Source: https://patentlyo.com/patent/patent-cases-2007
Timestamp: 2019-04-26 09:51:48+00:00

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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.
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.
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?
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.
BPMC v. California Department of Health (Fed. Cir. 2007).
There is a reason why states generally support strong patent rights: States are increasingly major patent holders – based on inventions developed through federal grants. At the same time, states are generally immune from being sued for infringement. In this case, the CAFC allows the State of California to assert immunity based essentially on a case-numbering technicality.
The facts are simple: Kaiser filed a declaratory judgment action against the patent holder BPMC back in 1997. The California DOH intervened in that case — an action generally considered a waiver of immunity. That case was dismissed for improper venue. In 2006, BPMC filed an identical (mirror image) infringement action against the DOH asserting the identical patent and issues and in the same venue as the 1997 action. The issue here is whether the waiver in the original case of California’s 11th Amendment immunity applies also to the new case.
The appellate panel also rejected BPMC’s argument that the DOH should be judicially estopped from changing its position in this litigation. According to the court, the about-face was excusable because of an intervening change in the law of immunity. (Florida Prepaid).
Expect that this case will receive a petition for certiorari.
Vas-Cath v. University of Missouri (Fed. Cir. 2006).
Pennington Seed v. Produce Exchange No. 299 and Univ. of Arkansas (Fed. Cir. 2006).
Expert Testimony: Following Ferring, the CAFC agreed that Nilssen’s failure to disclose a close relationship with his 132 declarant constituted inequitable conduct.
Priority Claims: Misleading priority claims can also constitute inequitable conduct.
Arminak v. Saint-Gobain Calmer (Fed. Cir. 2007).
In yet another serious blow to design patent protection the Federal Circuit has affirmed a lower court ruling that Arminak’s spray nozzle design is not infringed by Calmer.
Whoever during the term of a patent for a design, without license of the owner, (1) applies the patented design, or any colorable imitation thereof, to any article of manufacture for the purpose of sale, or (2) sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit, but not less than $250, recoverable in any United States district court having jurisdiction of the parties. 35 U.S.C. 289.
Infringement: Overshadowing the statutory guidelines is the CAFC’s judicially created infringement jurisprudence. According to the CAFC, infringement requires satisfaction of two distinct tests: First, in the eyes of an “ordinary observer,” the accused design as a whole must be deceivingly similar to the patented design. Second, the accused design must appropriate one or more points-of-novelty that distinguish the design from the prior art.
Ordinary Observer: Like the PHOSITA in utility patent cases, the ordinary observer is a mythical being. However, instead of being ‘skilled in the art,’ the ordinary observer is aware of the patented design, but is not an expert in the art.
Arminak manufactures and sells spray nozzles. However, Arminak does not sell on a retail level. Rather, the nozzles are purchased by other manufacturers who join them with bottles full of product.
The corporate nozzle buyers can distinguish between Arminak & Calmer nozzles without much trouble. Once assembled, retail customers have difficulty in distinguishing between the nozzles once assembled. The case then turns on whether the ordinary observer is defined as the corporate buyer of the nozzle or a retail customer of the fully assembled product.
Sitting by designation, Judge Holderman determined that the ordinary observer should be defined by the patentee’s corporate structure. Because Arminak’s products pass through a middle-man for further processing, it cannot count the downstream retail purchasers as ordinary observers who “buy and use” the sprayer. Rather, the ordinary observer is the corporate nozzle buyer. (Thus, eventual customer confusion regarding the final product makes no difference).
It was undisputed that a corporate buyer would not be deceived by overall similarities between the accused and patented designs — thus no infringement.
Point of Novelty: The panel also found that the accused design did not appropriate any “points of novelty” of the patented invention. In doing so, the court found that a side-by-side detailed comparison between the accused product and the patent design drawings was appropriate.
To establish infringement in a design patent case, the district court is required to compare the patented design with the accused design. Without comparing the patented design with the accused design, there was no way for the district court to determine whether an ordinary observer would find the accused design deceptively similar and whether the accused design appropriated points of novelty.
For utility patent experts, this type of analysis is second nature. However, for over 100 years prior to founding the CAFC, the rule has been that design patent infringement jurisprudence does not allow for such “side by side” examination. See Gorham Manufacturing Co. v. White, 81 U.S. 511 (1871) (rejecting a side-by-side comparison as leading to an ‘expert’ result rather than that of an ‘ordinary observer’).
