Patent Baristas

[This is the eighth in a series of postings regarding the various proposals in the Patent Act of 2005.]

Inter Partes Reexamination

The American Inventor’s Protection Act (The American Inventors Protection Act was enacted November 29, 1999, as Public Law 106-113 (AIPA) introduced the concept of inter partes reexamination prospectively (post-1999). (35 U.S.C. 314). This proposal would expand the availability of this procedure to all patents. It favors both the patentee and the non-patentee in different respects.

This form of reexamination is intended to be an alternative/improvement to the pre-existing ex parte reexamination. Inter partes reexamination may be requested by any third party and they are permitted to present prior art (comprising prior patents and printed publications) for review by a patent examiner. The requestor may also file comments on the patentee’s response to the prior art presented.

BUT, if the requestor fails, they have sealed their own coffin. The requestor is estopped from challenging any fact, in court, that was established during the inter partes reexamination procedure, unless that fact is later found to be erroneous based on information that was unavailable at the time of the inter partes reexamination.

Inter partes reexamination may lessen the volume of patent litigation but it is unlikely that this method will be utilized by potential defendants unless they have an airtight argument. When such arguments exist, however, this proposal offers a significantly less expensive alternative to infringement.

Previous: Part 7. Continuation Applications.
Next Up: Part 9. Prior User Rights.

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

Here at Patent Baristas, we love the mystery and intrigue that comes with litigation to establish priority of invention. These matters often bring out juicy details worthy of a good Dynasty episode.

In a particularly protracted example, the U.S. Court of Appeals for the Federal Circuit, in Medichem, S.A., v. Rolabo, S.L. (05-1179, 05-1248), reversed the priority rights between U.S. Patent No. 6,084,100 (the 100 patent), assigned to Medichem, S.A. (Medichem), and U.S. Patent No. 6,093,827 (the 827 patent), assigned to Rolabo, S.L. (Rolabo).

The District Court found the existence of an interference-in-fact and awarded priority of invention to Medichem but the CAFC reversed the courts award of priority to Medichem, based on the insufficiency of the evidence that Medichem introduced at trial to corroborate the testimony of its inventors regarding reduction to practice of the invention.

Rolabos 827 patent and Medichems 100 patent both claim a process for making loratadine, the active ingredient in the allergy medication Claritin. The only significant difference between the processes claimed by Medichem and Rolabo is that Medichems process, which requires a tertiary amine, is a species within the genus of the Rolabo invention.

The first step in an interference analysis is for the court to determine whether an interference exists under 35 U.S.C. §291 by asking whether the patents . . . have the same or substantially the same subject matter in similar form as that required by the PTO pursuant to 35 U.S.C. § 135. In order to make this determination, the court uses the two-way test which states that two patents interfere only if (1) invention A either anticipates or renders obvious invention B, where Party A‘s claimed invention is presumed to be prior art vis-à-vis Party B and (2) vice versa.

The Federal Circuit looked at whether the district court erred in awarding priority of invention to Medichem based on the oral testimony of Medichem co-inventors, testimony that Rolabo claims was not corroborated by independent evidence, and thus should not have been credited in the final determination of whether reduction to practice was established before the critical date.

Priority of invention goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice. The key issue on appeal was whether Medichem provided adequate corroboration of the inventor’s testimony regarding the alleged actual reduction to practice.

In a case involving reduction to practice, an unwitnessed notebook is insufficient on its own to support a claim of reduction to practice. In addition, the court stated that when an inventor claims a process for making a chemical compound rather than the compound itself, it is the successful reduction to practice of the process that must be corroborated, and not merely the successful production of the compound per se.

Medichem produced a documented request for the analysis of a loratadine sample, purported to have been produced via the claimed synthetic route, which was sent by one co-inventor to another. It also included the original laboratory notebook of co-inventor Dr. Rodriguez as well as the original laboratory notebook of former Medichem employee, and non–inventor, Lola Casas.

In its review, the CAFC stated that:

This court now turns to consider the corroborative value of the three principal pieces of potentially corroborative evidence: the NMR spectra, the notebooks of Medichems inventors, and the notebook of non-inventor Casas. We note at the outset that the problem with the dated NMR data is that at most they corroborate that the inventors were in possession of the chemical loratadine as of that date; they do not, in themselves, adequately corroborate the claimed process, as they do not establish whether the sample that was analyzed was actually produced by that process.

