The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.
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The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by the different conclusions in Classen Immunotherapies, Inc. v. Biogen IDEC and Momenta Pharmaceuticals, Inc. v. Amphastar Inc. The issue once again came before the Court in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., in a decision handed down earlier this month; the decision provides another example of the Court setting forth the contours of the scope of the safe harbor.
The case involved a district court's determination that U.S. Patent No. 7,575,886 was not infringed by Teva nor by Amphastar and additional defendants in companion cases decided together. The claims at issue were directed to enoxaparin, an anticoagulant drug marketed since 1993 under the brand name Lovenox. Momenta marketed the first generic version of the drug and sought to block additional generic entrants by asserting the '866 patent, which claimed methods for ensuring that each batch of the drug met quality standards. Teva imported batches of the drug made abroad and Momenta alleged infringement based on the provisions of 35 U.S.C § 271(g):
Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after— (1) it is materially changed by subsequent processes; or (2) it becomes a trivial and nonessential component of another product.
The District Court rejected this contention, because the asserted claims were directed to methods for analyzing the product for quality control purposes and not methods of making the drug. In addition, the District Court found that Teva's use of the analytical methods claimed in the '866 patent fell within the safe harbor provisions of 35 U.S.C § 271(e)(1).
The situation was different with regard to Momenta's infringement allegations against Amphastar, inter alia, because Amphastar manufactured enoxaparin in the U.S. In this case, the District Court held that Amphastar's activities fell within the safe harbor provisions of the Hatch-Waxman Act.
The Federal Circuit affirmed the District Court's decision as to Teva (relating to infringement under § 271(g) but vacated the lower court's grant of summary judgment in Amphastar's favor, in an opinion by Judge Wallach joined by Judge Moore and in part by Judge Dyk, who also dissented in part. The portion of the decision related to (non)infringement under § 271(g) was straightforward: the '866 patent claims did not encompass methods of "making" the enoxaparin. Momenta argued that the quality control methods in the '886 patent claims were "a crucial interim step" in making the drug, because batches were chosen for "further process[ing]" into the finished drug product based on the results of these testing methods. Saying that these arguments were "not without merit," the Federal Circuit nevertheless held that the District Court's decision of non-infringement was "more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual 'ma[king]' of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made," based on an "ordinary meaning" interpretation of the statutory language. The Court cited Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367, 1373 (Fed. Cir. 2003), and American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931), in support of their interpretation of the word "make."
Turning to Amphastar's § 271(e)(1) defense, the Federal Circuit turned to the purpose of the statute according to the legislative history:
[Section 271(e)(1)] provides that it is not an act of patent infringement for a generic drug maker to import or to test a patented drug in preparation for seeking FDA approval if marketing of the drug would occur after expiration of the patent . . . . This section does not permit the commercial sale of a patented drug by the party using the drug to develop such information . . . . The information which can be developed under this provision is the type which is required to obtain approval of the drug. . . . The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement [emphasis in opinion].
The opinion notes that while the contours of the safe harbor have been deemed broad (citing, inter alia, Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005), Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir. 2011), and AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027 (Fed. Cir. 1997)), the safe harbor is not without boundaries. These exceptions include research tools not subject to FDA approval (Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265–66 (Fed. Cir. 2008)) and information "routinely reported" to the FDA post-approval (citing Classen). Even though the Federal Circuit had earlier affirmed denial of Momenta's motion for preliminary injunction on the grounds that the movant was unlikely to prevail, this decision was not the "law of the case" nor was this panel bound by the earlier panel's decision, and that, in any event, courts had the ability to reconsider and come to a different conclusion. Here, the majority held that they were considering a fuller record than had been available at the preliminary injunction stage. That record was enough to convince the Court that the FDA submissions relied upon by Amphastar were sufficiently "routine" that they fell outside the scope of the § 271(e)(1) safe harbor.
