Patent Baristas

The Court of Appeals for the Federal Circuit, in what seems to be a confusion over neutralization of an acid versus a salt, held that a claim for an acid is not literally infringed by a salt in Kao Corp. and Andrew Jergens Corp. v. Unilever and Conopco.

Earlier, the U.S. District Court ruled that Kao’s U.S. Patent No. 6,306,382 was valid and enforceable but not infringed by Unilever’s accused product, Pond’s Clear Pore Strips – a cosmetic skin-care product used to remove “keratotic plugs” (a/k/a blackheads) from facial skin. The district court exercised jurisdiction pursuant to 28 U.S.C. § 1338.

Claim 1 recites as follows:

A method for removing keratotic plugs from skin with a cosmetic article, which comprises:
wetting the skin or said cosmetic article; applying onto the skin said cosmetic article; and peeling off said cosmetic article after drying; wherein said cosmetic article comprises: (i) a substrate selected from the group consisting of woven cloth, non-woven cloth and a plastic film; and (ii) on said substrate, a layer comprising a copolymer, in an amount effective to remove keratotic plugs, wherein said copolymer is a poly(alkyl vinyl ether/maleic acid) copolymer or a polyalkylvinyl ether/maleic anhydride) copolymer.

Claim 3 recites “The method of claim 1, wherein said substrate is a non-woven cloth.”

The district court also construed what it termed the “copolymer limitation” of claim 1 – the language stating “wherein said copolymer is a poly(alkyl vinyl ether/maleic acid) copolymer or a polyalkylvinyl ether/maleic anhydride) copolymer” to mean “either poly(alkyl vinyl ether/maleic acid) copolymer or poly(alkylvinyl ether/maleic acid anhydride) copolymer, but not the salt form thereof.” Concluding that “a salt copolymer is a distinct chemical entity from both an acid copolymer and an anhydride copolymer,” The court noted that after filing the application for the ‘382 Patent, Kao filed another application “with claims specifically directed to the salts of the copolymers claimed in the ‘382 patent.” The district court took this as evidence that the ‘382 Patent does not cover salt forms.

Kao argued that Unilever does not use the salt form of PVM/MA, but the acid form based on the fact that the addition of 2% AMP to the PVM/MA only slightly neutralizes the acid, such that “85.5% of the acid groups do not include a salt and only 14.5% of the acid groups include a salt.

The coating for the Pond’s strips is prepared by mixing 98% by weight of a solution of PVM/MA with 2% by weight of AMP. The AMP reacts with the PVM/MA to form what Unilever and the district court describe as a salt. The district court concluded that Unilever’s product did not literally infringe the ‘382 Patent because it did not meet the “copolymer” limitation of claim 1.

The Federal Circuit affirmed the lower court based on the belief that:

..it was “uncontested” that there were “differences in chemical composition between the claimed PVM/MA and the PVM/MA acid-salt” used by Unilever’s product. Id. The primary difference was that Unilever’s product contains 98% by weight of PVM/MA copolymer and 2% by weight of AMP, which “reacts with the PVM/MA to form a salt.” Id. at 541. The trial court noted that “[t]he experts also agree that the claimed PVM/MA copolymer and the PVM/MA acid-salt have different chemical compositions which can be characterized by differences in their solubility, viscosity, and infrared spectra data.”

The court stated that “the relevant question is not whether Unilever’s compound is a salt, but whether it is “a salt form of” PVM/MA.” Huh? The Federal Circuit seemed to hang the decision on the fact that Kao offered no response to Unilever’s account of the record testimony beyond a conclusory assertion, unsupported by citation to the record, that Unilever’s account is “not correct.” [Note to practitioners: Get this evidence in the record!]

Judge Newman, concurring in part, dissenting in part contested the result saying “the panel majority has misunderstood the chemistry, in holding that neutralization of 14.5% of the maleic acid groups means that the totality is a salt and not an acid. This flawed science led to an incorrect conclusion of law.”

This decision seems to point out two critical items for patent holders. One, in drafting chemical patents, the drafter should spell out what is or is not a salt as well as what is an equivalent. And two, in an infringement action involving chemistry, you need to get the court educated on the reactions involved. Preferably, have the nuances spelled out in the specification. Kao also lost any chance for infringement under the doctrine of equivalents because it did not raise the issue, which seems odd given that the chemical changes effected by combining PVM/MA with AMP have no effect at all on the function of the invention.