Not helping their cause was Medichem admitting to fraudulently backdating certain documents relating to a purported 1995 reduction to practice.

In the end, the CAFC held that:

Where a laboratory notebook authored by a non-inventor is offered into evidence pursuant to authentication by an inventor, where the author of the notebook has not testified at trial or otherwise attested to its authenticity, and where the notebook has not been signed or witnessed and has not been maintained in reasonable accordance with good laboratory practices sufficient to reasonably ensure its genuineness under the circumstances, then the corroborative value of the notebook is minimal. Given the facts of this case, Casas notebook should therefore not be accorded much corroborative value. In view of the minimal corroborative value of the inventor’s notebooks and the limited value of the NMR spectrum, we conclude that the evidence, evaluated as a whole under the rule of reason, is insufficient as a matter of law to corroborate Medichems reduction to practice.

See the entire opinion here.

[This is the seventh in a series of postings regarding the various proposals in the Patent Act of 2005.]

Continuation Applications

Ah, the ghost of Jerome Lemelson lives and continues to rattle his chains. (Even though his patents were adjudged invalid in Symbol Technologies Inc. et al. v. Lemelson Medical, Education & Research Foundation LP et al., No. 04-1451, 2005 WL 2173572 (Fed. Cir. Sept. 9, 2005)). Lemelson was a prolific inventor and obtained more than 500 patents in his lifetime. He is famous for the patents covering the use of bar code readers. In patent circles, however, he is even more famous for his method of submarine patenting. Lemelson kept patent applications alive in the U.S. Patent and Trademark Office for years, through a multitude of continuation applications, and then secured patent grants and attacked infringers for technology disclosed within the applications after widespread commercial use of the technologies had evolved.

Congress addressed this practice when they changed the patent term from seventeen (17) years from the date of issue to twenty (20) years from the date of filing. These changes arise from the GATT Uruguay Round implementing legislation (P.L. 103-465). The provisions relating to patent term went into effect on June 8, 1995. But in rapidly moving industries, particularly software, even twenty years has generated outcry that the monopoly granted by law is overly stifling to innovation.

So the proposed legislation allows the USPTO to issue regulations limiting continuation applications to address supposed continuing abuses. This is a dangerous idea that seems to be mainly directed at reducing workload in the patent office. (See also, the proposed Changes to Practice for the Examination of Claims in Patent Applications (DEPARTMENT OF COMMERCE Patent and Trademark Office, 37 CFR Part 1 [Docket No.: 2005P067] RIN 0651AB94) which were filed on December 30, 2005.) Intervening rights allow competitors to practice material that is claimed in a reissued or reexamined patent application.

This protects investment and limits the effect of submarine patents even within the twenty year patent term. (35 U.S.C. 252). Otherwise, inventors should be able to pursue patents on anything in an active application that meets the requirements of patentability.

Previous: Part 6. Injunctions.
Next Up: Part 8. Inter Partes Reexamination.

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

In an appeal from the USPTO Board of Patent Appeals and Interferences (Board), the U.S. Court of Appeals for the Federal Circuit (05-1119; Interference No. 103,586), in Brown et al. v. Barbacid et al., looked at an invention priority determination (interference” proceeding).

In an interference between Brown and Barbacid over an assay for identifying compounds that inhibit farnesyl transferase (“FT”), an enzyme involved in the control of cell growth, the CAFC reversed Board’s holding that Brown’s reasonable diligence had not been demonstrated. The CAFC held that a laboratory notebook recording daily experimentation does not need to include on every page a statement of the larger research purpose.

The contested subject matter is stated in the interference count was:

A method for identifying a candidate substance having the ability to inhibit a farnesyl transferase enzyme, comprising the steps of:
(a) obtaining an enzyme composition comprising a farnesyl transferase enzyme that is capable of transferring a farnesyl moiety to a farnesyl acceptor substance;
(b) admixing a candidate substance with the enzyme composition and farnesyl pyrophosphate; and
(c) determining the ability of the farnesyl transferase enzyme to transfer a farnesyl moiety to a farnesyl acceptor substrate in the presence of the candidate substance and in the absence of the candidate substance

Earlier, the Board held that Brown had established conception no later than November 15, 1989, but had failed to provide corroborated evidence of diligence and awarded priority to Barbacid.

