Source: https://www.ipo.org/index.php/ip-chat-channel/ip-chat-channel-licensing/
Timestamp: 2019-04-19 10:14:48+00:00

Document:
It’s been a little over five years since the U.S. Supreme Court issued its landmark decision in FTC v. Actavis, finding that payments made by brand­name drug companies to generic manufacturers in patent settlements can raise antitrust concerns. The prolific and ongoing litigation stemming from that decision is limited to the small-molecule drugs governed by the Hatch-Waxman regulatory scheme. Now some commentators believe that the FDA has set down a pro-competition gauntlet regarding large molecule biologic drugs governed by the BPCIA — and that the FTC is not far behind.
Up until now the economic arguments associated with pharmaceutical IP and antitrust litigation were based on the pattern of small molecule drugs, where generics usually achieve a substantial share of the market quickly with large price discounts. But the complexity and costs of developing biosimilar drugs, along with substantially different regulatory and market conditions, has already shaped a different pattern for biosimilar competition, raising new issues of which practitioners need to be aware.
Confusion can result if agencies and courts address similar legal issues. A case in point is the current muddle over the common law doctrine of assignor estoppel in patent litigation, where disputes over patent validity often proceed in parallel before the USPTO’s Patent Trial and Appeal Board and federal district courts. The doctrine, which prevents an inventor or patent owner who assigns a patent to another party from later challenging the validity of the patent, plays a role in a significant number of high-profile patent disputes. The Federal Circuit gives assignor estoppel a wide scope, while the PTAB has determined that assignor estoppel does not apply to AIAinter partes review (IPR) proceedings.
It appeared as if this conflict might be resolved soon, but that possibility has seemingly evaporated. EVE-USA/Synopsys petitioned the Supreme Court for certiorari, after assignor estoppel was applied against it in its case against Mentor Graphics. The Supreme Court asked for the views of the Solicitor General on the petition. But the parties stipulated to dismissal of the case in July.
Our panelists – two litigators both recently involved in significant cases involving assignor estoppel, as well as in-house counsel at a tech company, will discuss the fluid state of the law. The Federal Circuit in Husky Injection Molding Systems Ltd. v. Athena Automation Ltd. held that it lacked jurisdiction to review the PTAB’s determination that IPR challenges are not barred by assignor estoppel. But that decision relied on Achates, an earlier Federal Circuit decision which the Court has since overturned. The panel will also consider such corporate concerns as inventor mobility and patent sales in light of assignor estoppel.
The issues of privity, real parties in interest (RPI), and estoppel are becoming ever more important in the post-grant context. The recent Federal Circuit decision in Applications in Internet Time (AIT) v. RPX, an appeal from a PTAB inter partes review decision, found that the PTAB took an “impermissibly shallow” look at evidence presented by the patent owner about the relationship between the petitioner and another party. Our panel of experts will discuss how this decision is a significant addition to the Federal Circuit’s oversight of the PTAB and what the resulting implications are for practitioners.
They will also discuss the relationship of these issues with the time bar under Section 315(b) and the ongoing impact of the en banc Federal Circuit decision in Wi-Fi One v. Broadcom Corporation. That decision held “that time-bar determinations under §315(b) are reviewable by this court,” reversing the original Federal Circuit panel that had cited the Court’s holding in Achates that such judicial review was prohibited.
Questions of RPI and privity are woven throughout the AIA. Its estoppel provisions involving district court and ITC litigation apply not only to entities that are directly involved in adversarial proceedings, but also to privies. Likewise, in many IPRs, questions of RPI and/or privity are not limited to the business model of defensive groups, but are also raised by common fact patterns in supplier-customer relationships, indemnities, mergers & acquisitions, and use of the same counsel.
• The widely reported expectation that Wi-Fi One will file a petition for certiorari with the U.S. Supreme Court – as well as its efforts before the PTAB to raise the issue of a relationship alleged to be subject to the 315(b) time bar.
The U.S. Supreme Court granted certiorari in Helsinn v. Teva in late June, teeing up an important question about the on- sale bar under the AIA. In this particular case, which the Federal Circuit declined to rehear en banc, a patent was invalidated after the sale was partially made public: the details of the invention, an anti-nausea drug, were kept secret, but the existence of the sale was publicly disclosed.
(2) even if it serves as a bar to patentability under section 102, to what extent does a secret sale count as “prior art” for obviousness purposes? They will also consider the Justices’ options in this case.
Enhanced damages for patent infringement no longer is a rarity in the two years since the Supreme Court lowered the bar for alleging and proving willfulness in its Halo decision. In just the last few months, Illinois federal Judge Harry Leinenweber raised Chamberlain’s $3.8 million trial verdict to $11.4 million after finding the conduct of a rival garage door opener maker to be egregious. In May, Texas federal Judge Rodney Gilstrap found deliberate copying of a water filter design and awarded Whirlpool Corp. $3.8 million in enhanced damages on a $7.6 million verdict.
