speakers:

Tariq Hafiz, USPTO
David Longo, Oblon, McClelland, Maier & Neustadt, L.L.P.
Eli Loots, Knobbe, Martens, Olson & Bear, LLP




Definite Change: Nautilus Gets Some Traction

Webinar Date: 10/07/2015

Our panel — a pharmaceutical industry IP lawyer and two high-tech patent litigators — will analyze several recent Federal Circuit opinions with the aim of pinpointing the court’s newly-evolving rules regarding the definiteness of terms and measures and allegedly “subjective” claims in patent litigation. At first little seemed to change after last year’s U.S. Supreme Court’s Nautilus decision made it easier for defendants to prove a plaintiff’s patent to be indefinite. But the August decision in Dow Chemical v. Nova Chemical might have been something of a watershed, giving the Federal Circuit the opportunity to rule on the definiteness of the very same plastics patents both before and after Nautilus. Those patents describe a “slope of strain hardening” but do not describe which of several methods for measuring slope should be used. “Under Nautilus this is no longer sufficient,” the court said, since the patent does not provide a skilled artisan with “reasonable certainty.” Our panel will discuss several recent Federal Circuit opinions that cite Nautilus with different results – eg, Teva v. Sandoz, Ethicon v. Covidien, Interval Licensing v. AOL — and give tips for patent prosecutors as well as patent holders and defendants involved in disputes over definiteness.

Speakers:

Robert Kramer, Dentons US LLP
Chris Mammen, Hogan Lovells
Bryan Zielinski, Pfizer Inc.




New Litigation Scenarios after Akamai: Fact Pattern Hypotheticals

Webinar Date: 09/17/2015

Trying once again to meet the challenge posed by situations in which multiple parties work together and infringe a patent, in August the en banc Federal Circuit expanded the scope of a key aspect of patent law: the definition of direct infringement under Section 271(a) of the Patent Act. In the new Akamai opinion, the Federal Circuit adds to its own earlier precedent an additional category of direct infringement that falls within the scope of “control or direction”: “… Liability under § 271(a) can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.

Our panel of litigators will consider several different fact patterns to discern and discuss, at the margin, where the boundary will fall between infringement and non-infringement under this new scope. Some of these facts will be drawn from earlier Federal Circuit cases on joint infringement involving the Internet and software, such as McKesson v. Epic Systems and Golden Hour v. emsCharts; others will be hypotheticals to analyze joint infringement in personalized medicine and diagnostics.

Paul Berghoff, McDonnell Boehnen Hulbert & Berghoff LLP
Andrei Iancu, Irell & Manella LLP
Steve Moore, Kilpatrick Townsend & Stockton LLP




Amgen v. Sandoz: What Now?

Webinar Date: 09/02/2015

Now that the “patent dance” spelled out in the 2010 Biologics Price Competition and Innovation Act (BPCIA) has been declared by the Federal Circuit to be just one option open to biosimilar market aspirants, the expectations of many industry participants have been upended. Our panel includes two patent litigators, one who counsels on biosimilar launches and one who counsels on branded strategy, as well as an FDA regulatory attorney who represented biotech innovators in the lengthy legislative negotiations leading to the BPCIA. They will discuss:

  • Branded company strategy now that an innovator may have only six months notice before a biosimilar launch; the implications of having no information about the biosimilar maker’s patent strategy or manufacturing process; the new importance of competitive intelligence;
  • Biosimilar launch strategy, including the pros & cons of the BPCIA pathway – will any biosimilar aspirants still choose to go the BPCIA route?; the importance of due diligence and assessing at-risk launches;
  • New litigation dynamics outside the BPCIA, including crucial preliminary injunction battles, discovery, licensing, damages and willfulness; and
  • The next front and the end game: en banc at the Federal Circuit? How will this all end up?

Krista Carver, Covington & Burling
Kevin Nelson, Duane Morris
Elizabeth Weiswasser, Weil, Gotshal & Manges LLP




Elusive Global Patent Claims - Life Sciences

Webinar Date: 08/11/2015

Economic globalization continues, but patent owners still must reckon with differences among national and regional patent regimes that make it challenging to protect innovation across borders. Speakers will highlight key differences among law and practice that matter in their industry, and give examples when and how it is possible to tweak claims to meet foreign standards and when it is not.

  • Methods of treatment (MOT) claims, including combination claims and dosage regimes; MOT v. “medical uses” in Europe, dealing with statutory ban on MOT claims in China
  • Methods of diagnosis claims
  • Personalized medicine and biomarkers
  • Need for more data support in China and Europe
  • Composition of matter claims and Section 101 concerns, including pursuing protection outside the U.S. for inventions that are not patent-eligible here

Speakers:

Michael Lin, Marks & Clerk
James Mullen, Morrison & Foerster, LLP
Edward Oates, Carpmaels & Ransford LLP




Lessons from Proxyconn: Federal Circuit's First Reversal of an IPR

Webinar Date: 07/07/2015

In mid-June, for the first time, the Federal Circuit reversed and remanded the claim construction in an inter partes review back to the PTAB, breaking an almost unbroken string of Rule 36 summary affirmances. The appellate move offers encouragement to patent owners by illustrating circumstances where the Federal Circuit is willing to point out the flaws in a PTAB decision invalidating a patent.

Our panel, which includes a Federal Circuit specialist and two experienced PTAB litigators, will examine the lessons to be learned from Microsoft v. Proxyconn regarding both claim construction and amending claims, where the appeals court gave some reason for optimism to patent owners who want to appeal the PTAB’s denial of a motion to amend a patent. The panelists will also discuss procedural questions regarding the PTAB’s handling of remands and give their views on how the relationship between the Federal Circuit and the PTAB will evolve.

Speakers:

Gregory Castanias, Jones Day
Gerald Flattmann Jr., Paul Hastings LLP
David O’Brien, Haynes and Boone, LLP




Hatch-Waxman and Biologic Strategies at the PTAB

Webinar Date: 03/03/2015

This month was a watershed for biopharmaceutical patents in post-grant proceedings. The PTAB invalidated claims for three patents on Genzyme’s treatment for Pompe disease in an inter partes review brought by a would-be competitor, a first for a biologic. And an IPR attack even came from outside the pharma industry: a hedge fund manager linked up with a well-known non-practicing entity to target Acorda Therapeutics’ patent on a multiple sclerosis drug. Some fear threats of an IPR to win a settlement from a company even before a petition is filed.

