Patent Baristas

The Senate introduced their counterpart to the House Patent Reform Act this month (Patent Reform Act of 2006; S. 3818). Senator Orrin Hatch declared from the start that the pending bill represents a bipartisan compromise but acknowledges that both sides are in favor of a post-grant review process for patents and moving to a first-to-file system. Senator Hatch also acknowledged the need to reform the patent system (including granting the USPTO more authority with regard to rule-making) to deal with patents such as the one for the crustless peanut butter and jelly sandwich.

The two most substantial changes to the Patent Act involve limitations on the availability of enhanced damages upon a showing of “willful” infringement by a plaintiff and a parallel limitation on the availability of unenforceability under the doctrine of “inequitable conduct.” Like its House counterpart, the bill proposes these changes in an effort to streamline and reduce the cost of litigation. The bill, however, was not able to reach an agreement regarding the continued efficacy of the best mode requirement – elimination of this requirement would also serve to streamline litigation.

The bill makes further efforts to reduce the costs or, at least, improve the ability of litigants to predict those costs. For instance, the bill provides a broader safe harbor for prior users of patented technology. Senator Hatch stated “prior user rights are, in reality, a defense to infringement liability for those making or preparing to make commercial use of an invention prior to a patent being issued. Prior to a patent’s issuance, such a user often has no way of knowing that he is – or will be – infringing a patent. In some cases, the user has independently invented the subject matter in question, in which case it would be inequitable to subject him or her to infringement liability. Currently, the prior user defense is available only with respect to method patents. The bill expands the prior user defense to all categories of patents and makes related changes to this defense.” The bill also proposes a codified “apportionment” rule for calculation of damages. Finally, the bill requires courts to award attorneys’ fees to a prevailing party in cases where the non-prevailing party’s legal position was not substantially justified.

Finally, this section also addresses Section 271(f) of Title 35. Under current law, either a foreign or domestic patent holder may be able to obtain damages based on foreign uses of domestically-manufactured components of an infringing article. The House bill only sought to curtail the effect of this provision (entered by Congress in 1984) by applying it to tangible items (as opposed to software inventions per the 2005 Federal Circuit appeal of Eolas Techs. v. Microsoft Corp. The Senate bill goes a step further an repeals the 1984 provision in its entirety. This may be a case of throwing the baby out with the bath water as it will open the field for everyone to partially develop inventions in the United States, ship the components abroad, assemble them, and sell them in foreign countries without fear of infringement suits in those countries.

Conclusion

While much of patent reform still remains an open debate, it is clear that Congress is making progress toward reaching a resolution on many of the points discussed herein. Stay tuned for a deeper analysis of the actual language of the proposed bill when I actually have time to write one!

Today’s post comes from Guest Barista Ria Schalnat, a registered patent attorney in Frost Brown Todd’s Cincinnati office.

QuizLaw, which promises simple answers to complex legal questions, brings in Blawg Review #71 with a review of the latest big topics including The Legal Reader’s highlight of the Santa Venetia Center for the Arts and Humanities v. San Rafael Unified School Dist (CA1/1), where an Artists group had contracted to buy some land from the School District, but eventually defaulted and the District sued to quiet title and evict the Artists. The Artists declared bankruptcy and then settled.

Apparently, some of the Artists didn’t like this and hired a new lawyer who tried unsuccessfully to get a do-over. Before sanctioning both the Artists and their new attorney, the Court stated:

In sum, the artists lack standing to contest most of the matters they cite, their appeal is untimely as to anything of which they have standing to complain, their briefs are defective, their arguments lack merit and their attorney misrepresented the complexity of the issues, apparently as a means of delaying our consideration of the merits of the Artists’ arguments.

The court even reported the artists’ new attorney, Claire Leary, to the State Bar for possible disciplinary action.

While we appreciated learning that virgins don’t make good egg donors, we’ll just add our own nod to Ultimate Guitar for standing up to legal threats over copyright.

Without going into how much fun it is to look like a geriatric smoker walking around with an attractive nose cannula, there seems to be more and more interest in breathing in oxygen (at least air that has more oxygen than normal). There was even an oxygen bar at BIO this year. Now, the air may be sucked out of the market if these products are deemed drugs.

The Food & Drug Administration has stepped in and warned a company that makes and markets portable “oxygen enriched air” (OEA) for the treatment of a variety of ailments that it is selling a drug without an approved new drug application.

