Source: http://www.patentlyo.com/patent/patent_cases_2007/
Timestamp: 2013-12-13 19:05:38
Document Index: 581384385

Matched Legal Cases: ['§ 102', '§261', '§ 261', '§ 287', '§ 200', '§ 201', '§ 287', '§ 2']

Patent Law Blog (Patently-O): Patent Cases 2007
Public & Experimental Use: Reduction to Practice Requires Knowledge that Invention Works for Intended Purpose
In re Omeprazole Patent Litigation (Fed. Cir. 2008) The CAFC has affirmed a lower court trial finding that AstraZeneca's Prilosec (omeprazole with an enteric coating and a subcoating) patents are infringed by the ANDA filings of Apotex, Torpharm, and Impax. (See U.S. Patent Nos. 4,786,505 and 4,853,230). This complex consolidated case has been handled by Judge Jones of the Southern District of New York. The case includes several important procedural issues, but here I focus on public use. Public Use of a Pharmaceutical Formulation: Under 35 U.S.C. § 102(b), a patent will be considered invalid if the invention was "in public use" more than one year before the filing date. (i.e., before the "critical date"). The use in question was Astra's large clinical trials used to test its omeprazole formulation. The district court ruled for Astra on two separate grounds: First that the clinical trials were an "experimental use" and therefore cannot qualify as public uses and second that the formulation was not yet ready for patenting until after the trials were completed. Experimental Use and Reduction to Practice: In a series of cases over the past decade, the Federal Circuit has made clear that the experimental use defense "cannot negate a public use" that occurs after the invention is reduced to practice. At the same time, public use now requires proof that an invention is "ready for patenting" which generally requires reduction to practice (or at least being enabled to practice). For the most part, this rather new interpretation of public use subsumes the experimental use defense. Here, the pills had been manufactured and were being used by clinical subjects. However, there were not "reduced to practice" because RTP requires knowledge "that the invention would work for its intended purpose." On appeal, the Federal Circuit refused to overturn the lower court's factual findings – instead agreeing the formulation was not reduced to practice because the company lacked experience of how it would perform clinically: [Astra's expert witness] testified that as of May 1983 the Astra scientists did not have enough information to satisfy themselves that the Phase III formulation would work for its intended purpose. Instead, he testified that the Astra scientists thought the Phase III formulation "had a good possibility to be used as a marketing drug" but that the team did not have long-term stability data and had "no experience of how it performed in clinical studies." …. The Astra scientists had long understood that omeprazole could provide a safe and effective treatment for certain gastrointestinal diseases. The challenge they faced was developing a formulation to deliver omeprazole to the small intestine, a challenge that was made difficult by omeprazole's sensitivity to acidic environments, such as the stomach. Impax has not demonstrated that, without conducting the Phase III clinical tests, the inventors knew that the Phase III formulation would achieve the goals of long-term stability and in vivo stability such that it would be effective as a treatment for gastrointestinal disease. Because the efficacy of the formulation was not reduced to practice, its use could not be a public use. Notes: Of interest here is the idea that reduction to practice requires knowledge that the invention will work for its "intended purposes." The specification of these patents detail the need for stability, so that purpose is clear. Because "purposes of the invention" have been used to limit claim scope, many modern patent applications don't include such information. In those cases, will the purpose be found in extrinsic evidence? The court here focused on reduction to practice to fulfill the "ready for patenting" prong of the public use analysis. Seemingly, the defendants may have had a better shot trying to show ready for patenting based on evidence that "prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention."
