Tag Archives: Federal Circuit En Banc

Federal Circuit Makes En Banc Decision in Paxil Case: Patent Inherently Anticipated

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SmithKline Beecham Corp. v. Apotex Corp. (Fed. Cir. 2005) (en banc order)

Paxil(R) is a blockbuster drug sold by SmithKline Beecham (SKB).  SKB’s patent covering the drug was initially invalidated in an opinion by 7th Circuit Judge Richard A. Posner who sat by designation as a district court judge.  On appeal, a Federal Circuit panel (J. Rader) rejected almost all of Judge Posner’s reasoning, but affirmed the invalidation decision on other grounds. 

Now, the CAFC issued an en banc decision to vacate the panel’s original decision with regard to the issue of experimental use, and the panel (J. Rader) has issued its new decision.

This case involves involved PHC anhydrates (without water) and PHC hemihydrates (some water). In the 70’s PHC anhydrates were invented in the UK. In 1984, SKB invented PHC hemihydrates and eventually patented a PHC hemihydrate compound. (U.S. Patent No. 4,721,723).  In 1998, Apotex filed an ANDA to market a prior art PHC anhydrate.  The question of experimental use arises because SKB performed clinical trials that occurred more than one year prior to filing of the patent application.  Normally, a public use of a patented invention more than a year before filing invalidates the patent under 35 U.S.C. §102(b).  However SKB has argued that the clinical trials were a form of experimental use. 

In its new decision, the CAFC majority simply avoided the issue of experimental public use in totality.  Rather, they found alternative grounds to invalidate the patent, holding that the asserted claims “invalid for inherent anticipation by the ’196 patent under § 102(a).”

Judge Posner had rejected this argument because Apotex “did not prove by clear and convincing evidence that it was impossible to make pure PHC anhydrate in the United States before the critical date.”  The appellate panel, however, found that Judge Posner erred by requiring Apotex to meet this standard of proof, “which is too exacting.”

Apotex did not need to prove that it was impossible to make PHC anhydrate in the United States that contained no PHC hemihydrate, but merely that “the disclosure [of the prior art] is sufficient to show that the natural result flowing from the operation as taught [in the prior art] would result in” the claimed product.

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Teva’s Request for Rehearing of Declaratory Judgment Action is Denied

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Img285Teva Pharmaceuticals v. Pfizer (Fed. Cir. 2005) (On petition for rehearing).

In January 2005, the Court of Appeals for the Federal Circuit (CAFC) issued a controversial decision in the case of Teva Pharm. v. Pfizer.  Teva, a manufacturer of generic drugs had filed an Abbreviated New Drug Application (ANDA), seeking approval from the FDA to market a generic version of sertraline hydrochloride — a drug sold by Pfizer under the Zoloft® brand.  Under the provisions of the Hatch-Waxman Act, Pfizer had 45-days to sue Teva for patent infringement based on Teva’s ANDA filings.  However, Pfizer did not sue.  Teva then brought a declaratory judgment action against Pfizer, seeking a determination that its generic drug did not infringe Pfizer’s patent. 

The question on appeal was whether the Teva’s apprehension of suit was sufficient to create jurisdiction for its declaratory judgment action.  On appeal, the CAFC determined that Pfizer’s Orange Book listing along with Teva’s ANDA were insufficient to create an actual controversy

The listing of a patent in the Orange Book by an NDA filer is the result of a statutory requirement. Without more, Pfizer’s compliance with the Hatch-Waxman listing requirement should not be construed as a blanket threat to potential infringers as far as Pfizer’s patent enforcement intentions are concerned. . . . More is required for an actual controversy than the existence of an adversely held patent. . . . We are not prepared to hold that listing a patent in the Orange Book evinces an intent to sue any ANDA filer who submits a paragraph IV certification with respect to the patent.

As such, the CAFC affirmed the District Court’s dismissal of Teva’s action.  Now, Teva has requested an en-banc rehearing and amicus curiae briefs were field by the FTC, the Generic Pharmaceutical Association, Ivax Pharmaceuticals and Senators Edward Kennedy, John McCain, and Charles Schumer.  However, that request has been denied.

In a precedential order, the CAFC denied Teva’s petition for a rehearing — noting that “a poll was requested, taken, and failed.”

However Judges Dyk and Gajarsa both filed dissenting opinions explaining their reasons for hearing the case.