The FDA’s letter warns BetterThanAir that it was making false and misleading promotional claims when it said that the company’s canned air could cure or treat AIDS, lung cancer, cystic fibrosis, tuberculosis and high blood pressure. The BetterThanAir website claims that the proof of the effects of normal air (what they consider low oxygen) is the number of cases of cancer, AIDS, heart attacks and other illnesses that cripple and kill our bodies.

Among other products, BetterThanAir markets canned air under the brand names “Hangover Air,” “Oxygen Kit,” “B1ueAir,” the “Personal Oxygen System,” “O 2 Go,” “Oxycan,” “Oxygen Shot,” the “3rd Lung Kit” and the “BetterThanAir Emergency Oxygen M6 Travel Unit.”

The company claims its products can cure chronic mountain sickness, sleep apnea and hyperventilation and prevent other diseases. “Oxygen deprivation can, and is believed by the Medical Society to cause life-threatening diseases such as cancer,” according to their website. BetterThanAir claims “Certain health specialists say oxygen therapy is now a critical adjunct treatment for cancer, AIDS, diabetes, stroke, depression, chronic fatigue, lupus and fibromyalgia.”

Because BetterThanAir’s oxygen enriched products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and to affect the structure or function of the body, the FDA considers these to be drugs, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), [21 U.S.C. § 321(g)(1)].

Moreover, the FDA claims that these products are new drugs, as defined by section 201(p) of the Act, [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.

Further, the FDA claims that these oxygen products are also prescription drugs within the meaning of section 503(b)(1) of the Act, [21 U.S.C. § 353(b)(1)], because they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. Therefore, the FDFA contends that the “BetterThanAirâ„¢ oxygen enriched products” are misbranded within the meaning of section 503(b)(1) and 503(b)(4) of the Act, [21 U.S.C. §§ 353(b)(1) and 353(b)(4)] because they are marketed without a prescription and they lack the statement, “Rx only.” The inclusion of the disclaimer, “Not for medical and prescription use,” on the product’s label does not remove the product from the prescription dispensing requirement of section 503(b)(2) of the Act [21 U.S.C. § 353(b)(2)].

The FDA feels that because these products are offered for use for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use these products safely for their intended uses. Thus, the “BetterThanAirâ„¢ oxygen enriched products” labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. These products are not exempt from the adequate directions for use requirement because they do not meet the conditions set forth in 21 CFR § 201.100.

Finally, these products are considered misbranded under section 502(o) of the Act, [21 U.S.C. § 352(o)] and the products are subject to the Current Good Manufacturing Practice (CGMP) regulations at 21 CFR Parts 210 and 211. They may be considered adulterated under section 501(a)(2)(B) of the Act, [21 U.S.C. § 351(a)(2)(B)], if the methods used in, or the facilities or controls used during the product’s manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP.

The FDA has directed BetterThanAir to immediately correct these violations.

I noticed that BetterThanAir will host parties and events featuring oxygen-enriched air with and without aroma. No word on the effects of the aromas.

See the Warning Letter here.

ZymoGenetics, Inc. filed an infringement suit against Bristol-Myers Squibb over its patents related to fusion protein technology. The lawsuit, ZymoGenetics, Inc. v. Bristol-Myers Squibb Co., et al., District Court of Delaware, is for injunctive relief and damages over infringement, contributory infringement and/or inducement of infringement of US Patent Nos. 5,843,725 and 6,018,026.

The ‘026 Patent and the ‘725 Patent are directed to biologically active polypeptide fusion compositions and methods for producing biologically active polypeptide fusion compositions. Immunoglobulin fusion proteins are proteins that are produced using recombinant DNA technology where a portion of an antibody (e.g., heavy chain constant domain) is combined with the portion of a second protein (typically the portion of a cell-surface receptor that is responsible for binding to a growth factor). Amgen and Regeneron have previously licensed the use of the fusion protein technology.

Specifically, the ‘725 patent discloses a method for producing a secreted, biologically active dimerized polypeptide fusion. The method generally comprises a) introducing into a eukaryotic host cell a DNA construct comprising a transcriptional promoter operatively linked to a secretory signal sequence followed downstream by and in proper reading frame with a DNA sequence encoding a non-immunoglobulin polypeptide requiring dimerization for biological activity joined to a dimerizing protein; (b) growing the host cell in an appropriate growth medium under physiological conditions to allow the secretion of a dimerized polypeptide fusion encodes by said DNA sequence; and (c) isolating the biologically active dimerized polypeptide fusion from the host cell.

