Tag Archives: Inequitable Conduct

Court Finds Standing for Consumers to Bring Antitrust Claim of Asserting an Invalid Patent.

TAQMolecular Diagnostics Lab v Hoffman La Roche (D.D.C. 2005)

By S. Richard Carden

MDL, a purchaser of Thermus aquaticus DNA polymerase or "Taq" (a component used in performing polymerase chain reaction), brought suit against Roche, Applera and others for violations of the Sherman Act, allegedly arising from Roche's enforcement of U.S. Patent No. 4,889,818 ("the '818 patent") knowing that it had been procured through inequitable conduct.  The '818 patent claims a thermostable DNA polymerase isolated from the Thermus aquaticus bacteria.  Defendants moved to dismiss the complaint on several bases including (1) lack of standing, (2) tolling of the statute of limitations, (3) failure to sufficiently allege a conspiracy, and (4) failure to comply with the pleading requirements of Rule 9.  The D.C. District Court denied Defendants’ motion in its entirety, with a minor exception that precluded MDL from seeking damages for the period prior to the four year statute of limitations period prior to its filing of the suit.


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Inconsistency Between Views of Two PTO Examiners Found Relevant to Obviousness Determination During Litigation

PatentlyOImage043Syntex v. Apotex (Fed. Cir. 2005).

Apotex filed an ANDA to begin marketing a generic version of ACULAR, an ophthalmic NSAID protected by a patent owned by Syntex.  Based on the Section IV filing, Syntex filed suit against Apotex for patent infringement.

After a bench trial, the district court determined that the proposed generic infringed the claims of the ACULAR patent and that the patent was not invalid.

Regarding invalidity, the district court concluded that Syntex had overcome obviousness issues by showing that the prior art taught away from the use of the drug/surfactant for opthalmic uses and that such a use created “unexpected results.” In its decision, district court noted that because the prior art at issue had been before the examiner during prosecution, the burden of proving the challenged claims obvious “is particularly high” — and that Apotex had failed to meet this heightened burden. 

On appeal, the CAFC reversed — finding “clear error by the district court in several of the grounds that led it to conclude that the invention claimed by the claims in suit would not have been obvious.” 

Of the several grounds for reversal, the issues of examiner discrepancy, expert testimony, and commercial success may be the most interesting:

Examiner Discrepancies:

Two different PTO examiners worked on various portions of the asserted application and its parent applications and had seemingly inconsistent views regarding patentability of the application.  The CAFC found this relevant to the obviousness determination.

This statement contradicted the express finding of the initial PTO examiner that Syntex’s earlier data failed to show unexpected results. Whether the second examiner was aware of the earlier rejection of Syntex’s claims is unknown. But the relevance of the inconsistency between the views of two examiners is not insignificant.

Although we conclude . . . that Syntex did not commit inequitable conduct . . . we think the unvarnished view of the prosecution history shows some weakness in the conclusion that the patentee established unexpected results for the claimed surfactant.

Expert Testimony:

The Appellate Panel found that the district court erred by failing to examine Apotex’s expert testimony on the question of motivation to combine and unexpected results.

Commercial Success:

The district court relied heavily on the commercial success of ACULAR in its nonobviousness decision.  However, the CAFC requested that the lower court revisit this issue in light of the recent case of Merck v. Teva.

In Merck, the court found that commercial success of an FDA restricted product “has minimal probative value on the issue of obviousness. . . . Financial success is not significantly probative . . . because others were legally barred from commercially testing the [] ideas.”

Concurrence:

In a concurring opinion, Judge Prost disagreed with a portion of the majority opinion that made note of “inconsistency between the views of two examiners” who examined the asserted application and a parent application.

In general, I fail to see how the conduct of a patent applicant is relevant to an obviousness determination. Alleged misconduct at the PTO, in terms of either mischaracterizations or omissions, goes to the heart of an inequitable conduct inquiry but is simply irrelevant to an obviousness inquiry.