The party that is first to conceive the invention in interference, if last to reduce the invention to practice, is entitled to the patent based on prior conception if, as first to conceive, he exercised reasonable diligence from a time before the other party’s conception date to his own reduction to practice date.

The purpose of requiring reasonable diligence by the first to conceive the invention but second to reduce to practice is to assure that the invention was not abandoned or unreasonably delayed by the first inventor during the period after the second inventor entered the field. The question of reasonable diligence is one of fact. The admissibility of physical and testimonial evidence is determined in accordance with the Federal Rules of Evidence.

Barbacid argued that Brown must show diligence measured from the Barbacid date of conception, not Barbacid’s date of reduction to practice. Brown provided evidence from inventor Dr. Reiss and laboratory technician Ms. Morgan concerning the exercise of reasonable diligence during the period from Barbacid’s accorded date to Brown’s filing date. Dr. Reiss stated that after September 1989 he worked on the farnesyl transferase project “on a daily basis.” For the period following Barbacid’s actual reduction to practice on March 6, 1990, Dr. Reiss stated that his experiments were directed at further characterizing the FT enzyme, improving the methodology for purifying the enzyme, and improving the overall performance of the assay. He provided laboratory notebook pages recording this work.

The Board rejected Dr. Reiss’ testimony for lack of corroboration, and also observed that even if his notebook records showing this work were deemed to corroborate his testimony, they recorded work on only ten of the thirty-one days from March 6 to April 18, and thus were insufficient to establish reasonable diligence.

Precedent requires that an inventor’s testimony concerning his diligence be corroborated. But, unlike the legal rigor of conception and reduction to practice, diligence and its corroboration may be shown by a variety of activities, as precedent illustrates. The CAFC stated that:

The basic inquiry is whether, on all of the evidence, there was reasonably continuing activity to reduce the invention to practice. There is no rule requiring a specific kind of activity in determining whether the applicant was reasonably diligent in proceeding toward an actual or constructive reduction to practice.

The Board found that Ms. Morgan “worked for the inventors” and that “her work could inure to the benefit of the inventors to establish reasonable diligence over the entire period. “However, the Board refused to credit any of Ms. Morgan’s evidence, criticizing what it described as the absence of explanation of the content and purpose of these experiments.

The CAFC then held that:

We conclude that the Board erred in law, in failing to view the proffered evidence as it would be viewed by persons experienced in the field of the invention. See Mahurkar, 79 F.3d at 1577-78 (the trier of fact is aided by an understanding of how the evidence would be viewed by one skilled in the art). The Board is charged with expertise appropriate to the invention under examination, and with understanding that a laboratory notebook recording daily experimentation, reasonably considered from the viewpoint of persons experienced in the field, need not reproduce on each page a statement of the larger research purpose; this purpose may reasonably be shown in the various declarations.

It is undisputed that the subject matter recorded on the Morgan notebook pages and described in her declaration concerns the subject matter of the count. This is the same form and content of evidence that the court in Brown I deemed admissible for purposes of showing conception. The Board agreed that Ms. Morgan’s activity during the critical period, if accepted into evidence, established diligence. We conclude that the Board erred in refusing to accept this evidence, and that reasonable diligence is deemed established.

The Board’s holding that Brown’s reasonable diligence had not been shown was reversed and the case remanded for a determination on patentability.

See the entire opinion here.

[This is the sixth in a series of postings regarding the various proposals in the Patent Act of 2005.]

Injunctions

And we’re back to the original law in this match of patent reform ping-pong. (35 U.S.C. § 283 mandates that the courts may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent on such terms as the court deems reasonable). The pro-defendant proposal, which was removed in the latest round of amendments, would have required a court to consider the fairness of an injunction in light of all the facts and the relevant interest of the parties by codifying that “an injunction may be stayed pending appeal upon … showing that the stay would not result in irreparable harm to the patent owner.” It sought to overturn a recent ruling by the Court of Appeals for the Federal Circuit (CAFC). (MercExchange, L.L.C. v. eBay, Inc. et al., (CAFC – Docket No. 03-1600, March 16, 2005)).