The opinion contrasts the routine nature of the submissions made based on the use of Momenta's method with "non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications ('INDs'), new drug applications ('NDAs'), supplemental NDAs, or other post-approval research results." Because Amphastar's submissions using Momenta's patented technology were routine they were not "reasonably related to the development and submission of information" as required by the statute to qualify for the safe harbor, and the District Court's decision to the contrary was clearly erroneous in the majority opinion. This decision is based in part on the panel's apprehension that deciding in Amphastar's favor would "result in manifest injustice" because it would be the first case to have § 271(e)(1) encompass "activities related to ongoing commercial manufacture and sale."
In a footnote the opinion sets out the views of the government as amicus, wherein "the government argued that the routine use of a patented testing process in the commercial manufacture of a drug is not 'reasonably related to the development and submission of information to [the] FDA' and thus not shielded from liability by § 271(e)(1).'" While the decision is consistent with these sentiments, there is nothing in the opinion indicating that the government's views formed any basis for the opinion.
Judge Dyk dissented in part, over the question of whether Teva infringed under § 271(g). The grounds of his dissent are based in part on his disagreement with the majority's interpretation of Bayer v. Housey, which he believes is too limited and does not apply in this case. Specifically, the dissent contends that the patented method is used in the manufacturing process itself and becomes a part thereof, and thus should be encompassed in the "making" requirement contained in the statutory language. The dissent does not attempt to set forth any definitive rubrics on the question, which Judge Dyk recognizes must be considered on a "case-by-case" basis. Rather his dissent is based on his opinion that the majority misapplied the law in this instance, based at least in part on his understanding of the manufacturing process, complexity of the enoxaparin drug product and the need to rely on the patented testing methods to produce batches of the drug that conform with the standards set out by the FDA for the approved drug (which Judge Dyk characterizes as being "an integral part of the manufacturing of the enoxaparin drug product"). He finds legal support for his opinion in Bio-Tech. Gen. Corp. v. Genentech, Inc., 80 F.3d 1553, 1561 (Fed. Cir. 1996), and logical force in his perception that the majority's interpretation would lead to the "anomalous result" that "[p]atents on purification methods or the quality control method at issue here, which may be integral to the regulatory or commercial viability of a product, but which do not create or transform a product, combine components, or confer new properties, could be freely infringed simply by outsourcing those processes abroad." Congress could not have intended this result according to Judge Dyk and thus he dissents.
The U.S. Patent and Trademark Office (USPTO) announced today that it had launched Dossier Access, the first of a set of business services to be developed as part of the Global Dossier Initiative. The Global Dossier Initiative is a collaborative project of the IP5 Offices -- the European Patent Office (EPO), Japan Patent Office (JPO), Korean Intellectual Property Office (KIPO), State Intellectual Property Office of the People's Republic of China (SIPO), and USPTO – which aims to modernize the global patent system by providing a single portal/user interface for stakeholders. Dossier Access allows patent applicants to quickly and easily view, monitor, and manage patent protection around the world by providing access to the dossiers of related applications filed at participating offices.
According to the USPTO, the Global Dossier provides the following advantages:
• A single, secure point of access for the management of dossier and examination information • Increases efficiency and predictability of global patent family prosecution • Time and cost savings for patent applicants by reducing applicant burden • Enables and encourages streamlining of Office procedures among different IP Offices • Improves worldwide patent quality, resulting in higher value patents
Those wishing to provide input, feedback, and suggestions regarding the Global Dossier can do so through the Global Dossier Ideascale. Additional information regarding the Global Dossier can be obtained by contacting the USPTO at GlobalDossier@USPTO.gov.
In announcing the launch of Dossier Access, the USPTO noted that the IP5 was also evaluating other services, including a mechanism for sharing documents between offices.
Two recent District Court decisions show examples of "weak" claims, which in the past would likely be found invalid as lacking novelty or being obvious, but today are struck down as being unpatentable under § 101. The cases illustrate the need for software or computer-implemented claims to explicitly recite novel structural components or specific details for how functions are performed.
Listingbook, LLC v. Market Leader, Inc.
