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Intel faces trademark litigation on “Dual Core” September 9, 2007

Posted by mais in IP Systems, IPM Strategies, Litigation.

California-based ultramobile PC firm DualCor Technologies filed a suit accussing Intel of misappropriating the DualCor trademark.  DualCor applied for a trademark on its name in May 2004 and was granted the same by the U.S. Patent and Trademark Office in July 2006. read more on this from google news


Novartis’s challenge on validity of Indian patent laws was put down by Indian High Court August 7, 2007

Posted by mais in Drugs, India, IP Systems, Litigation, Patent, TRIPS.
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Swiss pharma giant, Novartis, faced another blow in India, when Chennai High Court rejected its writ petition challenging the validity of Indian Patent Laws.

Novartis had sought to declare Section 3 (d) of the Indian Patents Act as substituted by Patents (Amendment) Act (2005) as being “unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality).”  The section denies patent protection to the discovery of new form of known substance which does not result in enhancement of the known efficacy of that substance.

Novartis also rasied concerns over the discretion of patent authorities to define and determine the “enhancement of efficacy”. The Bench rejected the concerns by saying that the amended section cannot be invalidated solely on ground that there was a mere possibility of misuse of power.

Since Novartis’s 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate and the crystalline forms of imatinib mesylate. The crystalline forms of imatinib mesylate claimed in the application in question does not differ significantly in properties with respect to efficacy. In fact, with respect to efficacy, the current specification of Novartis itself admits that wherever β-crystals are used the imatinib free base or other salts can be used. The various forms of imatinib mesylate can, therefore, very well be considered the “same substance” under section 3(d) of the Patents Act.   view of IP practitioner Swarup Kumar

Novartis unlikely to challenge High court ruling in Indian Supreme Court. Novartis faced first setback  in January last year, when the Indian Patent Office rejected a patent application of its leukaemia drug Gleevec. It had filed appeal against the patent office decision to Intellectual Property Appellate Board and a writ petition in Chennai High Court.

Overview of Chinese Patent Litigation System April 24, 2006

Posted by mais in IP Systems, Litigation.
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An informative overview of Chinese Patent Litigation System "Patent Litigation in Chinese Courts" by J. Benjamin Bai, Helen Cheng and Peter Wang from JONES DAY appired on Mondaq.com A must read….

Navigating the patent maze: Nap Hal November 13, 2004

Posted by mais in India, IP Systems, Litigation, Patent.
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Navigating the patent maze: Nap Hal – Comments Addressed: “Nap Hal – Comments Addressed

An interested reader commented on the post in which I expressed approval for the decision of the Indian Government to not oppose the European Patent, now owned by Monsanto, that used Nap Hal. The reader raised several points that I would like to address. I also hope that it evokes more discussion on this topic area.

(Sidebar – there are currently 5 parties opposing this patent, including Greepeace and the European Flour Milling Association)

The reader raises several points. The first point, quoted below, speaks to whether the patent claims are in violation of the European Patent Convention.

The Patent in question explicitly claims a wheat variety, and so is squarely in violation of the European Patent Convention.??

The short answer is that the patent in question (EP 0 445 929) does not claim any plant varieties. The claims are directed to soft-milling wheat with particular characteristecs, flour prepared from that wheat, dough or batter prepared from the flour, edible products made from the dough or batter, and biscuits made from the flour.

The second point of the reader is that ‘the disclosure of the patent shows that the genetic traits which are key to the patent (double null allele in glu-D1 gene) were wholly derived from the landrace developed in India, namely, Nap Hal.’

I’m not sure what the reader’s objection is other than the landrace came from India. In fact, the landrace was obtained from a public germplasm bank. The accession was placed prior to the Convention on Biological Diversity, so that treaty does not control the situation. Until the CBD, typically there were no restrictions on accessions or, in the case of the CGIAR the restrictions regarding intellectual protection placed on germplasm held in FAO Trust were limited to the variety itself and did not extend to derivatives (such as the wheat claimed in the Monsanto”

