Bd. of Trs. v. Roche Molecular Sys., Inc., 2008-1509, -1510 (CAFC Sept. 30, 2009) Opinion

On September 30, the Court of Appeals for the Federal Circuit (“CAFC”) affirmed in part, vacated in part, and remanded with instructions the District Court for the Northern District of California decision. The lower court’s decision held several Stanford University patents invalid for obviousness, dismissed Roche’s counterclaim for judgment on ownership, and declined to consider Roche’s affirmative defense based on ownership.  The CAFC vacated the lower court’s decision that Stanford’s patents were invalid and ruled that the University did not have standing to sue, because of contract language indicating that the patent rights belong to an outside corporation. Additionally, the CAFC affirmed the lower court’s decision that Roche’s counterclaim for judgment on ownership was barred due to a four-year statute of limitations.  However, unlike the lower court, the CAFC held that statute of limitations does not preclude a party from raising affirmative defenses.

PatentlyO provides an overview of the case.  Inside Higher Ed expressed surprise that the case turns on the language of Stanford’s assignment agreement and not on other substantive issues, such as the interplay with federal Bayh-Dole Act and the bona fide purchaser arguments.

Stanford University received funding from the National Institute of Health to develop a new biochemical technique called polymerase chain reaction (PCR), as part of its efforts to measure the effectiveness of antiretroviral drugs that are used to treat Human Immunodeficiency Virus (HIV).  Stanford filed three patents related to the PCR method.  The Stanford-affiliated scientists signed a copyright and patent agreement (CPA).  The CPA included a provision in which the scientists “agree to assign” the right, title, and interest in the inventions created.  However, one scientist later signed a Visitor’s Confidentiality Agreement (VCA) with Cetus (a company later purchased by Roche) in order to consult with the outside corporation and refine the PCR technique.  The VCA included “do hereby assign” language.

In holding as it did, the CAFC reasoned that the “do hereby assign” language in the VCA “effected a present assignment of …future inventions” to the company.  In contrast, Stanford’s “agree to assign” language in its CPA “reflect[ed] a mere promise to assign rights in the future, not an immediate transfer of expectant interests.”  Consequently, the outside corporation’s title in the PCR-related patents vested first, thus leaving Stanford with a defective title.  Because Stanford could not establish ownership of the patents, the university did not have standing to sue for patent infringement.

The CAFC decision will likely force colleges and universities to review their intellectual property agreements with faculty and affiliated staff to ensure assignment of rights is immediately effective once the invention is created.  Additionally, the decision will prompt schools to implement a system to review collaborative agreements faculty and staff have with outside companies.

In re Lister, No. 2009-1060 (Fed. Cir. Sept. 22, 2009)
Slip Op.

The United States Court of Appeals for the Federal Circuit, siding with Dr. Lister, vacated and remanded the Board of Patent Appeals and Interferences decision, which had affirmed an examiner’s rejection of Dr. Lister’s patent application under 35 U.S.C. § 102(b).

The Federal Circuit held that the Board of Patent Appeals and Interferences erred in affirming the patent examiner’s rejection under 35 U.S.C. § 102(b). In so holding, the court determined that “persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence” could have located the disputed reference by using either the Westlaw or Dialog commercial databases, which permit keyword searches of reference titles. The court found that this provided sufficient support for a finding of public accessibility under § 102(b).  However, the court also found insufficient evidence that the reference “was in fact included in either Westlaw or Dialog prior to the critical date” of one year before application for patent, as required under § 102(b).

Patentcastle, Patently-O, and Patent Prospector provide overviews of the case, including some historical background.