Posted on Aug 22, 2008 at 03:50 PM in Patent Cases 2007, Public Use | Permalink
Patent Assignment Must be in Writing; But Some Transfers are not Assignments
Akira Akazawa v. Link New Tech (Fed. Cir. 2008). Yasumasa Akazawa was the inventor and owner of a patent covering a new way to change engine coolant. When he died intestate in 2001, his wife and daughters inhereted his entire estate. The daughters then transferred their interest to the mother, and the mother assigned the patent to Akira Akazawa. Akira Akazawa then sued New Link for infringement. The question on appeal is whether Akira Akazawa properly holds title (because of the non-written intestate transfer). 35 USC §261 has been interpreted to require that patent assignments be in writing. “Applications for patent, patents, or any interest therein, shall be assignable in law by an instrument in writing.” Thus, New Link questions whether the intestate transfer of rights satisfies the writing requirements of Section 261. The CAFC rejected this argument — holding that although ASSIGNMENTS must be in writing, there are other means of transfering patent ownership that need not be in writing. In particular, transfer through “operation of law” need not be in writing under the statute. On remand, the district court must determine whether, under Japanese intestate law, the title to the patent properly transferred as an operation of law – or whether an assignment was necessary. If the district court concludes that the ‘716 patent was transferred to [the heirs] upon Yasumasa’s death, then the subsequent transfers between [the heirs] and Akira conveyed ownership of the ‘716 patent to Akira. If, however, the district court concludes that under Japanese law the ‘716 patent was transferred to the estate of Yasumasa which then fell under the control of an administrator or executor, a written assignment in accordance with § 261 may then be necessary to convey the patent from the estate to Yasumasa’s heirs.
Vacated and remanded. Posted on Apr 07, 2008 at 09:27 PM in Patent Cases 2007 | Permalink
CAFC Reaffirms that Doctrine of Equivalents Applies to Ranges
US Philips v. Iwasaki (Fed. Cir. 2007)
Philips sued Iwasaki for infringement of its patents covering mercury-tungsten halogen light. The district court awarded summary judgment of non-infringement to Iwasaki. Vitiation and the Doctrine of Equivalents: The asserted patent claims a target concentration of 1.6 ± 0.4 × 10-4 µmol/mm3. Based on that claim language, the district court ruled that the claim was “intended to establish the demarcation of boundaries [with] the type of precision that is closely analogous to the metes and bounds of a deed of real property.” Thus, according to the court, allowing the claim to cover any concentration outside of the clearly claimed limits would vitiate the limitation. On appeal, the CAFC rejected the notion that an expanded numerical range would vitiate the claim language. “A reasonable juror could make a finding that a quantity of halogen outside that range is insubstantially different from a quantity within that range without “ignore[ing] a material limitation” of the patent claim.”
This decision conforms to prior decisions that allow equivalents for numerical ranges, but not for other limits (such as a claimed “majority.” Moore).
Notice of Infringement: 35 U.S.C. § 287(a) provides that damages for patent infringement only begin to accrue once the infringer was “notified of the infringement.” (Marking constitutes constructive notice). Notice requires a charge of infringement directed to a specific product, device, or action. The notice must also normally include the patentee’s identity. Here, the infringement letter (sent by “Mr. Rolfes”) did not specifically indicate that Philips was the assignee, but the court found notice sufficient because (1) Philips was correctly listed as the assignee of the patent and (2) Philips had granted the sending party the “responsibility for licensing and enforcing” the patent. Thus, Philips may collect damages from the date of receipt of the letter.
Notes: Rounding in Claim Construction: “‘1.0’ may be said to have more significant digits than ‘1’ with no decimal point. Because [the claimed] ‘10-6’ and ‘10-4’ are simply the numbers 0.000001 and 0.0001 expressed as powers of ten, the claim language provides no basis for inferring any level of precision beyond the single digit ‘1.’ The way that power-of-ten quantities are used in the specification, discussed supra, confirms that the quantities of halogen described by the claims are not intended to be more precise.” — Why does this matter — Less precision means that the accused product may still literally infringe due to rounding.
Approximately: “[T]erms like ‘approximately’ serve only to expand the scope of literal infringement, not to enable application of the doctrine of equivalents.”