Update:

A reader pointed out that Kao probably was sunk by its own patent application filed on the salt form. Because the district court determined that Unilever’s product used a salt, not the claimed acid, Kao could not meet literal infringement. Kao then tried to rely on Merck & Co. v. Teva Pharmaceuticals USA, Inc., 347 F.3d 1367 (Fed. Cir. 2003), for the proposition that “a claim that recite[s] an acid” may be “literally infringed by the salt of the acid” where “both the acid and its salt functioned similarly.” Kao argued that even Unilever does not dispute that the chemical changes effected by combining PVM/MA with AMP have no effect at all on the function of the invention.

However, the cited cases involve patent claims that were held to include salt forms. In the present case, the district court’s claim construction expressly excluded the salt form of PVM/MA. In addition, the court made note that Kao filed a separate application “with claims specifically directed to salts of the copolymers claimed in the ‘382 patent.” The Federal Circuit believed that if Kao had intended to claim salt forms of the copolymer in the ‘382 Patent, the subsequent patent application would have been superfluous. Therefore, by not filing on the salt forms in the original application, they may have given up any chance for a DOE claim.

The U.S. Court of Appeals for the DC Circuit, in Teva Pharmaceuticals v. FDA and Apotex (05-5401 & 05-5460), held that in a suit challenging agency action, the courts are not to choose between competing meanings of an ambiguous statute when the agency hasn’t weighed in first.

The Food, Drug, and Cosmetic Act grants a 180-day exclusive marketing period to the first generic drug manufacturer to file an Abbreviated New Drug Application (“ANDA”) that contains a challenge to the patents protecting a brand name drug. This exclusivity period begins to run either upon “notice [to the FDA] of the first commercial marketing of the drug” or on “the date of a decision of a court . . . holding the patent [to the branded drug] to be invalid or not infringed, whichever is earlier.” [Note: Congress eliminated the court decision trigger in 2003 but the application was filed before the amendment entered into force.]

Bristol-Myers Squibb Co. manufactures and sells Pravachol (pravastatin sodium), a cholesterol-reducing medication and owns or holds licenses to four patents covering Pravachol. The patent on the molecule itself (the “product patent”) expires on April 20, 2006. Teva Pharmaceuticals filed the first application to market generic pravastatin sodium and certified that it would not market its generic version of Pravachol until after the product patent expired.

Teva challenged the remaining patents by filing a certification that they are “invalid or will not be infringed” by the generic product. This paragraph IV certification is a form of patent infringement and triggers statutory notice requirements to allow the patentholder to bring suit. But, Bristol-Myers did not sue Teva or any of the other seven generic drug manufacturers that filed applications containing the identical patent certifications.4

Apotex then sued Bristol-Myers seeking a declaratory judgment that Bristol-Myers’s three patents covering Pravachol’s formulation and method of use were invalid or not infringed by Apotex’s generic pravastatin sodium product. Bristol-Myers did not answer the complaint; it instead moved to dismiss the complaint for lack of subject matter jurisdiction.

The parties then entered stipulation and order stated that because “[Bristol-Myers] repeatedly represented and assured Apotex that, notwithstanding any disagreement on the scope or interpretation [of the disputed patents], it had no intention to bring suit against Apotex for infringement,” Apotex stipulated that its complaint be dismissed “for lack of subject matter jurisdiction.”

Apotex then asked the Food and Drug Administration to rule that Apotex’s litigation produced a “decision of a court” that triggered Teva’s exclusivity period for generic pravastatin sodium. The FDA concluded that the Apotex “stipulation and order” qualified as a “decision of a court” and that Teva’s period of exclusivity therefore began to run on the date the stipulation and order became final.

Teva challenged the FDA’s decision and the district court granted Teva’s requests for a declaration that the FDA’s conclusions were contrary to law and for injunctive relief preventing the FDA from approving any other generic pravastatin sodium application sooner than 180 days after Teva begins marketing its product. The district court concluded that the voluntary dismissal of Apotex’s declaratory judgment action did not meet the statutory definition of a “decision of a court.”