 Links:

PATENT REFORM: Preventing Inequitable Results Under Knorr-Bremse Willfulness

This post is part of our continuing series discussing a US House of Representatives working draft of patent legislation, by Marcus Thymian, Jennifer Swartz, and Dennis Crouch.

In the landmark decision of Knorr-Bremse v. Dana Corp., an en banc panel of Federal Circuit judges recently held that no adverse inference is to be drawn from the absence of an opinion of counsel in willfulness determinations.  This ruling overruled the Court’s earlier precedent in Quantum and was a dramatic change.  The proposed legislation attempts to balance this swing in jurisprudence by adding a section on willfulness that incorporates the Knorr-Bremse holding while carving out broad exceptions.  

The proposed changes repeat the Knorr-Bremse holding that “[t]he absence of an opinion of counsel shall not create an inference that the infringement was willful.”  Further, the legislation makes mere knowledge of a patent or its contents insufficient for a finding of willfulness against the defendant.

The legislation diverges from Knorr-Bremse by listing “other factors” that may be considered in increasing damages against an infringer.  Included as one such factor is intentional copying by a defendant who has specific knowledge he is infringing patented subject matter.  However, unlike Knorr-Bremse, the defendant must rebut proof of specific knowledge by proffering evidence of an “informed good faith belief” that the patent is invalid, not infringed, or unenforceable (i.e. an opinion).  Thus, while no adverse inference of willfulness will be drawn in the absence of an opinion under the proposed changes, the defendant will still have the onus to provide an opinion in cases in which the plaintiff proves the defendant’s specific knowledge of infringement.

Finally, the legislation also proposes adding to the statute for increased damages the “factor” of prior litigation between the parties for substantially similar infringement.  Thus, in a later action between parties for colorably similar infringing conduct, willfulness may be based on the knowledge the infringer has maintained since the earlier litigation.< ?xml:namespace prefix ="" o />

Eli Lilly wins patent ruling on Zyprexa

PatentlyOImage024Eli Lilly v. Zenith Goldline (N.D. Ill. 2005).

In a much anticipated decision, Judge Richard Young of the Southern District of Indiana has ruled that Eli Lilly’s patent covering the drug Zyprexa is valid, enforceable and infringed.  The patent is not scheduled to expire until 2011.

The well-written 224 page opinion reads like a biography of Patent No. 5,229,382, the Zyprexa patent.  In particular, the court details the prosecution history of the patent and provides a full analysis of the prior art references that the generic manufacturers cited against the patent.  In the end, court determined that the generics could not prove invalidity or unenforceability:  

Defendants have failed to prove by clear and convincing evidence that claims 1, 2, 3, 7, 8, and 15 of the ’382 patent are invalid as anticipated under 35 U.S.C. § 102, as obvious under 35 U.S.C. § 103, under the double patenting doctrine, or as barred by prior public use under 35 U.S.C. § 102. Defendants have further failed to prove by clear and convincing evidence that the ’382 patent is unenforceable for inequitable conduct.

The defendant generic manufacturers had stipulated that if the ’382 patent is valid and enforceable, then their actions constitute infringement. Thus, the court found that their ANDA submissions constituted an act of infringement. 

Court Agrees that Sony PlayStation Infringes Immersion Patent

Immersion Picture

Brandon Rash at the EEJD blog provides info on the most recent win for Immersion technology.  Sony has been ordered by the Court to pay $90 million and halt to PlayStation sales in the United States for violating Immersion’s patents on “tactiley responsive” technology. Today’s ruling comes in the wake of last September’s jury verdict of infringement.  Microsoft was a named defendant, but settled prior to trial.

The permanent injunction is stayed pending appeal to the Federal Circuit. In her decision to issue the stay, Judge Claudia Wilken of the Northern District of California determined that four factors weighed in Sony’s favor: (i) the strength of Sony’s showing that it is likely to succeed on the merits of its appeal, (ii) whether Sony will be irreparably injured absent a stay, (iii) whether the stay will substantially injure Immersion, and (iv) where the public interest lies. Following Standard Havens Products, 897 F.2d 511, 512 (Fed. Cir. 1990).  “The Court finds that on balance, these factors weigh in favor of granting a stay.”