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Posted by mais in Drugs, Litigation, Patent.
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IPKat – fishing for IP stories for YOU: “Friday, October 29, 2004
Yesterday in Case C-53/03 Synetairismos Farmakopoion Aitolias & Akarnanias (Syfait) and Others v Glaxosmithkline AEVE Advocate General Francis Jacobs gave his Opinion as to whether a drug company may plead the threat of parallel trade as an excuse for limiting the amount of IMIGRAN, LAMICTAL and SEREVENTIT it sends to pharma wholesalers in ‘cheapo’ regimes. In his conclusion he recommends that the European Court of Justice rule as follows:
‘(1) A pharmaceutical undertaking holding a dominant position does not necessarily abuse that position by refusing to meet in full the orders sent to it by pharmaceutical wholesalers only by reason of the fact that it aims thereby to limit parallel trade.
(2) Such a refusal is capable of objective justification, and thus of not constituting an abuse, where the price differential giving rise to the parallel trade is the result of State intervention in the Member State of export to fix the price there at a level lower than that which prevails elsewhere in the Community, given the combined circumstances of the European pharmaceutical sector at the current stage of its development, and in particular:
�- the pervasive and diverse State intervention in the pricing of pharmaceutical products, which is responsible for price differentials between the Member States;
�- the regulation by the Community and the Member States of the distribution of pharmaceutical products, which establishes nationally demarcated obligations upon pharmaceutical undertakings and wholesalers to ensure the availability of adequate stocks of those products;
�- the potentially negative consequences of parallel trade for competition, the common market, ”

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The Use of Exculpatory Opinions in Defending Against A Charge of Willful Infringement (12/05/04) from Mondaq October 22, 2004

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McDermott Will & Emery – United States – The Use of Exculpatory Opinions in Defending Against A Charge of Willful Infringement (12/05/04) from Mondaq:

The exercise of intellectual property rights has become a mainstay of business over the last 10 years. Indeed, business models are proliferating where obtaining patents for the purpose of licensing and enforcement are the sole activity of the enterprise. Even among those entities that routinely engage in R&D or the manufacture and sale of products, more and more are investing in the acquisition of IP rights, and many have realized that enforcement of those rights against competitors is an effective tool in protecting markets and/or generating revenue. As a consequence, corporate executives and general counsels are likely to face, at least once in their careers, a charge that their companies are infringing upon another entity’s intellectual property rights.

Especially threatening is the receipt of a notice that your company’s products infringe patents held by another. The threat is worrisome for a variety of reasons. First, the threat is often leveled at a company’s core technology, changes to which are almost never trivial. Second, patent infringement carries with it the very real threat of devastating injunctive relief. Finally, damages in such cases, while nominally calculated in terms of a reasonable royalty or lost profits, may, at the discretion of the court, be enhanced up to three times for so-called willful infringement. In order to navigate this minefield and defend themselves against claims of willfulness, many companies engage counsel in order to obtain advice as to whether their actions violate valid patent rights of some third party and/or how to avoid such violations by design arounds. This article, addresses defenses to a charge of willfulness, and in particular, some of the issues which may arise when relying on opinions of counsel as a defense to a patent owner’s claim of willful infringement.

The “Totality of the Circumstances” Test

When considering whether an infringer acted in bad faith, thereby supporting an increased damage award, courts look at a “totality of the circumstances,” including (1) whether the infringer copied the invention of another; (2) whether the infringer, when it knew of the other’s patent, investigated the scope of the patent and formed a good-faith belief that it was either not infringed, invalid or both; (3) whether the infringer mounted a substantial (albeit unsuccessful) challenge in the issues of validity and infringement; (4) the closeness and complexity of the legal and factual issues presented; (5) whether the infringer engaged in good faith efforts to design around the patent; and (6) the infringer’s behavior in the litigation. 1 Because there are few situations where sufficient evidence of actual copying or litigation conduct egregious enough to find willfulness are present, the primary focus for courts when considering willful infringement claims is usually on whether an alleged infringer has formed a good-faith belief that its conduct was justified.

In the seminal case, Underwater Devices, Inc. v. Morrison-Knudsen Co.,2 the U.S. Court of Appeals for the Federal Circuit imposed as affirmative duty on a potential infringer to exercise due care to determine whether or not its activities are infringing. This duty includes obtaining competent legal advice from counsel before initiating possibly infringing activity. The requirements for an opinion of counsel as evidence of good-faith in defense to a charge of willful infringement has led to several problems relating to waiver of the attorney-client privilege with respect to such opinions, and often to matters beyond the scope of the opinions.