The ‘026 patent discloses a biologically active, dimerized polypeptide fusion, comprising first and second polypeptide chains, wherein each of said polypeptide chains comprises a non-immunoglobulin polypeptide requiring dimerization for biological activity joined to a dimerizing protein heterologous to said non-immunoglobulin polypeptide.

ZymoGenetics now alleges that Bristol is infringing the ‘725 and ‘026 patents by making, using, selling, distributing, advertising and marketing products, including but not limited to abatacept, that infringes the ‘725 and ‘026 Patents.

Abatacept (CTLA-4Ig; sold by Bristol-Myers Squibb as Orencia ®) is a fully human recombinant fusion protein categorized as a costimulatory or second-signal blocker of T cell activation. Abatacept disrupts the activation pathway of T cells causing a disturbance in key mechanisms of inflammation and progressive joint destruction in rheumatoid arthritis (RA). Because a large number of patients with RA have an inadequate or unsustained response to anti-tumor necrosis factor (TNF) therapy, abatacept, with its novel mechanism of action, has been studied in this population.

In Amgen Inc., v. Hoechst Marion Roussel, Inc. (Now Aventis) and Transkaryotic Therapies, Inc., (05-1157), the Court of Appeals for the Federal Circuit affirmed a District Court’s decision that Transkaryotic Therapies Inc. (TKT) and Aventis Pharmaceuticals Inc. infringe Amgen’s erythropoietin (EPO) patent estate. The court’s decision upheld the validity of two of Amgen’s EPO patents and the infringement by TKT of three patents and 12 claims, including a patent that does not expire until 2015.

The current appeal reviewed the District Court’s findings on the infringement and validity of two patents with claims to the production of erythropoietin, the infringement of one product patent under the doctrine of equivalents, and the validity of one product patent. The Federal Circuit found the production patents valid and infringed (U.S. Patent Nos. 5,618,698 and 5,756,349). The court reversed the District Court’s determination that TKT infringed Amgen’s U.S. Patent No. 5,621,080 under the doctrine of equivalents, and remanded to the District Court for further consideration of the remaining validity issue on one of the other product patents (U.S. Patent No. 5,955,422).

The patents at issue are directed to recombinant DNA technology relating to the production of the hormone erythropoietin (“EPO”). All five patents share a common specification and descend from Application No. 06/561,024, filed on December 13, 1983.

EPO, which is a naturally occurring hormone, stimulates the production of red blood cells in the bone marrow through a process called erythropoiesis. Thus, the production of EPO is useful in treating blood disorders characterized by low hematocrit, which is a low ratio of red blood cells to total blood cells. Amgen markets and sells its EPO product under the brand name “Epogen.”

This case has a sorted history dating back to 1997 when Amgen brought a declaratory judgment action against Hoechst (now Aventis) and Transkaryotic Therapies (“TKT”) alleging that TKT’s Investigational New Drug Application (“INDA”) for an EPO product infringed the five patents.

In what is known as Amgen I, the district court held the claims of the ’080, ’349, and ’422 patents valid and infringed with the exception of claim 7 of the ’349 patent and held the ’698 and ’933 patents not infringed. In Amgen II, the CAFC vacated and remanded the case to the district court to construe the term “therapeutically effective amount” in claim 1 of the ’422 patent and then determine whether certain claims are anticipated or obvious or if they are infringed. In Amgen III, the district court entered judgment in favor of Amgen. They’re now back for Round IV.

The patents at issue in this case relate to recombinant DNA technology for the production of EPO. In the invention of the five patents, prior to production of a protein from the mRNA with the sequence coding for EPO, the mRNA sequence is spliced to remove introns and to connect exons. After splicing, the mRNA is translated into the 166-amino acid protein shown in Figure 6 of the common specification of the patents.

Prior to secretion from the cell, the 166-amino acid EPO protein undergoes cleaving. In this process, the final amino acid in the sequence shown in Figure 6 of the ’422 patent, arginine, is cleaved off, leaving a 165-amino acid protein. This 165-amino acid protein is then secreted as mature human EPO by the cell. HMR and TKT collaborated to develop a drug known as HMR4396. HMR4396 consists of human EPO produced from TKT’s R223 cell line.

The ’422 patent claims: “A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.”

On remand, the district court construed “therapeutically effective amount” in claim 1 of the ’422 patent to require that the claimed EPO increase hematocrit and also be useful in healing or curing certain classes of patients, e.g., patients generally requiring blood transfusions.