The Court of Appeals held that although the court stated that the statute could be interpreted to include dismissals of declaratory judgment actions as triggering events, it left the final decision to the FDA:

In a suit challenging agency action, “it is not for the court ‘to choose between competing meanings’” of an ambiguous statute when the agency charged with its administration has not weighed in first. PDK Labs., Inc. v. DEA, 362 F.3d 786, 798 (D.C. Cir. 2004) (quoting Alarm Indus. Commc’ns Comm. v. FCC, 131 F.3d 1066, 1072 (D.C. Cir. 1997)). When a statute is ambiguous, Congress has left a gap for the agency to fill. See Chevron USA Inc. v. Natural Res. Def. Council, 467 U.S 837, 843-44 (1984). A court’s interpretation prevails only if it “follows from the unambiguous terms of the statute and thus leaves no room for agency discretion.” Nat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs., 125 S. Ct. 2688, 2700 (2005). We therefore generally remand for an agency to make the first interpretation of an ambiguous statutory term when it has failed to do so previously.

In an Op-Ed piece in the New York Times entitled “Patently Ridiculous,” the editors state that “something has gone very wrong with the United States patent system.

That’s not really “new” as far as patent reform claims of this sort go but the editors do finally concede that the problem lies “not just with the short-staffed patent office, but also with the courts.” The article attempts to draw blame away from patent holders themselves and to shine light on the ease with which patent holders can get an injunction to shut down a competing business. Since injunctions are such a heavy hammer, many companies settle rather than fight it out à la RIM v. NTP.

The article provokes one to contemplate the questions raised by new technological advances. It also gives a nod to the fact that not everyone is effected equally — high-tech and pharmaceutical industries are at odds on reform since patents affect their businesses so differently. The bottom line is that an understaffed Patent and Trademark Office needs to work cooperatively with inventors to carve out their inventions’ proper niche.

Congress is currently looking at draft patent reform legislation to deal with the issue of patent infringement injunctions. Companies like eBay, which have to contend with the possibility that one device might be infringing hundreds of patents, want Congress to clarify existing rules that give district court judges discretion in deciding whether to issue injunctions while patent cases make their way through the appeals process.

The pharmaceuticals industry, by contrast, wants the legislation to reflect recent federal circuit court decisions – particularly the one eBay is appealing – which say injunctions against patent infringers should be standard during appeal except in extraordinary circumstances. Pharmaceutical and biotech companies tend to face fewer numbers of patents in developing a particular product and so immediate injunctions are more critical.

Meanwhile, in the eBay v. MercExchange case, the Court of Appeals for the Federal Circuit felt that eBay should be subject to an injunction in holding that a permanent injunction must follow all judgments of infringement unless such a decision would “frustrate an important public need,” such as protecting public health. Note that RIM made this argument against an injunction on testimonials that its Blackberry e-mail device, used by doctors and emergency workers, fit that description.

When deciding whether to grant injunctions, the other federal appellate courts use a four-part test where the courts consider whether the plaintiff will be irreparably harmed if an injunction is not issued, whether the plaintiff has some other adequate legal remedy, whether an injunction is in the public interest, and whether an injunction (or lack of one) would pose an undue hardship to the plaintiff or defendant. A much less hardline approach.

Counterbalancing all this is the importance of an injunction for the “little guy” in all this. The power of an injunction can be the only weapon that a small start-up has to combat it’s larger foes seeking to cruch it out of the marketplace using its vast cash resources. It’s all a matter of balance and, hopefully, the Supreme Court will provide some guidance. The U.S. Supreme Court has agreed to review the ruling in the eBay v. MercExchange case will begin taking up the general merits of that case on March 29, when it is scheduled to hear oral arguments.

The U.S. government filed its own brief in the case arguing that the court handling eBay’s appeal did not stick to a “general rule” but instead used ample “discretion” in issuing an injunction. The government said no special exemptions should be made in cases involving companies like MercExchange that do not make products using their patents but instead simply licence them. A 1908 Supreme Court decision established that injunctions can occur even if the patent holder itself has “‘unreasonably’ failed to practice its own invention.”

For a round-up of amici briefs in the eBay v. MercExchange case, see Dennis Crouch’s Review: EBay v. MercExchange Amici Briefs, Patently-O, March 13, 2006.

In Rockey, Inc. v. Cordis Corp. (05-1236), the U.S. Court of Appeals for the Federal Circuit held that determining patent infringement is a two-step process consisting of the court construing the claims and then comparing the allegedly infringing device to the properly construed claims.