Dr. Richard Lister is an avid golfer who identified a difficulty that casual golfers have with the rule that a tee may only be used on the first shot of each hole. He then created a method of play in which golfers were allowed “to tee up their balls on every shot except for those taken from designated hazard areas or the putting green.” Dr. Lister, acting pro se, submitted a manuscript entitled “Advanced Handicap Alternatives to Golf” to the U.S. Copyright Office. The Copyright Office issued a certificate of registration on July 18, 1994. Dr. Lister later learned he needed a patent for his invention and applied for one on August 5, 1996. According to 35 U.S.C. § 102(b), a person shall not be entitled to a patent if the invention was publicly accessible “more than one year prior to the date of the application for patent.” After review and appeals, the Board of Patent Appeals and Interferences affirmed an earlier § 102(b) rejection of the patent due to its prior public accessibility at the Copyright Office. The court rejected Lister’s claim that the manuscript was not accessible to the general public by virtue of its location at the Copyright Office. In so holding, the court stated that “a reference can be considered publicly accessible even if gaining access to it might require a significant amount of travel.” The court also noted that once accessibility is shown, it is not required to show that anyone actually accessed it.

Dr. Lister also argued that the catalogs and databases were not sufficiently searchable to enable a reasonable, interested researcher to discover the manuscript. The court concluded that, given these facts, the Copyright Office’s catalog alone would not be sufficient to support a finding of public accessibility, as it allowed searching by author or first title word only. However, the court did hold that Dr. Lister’s manuscript was “publicly accessible” through either Westlaw or Dialog databases, which permitted keyword searches of titles. The court then turned to the question of timing. It held that the § 102(b) rejection was incorrect. It found that the evidence failed to show that the manuscript was made publicly accessible “as of the critical date [of one year before patent application] nor suffices to prove a prima facie case of accessibility that would shift the burden to Dr. Lister.” The court thus vacated and remanded the prior rejection, calling for proceedings consistent with the opinion.

No dissent was included in the opinion.

This ruling suggests that Westlaw and Dialog searches of title keywords provide a much higher level of “public accessibility” for § 102(b) purposes than the Copyright Office’s capacity to search by author name or title first word only. However, this conclusion is fact dependant; thus, an article located only within the Copyright Office database with a unique and readily guessable first word in the title might provide sufficient “public accessibility.” The court also maintained a firm position on the evidence required to show the date of accessibility, and was unwilling to accept an inference of timing based on limited evidence.

Prometheus Labs., Inc. v. Mayo Collaborative Servs., Case No. 2008-1403 (Fed. Cir. Sept. 16, 2009)

The United States Court of Appeals for the Federal Circuit (”Federal Circuit”) reversed the ruling of the United States District Court for the Southern District of California granting summary judgment of invalidity of U.S. Patents 6,355,623 (”the ‘623 patent”) and 6,680,302 (”the ‘302 patent”) under 35 U.S.C. § 101.

Circuit Judge Lourie delivered the opinion of the court, holding that patents claiming a method of treatment were drawn to patentable subject matter based on transformative administering and determining steps of the process. In so holding, the court noted that the “key issue for patentability” is “whether a claim is drawn to a fundamental principle or an application of a fundamental principle.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009).

Patently O provides an overview of the case. Patent Docs features a thorough analysis of the decision.

The ‘623 and ‘302 patents claim “methods for calibrating the proper dosage of thiopurine drugs” by measuring certain metabolites. Prometheus Labs., No. 2008-1403, slip op. at 2. Prometheus Laboratories, Inc. (”Prometheus”), the exclusive licensee of the ‘623 and ‘302 patents, marketed a test that used the technology claimed in the patents. Mayo Collaborative Services and Mayo Clinic Rochester (collectively, “Mayo”) began using and selling a test that measured the same metabolites as the Prometheus test. On June 15, 2004, Prometheus sued Mayo for infringement of various claims of the ‘623 and ‘302 patents. On January 29, 2007, Mayo filed a motion for summary judgment of invalidity, asserting that the patents were invalid for claiming unpatentable subject matter under 35 U.S.C. § 101. Finding the correlations measured by the claimed method to be natural phenomena resulting from a natural body process, the district court granted Mayo’s motion for summary judgment and held the patents invalid under § 101. Prometheus appealed the district court’s grant of summary judgment of invalidity.

