Patent Baristas

In a nonprecedential decision, the U.S. Court of Appeals for the Federal Circuit held that it won’t force the United States Patent and Trademark Office (USPTO) to issue a decision absent the authority to act. Somerset Pharmaceuticals v. Dudas (07-1447).

Somerset tried appealing from district court, which turned down its request to get the Director to issue a patent term extension. The district court said the issue was moot and the Federal Circuit agreed.

Somerset has a patent — Reissue Patent No. RE 34,579 – that is set to expire on August 18, 2007. The patent covers a method of treating depression using its drug product EMSAM®, a transdermal pharmaceutical patch that includes selegiline as the active ingredient.

Somerset filed a Patent Term Extension Application with the PTO on April 27, 2006, seeking to extend the term of the ’579 patent under 35 U.S.C. § 156(d)(1). Then, Somerset filed a request for an interim extension under § 156(e)(2).

I guess because it was in a hurry, Somerset filed suit in district court for the seeking to compel John Dudas — the Director of the PTO — to act on its request for interim extension.

Somerset was originally seeking an order compelling the Director to issue a decision on its request for interim extension under § 156(e)(1). Because the Director issued his decision on July 12, 2007, Somerset withdrew its request for interim relief.

Somerset still tried to press its appeal regarding the denial of injunctive relief compelling the Director to grant its request for an interim extension.

Note, though, to establish entitlement to a preliminary injunction you have to have a reasonable likelihood of success on the merits. The Court said Somerset can’t do it in this case.

Section 156(e)(2) provides

If the term of a patent for which an application has been submitted under subsection (d)(1) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Director shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension. (emphasis added)

This section only gives the Director the authority to extend a patent’s term beyond that provided for by section 154 when the patent for which a term extension is sought “would expire before a certificate of extension is . . . denied.”

In this case, the Director denied Somerset’s application for extension. Therefore, the Director has no statutory authority to issue the interim extension. Thus, Somerset can’t show a reasonable likelihood of success on the merits.

Basically, the Federal Circuit said that Somerset is SOL and affirmed.

On Remand from the Supreme Court, the U.S. Court of Appeals for the Federal Circuit applied the broad scope of the research exemption to the Integra case and reversed the district court’s judgment of infringement. Integra Lifesciences v. Merck KGaA (02-1052-1065).

Integra Life Sciences has five patents relating to peptides that contain the RGD sequence of amino acids — the contiguous sequence of arginine (R), glycine (G), and aspartic acid (D) within a peptide chain. The inventions are described as demonstrating various cell interactions with the extracellular peptide matrix, including ways of promoting cell attachment, blocking cell attachment, and disrupting cell attachment.

Merck KGaA and Scripps Research Institute were collaborating in research on the inhibition of angiogenesis since the development and growth of undesired blood vessels is a factor in several diseases, including solid tumor cancers, diabetic retinopathy, and rheumatoid arthritis. Integra then sued for infringement.

In the district court, two defenses were presented: first, that the early scientific studies at Scripps on RGD peptides are not subject to patent infringement, based on the common law research exemption; and second, that the ensuing studies were conducted in furtherance of drug development and the projected clinical trials, and are exempt from infringement under the FDA Exemption (or “safe harbor”) established by 35 U.S.C. ‘271(e)(1):

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products (emphasis added).

Integra argued that the FDA Exemption must be narrowly construed, explaining that the purpose of ‘271(e)(1) is to shield generic drug producers from patent infringement while they are preparing to enter the market on expiration of the patents on established products — a purpose quite removed from the activities for which Merck and Scripps were now seeking to invoke the Exemption

Merck and Scripps argued that ‘271(e)(1) is not limited to studies of safety for human subjects, and that information about efficacy, pharmacology, pharmacokinetics, and mechanism of action is properly included in the IND application and thus subject to the FDA Exemption.

The jury found infringement and the district court, sustaining the verdict, described the challenged experiments as “insufficiently direct to qualify” for the FDA Exemption.

A split panel of the Federal Circuit affirmed, holding that “the Scripps work sponsored by Merck was not clinical testing to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds.” Integra, 331 F.3d at 866.