During a telephone conversation, the Patent Examiner stated that a replacement office action would be forthcoming. Relying on that statement, the applicant did not respond to the already pending office action. Unfortunately, the Examiner did not issue the new office action and the case went abandoned.
37 C.F.R. 1.2 makes clear that an applicant should not rely on any oral promise from a patent Examiner. Applying this rule, the director of petitions rejected Milton’s petition for revival.
The oral promise could have immediately been memorialized in an interview summary — something that was not done in this case until after the abandonment.
At the time of Petitioner’s reliance, the understanding was a mere oral promise. This section of the C.F.R. expressly prohibits Petitioner’s reliance on the oral understanding, and withdrawal of the holding of the abandonment based on an action which is in contravention to a regulation would be improper.
Thanks to Hal Wegner for providing information on this case.
The real party here is HP.
During prosecution, Gillespie argued around a cited prior art mine roof bolt reference — arguing that the collar of the bolt ‘appears to be cylindrical on the outside, thus impractical…’ Reviewing claim construction de novo, the appellate panel led by Judge Newman limited the claim scope to only cover non-cylindrical collars. (Following the maxim that a “patentee is held to what he declares during the prosecution of his patent.”).
Gillespie argued that the claims should not be limited by his statements because the non-cylindrical collar shape did not turn out to be material to allowance. (The Examiner provided alternative reasons for allowance). The CAFC rejected that potential loophole – finding that Gillespie’s argument was sufficient regardless of its importance in the prosecution process.
DWIDAG’s bolts were thus found to not infringe this new construction.
The court appears to have been careful not to use the term disclaimer.
Automotive Technologies International v. BMW, et al. (Fed. Cir. 2007).
Following ATI’s suggestion, the district court construed the means limitation to include both mechanical and electronic sensor structures. Then, based on this interpretation, the district court ruled the patent invalid for lack of enablement. (summary judgment).
On appeal, the CAFC affirmed the ruling — finding that the specification did not enable the full scope of the claimed invention.
Enabling One Embodiment Is Insufficient: Following on the heels of Liebel-Flarsheim v. Medrad, this case reaffirms the principle that the full scope of a claim must be enabled. Enablement of a single embodiment is not sufficient. Thus, the patent’s enablement of one mode of practicing the invention (the mechanical sensor) was not sufficient to satisfy the enablement requirement.
Looking back, Liebel-Flarsheim discussed “full scope” enablement as being “at least reasonable enablement of the scope of the [claim] range.” Here, the CAFC further defines that principle by noting that electronic sensors must be particularly enabled because they are “distinctly different” from the enabled mechanical sensor.
Novel Aspects Must Be Enabled: ATI also argued that Figure 11 and its accompanying text were enabling — especially when coupled with the knowledge of one having ordinary skill in the art. This argument was rejected based on the CAFC’s combined measure of law and fact. As a matter of law, enablement of the novel aspects of an invention must be enabled by the specification even if implementation would have been within the PHOSITA’s skill level. As a matter of fact, the CAFC concluded that sensor mechanism must be a novel aspect based on statements in the specification that side impact sensing is a “new field” and that the only available side-impact switch was a crush sensor.
Its unclear how the enablement doctrine will work in conjunction with the doctrine of equivalents.
The summary judgment was reviewed de novo for clear and convincing evidence of non-enablement sufficient to overcome the patent’s presumption of validity.
Disclaimer: My former firm, McDonnell Boehnen Hulbert & Berghoff LLP, handled this appeal on behalf of the plaintiff. Although I have not worked on the case, MBHB took-over the case while I was of counsel last year.
Here, prosecution disclaimer narrowed Ormco’s patent claim scope, but only for some of the claims.
Ormco’s invention relates to computer-aided design of orthodontics. During prosecution Ormco distinguished its invention based on its automated calculation of final tooth position even though the claims do not explicitly require fully automated calculations. Although finding the disclaimer clear, the CAFC required some relation between the disclaimer and any affected claim before narrowing claim scope. As a consequence, the scope disclaimer only applies to claims directed at finish tooth positions and not to other claims — such as those directed to preliminary organization of tooth data.
Dissent: Dissenting from the majority opinion, Judge Kathleen O’Malley (N.D.Ohio, sitting by designation) criticized both the majority and the lower court for their procedural sloppiness. Judge O’Malley would have remanded to wait for a more developed opinion from the district court.
In passing, the court reminds us that the existence of prosecution disclaimer is determined within the claim construction phase – and thus reviewed de novo.
The patents at issue are quite hefty for this type of technology – 97 pdf pages.

References: § 102
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 § 261
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