Posted on Nov 09, 2007 at 01:02 PM in Patent Cases 2007, Vitiation | Permalink
Bayh-Dole Act is Not a "Patent Law" Sufficient to Create CAFC Jurisdiction
WARF v. Xenon Pharmaceuticals (Fed. Cir. 2007) (nonprecedential opinion). In 2006, WARF won a $1 million verdict in a breach of contract case against Xenon. Although contracts are normally issues of state law, WARF’s original complaint also raised technology transfer issues under the Bayh-Dole Act. (35 U.S.C. §§ 200, et seq.). On appeal, the CAFC found that it lacked subject matter jurisdiction over the appeal because it did not arise under the patent laws. In this vein, the court first concludes that Bayh-Dole’s inclusion in Title 35 does not necessarily indicate that it is a “patent law.” Rather, the general rule is that contract or licensing disputes do not implicate patent laws unless they require some determination of patent issues such as validity or infringement. “[M]ere inclusion in Title 35 of the United States Code does not make a statute a patent law under which a claim may arise. At its heart, the Bayh-Dole Act concerns government funding agreements – contracts in the language of 35 U.S.C. § 201 – an area that is outside our section 1295(a) jurisdiction.”
Of course, if Title 35 contains non-patent laws, it makes sense that there may also be patent laws not found in Title 35. Even if Bayh-Dole was a “patent law,” the appellate panel found that it would still not have jurisdiction over the case because the provisions of Bayh-Dole (1) did not create WARF’s cause of action and (2) are not necessary to determine any other rights of relief. Case transferred to the Seventh Circuit Court of Appeals. Posted on Oct 26, 2007 at 06:47 PM in Jurisdiction, Patent Cases 2007 | Permalink
Enablement: Claimed "surfactant" not enabled by three working examples
Par Pharmaceuticals v. Roxane Labs (Fed. Cir. 2007) (Nonprecedential)
Par’s megestrol acetate suspension is prescribed to people who lose their appetites — often during treatment for cancer or AIDS. Interestingly, the company created this popular drug while attempting to design around a megestrol patent owned by BMS. After obtaining patent protection, Par sued Roxane for infringement. The district court, however, granted summary judgment of invalidity under 35 USC 112 ¶ 1 — finding that “Par is not entitled to the broad claims it asserts.” Enablement analysis begins with the presumptions that an issued claim is enabled and that a challenge to enablement requires clear and convincing evidence. Unlike its close analog written description, enablement is reviewed by the CAFC on a de novo basis. A claim is enabled when a PHOSITA can make and use the claim without undue experimentation. Broader claims, of course, require broader disclosure to ensure that their “full scope” is enabled. The unpredictable nature of an area of technology often serves patentees well as they argue non-obviousness. (It cannot be obvious if the results could not have been predicted). However, the enablement requirement demands more disclosure for unpredictable arts. Broad Claims: Here, Par’s claim includes the following elements: “(a) megestrol acetate; … and (c) a surfactant.” The CAFC finds this claim very broad because it would “allow the choice of any surfactant in any concentration.” (emphasis in original). In its disclosure, Par described three working examples and only one new surfactant. As a matter of law, the CAFC found that “these three working examples do not provide an enabling disclosure commensurate with the entire scope of the claims.”
Notes: This opinion, drafted by Judge Moore may begin to provide some indication of her style. Does this make sense: Because the applicant broadly claimed “a surfactant,” the specification must enable various types of surfactants. If, the claim had been written even more broadly — by eliminating that limitation — there would have been no need to include a description of various types of surfactants. Posted on Oct 26, 2007 at 12:39 PM in Enablement, Patent Cases 2007 | Permalink
Important Unenforceability Case - CAFC Affirms Multiple Counts of Misconduct
Nilssen v. Osram Sylvania (Fed. Cir. 2007)
In a unanimous panel opinion, the CAFC has affirmed a district court finding that Ole Nilssen’s patents are unenforceable due to inequitable conduct. Although Nilssen prosecuted his own patents pro se, the CAFC cut him no slack since he was smart enough to “cite the [MPEP], patent statutes and regulations, and case law during prosecution.”
Unenforceability of Non-Asserted Patents: In a related family of patents, misconduct during prosecution of one of the patents can lead to the whole family being found unenforceable. Reversing that theory, the CAFC agreed that the lower court properly found several of Nilssen’s non-asserted patents to be unenforceable. (Although the court did not create any strict limit on the potential bleed-through, it should be noted that Nilssen originally asserted infringement of those patents, but later dropped those claims.)