In reversing the district court’s ruling, the Federal Circuit applied the test for patentability articulated in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (2009). Under the Bilski test, a claimed process is directed to patentable subject matter if (1) “it is tied to a particular machine or apparatus,” or (2) “it transforms a particular article into a different state or thing.” Id. at 953. Furthermore, under the Bilski “machine or transformation” test, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” Id. at 961-62. Applying Bilski, the court concluded that the claimed methods of treatment “transform an article into a different state or thing,” and that such a transformation is “central to the purpose of the claimed process.” Prometheus Labs., No. 2008-1403, slip op. at 14. The court reasoned that the transformation takes place within the human body following the administration of the drug, and the various physical and chemical changes allow the concentrations of the metabolites to be determined. The court emphasized that when a drug is administered, “the human body necessarily undergoes a transformation,” as “[t]he drugs do not pass through the body untouched without affecting it.” Id. at 16.

Furthermore, the Federal Circuit held that the transformation in the claimed process is “not merely insignificant extra-solution activity.” Id. at 18. The court reasoned that the administering step, which provides the drugs, and the determining step, which measures the drugs’ metabolite levels to assess the drugs’ dosage during treatment, are both a part of a “treatment protocol” and that those steps were both transformative. Id. Finally, the court noted that a subsequent mental step in the process does not undermine the transformative nature of the prior steps. Id. at 20.

The Federal Circuit’s successful application of the Bilski “machine-or-transformation” test to the treatment method in Prometheus secures patent protection for the medical diagnostics industry. This security may be temporary however as the diagnostics industry anxiously awaits the Supreme Court’s review of Bilski later this year.

On August 31, the Court of Appeals for the Federal Circuit (”CAFC”) reversed and remanded the Trademark Trial and Appeal Board (”TTAB”) decision, which ruled that fraud is committed when a registrant or applicant makes material misrepresentations it knows or should have known to be false or misleading.  The CAFC held the TTAB applied the should-have-known standard too broadly and thus ruled a registrant or applicant must have specific intent to deceive the U.S. Patent and Trademark Office in order to fraudulently acquire a trademark.  The evidence supporting the registrant’s or applicant’s intent to deceive must be clear and convincing.  The CAFC ruling significantly limits, if not overturns, Medinol v. Neuro Vasx, Inc., 67 U.S.P.Q.2d 1205 (T.T.A.B. 2003), in which the TTAB adopted the should-have-known standard.

The TTABlog provides an overview of the case.  Allen’s Trademark Digest, in addition to providing a detailed history of trademark fraud, criticizes the decision and asserts that the Bose holding implies that registrants and applicants have no duty of candor.  Furthermore, the article asserts the CAFC ruling is contrary to the Lanham Act and the Trademark Law Revision Act (”TLRA”) statutory definitions of “use.”

The dispute in Bose concerns Bose’s opposition against the Hexawave trademark application.  Bose alleged Hexawave would likely create confusion with Bose’s registered trademarks, including Wave.  Hexawave counterclaimed for cancellation of the Wave mark and asserted Bose fraudulently renewed the Wave mark because its general counsel knew or should have known Wave products were no longer manufactured.  Bose’s general counsel signed an affidavit of continued use and a renewal application thereby claiming the Wave mark was still used in commerce.  The general counsel stated he believed the products were technically in commerce because Bose still repaired Wave products and shipped the products back to customers.

In holding as it did, the CAFC reasoned that the should-have-known standard is not applicable and the TTAB “erroneously lowered the fraud standard to a simple negligence standard.” The court imposes a high standard to prove an intent to deceive in which there is “no room for speculation.” Although the court did not find fraud, it held that Bose’s registration must be revised to “reflect commercial reality” and remanded the case to the TTAB for appropriate proceedings.

The CAFC clarifies that negligence is not sufficient to infer fraud.  Bose likely marks the end of the should-have-known standard created in Medinol.  This decision will make it more difficult for trademark “use” fraud claims to prevail.