In the Supreme Court, the question was as follows:

Whether uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U.S.C. ‘271(e)(1).

The Supreme Court explained that ‘271(e)(1) “exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing information for submission” to the FDA and that “reasonably related” includes uses in research that are conducted after the biological mechanism and physiological effect of a candidate drug have been recognized, such that if the research is successful it would appropriately be included in a submission to the FDA.

On remand, Integra repeated that ‘271(e)(1) was never intended as a broad authorization to investigators to infringe the patents of others, and that the statute should be strictly construed.

But, the Supreme Court rejected, as a matter of statutory interpretation, Integra’s position that the Scripps experiments that were not included in the IND application are excluded from the FDA Exemption:

There is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.

In applying the Supreme Courts directions, the Fed Circuit said:

All of the experiments charged with infringement were conducted for the purposes of determining the optimum candidate angiogenesis inhibitor and proceeding with commercial development of the selected candidate in compliance with regulatory procedures, initially using three structurally related RGD peptides.

Integra also argued that much of this work is properly viewed as “discovery-based research” and is not the “routine FDA-related work” that Integra states is the proper limit of ‘271(e)(1) even on the Court’s view of the statute.

Integra alternatively proposes that each of the Scripps experiments should be classified as either “discovery” or “routine,” and that only those experiments devoid of discovery, and entirely routine, can be subject to the FDA Exemption. But, the Fed Circuit noted that the safe harbor does not depend on a distinction between “discovery” and “routine,” but on whether the threshold biological property and physiological effect had already been recognized as to the candidate drug:

That the experiments contributed to scientific knowledge does not deprive them of the safe-harbor benefit of ‘271(e)(1) when the requirements therefore are met.

Unfortunately, the Federal Circuit did not discuss how a case should be decided based on research tool patents and instead relied on a post-hearing letter in which the parties stated that research tools were not at issue.

Judge Rader, dissenting-in-part and concurring-in-part.

This decision casts a large shadow over patent protection by its overly expansive interpretation of the 35 U.S.C. § 271(e)(1) exemption. In particular, this court today expands the exemption beyond the Supreme Court’s limits on the provision to eliminate protection for research tool inventions. The Supreme Court stated “that § 271(e)(1)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the [Federal Food, Drug and Cosmetic Act (FDCA)].” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005). Thus, the exemption covers activities that develop information that will ultimately be submitted to the FDA, not patented processes and tools beyond the scope of the “patented compounds” that the Supreme Court placed within the statutory exemption. In this case, two of the patents are research tools that deserve protection. This court should remand with instructions that the district court examine and protect these research tool patents.

A careful examination of the patents shows that two of them have no application at all outside of a laboratory. If the patents in this case are not research tools, then of course this court could quickly construe the claims and show that they claim drugs or other products likely to undergo FDA clearance, not simply laboratory methods. Unfortunately even a cursory analysis of the patents (undertaken in this dissent) shows that two of them have no application outside the laboratory.

In another challenge to patents it just doesn’t like, the nonprofit organization Public Patent Foundation (PUBPAT) got the U.S. Patent and Trademark Office (USPTO) to grant a request for reexamination of four crop science-related patents held by Monsanto. PUBPAT seems to be on a roll after successfully getting reexams of patents on Pfizer’s Lipitor, WARF’s stem cells., and Gilead Sciences.

Basically, Monsanto sells genetically modifies seeds, e.g., canola, soybeans, corn, cotton, that are herbicide-resistant. The seeds are only good for one generation, so the company sells new seeds, plus the herbicide, to farmers every year and producing increased crop yields.

PUBPAT requested ex parte reexamination under 35 U.S.C. §§ 302-307 and 37 C.F.R. § 1.510 claiming they are all invalid under 35 U.S.C. §§102 and 103 and their existence is causing significant public harm and impeding scientific progress. In its Office Actions rejecting each of the patents, the USPTO held that evidence submitted by PUBPAT, in addition to other prior art located by the Patent Office’s Examiners, showed that Monsanto was not entitled to any of the patents.