Arlaine & Gina Rockey, Inc. (“AGR”) filed an action against Cordis alleging breach of the licensing agreement, breach of an implied duty to commercialize, and breach of the duty of good faith and fair dealing. After a Markman hearing, the District Court issued a claim construction order and granted summary judgment in favor of Cordis. The district court found that AGR is not entitled to royalties because the use of Cordis’ accused device (the “Palmaz-Schatz” stent) is not covered by AGR’s stent patent.

United States Patent No. 4,641,653, assigned to AGR, covers various medical devices and procedures involving stents. AGR claims that Cordis breached the license agreement by selling the accused device, the Palmaz-Schatz stent, without paying royalties.

Claim 2 of the ‘653 patent is directed to a method for inserting a stent into a blood vessel, manipulating the stent into position, and expanding it to the full diameter of the vessel. The stent remains in place due to the frictional forces created by the expanded device against the blood vessel wall, and helps to maintain an open passageway in a diseased vessel.

While the Palmaz-Schatz stent is used in a similar manner, the Palmaz-Schatz stent is a lattice-like cylinder that is delivered to a desired location within the blood vessel and then radially expanded by an internal balloon. The expanding balloon causes permanent deformation of the latticed-steel cylinder. The metal of the stent retains its new shape.

In contrast, the ‘653 patent illustrates the use of a stent that has a different means of maintaining itself in a permanently expanded configuration. Rather than relying on mechanical deformation of a steel-lattice, the Rockey patent relies on the introduction of a slowly-hardening substance.

To construe claims, the court first looks at the ordinary and customary meaning of the claim language. The claim’s “ordinary and customary meaning” is the reading a person of ordinary skill in the art would give the claim at the time of the invention. The person of ordinary skill in the art should read the claim term “not only in the context of the particular claim in which the disputed terms appears, but in the context of the entire patent, including the specification.”

Claim 2 of the ‘653 patent recited a “A method of treating an area of a body vessel, comprising the steps of … providing in the sleeve a material which increases in rigidity after expansion of said balloon …”

The district court defined “providing in the sleeve a material which increases in rigidity after expansion of said balloon” to mean “supply[ing] in the sleeve a material that is separate and distinct from the sleeve itself.” The district court held that the limitation requires the addition of a material to the stent at some point in the process.

AGR argued that the district court erred by improperly importing limitations of the preferred embodiment into the claims in its claim construction. On review, the Federal Circuit held that:

When interpreting the claims, we must read them “‘in view of the specification, of which they are a part.'” Phillips, 415 F.3d at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc)). In interpreting the ‘653 claim, the district court considered the intrinsic evidence contained in the patent specification to determine the meaning of the term “provided in.”

In light of this claim construction, the Federal Circuit held that the district court did not err in finding that there is no genuine issue of material fact whether the use of the Palmaz-Schatz stent is covered by the ‘653 patent. Thus, Cordis is not subject to royalty payments pursuant to the terms of the license agreement for the Palmaz-Schatz stent.

TechnoScore: 4.8 (Rated by 4 Users)

Introduction

SmartDraw.com’s SmartDraw Legal Solution enables legal professionals without any design expertise to create professional-looking graphics to persuade clients, judges, juries and even opposing counsel. The SmartDraw Legal Solution includes more than 1,000 templates and 50,000 images for accident reconstructions, crime scenes, maps, medical diagrams, Gantt charts, organizational charts, timelines, and more.

Though just a year old, the SmartDraw Legal Solution has the feel of more mature software thanks to the fact that it was built atop SmartDraw, a business graphics program launched in 1994 and now at version 7. According to the company, more than half of the Fortune 500 use SmartDraw.

Pricing for the SmartDraw Legal Solution starts at $449 with discounts and volume licensing available. You can also find it bundled with other legal software from time to time. It comes with a 30-day money back guarantee.

For this TechnoReview, we interviewed four SmartDraw Legal Solution users who rated it and discussed its use in their practice as well as its pros and cons. What did they think? Read on to find out.

Using The SmartDraw Legal Solution to Prove Misappropriation

In a recent wrongful termination case, Bruce Olson’s client asserted that its former employee had engaged in misappropriation of corporate property. To prove this assertion, Olson had to explain the context of some footage captured by his client’s surveillance cameras.

Olson, a civil litigation lawyer with Davis & Kuelthau in Green Bay, Wisconsin, felt that if the judge could see a clear layout of the building, and better understand the security camera placement and lines of sight, he would agree that a misappropriation had occurred on the premises.

“Short of putting everybody on a bus and taking them out to the company and walking them through,” Olson said, “you had to be able to demonstrate this using some kind of graphic.”