Expert Testimony: Following Ferring, the CAFC agreed that Nilssen’s failure to disclose a close relationship with his 132 declarant constituted inequitable conduct.
Small Entity Fees: Although not during prosecution, pretending to be a small entity when paying maintenance fees can also lead to unenforceability. Here, the court found that payment of the small entity fee after licensing to Philips demonstrated an “obvious intent to mislead.”
Priority Claims: Misleading priority claims can also constitute inequitable conduct. Notes: Patently-O Discussion of the District Court Case
Posted on Oct 10, 2007 at 10:50 PM in Patent Cases 2007 | Permalink
Sua Sponte Summary Judgment: A summary judgment motion for non-infringement must at least point to “specific ways in which the accused system [does] not meet the claim limitations.” (Exigent Technology). Without at least that threshold level of information, the court must reject such a motion. Here, the court issued its summary judgment decision on sua sponte grounds (i.e., using grounds that had not been particularly raised in the SJ motion). Because EON did not have an opportunity to respond, the CAFC vacated and remanded. “The district court should have given Eon-Net an opportunity to fully present its arguments on these issues, even if the district court ultimately would have reached the same conclusion. We have previously held that where a district court construes a patent without following the necessary steps, we should remand the matter for further proceedings so that the district court can follow the appropriate steps.”
Sanctions: Normally, an attorney is required to perform a “reasonable pre-filing inquiry” that includes an infringement analysis prior to filing a patent infringement complaint. Here, the district court sanctioned Eon’s counsel for not performing such an inquiry. In a major exception to the inquiry requirement, however, “an attorney may not be sanctioned solely for failing to conduct a reasonable inquiry as long as the complaint is well-founded.” Of course, in patent cases, a patent claim can rarely be deemed unfounded prior to claim construction. “[W]ithout a full claim construction analysis it is impossible to assess whether Eon-Net’s claim construction was unrealistic.”
Posted on Oct 10, 2007 at 10:35 AM in Patent Cases 2007, Summary Judgment | Permalink
Ford Design Patents Block Import of Repair Parts - Infringers Call for Patent Reform
In re Certain Automotive Parts, 2007 WL 2021234 (ITC 2007)
Ford Motor Company owns dozens of design patents covering various aspects of its vehicle designs. D496,890, for example, covers a vehicle grille; D493,552 covers a vehicle head lamp; D503,135 covers a bumper lower valance; and D496,615 covers a side view mirror. In 2005, Ford initiated a Section 337 action before the International Trade Commission (ITC) asking for an exclusion order against various auto parts importers whose imports violated the Ford design patents. For the most part, the accused parts are used to repair post-crash vehicles. An administrative law judge (ALJ) found that the majority of the asserted patents were valid and infringed, although some patents were invalid. The ITC then issued an order to exclude importation of the unlicensed repair parts. Repair doctrine: Over the years, courts have created a non-statutory doctrine of permissible repair. Under the doctrine, post-sale repairs made to a patented object are not considered actionable. On the other hand, reconstruction of the patented object will be actionable as an unlicensed “making” of the invention. Although interesting, the repair doctrine does not apply here. The accused infringers are not repairing anything — rather, they are importing replacement parts that on their own are infringing. Calls for Patent Reform: After losing on the merits, the would-be importers have jumped on the patent reform bandwagon asking for a “repair parts” exception to the design patent laws. [Quality Parts Coalition]. Car manufacturers would like to go the other way — adding vehicle hull design protection to the Copyright Act. [See Boat Hull statute]
Appeal: The case, captioned as Ford v. ITC, 07–1357, is now on appeal at the CAFC — A decision is expected summer 2008. The critical question for Ford — will the patents pass the CAFC’s dreaded points-of-novelty test?