Monsanto will not get a lot of sympathy from farmers who know Mansanto to be heavy-handed in filing dozens of patent infringement lawsuits asserting the four challenged patents, often for saving seed from one year’s crop to replant the following year, which is not allowed under patent law. PUBPAT argues that Monsanto is using them to harass, intimidate, sue – and in some cases literally bankrupt – American farmers.

The lawsuits filed by Monsanto against American farmers include Monsanto Company v. Mitchell Scruggs, et al, 459 F.3d 1328 (Fed. Cir. 2006), Monsanto Company v. Kem Ralph individually, et al, 382 F.3d 1374 (Fed. Cir. 2004) and Monsanto Company v. Homan McFarling, 363 F.3d 1336 (Fed. Cir. 2004).

The patents involved here are U.S. Patents 5352605, 5164316, 5196525, and 5322938, all of which assert claims to the CaMV 35S promoter, double 35S enhancer, and/or constructs containing them:

5,164,316 describes a plant cell comprising a DNA construct having as components, (a) a duplicated CaMV 35s enhancer sequence comprising an AluI-EcoRV fragment of a CaMV 35S upstream region; and (ii) a promoter comprising an RNA polymerase binding site and an mRNA initiation site; (b) a nucleotide sequence of interest for transcription to mRNA; and (c) a termination region;

5,196,525 provides for a DNA construct having as components, (a) a transcription initiation region including (i) a tandemly duplicated CaMV 35S enhancer sequence comprising an AluI-EcoRV fragment of a CaMV 35S upstream region; (ii) a promoter comprising an RNA polymerase binding site and an mRNA initiation site; (b) a nucleotide sequence of interest for transcription to mRNA; and (c) a termination region ;

5,322,938 provides for transcription initiation regions that provide for enhanced transcription or a DNA sequence, particularly a plant sequence; and

5,352,605 relates to the use of viral promoters in the expression of chimeric genes in plant cells. It also relates to chimeric genes which are capable of being expressed in plant cells, which utilize promoter regions derived from viruses which are capable of infecting plant cells. One such virus comprises the cauliflower mosaic virus (CaMV). Two different promoter regions have been derived from the CaMV genome and ligated to heterologous coding sequences to form chimeric genes. These chimeric genes have been shown to be expressed in plant cells.

Monsanto, of course, will now have an opportunity to respond so it ain’t over till it’s over. The patent office grants over 90 percent of the requests for reexamination and many of those patents are issued with substantially the same claims as before reexamination. This issue could take years to resolve. In the end, the USPTO could allow the claims, reject only certain claims, or allow the claims in an amended form.

See the requests for reexamination and the office actions at PUBPAT here.

PatentLens provides an excellent breakdown of the claims relating to the 35S promoter and duplicated CaMV 35S enhancer sequences. 

The Cincinnati USA Regional Chamber and CincyTechUSA announced their list of the Top 10 Best Blogs in Cincinnati (in alphabetical order) after receiving 154 nominations for 62 blogs in Cincinnati USA’s Best Blog Competition in a quest to name the best blog authored in Cincinnati USA and the best blog authored by a Chamber member.

“Building Cincinnati,” blogger Kevin LeMaster, coverage of Cincinnati development news, http://buildingcincinnati.blogspot.com/

“Cincinnati Blog,” blogger Brian Griffin, political and progressive news and opinion in Cincinnati, http://cincinnati.blogspot.com/

“DesignCincinnati,” blogger Drew Steinbrecher, design and architecture highlights around the region, http://www.drew-o-rama.com/designcincinnati

“Each Note Secure,” blogger Joe Long, WOXY.com staffer who has his finger directly on the pulse of the music world in Cincinnati USA and beyond, http://www.eachnotesecure.com/

“Fort’s Cancer Sux”, blogger Melissa McLaughlin, Melissa’s (Fort’s) inspiring journal of her quest to beat stage-four breast cancer, http://fortscancersux.blogspot.com/

“Freckle Photo,” blogger Melissa Speelman, outstanding photo journal by a local art teacher documenting her family, friends, and classroom activities, http://www.frecklephoto.com/

“Lance McAlister,” blogger Lance McAlister, arguably the premier overall sports blog in Cincinnati USA and the No. 1 fan site of Pittsburgh-bound lightning bolt Valerie Abati, http://1530homer.com/pages/lancesBlog.html