These patents are among the growing number of biopharmaceutical patents that have been targeted recently at the PTAB. This webinar will analyze how inter partes review and other post-grant proceedings should influence Hatch-Waxman/small molecule and biologic litigation strategies. Compliance with multiple tricky timelines is involved. Our panelists include a litigator who succeeded in the first-ever defense of a drug patent on a granted petition for IPR; a Hatch-Waxman litigator who represents generic companies; and a life science lawyer who has experience in biologics and leadership experience at the USPTO.

Speakers:

Cynthia Hardman, Goodwin Procter, LLP
Gerald Flattmann Jr., Paul Hastings
Teresa Stanek Rea, Crowell & Moring, LLP




The USPTO Revised Patent Eligibility Guidance: Life Science

Webinar Date: 01/14/2015

On December 15 the USPTO issued new “Interim Guidance” for determining whether claims are eligible for patenting under 35 USC § 101. Each of these webinar panels will bring together a senior counsel from the USPTO’s Office of Legal Administration with an in-house patent counsel at a major corporation and a law firm attorney who is an expert in that industry. The discussion will clarify the meaning of the new guidance, discuss which inventions are now more likely to be found patent eligible and how to write patent applications that clear current hurdles. The panelists will also consider the impact of subsequent appellate decisions such as the invalidation of Myriad patents in University of Utah Research Foundation et al. v. Ambry Genetics Corp.

Speakers:

Life Science Speakers (Jan. 14):
Raul Tamayo, USPTO
Deborah Martin, Pfizer, Inc.
Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP




Biosimilars: The Action Finally Starts

Webinar Date: 01/08/2015

The Biologics Price Competition and Innovation Act became law four-and-a-half years ago and for a long time not much happened to clarify how the high-stakes new regulatory pathway for biosimilars would work. Now finally the action is starting. In December the U.S. Court of Appeals for the Federal Circuit issued its first decision regarding a legal conflict over a biosimilar, while other pending lawsuits promise to show the life science industry how the law will be interpreted. Our panel of bioscience IP litigators will discuss the impact of these cases and other BPCIA developments:

  • The Federal Circuit opinion, Sandoz v. Amgen, which involves the blockbuster drug Enbrel and addressed whether a biosimilar developer can seek an early adjudication of questions of validity and infringement of patents before it files a biosimilar application and
  • Efforts by Celltrion and Hospira to get declaratory judgment on the invalidity of other biological drug patents and
  • Amgen’s complaint, filed in October in the Northern District of California, alleging that Sandoz unlawfully refused to follow BPCIA patent resolution procedures (colloquially known as the “patent dance”) regarding its application to the Food and Drug Administration for approval of a biosimilar to Neupogen. Amgen’s complaint asserts unfair competition under California law, conversion, and patent infringement.

Speakers:

Kevin Nelson, Duane Morris LLP
Brian Slater, Fitzpatrick, Cella, Harper & Scinto
Elizabeth Weiswasser, Weil, Gotshal & Manges, LLP




Inter Partes Reviews of Pharmaceutical Patents: Understanding How IPRs are Changing the Landscape of Innovator/Generic Litigation

Webinar Date: 07/23/2014

Hosted by IPO’s Pharmaceutical & Biotechnology Issues Committee

This webinar will focus on the rapidly increasing use of IPRs to invalidate pharmaceutical patents in ANDA litigation. The webinar will first give an overview of the IPR process and timelines, and discuss the outcomes of recent IPR challenges in the pharmaceutical space, and then will focus on how generic firms are using IPRs to challenge innovator patents. With that background, our panel of experts will present tips and strategies for both challenging pharmaceutical patents and defending against such challenges.

Please join us for this informative and topical webinar and learn the latest information on how IPRs are changing the landscape of generic challenges to innovator patents.

Moderator:  Paul Golian, Bristol-Myers Squibb Company

Speakers:

  • Aaron Barkoff, McAndrews, Held & Malloy, Ltd.
  • Grantland Drutchas, McDonnell Boehnen Hulbert & Berghoff LLP
  • Michael Fuller, Knobbe, Martens, Olson and Bear, L.L.P.



Double Patenting After Gilead: Prosecution and Litigation

Webinar Date: 05/28/2014

Recording and Materials not available

The recent Federal Circuit decision in Gilead Sciences v. Natco Pharma opens up new pitfalls for innovator bioscience companies and new opportunities for the generic industry. Patent owners and challengers in other industries may also benefit from a thorough understanding of this latest broadening of the scope of obvious-type double patenting.

In its decision, the Federal Circuit panel answered ‘yes’ to the question of whether a patent that issues after but expires before a second patent can qualify as a double patenting reference for that second patent. Our panel includes a veteran litigator for generic companies, a bioscience lawyer who prosecutes patents for innovator companies and also counsels on litigation, and the former general counsel of a large pharmaceutical company. They will discuss:

  • the implications of Gilead for patent litigation, including the battleground of just how similar subject matter has to be to serve as a double patenting reference
  • practice tips for innovator companies regarding issued patents, pending applications, and the ongoing prosecution of new inventions
  • Chief Judge Rader’s dissent and its impact on policy; In re Hubbell; and what issues in double patenting remain unresolved

Speakers:

  • Robert Armitage, Eli Lilly and Co. (retired)
  • Annemarie Hassett, Goodwin Procter, LLP
  • Jane Love, Wilmer Cutler Pickering Hale and Dorr, LLP



Myriad and Mayo: The New USPTO Examination Guidelines

Webinar Date: 03/20/2014

PTAB trials follow different rules than both USPTO re-examination proceedings and patent prosecution practice. PTAB trials are also very different from U.S. district court litigation – for example, neither the term “discovery” nor “deposition” mean what they do under the Federal Rules of Civil Procedure.

The statutory framework for the PTAB was set by the America Invents Act of 2011. Since its debut in September 2012, the PTAB has come a long way in clarifying its operating rules. Some important issues are still in flux, and may need to be resolved by the Federal Circuit. But many parts of PTAB procedural guidance are likely to remain unchanged.

Our panel includes two lawyers who have represented clients before the PTAB and one of PTAB’s leading administrative patent judges. They will discuss the PTAB’s published guidance and suggested practice regarding:.