Following Underwater Devices, in Kloster Speedsteel AB v. Crucible Inc.,3 the Federal Circuit found that silence by the accused infringer on whether it obtained legal advice relating to infringement could warrant an adverse inference that the accused infringer either had not obtained an opinion (as required by Underwater Devices) or that the opinion was adverse. The Court followed its Kloster Speedsteel decision with its holding that the failure of an infringer to introduce an exculpatory opinion of counsel at trial could lead to an adverse inference instruction to the jury. Fromson v. Western Litho Plate & Supply Co.4 Thus, although the test for determining willful infringement ostensibly requires a multifaceted review of the totality of circumstances, the Federal Circuit jurisprudence has, for many years, imposed an opinion requirement. In the view of many, the opinion of counsel “requirement,” coupled with the adverse inference, has led to a serious erosion of attorneyclient privilege.

Waiver of the Attorney-Client Privilege

Under the present state of the law, in addition to the affirmative duty to seek and obtain advice-of-counsel, if a company finds itself in a lawsuit facing a charge of willful infringement it is all but required to disclose the legal advice it received relating to infringement and/or validity. In other words, by merely raising the willful infringement claim, a patent owner presents the accused infringer with the Hobson’s choice of either waiving its attorney- client communications or confronting an adverse inference instruction on the issue of willfulness. Most choose waiver.

The “choice” mandated by the Federal Circuit authority requires considerations not found in any other area of law. The most obvious is the effect and scope of the privilege waiver resulting from reliance on an opinion of counsel. There is no question that reliance on opinions of counsel as evidence of goodfaith results in a waiver of privileged communications. The thorny question facing accused infringers is just how broad a waiver results. Accused infringers agonize over this question and district courts have found the task of line drawing to be a daunting one. The uncertainty on this issue is well illustrated by the following quote from a court struggling to fairly decide the issue:

“In few, if any, areas of the law has the tail taken to wagging the dog as vigorously as in the privilege waiver disputes endemic to patent infringement cases. Defendants often rely upon an advice-ofcounsel defense when confronting the threat of enhanced damages for willful infringement. The consequent waiver of privileges and protections that the adviceof- counsel defense entails, however, is now the basis of innumerable disputes like the one at bar, distracting the court and the parties from addressing the fundamental questions of infringement and validity. It seems that a whole subspecialty of opinion practice has developed as part of infringement defense strategy. Litigation resources are heavily invested in delaying the moment when an accused infringer must choose between relying on advice-of-counsel or maintaining typical privileges, or in seeking bifurcation on the issue of willfulness, or in trying to control the scope of waiver, once the advice-ofcounsel route is taken.” Rhodia Chimie, et al. v. PPG Industries, Inc. 5

Scope of Waiver

It is long settled that if an accused infringer chooses to rely on an advice-of-counsel defense, it waives privilege with respect to the communications transmitting the reliance opinion. Thorn EMI North America, Inc. v. Micron Tech.6 Materials considered by reliance counsel in rendering the opinion, but not communicated to the accused infringer, are typically protected as work product and are not discoverable. EMI No. Am. See also, Dunhall Pharm., Inc. v. Discus Dental, Inc.;7 and Steelcase, Inc. v. Haworth, Inc.;8 Even when a work product waiver occurs it is not unlimited in time but ends once a lawsuit is filed.9

However, some courts have extended the waiver to include all communications between the client and counsel, in some instances including trial counsel. Haney v. Timesavers, Inc.10 (Broad waiver found where “document logs show that a number of documents were sent from the [defendant’s trial counsel] to the [reliance opinion counsel] and to others concerning infringement and validity…as a result, [trial counsel] has provided opinions to advise [defendants]);” FMT Corp. v. Nissei ASB Co.;11 Electro Scientific12 (Trial counsel implied that communications with reliance opinion counsel were substantial.); Matsushita Elec. Corp. v. Loral Corp.13 (Defendant patentowner’s defense of good faith litigation was based on opinion given by trial counsel.); Carl Zeiss Jena GmbH v. Bio-Rad Labs. Inc.14 (Written and oral reliance opinion were given by trial counsel.); Fonar Corporation, et al. v. Johnson and Johnson15 (Various outside lawyers’ authored opinion signed by in-house counsel.).