By Debbie Rosenbaum – Edited by Stephanie Young
Martek Biosciences Corp. v. Nutrinova Inc., 2008-1459, -1476 (CAFC Sept. 3, 2009)
Opinion

On September 3, 2009, the Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s jury verdict finding that Martek’s patents were valid and infringed, but reversed the points of error Martek asserted on cross appeal. The Federal Circuit (”CAFC”), sitting as an expanded five-member panel: 1) upheld the district court’s denial of Lonza’s motions for judgment as a matter of law (”JMOL”); 2) found that the district court’s exclusion of Lonza’s prior inventorship evidence was appropriate; 3) upheld the district court’s construction of the term “non-chloride sodium salt”; 4) reversed the district court’s finding that two claims of the ‘567 patent were invalid as a matter of law; and 5) expanded the district court’s limited construction of the claim term “animal” in the ‘244 patent to include humans.

Briefs and relevant court documents are available here. The District Court’s 2007 decision may be found here. Patently-o and Patent Hawk both provide a discussion of merits. Patently-o and IP Watchdog discuss the significance of the five-judge panel.

Martek and Lonza make and sell products containing docosahexaenoic acid (DHA), an essential omega-3 fatty acid that plays an important role in the development of organs such as the heart, brain, and eyes, and is reported to have many additional health benefits. DHA is manufactured by extracting lipids from fermented microalgae.

Martek Biosciences sued Nutrinova Nutrition Specialties and Food Ingredients GmbH and Lonza, Ltd. for the infringement of a variety of patents. The patents at issue relate to specified processes for growing a mixture of microorganisms that produce high concentrations of DHA. The microorganisms are used in commercial production of human and animal food additives. In 2005, Lonza purchased the DHA-business from Nutrinova. The district court found that Nutrinova and Lonza had infringed certain claims of Martek Biosciences’ patents.

Based on a mixed culture limitation and a food product limitation analysis, the CAFC ruled that the district court did not err when it denied Lonza’s JMOL motion because substantial evidence supported the jury’s finding that the ‘594 patent claims are entitled to the priority date of the 1988 application.

As to the ‘281 patent claim infringement, the CAFC ruled that because Martek presented substantial evidence supporting the jury’s infringement verdict, the district court did not err when it denied Lonza’s JMOL motion.  Lonza tried to argue prior invention, though it could not corroborate its claim. Lonza sought to introduce the testimony of an alleged prior inventor, Dr. Long, under §102(g) for the purpose of invalidating a patent, but Lonza was required to produce evidence corroborating Dr. Long’s testimony.  The CAFC agreed with the district court that an abandoned patent application without more was insufficient to corroborate Dr. Long’s testimony.

The CAFC also upheld the district court’s claim construction on the term “non-chloride sodium salt,” as used in the ‘281 patent, by allowing that term to encompass sodium hydroxide (NaOH).  Additionally, the CAFC found that the ‘567 provisions were valid

Finally, the CAFC decided the issue of whether a human is an “animal” within the purview of these patents. The CAFC found that Martek had explicitly defined the term “animal” in the ‘244 patent in a way that would include humans: “The term ‘animal’ means any organism belonging to the kingdom Animalia.” ‘244 Patent col.5 ll.11-12. On remand, the district court will need to consider whether the patent has been infringed under this broader definition.

Circuit Judge Lourie and Rader, dissenting, focused on statements in the patent that allegedly show that the term “animal” refers to an organism intended for human consumption, therefore flatly excluding humans. The dissent does not disagree with the patentee’s right to define terms, but argues that the other statements limit the term in such a way that it could not reasonably be construed to include humans.  The claim discusses raising animals for human consumption, and methods of increasing DHA concentrations in said animals.

The case is also unusual procedurally since the Federal Circuit heard the case as a five-judge panel. However, this fact does not seem to have much legal significance beyond whether such a panel is actually acceptable under 28 U.S.C. 46(b).  The court did not give any reasons for expanding the panel.