  • Patent owner motions to amend claims
  • Motions to exclude the other side’s evidence
  • Effective use of declarations and experts
  • Deposition etiquette
  • The one-year bar
  • Joinder practice

Speakers:

  • Courtenay Brinckerhoff, Foley & Lardner, LLP
  • Duane Marks, Roche, Inc.
  • Raul Tamayo, USPTO



Doctrine of Equivalents: Latest on Patent Prosecution and Litigation

Webinar Date: 03/06/2014

Is the doctrine of equivalents dead? Is it coming back to life? Both questions have been raised by prominent IP commentators over the past few years. The answer these days is a nuanced one. Our webinar panel includes a patent litigator who recently won a significant victory for a defendant in a DOE case at the Federal Circuit, an experienced IP counsel at a biotech company, and a top law firm prosecutor in software, computers, and telecommunications. They will analyze recent case law and extract lessons for clearance and freedom-to-operate practice, patent prosecutors, patent owners and defendants. Among the Federal Circuit cases to be discussed:

  • Integrated Technology v. Rudolph Technologies, in which the Federal Circuit overturned a district court finding of equivalents infringement, basing its decision on a presumption of prosecution history estoppel when the patent applicant had made a narrowing claim amendment during PTO prosecution.
  • Brilliant Instruments v. GuideTech and Charles Machine Works v. Vermeer Manufacturing, opinions where the Federal Circuit continues to rein in and clarify the use of claim vitiation as an argument against noninfringement.
  • Ring & Pinion v. ARB which clarified that the foreseeability of a possible equivalent invention does not bar a patent owner from proving infringement under the doctrine of equivalents.

Speakers:

  • Daniel McDonald, Merchant & Gould
  • Andrew Shyjan, MedImmune
  • Judith Szepesi, Blakely Sokoloff Taylor & Zafman LLP



After Actavis: FTC Update

Webinar Date: 01/09/2014

The U.S. Supreme Court decision in Actavis last June removed the shield that had protected the pharmaceutical industry under the “scope of the patent”, allowing it to make settlement payments to generic companies in patent litigation. The court did not go so far as to find reverse payments presumptively illegal, but rather said a settlement’s possible pro-competitive benefits must be weighed against its potential anti-competitive effects. That leaves the parties designing a settlement, in the first instance, and then lower courts and the FTC, with the job of determining whether the terms of each deal constitute a likely antitrust violation.

The FTC is now reviewing the Hatch-Waxman settlements that have been submitted to it for review since June. Other recent relevant developments include Bayer’s $74 million payout to escape a consumer class action in November, decisions in the ongoing class action litigation regarding Nexium in the U.S. District Court of Massachusetts, and the FTC’s intention to pursue disgorgement of gains from past settlements.

An official from the FTC’s Bureau of Competition is the linchpin of a panel that includes two law firm attorneys. The topics they will discuss include 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.

Speakers:

  • Steven Lee, Kenyon & Kenyon LLP
  • Michael Perry, Federal Trade Commission
  • Bruce Wexler, Paul Hastings LLP



Written Description of Biotech Inventions

Webinar Date: 10/10/2013

In its July decision Novozymes v. DuPont Nutrition, the Federal Circuit found that a Novozymes amylase patent did not satisfy the written description requirement of 35 USC § 112, because the disclosure did not demonstrate possession of the claimed subject matter as a whole. This finding raised eyebrows. As one expert wrote, “doesn’t the identification of seven reference enzymes, 33 amino acid positions to be modified, and specific suggested modifications” indicate that the patent’s written description was adequate?

Novozymes is but the latest in a string of Federal Circuit opinions to reinforce the written description requirement as it applies to biotech inventions and to influence USPTO examination policy. This webinar features the Supervisory Patent Examiner for art unit 1644 at the U.S. Patent and Trademark Office, who will discuss how the agency’s Written Description Training Materials, last revised in 2008, mesh with recent court decisions. The panel, which also includes a top in-house counsel and biotech patent prosecutor, will consider how innovators can both protect their inventions and be sure of their freedom to operate. The panel will discuss, e.g., claims on an antibody which “binds to an antigen at residues X, Y, and Z of the antigen.” Are these claims patentable even though they provide no structural information about the claimed antibodies? What type of disclosure will help support patentability and broad scope? The panel will also discuss how recent case law should inform innovators’ filing strategies throughout drug discovery and development.

Speakers:

  • David Halstead, Ropes & Gray LLP
  • Daniel Kolker, USPTO
  • Deborah Martin, Pfizer, Inc.



Licensing Self-Replicating Technologies after Monsanto

Webinar Date: 08/20/2013

The U.S. Supreme Court’s unanimous decision this year in Monsanto v. Bowman put to rest the idea that the patent doctrine of exhaustion could be applied to many situations involving self-replicating technologies. But it also highlights the continued importance of the license contracts that biotech patent holders use to retain control over their inventions. Those licenses raise the legal issue of the limits of post-sale restrictions on patented products. This webinar will explore in this context the tension between the U.S. Supreme Court’s Quanta decision, which bolstered the exhaustion doctrine, and Federal Circuit jurisprudence since Mallinckrodt, which has authorized complex licenses that allow patentees to accomplish their business objectives without exhausting their patent rights.

Many biomedical self-replicating inventions do fall comfortably within the scope of the Monsanto opinion. For example, the maintaining of an initial cell culture in the hands of the licensee-purchaser, although it also involves replication, should be easily distinguished from distribution of the culture to unauthorized third parties. But other technologies may not present quite so simple an analysis. DNA vectors, for instance, can be used for a variety of purposes, not all of which require replication.

Our panelists will discuss the relevant case law and explore how patent owners of self-replicating biological inventions can legitimately craft their license provisions to draw a line between authorized and infringing activity.

Speakers:

  • Christopher Jeffers, Womble, Carlyle, Sandridge & Rice, LLP
  • Konstantina Katcheves, Lonza Group
  • Erich Veitenheimer, Cooley LLP



Reverse Payments: Impact of U.S. Supreme Court on Hatch-Waxman Litigation

Webinar Date: 06/20/2013

On June 17, the U.S. Supreme Court altered the landscape of Hatch-Waxman litigation. In its 5-3 opinion in FTC v. Actavis, the court denied antitrust immunity for litigation settlements including reverse payments from innovative pharmaceutical companies to generic companies. The majority said the scrutiny for anti-competitive effects of such settlements must be done under a “rule of reason” framework and rejected the FTC’s view that reverse payments are presumptively illegal.

This new guidance to lower courts will impact the two dozen or so pending antitrust cases regarding reverse-pending settlements and will change the patent-challenge calculus going forward for both generic and innovator companies. Our panel includes an antitrust advocate who supported the FTC position, an appellate litigator who supported the now-rejected industry position, and another litigator with a broad background in antitrust. They will consider:

  • How will the “rule of reason” structure evolve in these cases?
  • What are the new rules for counseling generic companies considering launching a challenge?
  • Will the number of patent challenges by generic companies decline?
  • How will plaintiffs in antitrust cases meet post- Twombley pleading standards?
  • What will be the role of the merit of the patent?
  • Is Chief Justice Roberts’ correct in his dissent that the “court’s attempt to limit its holding to the context of patent settlements under Hatch-Waxman will not long hold”?

