In re Hall, 781 F.2d 897 (Fed. Cir. 1986).

Facts:

The examiner rejected the claims of Hall’s reissue application on the grounds that they were anticipated under 35 USC 102(b) by a doctoral thesis in a university library in the Federal Republic of Germany that was made available to the public more than one year prior to the critical date. The examiner’s rejection was sustained on appeal to the Board of Patent Appeals and Interferences.

The director and manager of the university library loan department had made a statement that approximated the date the thesis would have been available to the public based on the library’s procedures for processing doctoral theses. The estimated date was over two months prior to the critical date. He also stated that theses were made available to the public by indexing in a dissertations catalog and placement in a dissertations section within the general stacks.

Issues:

1) Can the date the thesis was made accessible to the public be established based on a statement regarding the general practice of the library regarding the processing of theses, without specific evidence regarding the thesis itself?

2) Does a single thesis cataloged in a university library constitute sufficient accessibility to those interested in the art exercising reasonable diligence?

Holding:

1) Yes. Competent evidence of general practice can be used to establish the date the thesis became available to the public.

2) Yes. “The Sec. 102 publication bar is a legal determination based on underlying fact issues, and therefore must be approached on a case-by-case basis.” Under these facts, a copy of a thesis indexed and available to the public is a “printed publication” under 35 USC 102(b).

Disposition: Affirmed.

Further information:

In re Leo M. HALL

In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989).

Facts:

Gosteli filed a patent application with claims directed to Markush groups and dependent claims disclosing specific compounds used in the synthesis of antibiotics. The examiner rejected the claims under 102(e) as anticipated by two compounds disclosed but not claimed in United States Patent No. 4,155,912 by Menard.

Gosteli claimed the benefit of the foreign priority date of a patent application filed in Luxembourg that disclosed the two compounds of the Menard patent. The Menard patent would not have been an effective reference under 102(e) if Gosteli were entitled to the priority date of the Luxembourg patent application.

On appeal to the Board of Patent Appeals and Interferences, the Board upheld the examiner’s rejection and denied Gosteli the benefit of the filing date of the Luxembourg patent application. The Board reasoned that because the claims at issue contained additional subject matter not disclosed in the Luxembourg patent application, the claims in the US patent application were not the “same invention” as required under 35 USC 112. The court held that the effective priority date was the filing date of the US patent application because the Luxembourg application did not provide a written description of the entire scope of the claims at issue.

Issues:

1) Are patent claims entitled to the benefit of their foreign priority date only if the foreign patent application provides adequate support for the entire scope of the claims as required under 35 USC 112?

2) May an applicant use a reduction to practice outside the US to swear behind a prior art reference under 37 CFR 1.131(a)?

Holding:

1) Yes. The priority date of the earlier filed foreign application is available only if the foreign application provides adequate support for the claims in the US patent application.

2) No. An applicant may only use activity within the United States as a basis for swearing behind a prior art reference under 37 CFR 1.131(a).

Disposition: Affirmed.

Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).

Facts:

Markman obtained a patent for a system of monitoring clothes through the dry-cleaning process. The system included generating and attaching a bar code that could be read by optical detectors to each item of clothing. According to the claim at issue, the invention can “maintain an inventory level” and “detect and localize spurious additions to inventory.” The jury heard an expert witness testify regarding the claim’s meaning and found that Westview had infringed Markman’s patent. The trial court nevertheless entered a directed verdict for Westview, stating that the accused device did not track inventory within the meaning of Markman’s claim. The Court of Appeals affirmed and held that claim interpretation is a matter of law and therefore a matter to be decided by the court and not the jury.

Issue: Is claim interpretation a matter of fact to be decided by the finder of fact, or a matter of law to be decided by the court?

Holding:

Claim construction is a matter of law to be decided by the court. The Seventh Amendment right to trial by jury is to be defined according the right under English common law when the Amendment was adopted. The court held that infringement cases at common law were decided by juries. Terms in the specifications however were interpreted by the judge. This case has led to the practice of holding “Markman hearings” in which the court will hear testimony and receive evidence prior to trial in order to determine interpret the scope of the claims at issue.