The relevance of the Read factors (Read Corp. v. Portec, Inc., Fed. Cir. 1992) for egregious behavior in light of the fact that enhancement needn’t always follow a finding of willfulness.
Last year’s Supreme Court Lexmark decision poses a major problem for patent owners across many industries by dramatically broadening the scope of patent exhaustion. Apple’s pending litigation against Qualcomm underlines Lexmark’s impact because it challenges the chip maker’s business model for allegedly requiring customers to both purchase chips and take a patent license.
The IP world still awaits a significant Federal Circuit decision on exhaustion in the eight months since Lexmark. But many cases have been bubbling up from district courts, and companies would do well to examine these decisions and other fresh ideas that have been proposed to ameliorate Lexmark’s impact.
Obtaining separate patents on an inventions’ different methods of use.
On-Sale Bar After Helsinn: What is the Scope?
How can a recent Federal Circuit opinion on the on-sale bar, that appears to maintain the status quo, all the same be causing anxiety in the minds of some in-house counsel? This webinar will explore the ramifications of the April decision Helsinn v. Teva, that reversed a lower court by holding that the 2011 America Invents Act on-sale bar provision renders patents invalid if the invention was sold prior to patenting, even if the sale did not publicly disclose the invention.
Helsinn appears to be consistent with a long line of cases about secret sales, including Metallizing. But some in-house counsel, particularly in pharma and other regulated industries, are concerned about the facts of the case, in which the public disclosure of a private purchase-and-supply agreement between Helsinn and a third-party distributor was found invalidating. They worry that many contracts regularly inked by their in-house clients prior to filing a patent application will now need the added scrutiny of IP counsel. And if such transactions are known by the prosecuting patent attorney, will they have to be disclosed to the USPTO?
Our panel includes an in-house counsel at a global chemical company, a pharmaceutical industry litigator, and a professor of patent law.
After Laches: Equitable Estoppel Redux?
Our panel — an in–house counsel and two law firm litigators — will explore whether equitable estoppel defense can indeed be used in many fact scenarios where laches previously applied. According to the Federal Circuit, equitable estoppel can entirely bar a patent infringement suit, if (1) the patentee, through misleading conduct, led the alleged infringer to reasonably believe that the patentee did not intend to enforce its patent; (2) the alleged infringer relied on that conduct; and (3) due to its reliance, the alleged infringer would be materially prejudiced if the patentee were permitted to proceed with its charge of infringement. A defendant has successfully used equitable estoppel, for instance, where a patentee sent a cease-and-desist letter, but did not file suit for an extended period of time.
Last month, Federal Circuit Judge Taranto, writing for a unanimous panel, laid out a complete road map to the admissibility of settlements in patent infringement litigation. That detailed opinion, Prism v. Sprint, is likely to put an end to the seven-year unsettled period that has followed the Federal Circuit decision in ResONet v. Lansa. That 2010 opinion upset case law reaching back to 1889 that rarely deemed settlement agreements admissible in patent infringement litigation. ResONet asserted, to the contrary, that “the most reliable license in this record arose out of litigation.” Since then, district courts have tended to follow their own inclinations on the issue, with some assessing the admissibility of settlements in a fact-dependent case-by-case analysis, and others remaining more inclined to exclude settlements.
Our panel, which includes two litigators and a damages expert, will discuss how to best leverage Prism to keep settlements both in and out of evidence. They will also analyze Sprint’s recent filing of a petition for rehearing or rehearing en banc and discuss possible outcomes.
A damages expert is not always in the room when in-house counsel and their outside litigators must make money calculations regarding settlement of a patent infringement case. This webinar will consider what data is needed to calculate a settlement offer at every major point along the litigation timeline, how to use that data to calculate a timely range of offers, and when an outside expert might be needed. At the outset, for instance, an alleged infringer must decide how much it is willing to pay to make the other side go away — unless it has a deterrence policy of never settling with non-practicing entities. Parties may want to assess the value of a case early on before substantial legal costs are incurred, a process encouraged (at least in theory) by last year’s change in the Rules of Federal Procedure. The time period after an IPR petition is filed — but before the PTAB makes its institution decision — has turned into a productive window for settlement decisions. And, of course, there is important new data on the tables after a damages judgment, but before appeal.
Our panelists are an in-house counsel at a major multinational technology company, a litigator who often represents patent plaintiffs, and a damages expert.
Laurie Gathman Kowalsky, Koninklijke Philips N.V.
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Open source software (OSS) can shorten product development cycles and is likely something you use every day. OSS, however, is not free, and compliance with open source software may be in terms of a patent or copyright license instead of a monetary payment. In fact, OSS costs in an acquisition or merger can impact the valuation of the target, delay, or even scuttle the deal.
Possible ways to mitigate open source use of the target when such use does not align with the acquirer’s business model.
The moderator and panelists are experts in OSS at major technology companies.
They also will discuss strategy issues about how to best highlight the value of a portfolio, the inclusion of non-U.S. patents, the optimal size of a portfolio, and the use of brokers.
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?
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.

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