Speakers:

  • Jeffery Cross, Freeborn & Peters LLP
  • Albert Foer, American Antitrust Institute
  • Lawrence Rosenberg, Jones Day



Myriad: The Implications of the U.S. Supreme Court Decision

Webinar Date: 06/18/2013

Tuesday, June 18, 2:00pm ET

On June 13, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad that cDNA molecules are eligible for patent protection, but that a sequence of DNA molecules isolated from their natural state is not. That finding of patent-ineligibility contradicts decades of USPTO practice and the long-standing expectation of the biotech industry.

Both sides declared partial victory in the case, and many uncertainties follow the long-awaited ruling. Our panel includes the litigator who represented Myriad in the Supreme Court, a respected biotech patent prosecutor, and the assistant general counsel at a large pharmaceutical company. They will consider such questions as:

How many and which existing gene patents will be challenged in post-grant proceedings at the USPTO?

  • Will holders of gene patents seek reissue?
  • What does the decision mean for protein therapeutics, and other products that are arguably “found in nature”?
  • Are claims to isolated polypeptide sequences covering human proteins that are in therapeutic use no longer valid?
  • Where do comparative diagnostic claims stand after both Myriad and Prometheus?

Speakers:

  • Gregory Castanias, Jones Day
  • Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP
  • Paul Golian, Bristol-Myers Squibb Company



Myriad: The U.S. Supreme Court Argument

Webinar Date: 04/17/2013

In Monday’s U.S. Supreme Court hearing in the Myriad case, Justice Breyer noted that, “patent law is filled with uneasy compromises”. Our webinar panel will analyze the Justices’ questioning and try to deduce what kind of ruling is likely to emerge on the patent eligibility of human genes. They will also discuss the impact on the biopharmaceutical industry and possible industry responses.Several Justices appeared concerned that ruling out patents on genes would leave companies without sufficient incentives to innovate. But that concern may not overcome their reluctance to allow patenting of what they see as a product of nature.As expected, the argument focused heavily on the extent to which natural material must be altered before it can be covered by a patent. Much of the discussion relied on analogies, including the patent eligibility of the leaves and sap of a tree discovered in the Amazon or a baseball bat crafted from a different tree.

Speakers:

  • Ned Israelsen, Knobbe Martens Olson & Bear, LLP
  • Prof. Joshua Sarnoff, DePaul University College of Law
  • Stuart Watt, Amgen Inc.



Reverse Payments: U.S. Supreme Court Showdown

Webinar Date: 03/28/2013

Based on Monday’s U.S. Supreme Court argument in FTC v. Actavis, the devil may in the details of the opinion rendered. The FTC may not succeed in making all reverse settlements illegal until proven otherwise. But deals between research-based drug companies and generic companies that delay generic entry may face more scrutiny by judges than presently because of their potential impact on consumers.Some justices floated the idea of adopting a “rule of reason” test, widely-used in antitrust cases, which would require courts to weigh the pro- and anti-competitive aspects of the settlements. One point of contention among the justices: whether there needs to be a trial within a trial about the strength of the patent in question. “To say you can consider every other factor other than the strength of the patent is to leave out the elephant in the room,” stated Justice Scalia.

Our panelists, one of whom supports the FTC and the other the industry, will examine the nuances of the hearing and possible outcomes, including how companies should approach settlements now and what litigation about reverse settlements might look like in the future.

Speakers:

  • Jeffery Cross, Freeborn & Peters LLP
  • Albert Foer, American Antitrust Institute
  • Lawrence Rosenberg, Jones Day



Bowman v. Monsanto: The U.S. Supreme Court Hearing

Webinar Date: 02/22/2013

On Tuesday February 19, the Justices of the U.S. Supreme Court heard oral argument in Bowman v. Monsanto, the important case about the first-sale doctrine and self-replicating technologies. The litigation dates back to 2007, when Monsanto, inventor of a highly-successful pesticide-resistant soybean plant, sued Indiana farmer Vernon Bowman for patent infringement. A customer of Monsanto, Bowman had planted commodity seeds purchased from a grain elevator, most of which wound up being Monsanto’s variety, and then saved seeds from that generation for replanting. Bowman argued that Monsanto’s patent rights to the seeds he purchased from the grain elevator and their progeny were exhausted.

The Federal Circuit disagreed, and the Supreme Court is considering “Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?”

The Justices seemed to heavily favor Monsanto’s arguments. They questioned whether the facts actually posed a question of patent exhaustion at all because that doctrine “never permits you to make another item from that item you bought,” in the words of Justice Sotomayor. Chief Justice Roberts set the tenor with his first question: “Why in the world would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?

Our panel will discuss the details of the probable outcome of the case and other questions including whether the court could eviscerate the first-sale doctrine for biological inventions and what other consequences might follow. Panelists include a leading biotech patent lawyer; a law professor specializing in IP who co-authored a brief in favor of Bowman; and a top U.S. Supreme Court trial advocate who authored briefs in Quanta and Bowman.

Speakers:

  • Prof. Shubha GhoshUniversity of Wisconsin Law School
  • Kevin NoonanMcDonnell Boehnen Hulbert & Berghoff LLP
  • Andrew PincusMayer Brown LLP



Patent Term Adjustment: An Update

Webinar Date: 01/24/2013

Patent owners who have the potential to earn significant returns from the final years of their patent term have a big incentive to master all the many recent changes in patent term adjustment due to legislation, regulations, and court decisions. Our panel will consider:

  • what steps patents owners should take in light of recent court decisions such as Exelixis v. Kappos;
  • recent USPTO rule changes including revisions in the rules of practice regarding the period of appellate review; and
  • the impact of the technical amendments to the AIA that became law this month.

Our panel includes an in-house patent attorney at a major pharmaceutical company, the winning litigator in an earlier successful suit against the USPTO regarding PTA, and a patent prosecutor in the chemical and life sciences.

Speakers:

  • Patricia Carson, Kirkland & Ellis, LLP
  • Adrian Looney, Pfizer, Inc.
  • Eli Loots, Knobbe Martens Olson & Bear, LLP



Material Transfer Agreements: Best Practices & Pitfalls

Webinar Date: 11/29/2012

A Material Transfer Agreement (MTA) governs the transfer of tangible research materials between two organizations, and defines the rights of the provider and the recipient. The woes that can result from an ineffective MTA are highlighted by the recent petition for certiorari to the U.S. Supreme Court in Bard v. Gore, a long-running infringement dispute that started when Gore provided Bard with a material to see if it could become a blood graft. In her dissent to the Federal Circuit opinion, Judge Pauline Newman describes what can happen without a good MTA: “…A person who performs the requested test of a material that is provided to him for testing for a specified use, can then, when the test is successful, patent the material he was provided, for the use for which it was tested.”