Here are the case documents:

Appeals Court Orders New Trial in $500 Million Microsoft-Eolas Web Browser Case

Eolas v. Microsoft

Eolas v. Microsoft (Fed. Cir. March 2, 2005).

Eolas and the University of California sued Microsoft for infringement of its patent that involves a method of using a web browser to open third-party applications using plug-ins.  The District Court for the Northern District of Illinois granted final judgment to Eolas after a jury found that Microsoft infringed the patent and actively induced United States users of Internet Explorer to infringe. The district court also invoked 35 U.S.C. § 271(f) to include foreign sales of Internet Explorer in the royalty awarded to Eolas.  The jury awarded Eolas a royalty of $1.47 per unit of infringing product, which amounted to a total award of $520,562,280.

On appeal, the Court of Appeals for the Federal Circuit (CAFC) found that district court improperly granted judgment as a matter of law (JMOL) in Eolas’ favor on Microsoft’s anticipation and obviousness defenses and improperly rejected Microsoft’s inequitable conduct defense -- and thus vacated the district court’s decision and remanded for a new trial on these issues. The CAFC also affirmed the district court's claim construction and related jury instruction. 

Finally, the biggest news from a patent law perspective is that the Court affirmed the district court’s holding that "components," according to section 271(f)(1), include software code on golden master disks.


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Eight is Enough: Eight important patent cases for Spring 2005

There are lots of great cases on the Federal Circuit's spring calendar.  Several cases pending at either the Federal Circuit or Supreme Court that are 'worth a special look,' according to Hal Wegner.  Here are some highlights of Mr. Wegner's list, with my own comments.

  • Merck v. Integra, Supreme Court decision by June 27, 2005.
  • LabCorp v. Metabolite, petition for cert submitted, Supreme Court has requested Solicitor General's Opinion on Cert.  The case involves a patentability question -- whether Metabolite's patented method of detecting vitamin B deficiency should be invalid as "because one cannot patent laws of nature, natural phenomena, and abstract ideas." 
  • Purdue Pharma v. Endo, CAFC heard oral arguments in early November on the question of whether patentee's conduct was 'inequitable' for failing to disclose that results used to establish patentability were prophetic rather than experimental. A decision is expected soon.
  • SmithKline Beecham v. Apotex, awaiting decision on petition for rehearing.  This case now revolves around the question of whether use of an invention to confirm utility for FDA approval is an 'experimental use' that saves a patent from anticipation under 102(b).
  • Phillips v. AWH, awaiting en banc decision on claim construction methodology.
  • Eolas Technologies v. Microsoft, Federal Circuit decision awaited, hopefully discussing the scope of 271(f). The upcoming appeal of AT&T v. Microsoft presents the same 'golden master disk' scenario as Eolas, and will become important if Eolas is decided on other grounds.
  • Independent Ink v. Illinois Tool Works, In January, the CAFC determined that, in an antitrust tying case, a patent presumptively defines the relevant market as the nationwide market for the patented product itself.  There is some potential for cert in this case.
  • NTP, Inc. v. Research in Motion, Ltd., there is a good chance for a rehearing in this case involving RIM's BlackBerry product.  This case will be important in defining extraterritorial application of U.S. patent laws in the modern era of networked computing systems.
  • In re Fisher is not yet on the CAFC calendar.  In this case, the BPAI affirmed a rejection for lack of utility and enablement (101 and 112 p1) because the specification lacked a specific teaching of a substantial utility.  According to the decision, without a specific teaching of substantial utility, then virtually all chemicals would meet the requirements of section 101 as at least "useful in research."

Although not patent litigation, Sarah Stirland (one of the few reporters focusing on intellectual property) at the National Journal has written a nice article regarding the potential for legislation in the 109th Congress.

Printable Version


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