By Evan Kubota – Edited by Sarah Sorscher
Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 2007-1296, -1347 (Fed. Cir. Aug. 19, 2009)
Slip Opinion

On August 19, 2009, the Court of Appeals for the Federal Circuit, sitting en banc, held that 35 U.S.C. § 271(f), a statute providing for liability for exporting components of patented inventions, does not apply to method patents. The ruling overturned the Federal Circuit’s prior panel decision in Union Carbide Corp. v. Shell Oil Co., 425 F.3d 1366 (Fed. Cir. 2006). A Federal Circuit panel also reversed the District Court for the Southern District of Indiana’s grant of summary judgment on the issue of invalidity, restored the jury’s finding of infringement, and remanded the case for determination of damages.

Section 271(f) imposes infringement liability upon anyone who “supplies or causes to be supplied in or from the United States” components of a patented invention and induces their combination in a manner that would infringe the patent if it occurred within the United States.  It was intended to close the loophole created by a Supreme Court decision, Deepsouth Packing Co., v. Laitram Corp., 406 U.S. 518 (1972), that had rejected infringement liability where unassembled parts of a patented shrimp deveining machine were shipped abroad.  In 2007, the Supreme Court had expressly declined to answer the question of whether a method or process patent “qualifies as a patented invention” under section 271(f).  Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007).

Patently-O, Patent Prospector, and Conflict of Laws.net summarize the decision.  The AmLaw Litigation Daily provides an overview of the stakes for U.S. business interests, and a brief comment from a lawyer for one of the amici.

The dispute concerned implantable cardioverter defibrillators, small devices that detect and correct abnormal heart rhythms that can be fatal if left untreated. Cardiac brought an action against St. Jude for infringing on a Cardiac patent that covered a method of heart stimulation using electric shocks delivered by an implantable heart stimulator.

In its August 19th opinion, the Federal Circuit held that method patents are not subject to Section 271(f) because their components cannot be “supplied,” as the statute requires.  While method patents do have “components” -the steps of the process- such intangible steps cannot be “supplied” because the word “supply” implies “the transfer of a physical object.” The court also considered legislative history and applied a presumption against extraterritoriality-even though Section 271(f) “specifically extends the reach of U.S. patent law in a limited manner,” the court found lacking “any Congressional intent to protect patented methods under Section 271(f).”

Because Section 271(f) does not apply to method patents, the court held that defendant St. Jude’s shipments of the medical devices outside the United States did not infringe plaintiff Cardiac’s method patent.

Judge Newman dissented from the en banc ruling on Section 271(f)’s scope.  For her, “patented invention” in the statutory text embraces “all of the statutory classes of patentable invention,” including process inventions.  This reading, Judge Newman argued, is consistent with the scope of “patented invention” elsewhere in Title 35.  Judge Newman also provided more detail about Section 271(f)’s legislative history-earlier versions were limited to “a patented machine, manufacture, or composition of matter,” but the version that was eventually passed removed this limiting language.  Finally, Judge Newman pointed out that the majority’s extraterritoriality concerns are exaggerated for two reasons: first, because liability is based on actions taken in the United States by entities subject to American law, and second, because it would be an absurd result if process, but not machine, patents could be avoided simply by completing the steps offshore.

Callaway and Acushnet are golf equipment manufacturers. At issue were four of Callaway’s golf ball patents, U.S. Patent Nos. 6,210,293, 6,503,156, 6,506,130 and 6,595,873, known as the “Sullivan patents.” These specify a “dual-personality” ball — a golf ball that is capable of travelling great distances, yet does not exhibit diminished playability or durability — qualities not typically combined in one ball. Callaway sued Acushnet for patent infringement on February 9, 2006, in the United States District Court for the District of Delaware, claiming that three of Acushnet’s Titleist-brand golf balls infringed various claims of the Sullivan patents. Acushnet stipulated that its golf balls infringed, but contended that the asserted claims were invalid for anticipation and obviousness.

On the anticipation issue, Acushnet claimed that U.S. Patent No. 4,431,193 (“Nesbitt”), anticipates the Sullivan patents as a matter of law, when properly viewed as a single reference with U.S. Pat. No. 4,274,637 (“Molitor ’637”), which Acushnet contended Nesbitt incorporates. The district court granted Callaway’s cross motion for summary judgment on anticipation, concluding that Nesbitt does not incorporate Molitor ’637 by reference and that without Molitor, Nesbitt does not anticipate as a matter of law. On appeal, the Federal Circuit reversed.  Writing for a unanimous panel, Circuit Judge Dyk held that Nesbitt does incorporate Molitor ’637 by reference, concluding that Acushnet raised a genuine question of material fact concerning anticipation.