Our panel will focus both on best practices in MTAs and avoiding pitfalls. Their discussion will include contract negotiations and provisions regarding:

  • Confidential information to make sure the recipient does not suffer contamination of its own IP
  • The permitted uses of the materials in experiments
  • IP issues, including who will own the IP created by experiments, and agreements regarding research publication and patent applications
  • Liability protection for the provider
  • Termination, including the return or destruction of the material
  • Issues unique to agreements with universities and other institutions receiving federal funding

Our panel includes a university technology transfer specialist, a biotech transaction lawyer, and an in-house counsel for an energy company.

Speakers:

  • David Giannantonio, Emory University Office of Technology Transfer
  • Charles Hoyng, Latham & Watkins LLP
  • Michael Kolman, BP America, Inc.

 




Cross Winds in the Safe Harbor: Classen v. Biogen and Momenta v. Amphastar

Webinar Date: 09/27/2012

Two recent Federal Circuit opinions mark out highly divergent views on the scope of the § 271(e)(1) safe harbor of the Hatch Waxman Act. Both cases involve drug companies who used another’s patented invention while developing information to submit to the Food & Drug Administration about an already approved product. In last year’s Classen, a case involving immunization methods, the Federal Circuit panel reversed a district court decision and held that the defendants’ post-approval activities were not protected by the safe harbor. But in this summer’s Momenta, which was litigation between two generic manufacturers, the appellate panel ruled that post-approval activities could indeed be within the safe harbor. The panel vacated the lower court’s preliminary injunction, finding that Amphastar’s ongoing use of Momenta’s patented manufacturing method was noninfringing.

The U.S. Supreme Court has already twice addressed the scope of the safe harbor provision of the Hatch-Waxman Act, in Eli Lilly v. Medtronic (1990) and Merck v. Integra (2005). Recently it requested the solicitor general’s input on a petition for a writ of certiorari on Classen. Our panel, which includes two litigators and the assistant general counsel of a large pharmaceutical company, will discuss the current state of the case law and its future.

Speakers:

  • Steven Lee, Kenyon & Kenyon LLP
  • John (Jack) Griem, Jr., Loeb & Loeb, LLP
  • Paul Golian, Bristol-Myers Squibb Company



Update on Reverse Payment Settlements in Hatch-Waxman Litigation

Webinar Date: 07/19/2012

Taking action against “pay-for-delay” settlements remains at the top of the Federal Trade Commission’s Heath Care agenda.  A recent Eleventh Circuit court decision has set this divisive and important issue up for possible Supreme Court review next Term.  Pending legislation could also have a significant impact on the antitrust framework under which reverse payment settlements are analyzed.

Our panel will analyze the existing case law and pending cases and legislation, review recent trends in settlements reported to the Federal Trade Commission, and discuss in practical terms how this issue affects the conduct and resolution of pharmaceutical patent litigation today.  The panel includes an experienced patent litigator, a knowledgeable FTC staff attorney, and an in-house patent counsel for a global pharmaceutical company.

Speakers:

  • John M. Griem, Loeb & Loeb LLP
  • Patricia Lukens, Johnson & Johnson
  • Michael Perry, Federal Trade Commission



Licensing Trade Secrets

Webinar Date: 05/17/2012

Licensing of patents continues to grow as a major source of income for many patent owners, both practicing and non-practicing.

The time may be ripe for more companies to consider monetizing their trade secrets. It is well known that trade secret protection lasts as long as the information remains secret, and royalties from the license of a trade secret can also last a very long time, with some historic trade secret licenses yielding income to the licensor for over a hundred years.

This webinar will explore fine points of licensing trade secrets in manufacturing, technology, data, and software. Topics covered include:

  • Drafting confidentiality, non-disclosure, non-use, and residual knowledge provisions;
  • Structuring a license to include patent rights and know-how;
  • Licensing trade secrets in the life sciences, including issues involving biological materials; and
  • Valuing and pricing trade secret licenses.

Our panel includes the head of IP for a major multinational automotive company, a transaction specialist in the life sciences, and an expert in the financial valuation of intangible assets.

Speakers:

  • William Coughlin, Ford Global Technologies LLC
  • Matt Moyers, Ocean Tomo
  • Amy Toro, Covington & Burling LLP



Licensing Trade Secrets

Webinar Date: 05/17/2012

Licensing of patents continues to grow as a major source of income for many patent owners, both practicing and non-practicing.

The time may be ripe for more companies to consider monetizing their trade secrets. It is well known that trade secret protection lasts as long as the information remains secret, and royalties from the license of a trade secret can also last a very long time, with some historic trade secret licenses yielding income to the licensor for over a hundred years.

This webinar will explore fine points of licensing trade secrets in manufacturing, technology, data, and software. Topics covered include:

  • Drafting confidentiality, non-disclosure, non-use, and residual knowledge provisions;
  • Structuring a license to include patent rights and know-how;
  • Licensing trade secrets in the life sciences, including issues involving biological materials; and
  • Valuing and pricing trade secret licenses.

Our panel includes the head of IP for a major multinational automotive company, a transaction specialist in the life sciences, and an expert in the financial valuation of intangible assets.

Speakers:

  • William Coughlin, Ford Global Technologies LLC
  • Matt Moyers, Ocean Tomo
  • Amy Toro, Covington & Burling LLP



Recent Decisions in Hatch-Waxman Litigation

Webinar Date: 05/03/2012

Three recent appellate decisions have changed the patent litigation dynamic between branded pharmaceutical companies and their generic competitors, opening new ways for generic companies to get to market. The recent U.S. Supreme Court decision in Caraco v. Novo Nordisk expands the scope of the so-called “counterclaim provision” of the Hatch-Waxman Act. This provision lets generic companies challenge the accuracy of patent information that branded drug companies supply to the FDA; some experts say the clarification will motivate generic drug companies to consider new strategies concerning carve-outs of patented uses. In AstraZeneca v. Apotex, the Federal Circuit held that AstraZeneca’s complaint should be dismissed because the generic’s ANDAs included Section viii statements that carved out the methods claimed in the patents at issue. And in Bayer v. Lupin, the Federal Circuit held that for an ANDA filing to infringe a method-of-use claim, the FDA-approved label must indicate that the FDA has determined that the drug is safe and effective for the claimed method.

Our panel will discuss these opinions and how they will influence the future of patent prosecution and litigation. Our panel includes the litigator who represented Caraco at the Supreme Court, an in-house IP counsel at a large pharmaceutical company with experience in Hatch-Waxman litigation, and an FDA regulatory expert.