On November 13, 2015, the U.S. District Court for the Middle District of North Carolina issued an opinion in the case Listingbook, LLC v. Market Leader, Inc. that held claims ineligible for patent protection under § 101. Listingbook's U.S. Patent No. 7,454,355 describes a method and system where real estate agents use computers to log onto a website and create individual client accounts containing information about each client. After logging into their accounts, clients can view properties found by the agent, tag properties for future reference, and if authorized, conduct their own searches of the real estate information database. The clients' online activity is monitored and recorded in the system.
Claim 1 reads as follows:
A computer-implemented method of providing client-accessed real estate information to a real estate professional associated with a first client and a second client, and for providing professional-accessed real estate information to the first client and the second client, the method comprising: connecting to a database of real estate information; providing the professional with access to the real estate information; storing a first account for the first client and a second account for the second client, the first account and the second account being authorized by the professional; providing the first client with access to the first account and providing the second client with access to the second account; providing the first client, when accessing the first account, with access to the real estate information; providing the second client, when accessing the second account, with access to the real estate information; monitoring actions of the professional while the professional is accessing the real estate information; monitoring actions of the first client while the first client is accessing the first account; monitoring actions of the second client while the second client is accessing the second account; generating and storing professional-accessed real estate information for the first client and the second client in response to the actions of the professional as the professional reviews the real estate information; generating and storing first client-accessed real estate information in response to the actions of the first client; generating and storing second client-accessed real estate information in response to the actions of the second client; providing at least some of the first client-accessed real estate information and at least some of the second client-accessed real estate information to the professional, thereby providing the professional with knowledge of the actions of the first client and the actions of the second client; and providing at least some of the professional-accessed real estate information for the first client to the first client and at least some of the professional-accessed real estate information for the second client to the second client, thereby providing the first client and the second client with knowledge of the actions of the real estate professional.
The patent also includes a CRM independent claim and a system independent claim with a server and communications circuit, and each of these independent claims recite the steps of method claim 1.
The District Court first discussed recent uncertainty about whether a presumption of validity and standard of proof apply in cases challenging patent-eligibility under § 101. If so, Market Leader must show, by clear and convincing evidence, that none of the asserted claims meet the statutory requirements of 35 U.S.C. § 101. If not, Market Leader has a lower standard. The uncertainty arises because there is a question whether burdens of proof apply only to questions of fact, and whether a claim is directed to patentable subject matter is a question of law. There does not seem to be a controlling Supreme Court or Federal Circuit decision on this matter, and the District Court here applied both the presumption and the standard of proof in this case. As seen, however, even using the higher standard did not help the patent claims.
Using the two-step framework set forth by the U.S. Supreme Court's decision in Alice v. CLS Bank, the District Court first found the claims to be directed to an abstract idea. The District Court found that Claim 1 describes a computerized version of a "conventional interaction".
The District Court noted that Listingbook's patent specification confirms that real estate agents "conventionally" connect to a database of real estate information "to locate properties of interest for their clients," and contact each client to determine whether the client is interested in any of the resulting properties and whether the client has found any properties of interest from other sources, such as print advertisements or the Internet. Through this interaction, the agent and clients have exchanged information and collaborated in the real estate search process. The District Court found that Listingbook's invention simply places the interaction online, and the fact that Listingbook's method is performed online -- rather than in an office, over the phone, or through email -- does not change the Court's conclusion that Claim 1 is directed to an abstract idea.
Turning to the second step of the Alice framework, the question becomes whether the claims at issue contain an "inventive concept" that transforms the abstract idea into a patent-eligible application of that idea. Here, a generic computer is the only machine needed to perform the method of Claim 1, and "adding a computer to otherwise conventional steps does not make an invention patent-eligible."
The District Court thus found that the claims at issue in Listingbook's patent are directed to an abstract idea and lack an inventive concept to render the claims patent-eligible under § 101 of the Patent Act.
The claims here recite no novel features and really do just implement basic Real Estate agent functions over the internet. The patent has a priority date of April 27, 2000, but that is still not quite early enough to pre-date the computerized multiple listing services (MLS) of the 1970's. The claims here simply recite features that are too vague and lack details to provide an inventive concept, which now-a-days leads to being found invalid under § 101. When the claims are too vague, they are more easily considered to be directed to an abstract idea.