The question of obviousness was tried before a jury. Acushnet contended that the various separate elements of the Sullivan patents were all well known in the prior art — relying on Nesbitt, Molitor ’637, and three additional golf ball patents — and that one of skill in the art would have had reason to combine the prior art and would have had a reasonable expectation of success. The jury returned a verdict that dependent claim 5 of the ’293 patent was invalid for obviousness, but the remaining eight claims (including independent claim 4 of the ’293 patent) were not invalid. Although the district court agreed with Acushnet that these verdicts were irreconcilably inconsistent, it nevertheless denied Acushnet’s motion for a new trial, finding the inconsistency harmless since Acushnet stipulated that it infringed each of the patents, three of which were found valid. The district court subsequently issued a permanent injunction against Acushnet that prohibited it from selling Pro V1 products that used the patents in question.

The Federal Circuit vacated entry of the jury verdict on appeal. The court held that a broader independent claim cannot be non-obvious where a dependent claim stemming from that independent claim is invalid for obviousness; thus the verdicts with respect to claim 5 of the ’293 patent (invalid) and claim 4 of that patent (not invalid) were inconsistent. Rejecting the district court’s reasoning, the Federal Circuit determined that a new trial rather than entry of judgment was required as to claims 4 and 5 of the ’293 patent. The appeals court also lifted the injunction.  The Federal Circuit affirmed, however, the district court’s determination that Acushnet was not entitled to judgment as a matter of law on obviousness. The Federal Circuit also affirmed the district court’s claim construction as well as various evidentiary rulings.

Microsoft, Yahoo, Amazon Join Opposition to Google Settlement

The New York Times reports that Microsoft, Yahoo, and Amazon have joined library associations, nonprofits, and individuals in opposing the Google Books settlement in The Authors Guild v. Google. The settlement, which would allow Google to provide digital versions of millions of books, still requires court approval and remains the subject of a Department of Justice antitrust investigation. The opposition group, tentatively called the Open Book Alliance, will argue to the Department of Justice that the settlement agreement is anticompetitive.

Internet Law Group Brings Suit Against Unidentified Hackers

“John Doe” suits brought against unidentified Eastern European hackers may offer a glimpse of the hackers’ targets and techniques through subpoenas against defrauded banks. However, the banks may challenge the subpoenas in order to protect customer privacy. Unspam Technologies, a group that recently filed suit against bank hackers in the Eastern District of Virginia, hopes to improve bank security and potentially identify the hackers. The New York Times outlines the stakes and key players in the case, Project Honey Pot v. Does.

Mozilla Versus Microsoft in EU Browser Investigation

Ryan Paul at Ars Technica criticizes Mozilla’s complaints regarding Microsoft’s Internet Explorer bundling and default-setting practices. Paul not only argues that many of Mozilla’s complaints “lack substance,” but also claims that the European Union has no business intervening to encourage competition because Mozilla’s Firefox browser has a 22 percent market share “amidst an increasingly competitive browser market.” In contrast, Mitchell Baker of Mozilla argues that the Firefox browser is at a disadvantage because Internet Explorer has a “uniquely privileged position on Windows installations.”

By Dmitriy Tishyevich – Edited by Amanda Rice
Blackboard, Inc. v. Desire2Learn, Inc., No. 2008-1368, -1396 (Fed. Cir. July 27, 2009)
Slip Opinion

On July 27, 2009, the Court of Appeals for the Federal Circuit affirmed the United States District Court for the Eastern District of Texas’s partial summary judgment, holding that claims 1 through 35 of the patent were invalid for indefiniteness. However, the court reversed the jury’s finding that Desire2Learn had infringed claims 36 through 38, holding that, under proper construction, these claims were anticipated and rendered obvious by prior art.