While the scope of the waiver in any given case cannot be accurately predicted, the cases provide some guidance that will help counsel limit the potential scope of the waiver.

First, where practical, opinion counsel should be separate from trial counsel. Broad waivers, including trial counsel’s work product, have been found where trial counsel also rendered an opinion regarding the infringement or validity matters at issue. While the different counsel can be members of the same law firm, the risk of a broad waiver is mitigated if they are not.

Second, opinion counsel and trial counsel should not communicate on the substance of the opinions lest it be inferred that trial counsel influenced opinion counsel. Broad waivers have resulted where trial counsel and opinion counsel share information and theories. Though opinion counsel may be able to bring trial counsel “up to speed” more quickly, it must be remembered that opinion counsel was engaged to provide objective advice on issues of infringement and validity. Trial counsel’s view on whether opinion counsel was articulate and appropriately analytical is only marginally relevant to trying the substantive defenses of the particular action. In preparing an opinion memo, the opinion writer typically has no more than a commercial validity search report and/or a relatively abbreviated consultation with a person knowledgeable about the accused device or method. When this is compared to the resources typically available to defense counsel, it is no wonder that different prior art and different or additional reasons for asserting non-infringement are likely to percolate up. As long as the opinion was competent as delivered and was relied upon in good faith by the client, the Underwater Devices criteria are met.

Third, avoid any appearance of “opinion shopping.” Don’t engage counsel to prepare an opinion and then stop the process in favor of a new counsel without good cause to do so.

Are the Winds of Change Blowing?

Based upon recent actions, the Federal Circuit appears to be keenly aware that these scopes of waiver issues—sequela to the duty to obtain an opinion and the negative inference imposed if the opinion is not produced to the plaintiff—need to be reviewed and addressed. Recently, the Court sua sponte decided to review en banc certain issues regarding exculpatory opinions, waiver and the adverse inferences. In Knorr-Bremse Systeme Fuer Nutzfahrzeuge GMBH v. Dana Corp., et al.,16 the Court asked for amicus submissions on the following questions: (1) Is the adverse inference appropriate when an accused infringer invokes the attorney-client privilege and/or work-product doctrine with regard to willful infringement? (2) Is it appropriate to draw an adverse inference with respect to willful infringement when the accused infringer has not obtained legal advice? (3) Should the existence of a substantial defense to infringement be sufficient to defeat liability for willful infringement even where no legal advice has been obtained?

At least 14 amicus briefs were submitted. With near unanimity, the amici answered the Court’s questions as follows: (1) The adverse inference is inappropriate when a defendant invokes the attorney-client privilege and/or work-product doctrine with regard to willful infringement. (2) It is not appropriate to draw an adverse inference even when a defendant has not secured legal advice. (3) The existence of a substantial defense to infringement should be sufficient to defeat a willfulness claim regardless of whether legal advice was sought and obtained. Some parties went even further, asking the Court to simply abolish the Underwater Device rule. As of this writing, oral argument has been completed and the patent bar eagerly awaits guidance from the en banc Federal Circuit.

Given the Court’s request and the overwhelming call for change, it appears that some Federal Circuit guidance on these issues may soon be forthcoming. However, until that happens, it is important to understand the opinion “requirement” and the attendant attorney-client privilege waiver virtually inherent in presenting a defense to a charge of willful infringement.

Paul Devinsky Stephen J. Akerley Paul Devinsky, a Washington, D.C. based-partner, concentrates his practice on patent, trademark and copyright litigation, counseling and prosecution and on trade secret litigation. Stephen J. Akerley, a partner in Silicon Valley, focuses his practice on high-profile patent, trade secret, trademark and copyright cases as well as technology-related commercial disputes.


1 See, e.g., Anjimoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338 (Fed. Cir. 2000); SRI Int’l Inc. v. Advanced Tech. Labs. Inc., 127 F.3d 1462 (Fed. Cir. 1997); Gustafson, Inc. v. Intersystems Indus. Prods., Inc. 897 F.2d 508, 510 (Fed. Cir. 1990) (“Willfulness is determined from the totality of the circumstances….”); and Bott v. Four Star Corp., 807 F.2d 1567, 1572 (Fed. Cir. 1985).