Using the SmartDraw Legal Solution, Olson recreated the scene of the alleged misappropriation. In the past, Olson said that he would have had to hire a draftsman at great expense to produce a trial graphic. This time, he opened a SmartDraw Legal Solution template on his computer, clicked and dragged with his mouse, and produced an illustration of the office space in question.

Olson likes the SmartDraw Legal Solution so much he joined SmartDraw.com’s Advisory Board (an unpaid position). Among his duties, he advises SmartDraw.com on how to improve future versions of its legal solution.

At the top of his wish list is the ability to create a blank document without being forced to use the available standard templates. Some templates have blank drawings available and some do not. “Sometimes my projects don’t fit into the available categories,” said Olson. “Selecting from the templates should be an optional not a mandatory way to start. This should be changed in future releases.”

Olson also ran into some difficulty when trying to import a client’s AutoCAD files. Because the SmartDraw Legal Solution doesn’t currently support the latest AutoCAD file format, his client had to convert the files to an older format. Olson would like to see a smart import filter in the next version that would provide information when trying to import an incompatible file format.

That said, Olson praises SmartDraw.com’s in-house tech support for helping him figure out the problem. He considers the SmartDraw Legal Solution’s free tech support one of its biggest benefits. The fact that it’s free suggests that the company is not overwhelmed with support calls. We wish more software companies would provide free support as an incentive to develop intuitive products that rarely require support.

Visualizing A Revocable Trust

Have you ever tried to explain to a client how a revocable trust works in conjunction with a pour-over will? In less than 100 words? Jason Havens prefers charts, and so do his clients.

Havens focuses on estate and charitable gift planning in the Florida panhandle. He has become so good at chart-making with the SmartDraw Legal Solution that SmartDraw.com now includes some of his charts in the software and invited him to serve as an Advisory Board member. His charts feature snappy pictures of homes, dollar bills, and families next to connected boxes labeled according to type — a trust, estate, or charity. After looking at one for a minute, a revocable trust doesn’t seem so complicated after all.

“The SmartDraw Legal Solution allows me to do what I want to do and show the client in an easy way. That’s where the rubber hits the road for lawyers,” Havens said.

Before he started using the SmartDraw Legal Solution, Havens used PowerPoint, but found it too difficult to move objects around and change fonts. For this reason he’s especially fond of the SmartDraw Legal Solution’s ability to snap objects to a page. He also finds the export function useful when he wants to insert diagrams into Excel, PowerPoint, Visio, or Word documents, or save them as PDF files.

SmartDraw.com has not incorporated all of Havens’ submissions into the program. As a result, Havens is lobbying SmartDraw.com to host a community on its Web site for users to upload and share their templates. This way “even if SmartDraw decides not to incorporate someone’s template, another user can still find another template that would be useful,” he said.

He also has a few quibbles with the program itself. “I sometimes find it difficult to detach objects from an organizational tree,” he said. “For example, if we want to move a trust from one part of the plan to another, it’s not always easy to do that because the objects are ‘snapped’ to the workspace. The snapping effect is definitely an advantage, but it can make reconfiguration and changes a bit more difficult at times.”

Havens sometimes finds it “challenging” to resize his organizational trees. “SmartDraw does an excellent job of maintaining spatial ratios and relationships among connected objects. However, there are times when we want to manipulate the space within an organizational tree, for example, to show that two trusts are very separate and allow space for text boxes to explain them a bit. Occasionally we run into problems grabbing a line or part of the tree to accomplish this.”

As for his wish list, Havens relies so heavily on the SmartDraw Legal Solution, he would like it to share data with case management, document assembly, and other legal-specific programs — perhaps via an API. “That way, I could auto-generate a particular flowchart created with the SmartDraw Legal Solution that includes client-specific information.”

From Blueprints and Trusts to Patent Applications

Al Harrison of Harrison Law Office worked as a computer system designer and software analyst for 15 years before he turned to computer law and intellectual property. As a former engineer, he said that he has “a profound appreciation for good quality software and hardware.”

When Harrison files a patent application for computer hardware or software, he creates hierarchical system flow diagrams. “That can get pretty complicated,” Harrison said.

Recently, he created a chart for a patent application that used assorted shapes to illustrate different entity relationships — a concept nearly impossible to glean from a narrative description. Harrison needed a diagram. He turned to the SmartDraw Legal Solution.