Stanacard v. Rubard
On November 18, 2015, the U.S. District Court for the Southern District of New York issued an opinion in the case Stanacard v. Rubard, LLC that also held claims ineligible for patent protection under § 101.
Stanacard's patent in this case (U.S. Patent No. 7,346,156) is for an invention on a method for routing a long distance call. Claim 1 of the Patent is a method claim, requiring as follows:
A method comprising: detecting an identity of a caller; receiving an assigned incoming telephone number; identifying a recipient associated with the assigned incoming telephone number and the identity; connecting the caller and the recipient; wherein said caller has a plurality of assigned incoming telephone numbers to choose from, at least one of said plurality of assigned incoming telephone numbers being associated with said recipient, wherein each assigned incoming telephone number is associated with multiple recipient telephone numbers, a particular telephone number of a recipient being determined solely by a particular assigned incoming telephone number used by a particular identified caller and without input of further data by said caller, whereby said caller is not required to be within a particular network for making calls.
The District Court characterized the system as follows: a telephone service provider or prepaid calling service assigns to its customer (the "end user") a unique ten digit telephone number, which the caller can dial from his personal telephone (whether a land line or a cellular device) in order to reach a designated recipient. The caller associates that number ("the assigned incoming telephone number") with a particular, specified recipient (the "recipient telephone number"). When the customer dials those ten digits - no more - from his personal telephone, he is connected to the person whose number he has previously designated as the "recipient telephone number," without the need to enter a PIN or any additional information, including a country or city code.
The District Court also provided an illustrative example: suppose I am the end user. My service provider assigns me the number 555-222-1234; I tell the service provider that, when I dial those digits, I want to be connected to my best friend (the recipient), who lives in Ohio, and whose telephone number is 614-555-1213. When I dial the assigned incoming telephone number (555-222-1234) from my personal telephone number (987-654-3210) -- which number is recognized via some unclaimed but well known device like Caller ID -- the call is forwarded directly to my best friend's home telephone number (614-555-1213). I need not input any additional information in order to get the call routed to its intended recipient. The invention only works when the end user dials the assigned incoming telephone number from his own telephone.
But because a particular incoming number must correlate with a particular recipient, a service provider can assign the same incoming telephone number (555-222-1234) to thousands of different customers -- each of whom can specify a different person who should receive a call if he dials those ten digits from his phone.
The District Court commented that the claim is directed to a well-known activity that is almost as old as telephony itself -- making a long distance telephone call. The District Court noted that what plaintiff did was figure out a way to make such a call more cheaply, by dialing a ten digit local number and nothing more. He combined two activities that have long been performed, by humans and by machines -- caller ID and call forwarding -- such that the recipient of a local call (area code plus seven digit number) uses some type of caller ID to recognize who the incoming caller is, and then forwards the incoming call to its intended recipient by associating the assigned incoming telephone number with a particular recipient's telephone number. Importantly, the District Court commented that "Neither caller ID nor the method by which the call actually gets forwarded to its intended recipient (over what telephone network, using what switching facilities) is claimed." No physical aspect of this process is claimed. What is claimed is the idea of dialing only ten digits, at which point some unspecified intermediary will identify both the caller and the intended recipient of the call and connect them.
The District Court reiterated a number of times that the claims do not recite any sort of physical structure and lack details for how the functions are performed. Using the two-part test, the District Court first found that the claims are directed to an abstract idea of connecting two people via long distance telephony through the medium of using caller ID and call forwarding when a local number is dialed, rather than to a "process," "machine," "manufacture", or "composition of matter." Applying the second part of the test, the District Court found that the patent does not "specify" how "claim elements" interact to achieve a "desired result which overrides conventional practice," and thus, include no inventive concept that would save the claim.
Interestingly, here, the District Court hinted several times that had the claims recited some physical components and details for how the components function in a way different from conventional practice, then the claims would likely satisfy § 101. The concept described in the patent appears to be novel, but the claims were drafted in a way that left them too vague and lacking detail.