Speakers:

  • James Hurst, Winston & Strawn LLP
  • Andrea Kamage, Johnson & Johnson
  • Christina Markus, King & Spalding



Personalized Medicine after Prometheus: Exploring the Limits of Patent-Eligibility

Webinar Date: 04/05/2012

The buzz continues in the biotech and pharmaceutical industries after the U.S. Supreme Court’s recent decision in Prometheus v. Mayo and its subsequent remand of the Myriad gene- patenting case back to the Federal Circuit. The justices declared all of Prometheus’ claims for diagnostic methods patent-ineligible, unanimously reversing the Federal Circuit. Post-Prometheus, discovering and claiming indicative correlations is an impermissible attempt to monopolize a natural phenomenon, or a law of nature, unless the claim contains other features that add something beyond a statement of the correlation.

This webinar will examine ways forward. Some experts say that even if granted claims look uncomfortably similar to Prometheus’, it may be possible to strengthen or uphold the validity of the patent through the reissue process at the USPTO. Pending applications might be amended to more directly focus on specific applications of any underlying laws of nature. Possible “fixes” include using claims that recite “active” steps that will be harder to pigeonhole as “laws of nature” and using claims reciting novel “determining” steps (where what is administered is novel, or the relationship between what is detected and a particular disease is novel, or the method by which a biological molecule is administered or detected is novel).

Our panel includes the life sciences litigator who represented Mayo throughout its case, a well-known biotech patent prosecutor, and a high-ranking IP counsel at a large pharmaceutical company.

Speakers:

  • Kevin E. Noonan, McDonnell Boehnen Hulbert & Berghoff LLP
  • Jonathan E. Singer, Fish & Richardson P.C.
  • Bryan Zielinski, Pfizer, Inc.



The FDA’s Guidance on Biosimilars: Understanding the Impact on Patent Prosecution and Litigation

Webinar Date: 03/22/2012

In February the Federal Drug Administration issued the first three draft Guidances on the development and approval of biosimilar products under the Biologics Price Competition and Innovation Act of 2009. As expected, the FDA retained a lot of discretion to evaluate different biosimilar products by varying criteria depending on the science involved, leaving unclear what will be needed for approval in any specific instance.

However, the new FDA guidance does give some important clues on how innovator companies should proceed in their patent prosecution to best evade biosimilar threats. Likewise they give companies planning to enter the biosimilar market (sometimes a corporate entity that is also an innovator) hints on how to direct their patent and scientific strategy.

Our panel includes the chief counsel for IP at the Federal Trade Commission, who will give her views on patent litigation and the biosimilar marketplace, as well as the assistant general counsel of a large drug company and a law firm expert on FDA regulation.

Speakers:

  • Henry Hadad, Bristol-Myers Squibb Company
  • Erika Lietzan, Covington & Burling LLP
  • Suzanne Munck, Federal Trade Commission



Successfully Navigating Claim Construction in Life Sciences Litigation

Webinar Date: 01/27/2012

Claim construction can be the single most important event in the course of a patent litigation. Yet, as many litigators know, the judges on the U.S. Court of Appeals for Federal Circuit are divided about how to do it properly. Judge Moore, in her dissent this fall to the Federal Circuit’s decision not to grant a petition for en banc rehearing in Retractable Technologies v. Becton, Dickinson, noted that “claim construction appeals are ‘panel dependent’ which leads to frustrating and unpredictable results for both the litigants and the trial court.”

This webinar will concentrate on issues in claim construction in the life sciences, focusing on disputes involving pharmaceutical inventions such as:
• compounds;
• formulations;
• polymorphs and enantiomers; and
• methods of treatment.

Our panel includes the former Chief Judge of the Federal Circuit and two experienced pharmaceutical patent litigators.  The panelists will consider real-world situations, for instance, where a narrow claim construction might result in a finding of no infringement, but lessens the risk of patent invalidity, and also the opposite situation, where a broad construction casts a wide net for infringers, but increases the risk of encompassing the prior art.  They will also consider when claim construction may be unnecessary altogether, and whether the Federal Circuit should revisit its Cybor Corp. decision and begin giving deference to a district court’s claim construction. Practice tips will touch on all the tools used in building a claim construction case, including intrinsic and extrinsic evidence.

Speakers:

Vincent Capuano, Duane Morris, LLP
Hon. Paul Michel
Bruce Wexler, Paul Hastings LLP




Supreme Court Hearing in Mayo v. Prometheus

Webinar Date: 12/15/2011

In its most important debate of IP issues this session, on December 7 the U.S. Supreme Court held oral arguments in Prometheus v. Mayo, a case involving Section 101 and the patent-eligibility of personalized medicine claims. Our panel, which includes a biotech in-house counsel, a top patent prosecutor and appellate specialist, and a law professor, will parse the Justices’ questioning, outline possible outcomes, and give their views on implications of such outcomes. They will also offer practical tips on how to proceed with patent prosecution and other matters in the present period of uncertainty.

The case was remanded to the Federal Circuit after last year’s Bilski decision, which found that the Federal Circuit’s “machine-or transformation” test for patent eligibility, while useful, was not the sole test. On remand, the Federal Circuit again upheld Prometheus’ patents for a process of determining the proper dosage of a drug, finding that they involved a transformation in the body of the patient. The Supreme Court granted certiorari again in June.

The parties cast the debate in broad terms. The Mayo Clinic portrayed the patent as an attempt to monopolize a law of nature, while Prometheus claimed that the U.S. biotech industry would lose its global leadership if research in personalized medicine could not be patented. Stephen Shapiro of Mayer Brown argued on behalf of Mayo, and Richard Bress of Latham & Watkins appeared on behalf of Prometheus. Also appearing was U.S. Solicitor General Donald Verrilli, Jr., whose brief put a foot in both camps, defending the patent-eligibility of the claims, but saying they are probably invalid due other reasons, such as obviousness.

Speakers:

  • Courtenay Brinckerhoff, Foley & Lardner
  • Charles Doyle, Roche Molecular Systems
  • Katherine Strandburg, New York University School of Law



Divided Infringement: A Gordian Knot Still

Webinar Date: 10/04/2011

This webinar will analyse the recent opinions of the en banc U.S. Court of Appeals for the Federal Circuit in Akamai v. Limelight and McKesson v. Epic Systems. The majority opinion eased the standard for inducing infringement, holding that induced infringement can be found even if a single entity is not liable for direct infringement. Both cases were remanded back to the district courts.