In that case, MercExchange challenged the district court’s refusal to enter an injunction against the defendant. Courts may decline to enter an injunction when such a refusal may serve the public interest, such as the need to use an invention to protect the public health. But the CAFC did not feel that sufficient public interest was served by the “growing concern over the issuance of business method patents.” Neither was the CAFC persuaded by the District Court’s fear that an injunction would result in continuing disputes over whether the defendants’ subsequent actions would also violate MercExchange’s rights – that is, create more work for them.

Injunctions are further not reserved for patentees who intend to practice their patents, as opposed to those who choose to license (not so affectionately called patent trolls). The statutory right to exclude is equally available to both groups. The CAFC ruled that courts should issue permanent injunctions against patent infringement absent exceptional circumstances.

Stay tuned, the Supreme Court may beat the legislature to a decision on this issue as they just granted cert for this case. (MercExchange, L.L.C. v. eBay, Inc. et al., (CAFC – Docket No. 03-1600, March 16, 2005), cert granted, (No. 05-130), November 28, 2005.)

Previous: Part 5. Apportionment of Damages for Infringement in the Case of a Combination.
Next Up: Part 7. Continuation Applications.

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

[This is the fifth in a series of postings regarding the various proposals in the Patent Act of 2005.]

Apportionment of Damages for Infringement in the Case of a Combination

If 35 U.S.C. 271(f) remains unchanged, there may be some relief offered to defendants by the proposal that damages should be assessed according to the inventive contribution of the patent rather than the product taken as a whole. In determining a reasonable royalty, the court shall consider the portion of the realizable profit or value that should be credited to the inventive contributions arising from the claimed invention as distinguished from contributions arising from features, manufacturing processes or improvements added by the infringer and from the business risks the infringer undertook in commercialization.

Emery Simon, giving testimony for the Business Software Alliance, (Before the United States House of Representatives Committee on the Judiciary Subcommittee on Courts, the Internet, and Intellectual Property Hearing on: An Amendment in the Nature of a Substitute to H.R. 2795 the “Patent Reform Act of 2005” (September 15, 2005)) objects to codifying a modified version of factor #13 of the Georgia Pacific case.

That case actually directs the court to look at the contribution from the “claimed invention” instead of the “inventive contribution.” Georgia-Pacific Corp. v. United States Plywood Corp., 318 F.Supp 1116, 1120 (SDNY 1970), modified and aff’d sub nom., Georgia-Pacific Corp. v. United States Plywood-Champion Papers, 446 F2d 295 (2d Cir. 1971), cert. denied, 404 US 870 (1971). Mr. Simon is concerned that “the damage claim often seeks some portion of the product as a whole, … such as a computer, rather than being limited to only the value of the infringing feature. This often leads to unduly inflated verdicts or settlement demands, and is unworkable when thousands of patents can apply to a single product.” (Before the United States House of Representatives Committee on the Judiciary Subcommittee on Courts, the Internet, and Intellectual Property Hearing on: An Amendment in the Nature of a Substitute to H.R. 2795 the “Patent Reform Act of 2005” (September 15, 2005).

But Philip S. Johnson, on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), (Before the United States House of Representatives Committee on the Judiciary Subcommittee on Courts, the Internet, and Intellectual Property Hearing on: An Amendment in the Nature of a Substitute to H.R. 2795 the “Patent Reform Act of 2005” (September 15, 2005)) offers the counterpoint that this kind of analysis would undermine the reasonable royalty determination because “A patented invention should not be dissected into its subparts … and then evaluated piecemeal … the true value of the invention will likely be lost.”

The problem is that a reasonable royalty is a difficult thing to determine no matter how many factors you throw into the framework. Even if an inventive contribution is small, it may be the lynchpin which sells the entire product. On the other hand, the inventive contribution may be the thinnest differentiation against the known prior art.