Amgen argued that the district court correctly interpreted the term since only amounts of EPO producing effects—particularly increased hematocrit—that counteract these anemia-like diseases are “therapeutically effective.”

The CAFC held that:

In Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), we stated that claim construction must begin with the words of the claims themselves. Id. at 1312. A claim term has “the meaning that the term would have to a person of ordinary skill in the art. . . .” Id. at 1313. This meaning is ascertained “in the context of the entire patent, including the specification.” Id. In particular, we stated in Phillips that “we must look at the ordinary meaning in the context of the written description and the prosecution history.” Id. (quoting Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005)). When dealing with technical terms, we noted, a court should look to “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id. (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)).

We think the district court made an artificial distinction between the first four effects listed in column 33, lines 11-22, stimulation of reticulocyte response, development of ferrokinetic effects, erythrocyte mass changes, and stimulation of hemoglobin, and the fifth effect, an increase in hematocrit. The specification lists all five effects after stating that “any or all” of them may be an effect of therapy with the claimed invention. Thus, this section of the specification supports the construction that the ’422 patent encompasses a pharmaceutical composition which produces “any or all” of the five listed effects.

This doesn’t seem to take into account the fact that increasing hematocrit is the mechanism in all of the patient treatments listed.

In looking at infringement under the doctrine of equivalents of the ’080 patent, the CAFC disagreed that Amgen met its burden of showing that the reason for the addition of the reference to the “amino acid sequence of FIG. 6” was merely tangential to the alleged equivalent stating:

We must reject Amgen’s argument that the sole reason for the amendment requiring EPO with 166 amino acids was to limit the ’080 patent to human EPO and that therefore the amendment was merely tangential to a 165-amino acid equivalent … claim 1 contains no limitation pertaining to human or non-human EPO. Claim 1 of the ’933 patent, which covers both human and non-human EPO, also lacks any limitation concerning the amino acid sequence of the claimed EPO product. Accordingly, claim 1 of the ’933 patent broadly encompasses EPO with any amino acid sequence, which would include amino acid sequences differing from that set forth in Figure 6.

Finally, we think that if the patentee had wished only to limit the claims to human EPO, the patentee could have done so by continuing to use the adjective “human” when referring to EPO in the third preliminary amendment; instead the patentee chose to further narrow the claims in the third preliminary amendment by making reference to the specific sequence in Figure 6 rather than human EPO.

Chief Judge Michel, dissenting-in-part, summed up things thusly:

This litigation has already dragged on for almost ten years, yet the end is nowhere in sight. … When will it end? Ironically, the patents in dispute may expire before this litigation concludes.

Moreover, since the majority holds that other asserted patents are not invalid and are literally infringed by HMR 4396, (and here I agree), the district court likely will enter an injunction precluding appellants from marketing HMR 4396 until the expiration of at least the ‘698 and ‘349 patents. Prolonging this litigation seems futile when, in the end, an injunction will likely issue regardless of how “therapeutically effective” is construed or whether claim 1 of the ‘422 patent is invalid.

Sanofi-Aventis SA and Bristol-Myers Squibb filed for a preliminary injunction against Apotex Inc . to stop sales of a generic version of Plavix® (clopidogrel bisulfate). The companies are seeking an immediate halt on the sale of Apotex’ generic drug as well as a recall of drug already shipped. In the filing, the companies cited four reasons the injunction should be issued, including the likelihood that they will prevail in the patent case and that Apotex’s launch last week is causing them irreparable harm.

The motion, filed in the U.S. District Court for the Southern District of New York, is set for a hearing on the motion on August 18, 2006. This is the court hearing the patent infringement suit, Sanofi-Synthelabo v. Apotex Inc., 2:02-cv-02255. The companies had to wait five days before they could file the motion under the terms of their earlier agreement in which Apotex agreed not to sell its generic. This follows the announcement by Apotex that it had launched a generic version of clopidogrel bisulfate at risk. The drug companies also have begun discounting Plavix.

Earlier, Apotex agreed to delay selling its drug in return for a minimum of $40-million from Bristol and Sanofi. In return, Apotex would be allowed to introduce its version of Plavix before the patent expired sometime in 2011. The deal between the drug companies was rejected by state attorneys general, who must approve arrangements between Bristol-Myers and generic drug makers as a result of earlier litigation.

Now, the U.S. Federal Trade Commission has initiated a criminal investigation by the Department of Justice. FBI agents have already confiscated documents at Bristol-Myers’ New York headquarters, and both companies received grand jury subpoenas to determine if the agreement broke antitrust laws.