Our panel includes the former chief judge of the Court of Appeals for the Federal Circuit, and two litigators who represented opposing sides in the litigation. Their presentation will include discussion of:

  • The majority opinion and the two dissenting opinions
  • The current state of the law for joint direct infringement
  • The new standard for induced infringement and its ramifications for different industries such as software and biotech
  • Possible paths for future litigation

Speakers:

  • Daryl Joseffer, King & Spalding
  • Hon. Paul Michel
  • Steve Moore, Kilpatrick Townsend & Stockton LLP



Gene Patents and Personalized Medicine: Myriad and Prometheus

Webinar Date: 08/18/2011

At the end of July, the Federal Circuit issued its long-awaited opinion in Association for Molecular Pathology v. Myriad Genetics. The panel overturned the district court to rule that isolated DNA molecules are patent-eligible, at the same time as it held ineligible for patent protection some of Myriad’s claims comparing DNA sequences.

Pharma, biotech and personalized medicine companies need to consider how to draft their claims and specifications to support patent eligibility as defined in Myriad. Statements in the judges’ opinions, albeit dicta, could potentially impact a wide range of subject matter beyond DNA, such as polypeptides, proteins, antibodies, stem cells and other biologics, as well as small molecule compounds. Our panel will give specific advice on both product and method claims.

At the same time, this decision is unlikely to be the end of the road for this case, as the plaintiffs are considered likely to ask for their appeal to be heard by the U.S. Supreme Court. Our panel will also give their thoughts on the future path for this litigation, including the issue of standing and how this case may interact with the Prometheus case in which the Supreme Court has already granted cert.

Our panel includes a top IP appellate litigator, a patent prosecutor with many clients in the area of personalized medicine, and a law professor who is active with early-stage bioscience companies.

Speakers:

  • Jacqueline Wright Bonilla, Foley & Lardner
  • Kenneth Chahine, University of Utah’s S.J. Quinney School of Law
  • Edward Reines, Weil Gotshal



Antibody Ptants After Centocor

Webinar Date: 03/23/2011

The February Federal Circuit decision in Centocor threw out a $1.7 billion judgment by finding the patent invalid. But in doing so, the court also left open a problematic ambiguity relating to the written description requirement for antibodies in general. The USPTO’s written description guidelines seem to suggest that disclosure of an antigen alone can provide Section 112 support for any antibody that binds to that antigen. But many experts believe those guidelines are in tension — if not complete conflict — with the requirement for written description recently described in Ariad v. Eli Lilly.

In Centocor, the court better defined and limited the application of the PTO’s rules. But it is still a struggle for inventors, patent prosecutors and possible infringers to know how much enough is when it comes to written description for antibody patents. This is likely to result in more litigation in this growing multi-billion dollar market. The panel will also discuss the obviousness challenges antibody patents face since KSR.

Speakers:

  • Jack Brennan, Fish & Richardson
  • Nicholas Groombridge, Weil Gotshal
  • Jane Gunnison, Ropes & Gray



Focus on Indefiniteness: Enzo v. Applera

Webinar Date: 02/09/2011

Just how definite do the claims of a patent need to be? The mid-December request by the U.S. Supreme Court to the Solicitor General to weigh in on Applera’s appeal of a decision by the Federal Circuit is putting new emphasis on the jurisprudence in this area.

The Federal Circuit decision earlier this year revived two Enzo patents that had been invalidated for indefiniteness by a district court in patent litigation against Applera. Applera asked the Federal Circuit for a reconsideration en banc, which was denied. However, as part of that denial, Judge Plager wrote a strong dissent, casting a bright light on the difference between the more rigorous standard of definiteness that the PTO insists on to grant a patent and the looser standard allowed by the Federal Circuit for a patent to remain valid. Judge Plager decried the waste of judicial resources caused by Federal Circuit frequent review of lower courts’ claim construction, and said it could be avoided if the Federal Circuit itself adopted an indefiniteness standard closer to the PTO’s. The U.S. Supreme Court is deciding whether to grant certiorari in the case.

In this webinar, a panel of experts will consider not only the issues raised by the Enzo case, but also the ways a patent can presently be found indefinite under 35 USC §112. These include indefinite means-plus-function claims and apparatus-plus-method claims in such cases as Telcordia, Aristocrat, Finisair and IPXL.

The panelists will discuss the ongoing practical impact of the conflict between the PTO’s standard and the Federal Circuit’s; and give advice on how patent prosecutors and litigators should proceed now while it is not clear whether the Supreme Court will hear the case.

Speakers:

  • John Dragseth, Fish & Richardson
  • Michael Meurer, Boston University
  • Mark Pals, Kirkland & Ellis



Double Patenting: The Legacy of Sun Pharmaceuticals v. Eli Lilly

Webinar Date: 02/03/2011

Just how definite do the claims of a patent need to be? The mid-December request by the U.S. Supreme Court to the Solicitor General to weigh in on Applera’s appeal of a decision by the Federal Circuit is putting new emphasis on the jurisprudence in this area.

The Federal Circuit decision earlier this year revived two Enzo patents that had been invalidated for indefiniteness by a district court in patent litigation against Applera. Applera asked the Federal Circuit for a reconsideration en banc, which was denied. However, as part of that denial, Judge Plager wrote a strong dissent, casting a bright light on the difference between the more rigorous standard of definiteness that the PTO insists on to grant a patent and the looser standard allowed by the Federal Circuit for a patent to remain valid. Judge Plager decried the waste of judicial resources caused by Federal Circuit frequent review of lower courts’ claim construction, and said it could be avoided if the Federal Circuit itself adopted an indefiniteness standard closer to the PTO’s. The U.S. Supreme Court is deciding whether to grant certiorari in the case.

In this webinar, a panel of experts will consider not only the issues raised by the Enzo case, but also the ways a patent can presently be found indefinite under 35 USC §112. These include indefinite means-plus-function claims and apparatus-plus-method claims in such cases as Telcordia, Aristocrat, Finisair and IPXL.

The panelists will discuss the ongoing practical impact of the conflict between the PTO’s standard and the Federal Circuit’s; and give advice on how patent prosecutors and litigators should proceed now while it is not clear whether the Supreme Court will hear the case.

Speakers:

  • John Dragseth, Fish & Richardson
  • Michael Meurer, Boston University
  • Mark Pals, Kirkland & Ellis



Whole-Genome Sequencing v. Gene Patents

Webinar Date: 11/03/2010

A whole nascent industry of life-science companies is focusing on the aim of pushing the cost of sequencing an entire human genome down to $1,000 per individual. Yet widely-available sequencing of the whole genome is already being seen as a threat to companies that have their IP tied up in patents involving single genes.

A newly announced free software-based test, published by Steven Salzberg of the University of Maryland’s Center for Bioinformatics & Computational Biology, brings that tension into particularly sharp relief. The test compares genomic sequence data against a set of known mutations in the BRCA genes.