Patent law blogs PatentlyO and The Patent Prospector summarize the opinion. Inside Higher Ed provides commentary about the decision. Sakai Blog speculates about Blackboard’s motives and the future of Blackboard’s numerous patent disputes.
Blackboard and Desire2Learn are the primary competitors in providing educational institutions with course management software that allows online interaction between students and teachers. After receiving a patent for its Internet-based educational support systems and related methods, Blackboard filed an infringement action against Desire2Learn’s competing software.

After holding a pre-trial claim construction hearing, the district court entered partial summary judgment for Desire2Learn, holding that claims 1 through 35 of the patent were invalid for indefiniteness. The court then conducted a jury trial on the alleged infringement of claims 36 through 38. At trial, Blackboard took the position that claims 36 through 38 required that the software user have the capacity to access multiple courses and multiple roles through a single login ¾ for example, a graduate student who was a student in one class and a teacher of another class could use a single login to obtain varying degrees of access to each course. Desire2Learn argued that the claims did not require this single login access, and that the claims were thus invalid in light of prior art. The jury found that claims 36 through 38 were neither anticipated nor obvious, and that Desire2Learn had infringed those claims. The district court denied Desire2Learn’s subsequent motion for judgment as a matter of law, agreeing with Blackboard that claims 36 through 38 required single login access.

On appeal, the Federal Circuit held that claims 36 through 38 do not contain a single login limitation. It rejected Blackboard’s claim that the definition of the word “user” requires that access to multiple roles in multiple courses be achievable through a single login, noting that the claim specification repeatedly employed the term “user” in its ordinary sense to refer to an individual who uses the system, rather than an electronic representation of that person. The court also noted that the limitation argued for by Blackboard is not inherently contained in the language of the claim specification, as other subsequent claims explicitly outline the requirements that the user enter a login sequence to obtain access to course files and that, after a single login, the user be provided with access to all of the courses with which that user is associated. A contrary interpretation, the court reasoned, would render the subsequent dependent claims superfluous. The court also interpreted the permissive language of the specification ¾ such that a user “may” be required to enter a login sequence to be provided with access to all courses he is associated with ¾ to further show that the “single login” was only an optional feature of the software. It dismissed Blackboard’s argument that the prosecution history of the patent indicated that the claims contained a single login limitation, concluding that the patent examiner’s statements referred to enabling users to have multiple roles rather than a single one, that they did not refer to the ability to access these multiple roles after a single login, and that the remarks did not even address the single login issue.

At trial, Blackboard’s trial expert had identified the “single login” as the only difference between the system and methods of the Blackboard patent and the prior art systems. Having determined that claims 36 through 38 did not contain a single login limitation, the Court of Appeals went on to hold that without it, the claims were invalid for anticipation as a matter of law by prior art such as CourseInfo 1.5 and Serf, earlier online educational support systems.

The court affirmed the district court’s ruling that claims 1 through 35 were invalid for indefiniteness. The district court held that claim 1, which included a broad means-plus-function clause for assigning a level of access and control through an Access Control Manager, had insufficient structure to support the limitation. Because claims 2 through 35 were dependent on claim, 1, the district court concluded that those clams were likewise invalid. The Court of Appeals noted that the specification did not provide a description of the structure, but rather contained only an abstraction that described the function of controlling access to course materials, which itself was performed by some undefined and undisclosed component of the system. The court said that such a general reference is insufficient, and that a means-plus-function claim must be supported by specific disclosures and an explanation of how the claimed function is performed. The court rejected Blackboard’s argument that a specific description of how the function is performed is unnecessary because a person skilled in the art could readily fashion a computer-based means for performing the function, noting that the argument confused the definiteness requirement with the enablement requirement.