Gajarsa Dissent: Judge Gajarsa, who was a member of the original Teva panel, argues that the ANDA situation is quite different from other patent infringement situations and requires a separate form of analysis.

The contextual differences between the second ANDA filer and the typical patent infringement case make the reasonable apprehension test inappropriate for this action. By guiding the patentee’s conduct in the typical case, the reasonable apprehension analysis allows the patentee to avoid litigation. Identifying a justiciable controversy in terms of a threat of infringement litigation, the doctrine establishes the circumstances in which the uncertainty of legal rights materially harm a potential infringer in the marketplace. The injury facing Teva in this case is different in kind, but no less actionable.

Gajarsa goes on to say that the panel decision’s Constitutional analysis (Article III limitations) “forestalls legislative correction” of the decision.

Dyk Dissent: Judge Dyke provides a full Article III analysis and concludes that the Teva panel was wrong in determining that a reasonable apprehension or imminent suit was required for declaratory judgment jurisdiction.

There are relatively few Supreme Court cases dealing with Article III and declaratory judgments, but the few cases that do exist provide no support for a reasonable apprehension of imminent suit requirement.

Teva and its cohort of supporters are expected to appeal petition for certiorari.

The Senators’ Brief: Senators Edward Kennedy, John McCain and Charles Schumer filed an amicus brief supporting the petition for rehearing. The brief made the point that there was a Congressional intent surrounding the passage of the Hatch-Waxman Act to expand subject matter jurisdiction over declaratory judgment actions by generic drug companies “to the constitutional limit” and that the panel opinion in Teva v. Pfizer frustrates the purposes of the amendments. (Thanks to Theodore Whitehouse at Willkie Farr for providing a copy of the Senators’ brief)

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Microsoft requests rehearing in Eolas Appeal.

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“Exporting this brief could violate 35 U.S.C. Section 271(f) under the Panel’s mistaken construction of that statute.”

So begins the Amicus brief submitted by Bentley Systems, et al., in support of Microsoft’s petition for rehearing in Eolas v. Microsoft (Golden Master I).  Bentley goes on to argued that the Court should maintain a principled and clear distinction between (a) supplying physical components of a physical patented invention, versus (b) supplying engineering design information that can be used to manufacture components of a patented invention. 

In Eolas v. Microsoft, a three member appellate panel at the Federal Circuit appears to have expanded the scope of Section 271(f) – a statute that creates a cause of action for infringement due to foreign sales when a component of a patented invention is supplied from the U.S., knowing that the component will be combined in an infringing manner outside the U.S.  Microsoft had shipped a “Golden Master” of computer code for Internet Explorer (IE) to its foreign suppliers who then copied the disk and sold the copies on foreign soil.  This activity was seen as infringing, even though the patented invention was not practiced until at least the 3rd step above.

Of course, Microsoft agrees that the CAFC’s decision was mistaken.  In its petition for a rehearing Microsoft argues that the that the panel decision is contrary to Pellegrini v. Analog Devices — a case that were virtually ignored by the CAFC opinion.  In their brief, AOL & Intel agree that the panel’s application of 271(f) cannot be reconciled with Pellegrini and prior U.S. patent law. [AOL & Intel Amicus Brief].

As I have mentioned before, this case may have wide reaching effects.  In its amicus brief, Shell Oil notes that the panel’s opinion overreached when it declared that “every form of invention eligible for patenting falls within the protection of section 271(f).” Specifically, Shell, one of the most multinational of corporations, is concerned that they will be found to be violating patented processes that were somehow exported from the U.S. [Shell Oil Amicus Brief].

In disagreeing with the CAFC decision, the Business Software Alliance (BSA) makes both a legal argument and a policy argument.  On the legal side, BSA describes the Golden Master disks as templates that are not incorporated into patented inventions.  Their argument, that is not controverted by the CAFC decision, is that 271(f) was not enacted to “ensnare companies that transmit know-how.” On the policy side, the BSA notes that the decision hurts U.S. software developers and adds another incentive to outsource such work to developers in another country. [BSA Amicus Brief].

It is difficult to even make an educated guess as to how long it may take for the Federal Circuit to decide the petition.  In one case, a petition for rehearing has now been pending for almost a full year.

Thanks to Joseph Milowic, Janine Carlan, Joe Miller and John Vandenberg for helping me locate the briefs.

Eight is Enough: Eight important patent cases for Spring 2005

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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.

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