2 717 F.2d 1380, 1389-90 (Fed. Cir. 1983).

3 793 F.2d 1565, 1580 (Fed. Cir. 1986).

4 853 F.2d 1568, 1572-73 (Fed. Cir. 1988).

5 Civil Action No. 01-389-KAJ, Memorandum Opinion, October 8, 2003.

6 837 F. Supp. 616 (D. Del. 1993).

7 994 F. Supp. 1202, 1205-06 (C.D. Cal. 1998).

8 954 F.Supp. 1195 (W.D. Mich. 1997).

9 Dunhall, supra.

101995 U.S. Dist. LEXIS 15222, *8-9 (D. Ore. 1995).

111992 U.S. Dist. LEXIS 21500, *7, 24 U.S.P.Q.2D (BNA) 1073 (N.D. Ga. 1992)

12175 at F.R.D. 539, 540 (N.D. Cal. 1997).

131995 U.S. Dist. LEXIS 12880, *1-4 (S.D.N.Y. 1996).

142000 U.S. Dist. LEXIS 10044 *1.

15227 U.S.P.Q. (BNA) 886, 887 (D. Mass. 1985).

16Case Nos. 01-1357, – 1376, 02-1221, – 1256 (Fed. Cir.); on appeal from the U.S. District Ct for the Eastern District of Virginia (Case No. 00-CV-803).

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Detectability and Software Patents October 16, 2004

Posted by mais in Litigation, Patent, software.
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Bloglines | My Blogs: “Detectability and Software Patents
By krajec on Patents in Business
Some software ideas suffer from a unique problem: detectability. When an embodiment of an idea is expressed in a language that is compiled and distributed as executable code, how can that idea be detected? If it cannot be detected, there is no way to know if someone infringes.
There are many ways patents may be used. In some cases, patents merely buttress a resume, an advertising brochure, or a marketing message. These patents sometimes can also deter other competitors from entering the market and act as a deterrent effect.
Enforceable patents that protect the foundational technologies of a company should be detectable. In other words, the patent owner should be able to detect when a competitor is unlawfully copying his idea and take measures to enforce the patent.
Some of the most creative and ingenious ideas fall into the first category. For example, a very clever and improved sorting algorithm used deep in the bowels of a software application may be tremendously novel, useful, and non-obvious, but it makes little business sense to patent that technology. The sorting algorithm is best protected as a trade secret, even if the executable code is widely distributed under a license. A competitor may use a completely different sort algorithm to achieve the same result, even if the competitor�s algorithm is much more cumbersome.
Patents of the second category typically focus on the overall function of a software application, relate to interfaces used by the application, or define data structures. In each case, clear and immediate detection of infringement is possible. Patents covering this second category are much better suited to licensing or infringement enforcement.
For the Patent Office, it may be enough that an invention is novel, useful, and non-obvious, but for ”

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ANDA filing doesn’t constitute Willful patent infringement August 16, 2004

Posted by mais in Drugs, Litigation, Patent, USA.
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Glaxo Group Limited v. Apotex, Inc., 2004 U.S. App. LEXIS 15489 (Fed. Cir., July 27, 2004)
Apotex, Inc. (‘Apotex’) appeals the judgment of the United States District Court for the Northern District of Illinois, which found that Apotex’s filing of an Abbreviated New Drug Application (‘ANDA’) for a generic version of the antibiotic CEFTIN willfully infringed U.S. Patent No. 4,562,181 (the ”181 patent’) and U.S. Patent No. 4,820,833 (the ”833 patent’) owned by Glaxo Group Limited and SmithKline Beecham Corp. (collectively ‘Glaxo’). The Federal Circuit affirmed the district court’s determination that Apotex’s ANDA infringes both the ‘181 and ‘833 patents pursuant to 35 U.S.C. � 271(e)(2), and also affirmed that the patents at issue are not invalid. The Federal Circuit, however, reversed the district court’s finding that Apotex’s ANDA filing constituted willful infringement. The Federal Circuit held that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney’s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Federal Circuit explained that 35 U.S.C. � 271(e)(2) and 35 U.S.C. � 271(e)(4) create only an ‘artificial’ act of infringement for a ‘very limited and technical purpose that relates only to certain drug applications.’ This purpose is to permit patent holders to bring suit against generic companies despite the fact that the generic companies have not yet infringed the patents at issue. The Federal Circuit eloquently wrapped up its analysis by saying: ‘[t]he district court therefore erred in hanging a finding of willfulness on such a special-purpose peg.'”