The proposed legislation, however, overlooks some additional “wiggle” factors, cited in Georgia-Pacific, to consider in a damages assessment, including the opinion testimony of qualified experts and the nature of the patented invention, its character in the commercial embodiment owned and produced by the licensor, and the benefits to those who used it.

It may be better to rely on these as the means for assessing the inventive contribution rather than codifying a rigid formula.

Previous: Part 4. Willful Infringement and Repeal of §271(f) for Software.
Next Up: Part 6. Injunctions.

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

[This is the fourth in a series of postings regarding the various proposals in the Patent Act of 2005.]

Willful Infringement

The phrase treble damages strikes terror into the heart of all non-patentees. It further promotes a balancing act between maintaining an ostrich mentality and risking that curiosity will kill the cat. An individual who is about to invest in a new technology must choose between allocating resources to determine what is out there or putting on their darkest sunglasses for fear that they may come across a patent that may potentially cover what they are doing. Note that courts/juries decide whether or not a patent actually covers a given technology. A well-drafted freedom-to-practice opinion from a licensed patent attorney may protect one from a willful infringement claim but it will not necessarily protect one from a finding of infringement even when there is a good argument to the contrary.

One area that is still being considered is whether a court or a jury will be responsible for the willfulness determination. The changes proposed here seek to make sure that the infringer willfully infringed rather than fictionally assuming that they infringed because they (or more likely their attorneys) may have glanced at the patent at some point. The proposal would codify that a court may find an infringer guilty of willful infringementif the patentee presents clear and convincing evidence meaning that the fact-finder must be persuaded by the evidence that it is highly probable that the claim or affirmative defense is true – that:

1. the infringer received written notice from the patentee either alleging specific acts of infringement AND the infringer, after a reasonableopportunity to investigate, infringes anyway;
2. the infringer received written notice from the patentee educating the infringer with the specific claims of his patent and identifying the product/process which he believes infringes those claims AND the infringer, after a reasonable opportunity to investigate, infringes anyway;
3. the infringer intentionally copied the patented invention with knowledge that it was patented;
4. after being found guilty of infringement, the infringer CONTINUES to infringe;
5. after being found guilty of infringement, the infringer is, again, found guilty of infringement of the same patent for behavior that is not substantially different from the original finding of infringement.

A good faith belief that the patent was invalid or unenforceable, based upon advice from a licensed patent attorney, may serve as a defense to willful infringement.

These proposed changes are good for the progress of the arts and sciences because they allow individuals to make a reasonable assessment a technology area and then make an educated decision about whether or not to proceed without being crippled with fear from the specter of increased damages.

Repeal of §271(f) for Software

Section 271(f) reads:

(1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

(2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial non-infringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

Oh boy, is this a complicated one! Here’s the deal. United States Patent law allows the patentee to exclude others from making, using, selling, and exporting the patented invention. But, once upon a time, some clever people figured out that they could export the pieces that make up the patented invention (or a major component thereof) without running afoul of the patent holders exclusion rights (since exporting components was not part of the exclusionary rights granted by the law). They would assemble the patented invention abroad, outside of the jurisdiction of U.S. law, and then sell it abroad.

So, around 1984, Congress put a stop to this kind of thing by allowing patent holders to tag those clever people as infringers. The patent holders could then get damages on both the domestic and foreign sales of the finished product.

There was some doubt as to whether this would apply to software but the Court of Appeals for the Federal Circuit recently held (Eolas Techs. v. Microsoft Corp., 399 F.3d 1325, 1339 (Fed. Cir. 2005)) that these damages are not limited to physical machines. This proposal seeks to overturn that ruling by requiring that 35 U.S.C. 271(f) only apply to tangible items.

This is good for software developers who partially develop in the United States and then sell abroad. If the statute remains unchanged, it creates a potent argument for moving all development of software outside of the United States.

Previous: Part 3. Duty of Candor in Front of the USPTO.
Next Up: Part 5. Apportionment of Damages for Infringement.

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

Last June, we detailed that the U.S. Court of Appeals for the Federal Circuit upheld a trial court decision that three patents held by Purdue Pharma LP couldn’t be enforced because of misrepresentations to the U.S. Patent and Trademark Office about the painkiller’s effectiveness thus giving Endo Pharmaceutical Holdings Inc. the right to sell a generic version. OxyContin, a time-release painkiller generally prescribed to cancer patients and chronic-pain sufferers, had about $2 billion in sales last year.