Disposition: Affirmed

Argued: January 8, 1996

Decided: April 23, 1996

Majority by: Souter

Joined by: Unanimous

Diamond v. Diehr, 450 U.S. 175 (1981).

Argued October 14, 1980. Decided March 3, 1981.

Facts: The PTO rejected claims in Diehr’s patent directed to a process for curing rubber. The Patent Office contended that steps that are performed by a computer by means of a stored program do not constitute statutory subject matter under 35 USC 101. On appeal, the PTO Board of Appeals upheld the examiner’s rejection. On appeal to the Court of Customs and Patent Appeals, the Court reversed, finding in favor of Diehr.

Issue:Are otherwise valid claims rendered invalid by including mathematical formulas?

Holding: Claims that include mathematical formulae are not necessarily invalid. A process is “an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing. If new and useful, it is just as patentable as is a piece of machinery. . . . The machinery pointed out as suitable to perform the process may or may not be new or patentable.”

The mere use of a mathematical formula, computer program, or digital computer does not render a process unpatentable. The claims must be considered as a whole; if the structure or process, when considered as a whole, is otherwise patentable subject matter, the utility requirements of 35 USC 101 are satisfied.

Disposition: Affirmed.

Notes:

Diamond v. Diehr was instrumental in paving the way for State Street v. Signature Financial and the patentability of business methods.

Diamond v. Chakrabarty was also instrumental in establishing the Court of Appeals for the Federal Circuit’s expansive approach to patentable subject matter: “the Supreme Court has acknowledged that Congress intended § 101 to extend to anything under the sun that is made by man.”

Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Argued March 17, 1980. Decided June 16, 1980.

Facts:

Chakrabarty filed a patent application directed to an oil-eating bacterium. The PTO rejected a claim to the bacterium itself on the grounds that living matter is not patentable subject matter. The Board of Patent Appeals and Interferences upheld the examiner’s rejection. The rejection was overturned on appeal to the US Court of Customs and Patent Appeals and the US Supreme Court granted certiorari.

Issue: Are human-made micro-organisms patentable subject matter?

Holding:

Living organisms are patentable subject matter under 35 USC 101 and Chakrabarty’s micro-organism constitutes a “manufacture” or “composition of matter” within the meaning of that statute. The Court held that the terms “manufacture” and “composition of matter” are to be given a broad construction.

The court noted that the judiciary must be cautious when contemplating expanding patent law to new areas that Congress had not foreseen. The court noted however that title 35 contains no ambiguity and was to be construed broadly. The PTO also argued that the court should reject the patenting of living organisms as against public policy. The court held that such a determination was the province of the judiciary and held that the oil-eating bacterium was patentable subject matter.

Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed. Cir. 2006).

Generic drug manufacturer Apotex wanted to market a generic form of Sanofi’s Plavix (clopidogrel bisulfate) and filed an ANDA alleging that Sanofi’s patents were invalid.

The two parties worked together to negotiate a settlement. The agreement was not accepted by state attorneys general even after new terms were presented. Under provisions of the agreement, the regulatory denial killed the settlement and the parties resumed litigation.

Sanofi then filed a motion for preliminary injunction to stop Apotex from selling its product. Within 21 days, the district court issued a preliminary injunction. During that time, Apotex shipped six-months of product. Apotex then appealed. In order to be granted a preliminary injunction, a party must show:

• Reasonable likelihood of success on the merits
• Irreparable harm if an injunction is not issued
• Balance of hardships tipped in favor of the party
• Injunction would have no negative impact on the public interest

The major difference between the factors for consideration in preliminary injunctive relief and those for permanent relief is that preliminary relief requires a showing of a likelihood of success while permanent relief requires success on the merits as a precondition. Thus, the final three factors will give some indication of how the court will rule in post-eBay injunction cases.

Likelihood of success on the merits: Apotex argued anticipation based on a broadly worded claim of a prior art patent that was considered by the examiner during prosecution. The court confirmed that this made the burden of proving invalidity at trial “especially difficult.” On obviousness, the CAFC confirmed that the unpredictability of enantiomer activity made the claimed dextrorotatory formation nonobvious even if the molecule as a whole was known.