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Who lost it…. plant breeder or farmer or we August 16, 2004

Posted by mais in Litigation, Patent, USA.
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Navigating the patent maze: Court Decisions: “Schmeiser v Monsanto
By this time, most of you have heard that ‘Monsanto won’ over Percy Schmeiser in the Canadian Supreme Court. Actually, Mr Schmeiser was found to have infringed Monsanto’s patent but no damages were assessed. It was a close decision and a momentous one for two main reasons. Several commentators have written about how genetically-engineered plants are essentially, if not expressly, protectable because of the gene introduced. In another blog entry, I will discuss that issue. For this entry, however, I raise the possibility that the Court has defined ‘use’ of a patented invention in such a way that that there may now be an exemption for basic science research in Canada.
Monsanto Canada Inc v Schmeiser 2004 SCC 34.

In particular, the court defined ‘use’ as utilization with a view to production or advantage. The use then that interferes with the rights granted to the patent owner is infinging. Amazingly, the Court characterized deprivation of their rights when ‘another person, without licence or permission, uses the invention to further a business interest.’
Does this imply that a use that is not commercial or furthering a business interest is non-infringing? Would a research use in the confines of a non-profit or educational institute be non-infringing?
There are several ways that the Canadian Courts can go. For example, the Canadians, like their southern neighbor counterpart court, may say that essentially all uses have a business purpose, even universities who may ‘use’ in furtherance of their business of education and money raising. Or, they may hold that that commercial use is not the only use that can be infringing. The Canadian Supreme Court hints that the latter route is appropriate when they write ‘Even in the absence of commercial exploitation, the patent holder is entitled to protection.”

In Schmeiser’s case, Mr Schmeiser contended that he didn’t use the patented gene, which conferred resistance to roundup, because he didn’t spray the canola crop with the herbicide. But, the court still found ‘use’ of the invention because Mr Schmeiser’s business was growing canola, and he grew canola containing the patented seeds. Furthermore, he had the advantage of the stand-by use, meaning that he could have sprayed Roundup ™ or could have sold the seed to other farmers who didn’t want to pay the fee to Monsanto.

Where does this leave those who may use a patented invention in the context of research? Without clarification of this issue by the Canadian courts, I wouldn’t assume that there is now a research exemption. That said, despite what is likely a huge amount of infringment of patents in university settings, very rarely are universities and scientists there ever stopped from using a patented invention. For more on this subject, I refer you to this article: “Accessing other people’s technology for non-profit researchAJARE.pdf Australian Journal of Agricultural and Resource Economics 46:3 389-416 (September 2002).

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ANDA Filing is not per se willful patent infringement July 29, 2004

Posted by mais in Litigation, Litigations, Patent, Patent infringement.
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Patently Obvious: MBHB Patent Law Blog: “ANDA Filing is not per se willful patent infringement

Glaxo v. Apotex (Fed. Cir. July 27, 2004)
Apotex appealed the district court judgment, which found that Apotex’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the antibiotic Ceftin� willfully infringed Glaxo and SmithKline Beecham’s patents. (U.S. Patents 4,562,181 and 4,820,833).
On appeal, the Federal Circuit (GAJARSA) affirmed the infringement holding, but refersed the the district court’s finding of willful infringement.
We hold that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney�s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act.
Because, the ANDA filing did not constitute an ‘exceptional case,’ the willfulness holding was reversed
In dissent, DYK argued that the case was moot and thus should not be decided.
The questions of infringement and invalidity are moot since, as the parties conceded at oral argument, there are no past damages being sought for infringement, and the patents have expired. I dissent from the majority�s decision to address the issues of infringement and invalidity in the absence of a live case or controversy.”