Harrison uses a lot of lines in his diagrams. As a result, he points to the SmartDraw Legal Solution’s drag and drop arrows and lines in the “Connector Bar” as one of his favorite features. He also praises the SmartDraw Legal Solution’s “treasure trove of templates” and the 50,000 elements (symbols, images, and other graphics) from which to choose when he builds charts.

“If you make a judicious choice of a proper template it saves you a lot of work and comes out looking like a professional drawing,” he said.

Harrison also likes the SmartDraw Legal Solution’s integrated tutorials. Whenever you click on a new screen, a tutorial becomes available that explains your options and guides you through a series of screens to the function that you need.

When asked what the SmartDraw Legal Solution could improve, Harrison joked “It does such a good job that you sometimes get the false impression that it can do everything, like illustrate a clandestine security system or fanciful external landscaping.” He’s currently using one of the office plan templates to design his new office.

Notwithstanding his praise, Harrison does see room for improvement, especially with regard to its file management capabilities. For example, he would like the ability to open several files simultaneously. Equally important, Harrison thinks the SmartDraw Legal Solution should “remember folders and subfolders from which files are retrieved and to which files are saved” to prevent saving files in the wrong location. Finally, Harrison would like the ability to create a “sub-template” from existing templates because he sometimes needs only a portion of a template for his patent illustrations.

Large Firms Like it Too

The SmartDraw Legal Solution has also attracted the attention of larger firms. Beverly C. Seche, the Assistant IT manager at New Jersey-based Stark & Stark, oversees 250 users. She has already bought 20 licenses of the SmartDraw Legal Solution, including 10 last week for a group of paralegals clamoring for their own copy.

Conclusion

Every once in a while, a product comes along that creates a new category in the legal market. The SmartDraw Legal Solution is such a product — the only illustration software designed from the ground up for lawyers. Given its success, competitors will likely surface, but for the time being, if you need to translate legalese into charts and diagrams, the SmartDraw Legal Solution merits a serious look given its loyal and growing user base. www.smartdrawlegal.com

© 2006 PeerViews Inc. Reprinted here by permission.

Today’s post is a guest feature from TechnoReview, a new service of TechnoLawyer. TechnoReview is a monthly newsletter that features legal product reviews from multiple perspectives as well an average TechnoScore. Tech expert Jill Bauerle interviews users and reviews the latest versions of many legal products and services. Best of all, TechnoReview is free. Subscribe now to TechnoReview and any of our other newsletters here.

The biggest invention news this week has not been American Inventor but an update to the way patent applications are filed. While we’ve been participating in the beta testing program for months now, the United States Patent and Trademark Office’s (USPTO) has officially released the new electronic filing system (EFS-Web) that will allow applicants to file over the Internet.

The new system offers a number of advantages including patent applicants can file applications and related documents using the Internet without the need for specialized software. Users of PASAT (or attempted users, as the case may be) will certainly cheer over this. And no, not that one. In the new system, applicants submit documents by simply creating applications and related parts as normal, converting these to PDF files and then uploading the PDF files directly over the web. If you don’t have Adobe Acrobat, you can use other PDF creators, e.g., CutePDF (we just love it for the name). Patent fees can also be paid over the Internet using a credit card.

EFS-Web submissions are automatically processed through the USPTO so patent filers receive rapid access to their applications through the Patent Application Information Retrieval (PAIR) system. In my experience with using the system, I found that I can view submissions and confirm that documents have been securely and accurately received almost instantaneously. Most importantly, you receive an automatic electronic filing receipt immediately upon uploading – no more return postcards to get lost!

The PTO is planning to add additional functionalities over the coming months but we already think this is a giant step for Mankind.

For more information on EFS-Web, see here.

The Food and Drug Administration (FDA) released an initial list of priority research projects that could advance innovation in medical products. The announcement of the Critical Path Opportunities List signals the next major step in FDA’s Critical Path Initiative aimed at modernizing medical product development, so new medical discoveries are brought to patients faster and at a lower cost.

Critical Path is the FDA’s initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments by creating new tools to find answers about how the safety and effectiveness of new medical products can be demonstrated in faster timeframes with more certainty, at lower costs, and with better information.

The Opportunities List outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies.

The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers; clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. FDA’s outreach efforts uncovered a consensus that the two most important areas for improving medical product development are biomarker development and streamlining clinical trials.