]]> http://jolt.law.harvard.edu/digest/patent/blackboard-inc-v-desire2learn-inc/feed 0 http://jolt.law.harvard.edu/digest/patent/bayer-schering-pharma-v-barr-labs http://jolt.law.harvard.edu/digest/patent/bayer-schering-pharma-v-barr-labs#comments Fri, 14 Aug 2009 02:01:48 +0000 lwelling http://jolt.law.harvard.edu/digest/?p=172

Bayer Schering Pharma v. Barr Labs

By Aaron Dulles – Edited by Evelyn Breithaupt
Bayer Schering Pharma AG and Bayer Healthcare Pharm., Inc. v. Barr Labs., Inc., No. 2008-1282 (Fed. Cir. Aug. 5, 2009)
Slip Opinion

On August 5, 2009, a Federal Circuit panel affirmed the decision of the District of New Jersey, which had found Bayer’s U.S. Patent No. 6,787,531 (”‘531 Patent”) invalid because of obviousness. The ‘531 Patent concerns a formulation of the well-known contraceptive drug drospirenone. The patent previously protected Bayer’s formulation of a daily oral contraceptive product, marketed as the drug Yasmin. When Barr Labs sought approval from the FDA to market a generic version of Yasmin, Bayer filed a patent infringement suit. The district court found that under KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the formulation of drospirenone in the Yasmin product was obvious. The sole issue of appeal was obviousness, and by a 2-1 vote the Federal Circuit affirmed the district court’s decision.

Passino PLLC suggests that the majority’s application of the In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) standards was too rigid, and thus appeared to go against warnings in KSR concerning rigid application of tests. Patent Docs agreed, asserting that the judges both at the trial and appellate levels disregarded important evidence and emphasizing that the “common sense” of obviousness is that of the practitioner, not the judge. AboutLawSuits.com noted the ruling, but focused on known potential negative side effects of the drospirenone-based contraceptives such as Yasmin.

Drospirenone had been a well-known contraceptive. In formulating the drug as a daily oral pill, however, Bayer ran into two problems: it is hydrophobic, resisting dissolution in water; and it is acid-sensitive, isomerizing (changing shape but not composition) in acids such as those found in the stomach, thereby losing certain important qualities. While the usual solution of “micronization” for hydrophobic chemicals ordinarily may have seemed to be a clear solution, that process was known to worsen acid sensitivities. Bayer scientists considered certain protective coatings for a time, but during experimentation they found that drospirenone’s bioavailability – its crucial ability to be absorbed into the bloodstream to work – could be assured by micronization and without any protective coatings. Yasmin was formulated as such, and in prosecuting the ‘531 Patent, Bayer relied on the fact that prior art had pointed against micronization due to the isomerization problem.

Writing for the majority, Mayer, J., applied the KSR standard to the micronization, first examining whether a person of ordinary skill would have attempted the formulation. Citing In re O’Farrell, the Court considered two identifiers of non-obviousness: first, a solution may be non-obvious where there is not a limited and relatively small set of solutions that may be investigated; and second, a solution may be non-obvious where prior art is vague and does not give clues about future courses of study.

In considering the obviousness of micronization, the Court relied in large part on the text of a pharmacology textbook that gave clues as to why a formulator would nevertheless consider micronization. The Court further cited prior art that pointed towards micronization, as well as the testimony of a Bayer expert who stated that micronization would generally be a first-choice solution.

Bayer argued foregoing the coating was non-obvious because certain prior art points towards using the coating, while Barr argued that other prior art points against using the coating. The Court noted that the parties’ disagreement neatly proved that a drug formulator would have been presented with options to investigate, thus avoiding the first indicator of non-obviousness in O’Farrell. Moreover, the inconclusive prior art on coating of drospirenone would clearly have indicated a topic for exploration.

Dissenting, Newman, J., emphasized that ex post bias may have caused the Bayer formulation to appear obvious to the majority. Citing the same textbook, the dissent showed that it also advised against micronization of acid-sensitive drugs. Moreover, the prevailing knowledge available showed that drospirenone was sensitive to acids, and so a formulator would not ordinarily contemplate direct exposure to stomach acids without a protective coating. Interestingly, the dissent characterized the district court’s finding on micronization – that it was viable but uncertain – as insufficient to find obviousness, stating that predictability was a more important factor than such fortuitous experimentation.