Aspects of the agreement still in place protect Apotex by stating that Bristol-Myers and Sanofi wouldn’t seek a court order to prevent Apotex from selling the drug and would give Apotex five days’ notice before they sought a court ruling to halt sales once they started. In addition, they also agreed to limit how much Apotex would have to pay if it began selling the generic drug and then lost the patent suit. Under the revised settlement agreement, Bristol and Sanofi could collect damages limited to 40-50% of Apotex’s net sales of the generic drug. In addition, the companies waived their right to seek triple damages under applicable patent laws if they were to prevail in the pending patent litigation.

There’s not a lot of love lost. At an Aug. 4 hearing, Bristol-Myers lawyers said Apotex had a clear strategy to “derail this settlement negotiation” claiming that Apotex told regulators the companies had reached a “secret side agreement” in which Bristol-Myers pledged not to introduce its own authorized generic of Plavix in competition with Apotex, even though it had removed such a promise from the agreement.

While Sanofi could win the suit against Plavix generic, the failure of the parties to agree doesn’t bode well. It’s also telling that Sanofi and Bristol made a lot of concessions to settle the patent litigation. Apotex must feel fairly secure to start selling the generic at risk. I doubt they’ll be getting any good deals from the brand name drug makers any time soon, though.

See earlier posts from the Patent Baristas:

Apotex To Launch Generic Plavix At Its Own Risk
FTC Rejects Patent Deal by Bristol-Myers and Sanofi
Does Sanofi-Aventis Patent Settlement With Apotex Reveal a Trend?

In Pennington Seed et al. v. Produce Exchange No. 299 et al. (05-1440), the Federal Circuit affirmed that claims against the University of Arkansas for infringement of a patent were barred by the Eleventh Amendment to the United States Constitution.

Pennington filed suit against the University of Arkansas for infringement and conversion of U.S. Patent No. 6,111,170 (the ‘170 patent). The ‘170 patent claims a type of non-toxic fescue grass that does not adversely affect livestock that graze upon it. AgResearch developed the grass and received the ‘170 patent on August 29, 2000. It then licensed the patent to Pennington, which markets it as MAXQ.

The District Court dismissed the original complaint due to the University’s Eleventh Amendment immunity. Concurrent with that dismissal, the court granted Pennington’s motion to file its First Amended Complaint against several university officials for infringement of the ‘170 patent, deprivation of federal rights, and conversion. The district court subsequently dismissed the First Amended Complaint based on Eleventh Amendment immunity and lack of personal jurisdiction.

The Eleventh Amendment to the United States Constitution limits the judicial authority of the federal courts and prevents citizens from bringing suit against a state in a federal court without its consent. While Congress may abrogate, under certain circumstances, a state’s Eleventh Amendment immunity under Section 5 of the Fourteenth Amendment, it may not do so under its Article I Commerce Clause power in patent cases.

In Florida Prepaid, the Supreme Court held that Congress did not have the authority under Article I, Section 8 of the Constitution to abrogate state sovereign immunity. The amendment to the Patent Act that abrogated state sovereign immunity, 35 U.S.C. §§ 271(h), 296(a), did not reflect any Congressional findings upon which Congress could base the abrogation of the Eleventh Amendment sovereign immunity of the states pursuant to the Fourteenth Amendment. The Act merely served as a uniform remedy for patent holders against states instead of a remedy for constitutional violations, such as where a state provides inadequate or no state court remedies.

The infringement of a patent by a state may be actionable in federal courts “only where the State provides no remedy, or only inadequate remedies, to injured patent owners for its infringement of their patent.” The Act’s legislative history in Florida Prepaid, however, provided no factual premise that Congress was attempting to remedy Fourteenth Amendment violations. The Court noted that the State of Florida provided various alternative remedies to recover for patent infringement, such as a legislative remedy through a claim for payment or a judicial remedy through a takings or conversion claim against the state.

In affirming the dismissal, the Federal Circuit held that:

In Xechem, we noted that Florida Prepaid requires a showing “that the state action ‘left [the patentee] without a remedy under state law,'” 382 F.3d at 1332; however, such a showing is predicated upon Congress’s abrogation of Eleventh Amendment sovereign immunity. As specifically explained in Florida Prepaid, it is the Congress, not this court, that can abrogate Eleventh Amendment sovereign immunity for patent infringement, pursuant to Section 5 of the Fourteenth Amendment, if there is a showing that state remedies were insufficient and violated due process. 527 U.S. at 642-43, 646-47; see also Chew v. Cal., 893 F.2d 331, 336 (Fed. Cir. 1990).