“My Wine Education,” blogger Michelle Lentz, very tasty site about the local and worldwide wine scene, http://www.wine-girl.net/

“Patent Baristas,” blogger Stephen Albainy-Jenie, provides pertinent information about intellectual property topics, https://patentbaristas.com/

“Strategic Public Relations,” blogger Kevin Dugan, insights on the latest in PR developments and issues locally and globally, http://prblog.typepad.com/

The final two winners — who will receive a cool new iPhone — will require yet another round of judging and will be announced on Aug. 2.  I don’t think I’ll be canceling my current service, though.

More at the Cincinnati USA Regional Chamber.

The USPTO has published in the Federal Register a notice of proposed rulemaking regarding appeals to the USPTOs Board of Patent Appeals and Interferences (BPAI).  The proposed rules are in anticipation of the flood of appeals that will result if (read: when) the new USPTO rules limiting continuation practice go into effect.  (see:  USPTO Proposes Limiting Continuations)

The new rules, if enacted, will try to box in applicants and prevent attempts to use the appeals route in lieu of filing unlimited continuing applications.  The final continuing applications rules that are expected as early as the week of August 13, 2007 (and which will have a 60 day period from the publication date until they become effective).

These are being offered to change procedures in such a way as to allow the Board to continue to resolve ex parte appeals in a timely manner, essentially by placing more of a burden on applicants to submit very concise appeals.

Among the fun new rules:

Proposed Bd.R. 41.37(o)(3) would require that, when responding to points made in the final rejection, the appeal brief shall specifically (1) identify each point made by the examiner and (2) indicate where appellant previously responded to each point that appellant has not previously responded to the point. 

Proposed Bd.R. 41.37(o)(4) would require, for each rejection under 35 U.S.C. 112, first paragraph, that the argument shall also specify the errors in the rejection and how the rejected claims comply with the first paragraph of 35 U.S.C. 112, including, as appropriate, how the specification and drawings, if any, (1) describe the subject matter defined by the rejected claims, (2) enable any person skilled in the art to which the invention pertains to make and use the subject matter of the rejected claims, or (3) set forth the best mode contemplated by the inventor of carrying out the claimed invention.

Proposed Bd.R. 41.37(o)(5) would require, for each rejection under 35 U.S.C. 112, second paragraph, that the argument shall also specify how the rejected claims particularly point out and distinctly claim the subject matter which appellant regards as the invention.

Proposed Bd.R. 41.37(o)(6) would require, for each rejection under 35 U.S.C. 102 (anticipation), that the argument shall also identify any specific limitations in the rejected claims which are not described (explicitly or inherently) in the prior art relied upon in support of the rejection and, therefore, why the rejected claims are patentable under 35 U.S.C. 102.

Proposed Bd.R. 41.37(o)(7) would require, for each rejection under 35 U.S.C. 103, that the argument shall (1) specify the errors in the rejection, (2) if appropriate, specify the specific limitations in the rejected claims that are not described in the prior art relied upon in support of the rejection, and (3) explain how those limitations render the claimed subject matter unobvious over the prior art. A general argument that all limitations are not described in a single prior art reference would not satisfy the requirements of this paragraph.

If you wish to comment on the proposed rules, send them to mailto:BPAI.Rules@uspto.gov or facsimile to 571–273–0042, no later than September 28, 2007.  The USPTO will make the comments available here.

See the Federal Register notice here.

Patent Baristas has been featured in BlawgWorld 2007, an outstanding presentation of some of the top law blogs around the web in an eBlook format put together by Editor Sara Skiff, Publisher Neil Squillante and the eBook Team at TechnoLawyer.

BlawgWorld 2007 is a compilation of exemplary posts from authoritative law blogs of various specialties that presents them in an easy-to-navigate e-book pdf format you can download here for free.  The format provides added access to these influential law sources for many lawyers who might not yet be reading or writing blogs regularly. The new eBook format makes it really easy to navigate this sampling to get a feel for law blogs.