Irreparable Harm: The settlement agreement between the parties included a provision that capped any damages for infringement by Apotex — seemingly an admission that Sanofi would settle for money damages. The court did not buy-into this argument because the agreement also contemplated an injunction.

Balance of hardships tip in Sanofi’s favor because Apotex chose to launch its product under threat of injunctive relief. It could have avoided the situation altogether and thus should not benefit from this factor.

Public Interest:

The court found no error in the lower court’s conclusion “that the significant public interest in encouraging investment in drug development and protecting the exclusionary rights conveyed in valid pharmaceutical patents” outweighs the public interest concerns offered by generic manufacturers and amici, including possible deaths due to patients opting to forgo purchasing medicine because of the lack of a less expensive alternative.

Eli Lilly & Co. v. Zenith Goldline Pharms., Inc. 471 F.3d 1369 (Fed. Cir. 2006).

Background: Lilly obtained a patent directed to olanzapine (Zyprexa®) and its use for the treatment of schizophrenia. The defendant generic manufacturers filed an ANDA and Lilly responded by filing a complaint in the Southern District of Indiana. After a bench trial, the district court found in favor of Lilly and held that the patent was valid, enforceable, and infringed. The defendants appealed to the Court of Appeals of the Federal Circuit.

Anticipation: To anticipate an invention, a prior art reference “must disclose each and every feature of the claimed invention, either explicitly or inherently.” In both Petering and Schaumann, prior art references that disclosed the family of the claimed compound were found to anticipate the claimed compounds even though the claimed compounds were not specifically identified. Here, the CAFC found that those cases were not applicable because the closest reference to olanzapine did not spell out “a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member in this limited class.”

Obviousness: The CAFC agreed that the prior art references did not suggest the compound. In addition, Lilly provided strong evidence of secondary indicia of nonobviousness including: “(1) a long-felt and unmet need; (2) failure of others; (3) industry acclaim; and (4) unexpected results.”

Public Use: Lilly conducted Phase I clinical trials before filing the application. The court found that the trials were well within the experimental use exception:

“In this case, Lilly tailored its tests to their experimental drug safety and efficacy purpose, adequately monitored for results, and maintained confidentiality throughout the duration of the study. The trial court did not err in finding no public use.”

Aventis Pharma & King Pharma v. Lupin Ltd. (Fed. Cir. 2007).

Altace is the King/Aventis brand of ramipril – a top-selling ACE inhibitor. The patent claims ramipril formulated “substantially free of other isomers.” The district court found the patent not invalid, but only by a slim margin. On appeal the CAFC reversed – finding the patent invalid as obvious.

Prior Art: One reference (‘944 patent) was filed as a continuation-in-part of an already abandoned patent application. That application was eventually revived, but Aventis argued on appeal that the ‘944 patent should not be awarded the filing date of the parent. The CAFC found this a potentially interesting argument, but refused to hear the argument because Aventis had failed to make the argument at the district court level.

The appellate panel also agreed that the experimental results of a Shering Doctor constituted 102(g)/103(a) prior art because the Doctor had not abandoned, suppressed, or concealed her prior invention.

Obviousness of a Purified Form: The district court, ruling pre-KSR, found the patent nonobvious. On appeal, the CAFC took a different view – finding that the purified form of a known mixture is prima facie obvious if a PHOSITA would have some reason to believe that the mixture derives properties from particular components.

However, if it is known that some desirable property of a mixture derives in whole or in part from a particular one of its components, or if the prior art would provide a person of ordinary skill in the art with reason to believe that this is so, the purified compound is prima facie obvious over the mixture even without an explicit teaching that the ingredient should be concentrated or purified.

The prima facie case of obviousness is especially difficult to rebut where, as here, the potency of the mixture varies directly with the amount of isomer in the mixture.

The court implicitly distinguished this case from Forest Labs — noting that obviousness may be rebutted by showing difficulty in purifying the mixture.

[A] purified compound is not always prima facie obvious over the mixture; for example, it may not be known that the purified compound is present in or an active ingredient of the mixture, or the state of the art may be such that discovering how to perform the purification is an invention of patentable weight in itself.

Reversed, Patent Invalid as Obvious