Here, Pennington alleged in its complaint that the Arkansas Claims Commission is the only body allowed to hear claims against the state, but that it could not issue injunctions, conduct discovery, or issue a monetary award over $10,000. Pennington, however, fails to allege or explain how Congress made the specific finding that these state procedures are so inadequate that it abrogated state sovereign immunity to allow a patent infringement claim to be filed in federal court. Without such a finding, abrogation would be suspect under Florida Prepaid.

Although the district court found that there was no state forum in which to contest patent infringement claims, it did not find that other available remedies pursuant to state law were so insufficient that they violated the Fourteenth Amendment. In fact, Pennington’s First Amended Complaint inherently recognizes the sufficient state remedies acknowledged in Florida Prepaid. Namely, the complaint notes that the State legislature may consider claims and appropriate monetary awards greater than $10,000 (a legislative remedy), and it alleges that the state remedy for conversion (a judicial remedy) may be available. See Fla. Prepaid, 527 U.S. at 644 n.9. Moreover, Arkansas law allows other forms of relief aside from the Claims Commission. See, e.g., Austin v. Ark. State Highway Comm’n, 895 S.W.2d 941, 943 (Ark. 1995) (“[L]andowner, claiming a taking of property, may either seek prospective injunctive relief in chancery court or damages from the State Claims Commission.”); Cammack v. Chalmers, 680 S.W.2d 689 (Ark. 1984) (allowing injunctive relief for State acts that are illegal, unconstitutional or ultra vires). While these remedies may be “uncertain” or “less convenient,” or may “undermine the uniformity of patent law,” these attributes are not sufficient to show that the patentee’s due process rights have been violated. Florida Prepaid, 527 U.S. at 644-45; see also Xechem, 382 F.3d at 1332; Jacobs Wind Elec. Co. v. Fla. Dep’t of Transp., 919 F.2d 726, 728 (Fed. Cir. 1990).

We’ve said that nanotech is the next big thing in biotech. Now, the U.S. Food and Drug Administration has formed an internal task force to focus on the use of nanotechnology materials in drugs, medical instruments, and other products regulated by the agency. The new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

The task force will identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials. FDA will continue to address product-specific nanotechnology-related issues on an ongoing basis.

Specifically, the task force will:

Chair a public meeting to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products, including new and emerging scientific issues such as those pertaining to biological interactions that may lead to either beneficial or adverse health effects. This public meeting is scheduled for October 10.

Assess the current state of scientific knowledge pertaining to nanotechnology materials for purposes of carrying out FDA’s mission.

Evaluate the effectiveness of the agency’s regulatory approaches and authorities to meet any unique challenge that may be presented by the use of nanotechnology materials in FDA-regulated products.

Explore opportunities to foster innovation using nanotechnology materials to develop safe and effective drugs, biologics and devices, and to develop safe foods, feeds, and cosmetics.

Continue to strengthen FDA’s collaborative relationships with other federal agencies, including the agencies participating in the National Nanotechnology Initiative such as the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), as well as with foreign government regulatory bodies, international organizations, healthcare professionals, industry, consumers, and other stakeholders to gather information regarding nanotechnology materials used or that could be used in FDA-regulated products.

Consider appropriate vehicles for communicating with the public about the use of nanotechnology materials in FDA-regulated products.

Submit its initial findings and recommendations to the Acting Commissioner within nine months of the public meeting.

The National Nanotechnology Initiative (a United States government research and development coordinating program,) refers to nanotechnology as “the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications.” A nanometer is a billionth of a meter.

Materials made in the nanoscale size range can often have chemical or physical properties that are different from those of their larger counterparts. Such differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity. Because of these properties, nanotechnology materials have great potential for use in a vast array of products. Also because of some of their special properties, they may pose different safety issues than their larger counterparts.

This comes as the Motley Fools warn everyone to “Beware the Nano Lawyers!” (sounds like a great Hollywood thriller) .

Demand for nanotech health-care products is projected to hit $6.5 billion in 2009, up from $906 million in 2004, according to a 2005 report from the Freedonia Group. The total market may exceed $100 billion by 2020. Sales of pharmaceuticals created or modified with nanoparticles will grow to $16.6 billion by 2014.

Additional information about FDA’s Public Meeting is here.