Over the next few weeks, the FDA will identify several priority Critical Path research opportunities. Some of the projects in the list could be undertaken by one organization; some will require collaborations coordinated and supported by the FDA.

Information on the Critical Path Initiative, is available here.

The European Medicines Agency (EMEA) published a set of five final guidelines on similar biological medicinal products. They are intended to give guidance to industry in the development of this new type of applications for marketing authorisation.

They give guidance on quality, non-clinical and clinical issues. The product class specific annexes to the guideline on non-clinical and clinical issues give guidance for certain classes of medicines: those containing insulin, containing somatropin and those containing recombinant granulocyte-colony stimulating factor (an annex for medicines containing epoetin will also be available soon). The guidelines come into effect from June 1, 2006.

EMEA has also published two new concept papers. The first is a concept paper on comparability of biotechnology-derived medicinal products after a change in the manufacturing process (non-clinical and clinical issues). The second is a concept paper on immunogenicity assessment of therapeutic proteins.

The guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance addresses (a) when a change is introduced in the manufacturing process of a given product (either before the granting of a marketing authorization or after the granting of a marketing authorization) and (b) when a product is claimed to be similar to another one already authorized in the EU after the expiry of the data protection period.

The guideline addresses the requirements regarding manufacturing processes, the comparability exercise for quality, considering the choice of reference product, analytical methods, physicochemical characterization, biological activity, purity and specifications of the similar biological medicinal product. A company may choose to develop a new biological medicinal product claimed to be similar (Similar Biological Medicinal Product) in terms of quality, safety and efficacy to an original, reference medicinal product, which has been granted a marketing authorization in the EC.

Similar biological medicinal products are manufactured and controlled according to their own development, taking into account relevant and up-to-date information. Comparison can be made against the official data, e.g. pharmacopoeial monographs or against other published scientific data. However, such comparisons at the level of both active substance and finished product are limited and not sufficient to establish all aspects pertinent to the evaluation. Consequently, an extensive comparability exercise will be required to demonstrate that the similar biological medicinal product has a similar profile in terms of quality, safety and efficacy to the reference medicinal product.

The manufacturer developing similar biological medicinal products would normally not have access to all necessary information that could allow an exhaustive comparison with the reference medicinal product. Nevertheless the level of detail must be such that firm conclusions can be made. Based on the comparability approach and when supported by sufficiently sensitive analytical systems, the comparability exercise at the quality level may allow a reduction of the non-clinical and clinical data requirements compared to a full dossier.

The similar biological medicinal product may refer to the non-clinical and clinical data previously generated with the reference product; however, non-clinical and clinical data will normally be required as identified in related non-clinical and clinical guidelines on similar biological medicinal products.

The guideline addresses quality issues during demonstration of comparability for Similar Biological Medicinal Products containing recombinant DNA-derived proteins. As a consequence, the principles adopted and explained in this document apply to proteins and peptides, their derivatives and products of which they are components (e.g. conjugates).

The similar biological medicinal product, as for any other biological medicinal product is in part defined by its own specific manufacturing process for both active substance and medicinal product. These processes should be developed and optimized taking into account state-of-the-art information on manufacturing processes (i.e. expression system / cell substrate, culture, purification, viral safety, excipients, formulation, primary packaging interactions, etc.) and consequences on product characteristics.

In addition, each medicinal product is defined by the molecular composition of the active substance resulting from its process, which may introduce its own process related impurities. Consequently, the similar biological medicinal product is defined by the following two sets of characteristics: i) related to the characteristics of the molecule (including product related substances/impurities), and ii) related to its process (which may affect molecular characteristics and includes process related impurities).

The Applicant must demonstrate the consistency and robustness of his own process according to existing guidelines. Formulation studies should be considered in the course of the development of a suitable dosage form, even if excipients are qualitatively and quantitatively the same as the reference product. These studies should demonstrate the suitability of the proposed formulation with regards to stability, compatibility (i.e. with excipients, diluents and packaging materials), and integrity of the active substance (both biologically and physico-chemically) for its intended medicinal use.

As is the case for any biotechnology-derived medicinal product, a comparability exercise should be considered when a change is introduced into the manufacturing process (active substance and finished product) during development. For the purposes of clarity, any comparability exercise(s) for process changes introduced during development should be clearly identified and addressed separately from the comparability exercise versus the reference product. It is not expected that the quality attributes in the similar biological and reference medicinal products will be identical.

Adopted Guidelines