A combined petition for panel rehearing and rehearing en banc by Purdue Pharma was filed along with amicus briefs by the Biotechnology Industry Organization; Richard L. Edelson, M.D.; the International Intellectual Property Institute; Congressman Darrell Issa; Law Professors John F. Duffy, et al.; the Pharmaceutical Research and Manufacturers of America; and the Washington Legal Foundation. The CAFC then granted the panel rehearing and withdrew the previous opinion and issued a new one.

This was a patent infringement case in which the patents were held unenforceable by the trial court due to inequitable conduct during prosecution before the USPTO. The district court found that Endo would infringe Purdue’s patents, but determined the patents were unenforceable due to the inequitable conduct that occurred during prosecution. Purdue then appealed the inequitable conduct judgment.

For a claim of inequitable conduct, applicants for patents have a duty to prosecute patents in the PTO with candor and good faith, including a duty to disclose information known to the applicants to be material to patentability. A breach of this duty may constitute inequitable conduct, which can arise from an affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive or mislead the PTO. A party asserting that a patent is unenforceable due to inequitable conduct must prove materiality and intent by clear and convincing evidence.

Regarding materiality, the court stated that:

A failure to inform the PTO whether a “surprising discovery” was based on insight or experimental data does not in itself amount to a material omission. In this case, however, Purdue did much more than characterize the four-fold dosage range of the claimed oxycodone formulation as a surprising discovery. Purdue repeatedly relied on that discovery to distinguish its invention from other prior art opioids while using language that suggested the existence of clinical results supporting the reduced dosage range. Presented with these unique facts, we cannot say the trial court erred in finding that Purdue failed to disclose material information to the PTO. … Some language in its opinion, however, indicates the trial court considered Purdue’s failure to tell the PTO the basis for its discovery to be highly material. As discussed below, the trial court may have erred to the extent it relied on a high level of materiality in determining whether Purdue intended to deceive the PTO and whether Purdue ultimately committed inequitable conduct.

Regarding intent, the court stated that:

Intent to deceive, however, cannot be “inferred solely from the fact that information was not disclosed; there must be a factual basis for a finding of deceptive intent.” Hebert v. Stryker SalesLisle Corp., 267, 99 F.3d 1370, 13811109, 1116 (Fed. Cir. 1996). When determining whether intent has been shown, a court must weigh all evidence, including evidence of good faith. Baxter, 149 F.3d at 1330.

…

While Purdue alleged during prosecution that ease of titration would result from a reduced dosage range, the two concepts are different. Furthermore, the quantum of proof necessary for FDA approval is significantly higher than that required by the PTO. Therefore, evidence that Purdue personnel believed it would be difficult to satisfy FDA requirements is at best marginally related to whether they intended to deceive the PTO. For these reasons, the trial court erred in giving the weight it did to this evidence when determining that Purdue acted with deceptive intent during prosecution of its patents.

Purdue then claimed that the trial court erred by importing the four-fold dosage range limitation into the claims and that, if the claims do not include that limitation, the CAFC should affirm the trial courts infringement determination because Endo does not dispute that its product satisfies the remaining claim limitations.

Regarding infringement, the court stated that:

In this case, the trial court concluded that during prosecution Purdue “deliberately and clearly relinquished, disclaimed and surrendered controlled release oxycodone formulations that do not control pain relief in approximately 90% of patients with an approximately four-fold dosage range.” Purdue Pharma, 2004 WL 26523, at *14. We agree with Purdue that it made no such disclaimer or disavowal, and the trial court’s holding to the contrary was in error. While it is true that Purdue relied on its discovery of the four-fold dosage range to distinguish its claimed oxycodone formulations from other prior art opioids, Purdue’s statements do not amount to a clear disavowal of claim scope.

The CAFC then vacated the trial court’s judgment that the patents-in-suit are unenforceable due to inequitable conduct and remanded the case for further proceedings consistent with this opinion. The trial court’s judgment of infringement was affirmed.

We’ll keep you posted on further developments.

See the revised Opinion here.

See the Order here.