Seventy-seven exceptional blogs are featured in this year’s BlawgWorld 2007, including Adam Smith, Esq., Blawg Review, May It Please The Court, Morepartnerincome, Patent Baristas, PHOSITA, Promote the Progress, SCOTUSblog and Wired GC.

The Barista article, “Are Conflicts of Interest on the Rise?,” provides a discussion of the global pharmaceutical market’s pressure on the marketplace—and the regulations that try to hold it back.

Congratulations to all whose blogs were selected for BlawgWorld 2007. This has been a enormous effort and we encourage you to check it out this great offering for yourself.

Download Your Free Copy of BlawgWorld 2007 with TechnoLawyer Problem/Solution Guide here now!

In a new paper “Confronting Myths and Myopia on the Road from Doha,” Daniel Cahoy, associate professor of business law at Penn State’s Smeal College of Business, looks at recent patent compulsory licenses issued by Thailand in terms of balancing access and innovation in essential medicines.

The WTO’s Doha round of trade negotiations expanded the rights governments to issue patent compulsory licenses, which allow countries to manufacture cheaper versions of patented pharmaceuticals for non-commercial use or in cases of health care emergencies.

For example, the government of Thailand announced in 2006 that it intended to issue several “compulsory licenses” for patents related to AIDS and heart medications. The move was directed specifically to reducing the price of branded drugs; the licenses set compensation to patent owners at a mere 0.5% royalty on generic sales.

Unfortunately, international laws supporting access to medicines appears to be ambiguous with few limitations on which countries can “break” patents simply to control costs, what circumstances create a necessary condition, or even what level of remuneration is required.  Chief among his concerns is the level of compensation owed to a patent owner for the loss of exclusivity given the lack of standards in international law.

A lack of a clear floor or ceiling to compulsory license compensation can make patent property rights less predictable, encourage gamesmanship by developing or developed countries wishing to cut expenditures and even stifle access.

He suggests an innovative licensing framework that separates countries into three economic development tiers with different royalty mechanisms.  Such a nuanced system, the article argues, will lead to more predictability and effective institutional mechanisms, ensuring continued innovation and greater access to essential medicines.

The recent fear of an explosion of avian influenza could impact both the developed and developing world equally harshly, and at the same time, making the need for effective medicines urgent.  Therefore, should all nations — rich and poor — be able to benefit from lower costs as a result, perhaps to the detriment of innovation incentives?

Cahoy discusses multiple remuneration myths that have led many to overlook the potential of a remuneration-based approach to compulsory licenses.

Myth One: Equitable Compulsory Licenses Must Offer a Savings from the Market.  Although compulsory licenses have been imposed to achieve many different ends over the years, recent attention has focused on licenses to “break” the patent owner’s power to impose monopoly pricing for a greater good.

The underlying belief is that fair remuneration or compensation is inevitably restricted to a small royalty figure. Cahoy argues that there is a very rational argument for requiring market compensation for compulsory licenses that does not completely undermine their use.

Myth Two: Pharmaceutical Companies should be Indifferent to Compulsory Licensing so Long as “Reasonable” Remuneration is Available.  Regardless of whether there are justifications for the market compensation model of remuneration, many compulsory licensing advocates would argue that this high level of payment is simply not necessary.  That is, so long as a pharmaceutical company can make back its costs, it will break even and not face a disincentive to future investment.

However, determining the adequacy or reasonableness of a license is a difficult analysis since the reasonableness of any payment depends on one’s perspective. Given the global nature of the market for a particular pharmaceutical, any attempt to value the impact of a single license on a drug’s investment return would be largely speculative and arbitrary.

Myth Three: Antitrust Compulsory Licenses Provide a Reliable Royalty Benchmark.  Cahoy notes that essential in understanding remedial licensing is that the rates act as part of a corrective measure for bad behavior on the part of a patentee

Often as a consequence of monopolistic acquisition or licensing behavior, a patentee will be compelled to offer access to the patented invention to competitors on favorable licensing terms.  Such terms could be based on a relatively small royalty, or even royalty free depending on the severity of the triggering offense. For proponents of greater use of low-cost licenses, remedial rates look attractively low. The nature of this remedial form of licensing casts doubt on whether such rates contribute much to the debate.