The new software poses a broad important legal question: when sequencing all or a portion of an individual’s genome, are individual gene patents infringed upon by either the company providing the sequence, a company selling software to analyze the sequence, or the individual purchasing or requesting it? Who will be the direct infringer, and is someone liable for indirect infringement?

The answer probably rests on the specifics of the gene patents. That’s why it’s important for companies with bets on either side, ie, gene patents or whole-genome sequencing – and there are some with bets on both sides – to be thinking about the issues in sophisticated ways. And biotech litigators will certainly need to be informed about the dimensions of possible suits.

Speakers:

• Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP
• Ned Israelsen, Knobbe Martens Olson & Bear, LLP
• Ken Chahine, University of Utah




The USPTO’s 2010 KSR Guidelines Update: A Discussion by Expert Prosecutors - Industrial, Biochem & Life Sciences

Webinar Date: 10/06/2010

The PTO’s new examination guidelines to determine obviousness post KSR, published recently in the Federal Register, are being carefully scrutinized by patent prosecutors all around the U.S. They are wondering how it will impact them and change their strategy on a daily basis, in terms of what evidence and arguments they should offer the examiner on each patent application.

Prosecutors in the life sciences see themselves as a breed apart from prosecutors in electronics, and vice versa. So I suggest we hold two webinars on these guidelines on the same day, each featuring top patent practitioners in the respective fields:

  • Avoiding Obviousness Rejections in the Life Sciences, both chemistry and biotech
  • Avoiding Obviousness Rejections in the Electronic Arts, including both hard EE such as semiconductors and computers, and soft EE such as Internet, finance and business method patents

Each panel will include two top patent prosecutors, and an in-house counsel experienced in patent prosecution. We’d try to have at least one person on each panel who has worked as PTO examiner.

Speakers:

  • Gary Ganzi, Siemens Corp
  • Peter Knudsen, Woodcock Washburn
  • Jane Love, WilmerHale



Patent Term Adjustment: The Next Chapter

Webinar Date: 08/05/2010

The story of Wyeth v. Kappos took a new, very interesting turn in early July when Novartis filed a suit in the U.S. District Court of the District of Columbia, seeking review of the USPTO’s patent term adjustment (PTA) determinations for eleven Novartis patents. Novartis’ action is the first to question the USPTO’s interim procedures for requesting PTA recalculation in light of the Federal Circuit’s decision in Wyeth v. Kappos.  Novartis contends, among other things, that “[the Director’s] refusal to accord the benefits of Wyeth to [applications filed by May 29, 2000 and issued on or before September 1, 2009] is arbitrary, and in excess of statutory jurisdiction, authority or limitation.” For the pharmaceutical and biotech industry as a whole, the revenue at stake on this dating issue may reach into the billions.

Panelists include the patent prosecutor who first discovered a separate calculation error by the USPTO, another patent expert with extensive experience at the USPTO, the litigator who successfully argued the Wyeth case at the district court and the Federal Circuit, and a professor who specializes in the historical theoretical and doctrinal connections between patent law and property law. They will consider the issues raised by the Novartis suit, its chances of success, and what other patent owners should do now.

Speakers:

  • Jack Brennan, Fish & Richardson P.C.
  • Patricia Carson, Kaye Scholer
  • Adam Mossoff, George Mason University School of Law



The Gene Uncertainty: What to Do After Myriad

Webinar Date: 05/25/2010

This webinar will not focus on the correctness of U.S. District Court Judge Sweet’s decision this spring in Assoc. for Molecular Pathology v. USPTO. The court found that claims to isolated DNA and methods of use for diagnosis do not qualify as patentable subject matter. Instead this webinar will offer advice to biotech companies, universities, other researchers — and their outside counsel — on how to deal with several years of uncertainty as the Myriad case likely winds its way to the U.S. Supreme Court. This expert panel will offer patent prosecution strategies and assess the alternative of trade secret protection. They will also address: How is the case already impacting industry royalty negotiations and rates? How much protection will Myriad and other companies have from their remaining claims to stand up to infringers?

Speakers:

• Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP
• Ken Chahine, University of Utah, S.J. Quinny College of Law, BioLaw Project
• Ned A. Israelsen, Knobbe Martens Olson & Bear, LLP




Biosimilars: The New Patent Litigation Landscape

Webinar Date: 04/22/2010

The healthcare reform measure that President Obama signed in to law in March creates, for the first time, a regulatory pathway for “generic” versions of large-molecule biotech drugs. The route to market for such “biosimilar” drugs bears some resemblance to the longstanding Hatch-Waxman legal regime that sets out how generic drug companies can challenge the patents held by pharmaceutical companies on small-molecule medicines. But the differences are profound and will prove to be of great importance in the years ahead. The experts on this panel will give an overview of the new law, and how the litigation landscape will develop.

Speakers:

  • Steven Lee, Kenyon & Kenyon LLP
  • Henry Renk, Fitzpatrick, Cella, Harper & Scinto
  • Stuart Watt, Amgen, Inc.



Ariad v. Lilly: What Are the Lessons?

Webinar Date: 04/06/2010

On March 22, the Federal Circuit reached an en banc decision in Ariad v. Lilly, a case that raised the question of whether patent law contains a written description requirement separate from the enablement requirement, and if so, asked what is the scope and purpose of that requirement. “Yes” was the Court’s answer to the first part of the question, but its opinion is more equivocal in the answer to the second part. This panel brings together opposing litigators who represented Ariad and Lilly, as well as the attorney who wrote the amicus brief to the Federal Circuit for IPO. They will discuss the implications of the decision for both patent litigation and prosecution going forward.

Speakers:

  • James W. Dabney, Fried Frank
  • Charles Lipsey
  • Pete Pappas, Sutherland



Patent Term Adjustment - What to do now, What to Expect in the Future

Webinar Date: 01/21/2010

The Federal Circuit has disagreed with the PTO on patent term adjustments. The appellate court’s opinion on January 7th in Wyeth v. Kappos said the agency’s “strained interpretation” of 35 U.S.C. § 154(b) regarding patent term adjustment was wrong. That’s good news for the plaintiffs Wyeth and Elan Pharma – they are set to gain nearly a year’s additional term on two patents. But there are still unanswered questions about how other companies should proceed if they hold patents that are PTA-eligible. For one thing, the PTO has not ruled out appealing to the Supreme Court. Our panel of patent prosecution experts will lay out the decision tree.

Speakers:

  • Jack Brennan, Fish & Richardson P.C.
  • Gary C. Ganzi, Siemens Water Technologies Corp.