Posted on Sep 27, 2007 at 04:29 AM in Design Patent, Patent Cases 2007 | Permalink
When LG sued a host of Intel chip-based computer manufacturers for infringement, they complained of attempted double-dipping. According to the defendants (including Quanta), their use of licensed Intel chips implicated the first sale doctrine of patent exhaustion. Now the Supreme Court has granted certiorari to determine whether LG’s narrow license terms avoid exhaustion. Question presented: “Whether the Federal Circuit erred by holding, in conflict with decisions of this Court and other courts of appeals, that respondent’s patent rights were not exhausted by its license agreement with Intel Corporation, and Intel’s subsequent sale of products under the license to petitioners.”
Exhaustion – also known as the first sale doctrine – serves as a default rule in both patent and copyright laws. Under the principle, a license fee is only be charged one time per object. Thus, a rights holder controls the first sale of a protected object, but does not control subsequent sales. The copyright rule is codified in Section 109. The patent rule, however, is only based on case law. Lower Court Ruling: The lower court found that Intel’s "unrestricted" license and Intel's sale of its chips under the license exhausted LG's rights to any additional patent recovery. CAFC Ruling: On appeal, the Court of Appeals for the Federal Circuit (CAFC) reversed, finding that when restrictions are placed on a license, "it is more reasonable to infer that the parties negotiated a price that reflects only the value of the ‘use’ rights conferred by the patentee." The appellate panel found that there was no exhaustion because of express conditions on the use of Intel's licensed products -- specifically that the products could not be combined with non-Intel parts.
Intel sold chipsets to the petitioners; Those sales were fully authorized under the LG license and were made without restriction; Therefore, LG's patent rights are exhausted. Quanta goes on to say that under Supreme Court jurisprudence, a sale cannot be conditional. (No improper restraints on alienation). And, without citing Arizona Cartridge, the petition lists a set of upcoming problems if conditions for sale are allowed for patented items: [T]he Federal Circuit's new jurisprudence threatens to kick off a new era of "notices" attached to sold goods. Obvious candidates include "single use only," "no use outside of Massachusetts," "no repair," "no resale," or "no resale for less than the price of purchase."
It turns out that the patents were originally issued to Wang Labs and are indeed quite broad. U.S. Patent Nos. 4,918,645; 5,077,733; 4,939,641; 5,379,379; and 5,892,509 Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992) Jazz Photo v. ITC, 264 F.3d 1094 (Fed. Cir. 2001), cert. denied, 536 U.S. 950 (2002)("United States patent rights are not exhausted by products of foreign provenance. To invoke the protection of the first sale doctrine, the authorized first sale must have occurred under the United States patent."). Arizona Cartridge Remanufacturers Association Inc. v Lexmark International Inc, 421 F.3d 981 (9th Cir. 2005) United States v. Univis Lens Co., 316 U.S. 241 (1942)
Posted on Sep 25, 2007 at 11:11 AM in Patent Cases 2007, Supreme Court | Permalink
Threatening Letters to Infringer's Clients Are Not Actionable Unless "Objectively Baseless" (Although They Will Create DJ Jurisdiction)
GP Industries v. Eran (Fed. Cir. 2007)
Eran makes “leakproof” rain gutter covers. Several Eran employees were fired during the summer of 2005. Those individuals reorganized as GPI — a potential competitor to Eran. As a preemptive strike, Eran mailed letters to its distributors and contractors noting that GPI’s planned to sell a competitive product that infringed Eran’s patent. After GPI filed for declaratory judgment, the district court (Nebraska) granted GPI’s motion for a preliminary injunction — stopping Eran from “(1) seeking to prevent GPI from making and selling its gutter products during the pendency of this litigation and (2) making vague and unspecified allegations of infringement against GPI in the marketplace.”
On appeal, the CAFC reversed — finding that the preliminary injunction had been improperly granted. The party seeking a preliminary injunction has the burden of showing: “(1) a reasonable likelihood of success on the merits; (2) irreparable harm; (3) a balance of hardships in its favor; and (4) public interest in favor of the injunction.” Once granted, a preliminary injunction will only be vacated for clear error. Injunction against Communications: Based on First Amendment rights and 35 U.S.C. § 287 (notice), injunctions relating to communications must pass a higher hurdle. In particular, “bad faith” is required in order to bar communications. “One has a right to inform others of his or her patent rights. See 35 U.S.C. § 2