Using a remuneration-oriented approach, Cahoy’s proposes licensing schemes that keeps
innovation incentives intact, but also ensures that developing countries have access to pharmaceuticals.  During public health crises, he argues for a three-tiered arrangement, in which remuneration is based on the economic status of the country issuing the compulsory license. Industrialized nations will be required to pay full market price, even during a pandemic.

To permit the most equitable accounting of the burden of public health expenses while ensuring relative ease of administration, the three-level system would provide: (1) a high compensation state for industrialized nations, (2) a development-factored royalty state for developing countries, and (3) a zero-royalty state for least developed countries.  The strata might be initially defined by the WTO’s grouping of nations, which would be subject to change as a nation’s economic state either improves or declines.

Cahoy also identifies the adoption of a national exhaustion rule, which would limit importation into non-licensing countries, and manufacturing limits as important elements to any new compensation system. The likelihood that industrialized markets will yield reduced profits as a consequence of compulsory license negotiations is due to price-limiting strategies such as (1) parallel importation and (2) reference pricing.

Clearly, the issue of compulsory licensing requires further debate.  Hopefully, we can all arrive at more equitable solutions.

See Cahoy’s entire article: “Confronting Myths and Myopia on the Road from Doha”

Several readers recently asked if there is a good (free) site that lists the expiration dates of pharmaceutical patents. The Generic Pharmaceutical Association (GPhA) has a chart listing Upcoming Patent Expirations for 2007-09.  One fee-based service I know of is Drug Patent Watch. 

One can also do the reviewing themselves, of course, but determining if a patent has truly expired can be a tricky business full of pitfalls.  For those who want to get look into a patent’s status, there are a number of steps to perform.

First, if the patent application was filed after June 7, 1995, the expiration date is 20 years from the date it was filed. If the application was filed by June 7, 1995 and issued before June 8, 1978, the expiration date is 17 years from issuance. But, if the application was filed by June 7, 1995 and issued after June 7, 1978, the term is the later of 17 years from issuance or 20 years from filing.

However, keep in mind that a patent term may be extended for various reasons.  Some patents have had their terms extended based on extreme delays in government approvals outside the Patent Office. This is very unusual, and applies almost always to pharmaceuticals (for example, Claritin® or Prozac®), food products (Aspartame) or medical devices or procedures, where FDA approval can sometimes eat up most of the patent term before the drug can be brought to market.

For a list of patents with term extensions, see the Patent and Trademark Office’s Extended Term List.

Some patents have less than the normal life span because their terms are limited to the terms of earlier-issued patents through the use of a terminal disclaimer, which is a result of filing two applications which claimed essentially the same invention. Terminal disclaimers will be marked on the later-issued patent. Sometimes these are flagged by an asterisk after the patent issue date, but sometimes they only appear in the text of the patent or with the related application data on the face of the patent.

Even after issuance, there are various ways a patent can expire early. For example, if the maintenance fees are not paid, the patent expires at the end of the surcharge period (4.5, 8.5 or 12.5 years after issue). However, the caveat to this is that expired patents may be revived up to 24 months after they expire, so long as the failure to pay the fee was unintentional. If the expiration date was more than two years in the past, the patent cannot be revived.

You can use the USPTO’s Patent Application Information Retrieval (PAIR) system to determine if maintenance fees have been paid.

In addition, you must determine if there has been any reexamination or voluntary disclaimer which resulted in a loss of some or all of the claim scope. This should be noted on a certificate attached to the patent image on the USPTO database, usually as the last page in the image file.  It is possible that an issued patent can be withdrawn from issue on the order of the Commissioner of Patents.

Finally, you must also check to see if the patent been declared invalid by a court.  Unfortunately, this can also be a tedious task to search through court records.

If you are genuinely concerned about a particular patent, it may be advisable to have a patent attorney (for example, one of the attorneys here at Frost Brown Todd) do a validity study and opinion on the patent. The attorney can perform a search to find prior art which might invalidate the patent, and will review the patent’s file at the USPTO to see if there is anything which might affect the validity or scope of the patent.

If you know of other sources for expired patent information, drop me a line and I will provide updated information here.