Also, an interesting side-note to consider for § 101 analysis is whether courts should consider some type or form of "secondary considerations" during the second step of the two-prong test (i.e., when determining whether the patent claims recite any inventive concept). In this case, the plaintiffs' expert testified that the system disclosed by the patent completely changed the calling paradigm of prepaid telecommunications by, among other things, eliminating the PIN entry as a prerequisite to placing an international telephone call and thereby solving - creatively - the major handicap of every calling card. Further, observing that persons (including plaintiff's expert) had been trying to design a less expensive and more convenient method of placing international telephone calls for "many years," the expert further testified that, "[t]he idea behind the '156 patent -- combining the customer's telephone number and the dialed local access number into a unique 20-digit combination is elegant, simple, beautiful but by no means obvious; none of us working in this field came up with the method set forth in the '156 patent, and not for the lack of trying." Lastly, the expert also testified that, "[t]he method disclosed by the '156 patent made an immediate and loud splash in the market place of prepaid telecommunications and garnered a market share away from others." The District Court noted that such evidence of secondary considerations creates a genuine issue of fact about whether the patent is or is not "obvious" within the meaning of the patent laws, 35 U.S.C. § 103. But, as to § 101, the District Court gave such evidence no weight.
It is curious from a patentee's perspective that claims are found to be unpatentable under § 101 if they are directed to abstract ideas AND ALSO lack inventive concept, but evidence to support inventive concept including secondary considerations has no weight for the § 101 analysis. Because the § 101 analysis is so intertwined with novelty and obviousness components, it would seem that the secondary considerations should come into play as well.
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. 5:15-cv-00415; filed August 21, 2015 in the Eastern District of North Carolina
Infringement of U.S. Patent No. 5,952,323 ("Carbapenem Antibiotic," issued September 14, 1999) following a Paragraph IV certification as part of Savior's filing of an ANDA to manufacture a generic version of Merck's Invanz® (ertapenem, used for the treatment of complicated intra-abdominal infections, complicated skin and skin structure infections, community acquired pneumonia, complicated urinary tract infections, and acute pelvic infections, and for the prophylaxis ofvsurgical site infection following elective colorectal surgery). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Standard Chem. & Pharm. Co., Ltd et al. 1:15-cv-06353; filed August 21, 2015 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.
Par Pharmaceutical, Inc. et al. v. TWi Pharmaceuticals, Inc. et al. 1:15-cv-00710; filed August 18, 2015 in the District Court of Delaware
• Plaintiffs: Par Pharmaceutical, Inc.; Alkermes Pharma Ireland Ltd. • Defendants: TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.
Infringement of U.S. Patent No. 9,107,827 ("Nonoparticulate Megestrol Formulations," issued August 18, 2015) in conjunction with Twi's filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients). View the complaint here.
Dr. Reddy's Laboratories, Inc. et al. v. Fresenius Kabi USA, LLC 1:15-cv-00714; filed August 18, 2015 in the District Court of Delaware
• Plaintiffs: Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd. • Defendant: Fresenius Kabi USA, LLC
Declaratory judgment of non-infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) in conjunction with Dr. Reddy's filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations). View the complaint here.
Strafford will be offering a webinar/teleconference entitled "Duty of Candor, Fixing Mistakes, Ex Parte Communications, Sanctions & Professionalism Before the PTAB in Contested Proceedings" on December 3, 2015 from 1:00 to 2:30 pm (EST). Thomas L. Giannetti, Lead Judge, U.S. Patent and Trademark Office, and Mercedes K. Meyer of Drinker Biddle & Reath will provide guidance to patent counsel involved in patent prosecution and contested proceedings before the USPTO on the duties of candor and disclosure; examine related issues of privilege, ex parte communications and conflicts of interest; and offer best practices for meeting duties of candor, disclosure, and privilege before the USPTO. The webinar will review the following questions:
• How does the duty of candor apply in IPRs, PRGs and CBMs? • What enhanced duty of candor do patent counsel have under MPEP 2001.06(c)? • What potential repercussions do patent owners and challengers face if they fail to meet their obligations of duty of candor and disclosure?
The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the webinar, can do so here.