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December 3, 2012

ACLU's Myriad Genetics Appeal to Be Heard by Supreme Court: Human Gene Patentability at Issue

DNA2.jpgOn November 30, 2012, the U.S. Supreme Court decided to consider the question of whether human genes are patentable subject matter. The American Civil Liberties Union ("ACLU"), representing petitioner Association for Molecular Pathology, challenged Myriad Genetics' patents claiming "isolated" DNA molecules. The ACLU's position is that such patents improperly claim laws of nature and, thus, are not patentable. The Federal Circuit Court of Appeals disagreed, however, determining that Myriad's claims to isolated DNA molecules are patent-eligible. Now, the Supreme Court may have the final word.

At issue is the patentability of human genes, i.e., DNA. Natural DNA exists in the human body as one of forty-six large, contiguous DNA molecules. In contrast, isolated DNA is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. The Federal Circuit reasoned that isolated DNA has a "markedly different chemical structure compared to native DNA." This is because isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, which imparts a distinctive chemical identity on that isolated DNA. Thus, the Federal Circuit decided that the "claimed isolated DNA molecules are distinct from their natural existence as portions of their larger entities" and are patent-eligible subject matter.

In its Supreme Court petition, the ACLU argued that patents on isolated DNA improperly claim products and laws of nature because isolated DNA is defined according to a naturally-occurring functional characteristic, namely coding for a naturally-occurring polypeptide. The ACLU alleges that isolated DNA does not have markedly different characteristics from DNA found in nature because both are DNA, their structures are not markedly different, the protein coded by each is the same, and their use in storing and transmitting information about a person's heredity is identical. Based on this, the ACLU believes that isolated DNA is not patentable subject matter.

Continue reading "ACLU's Myriad Genetics Appeal to Be Heard by Supreme Court: Human Gene Patentability at Issue" »

November 12, 2012

FLH Attends ITC Trial Lawyers Association Annual Meeting in Washington, D.C.

Thumbnail image for ITC.bmpOn November 7, 2012, FLH Partner Brian J. Malkin and Associate Christopher Gosselin were in attendance at this year's International Trade Commission Trial Lawyers Association Annual Meeting at the International Trade Commission ("ITC") in Washington, D.C. The theme of this year's meeting was the enforcement of ITC exclusion orders at the border, and the relationship between customs and the ITC.

ITC Chairman Irving A. Williamson opened the meeting, stressing his commitment to reducing the overall length of Section 337 Investigations from 16 months to 13.5 months. He also promised to continue efforts to reign in the cost of discovery during Section 337 Investigations.

During the refreshment break, guests were invited to view the new courtroom on the second floor, and heard brief remarks from Chief Administrative Law Judge ("ALJ") Charles E. Bullock. The new courtroom is spacious and well equipped with modern technology ranging from video projection screens to LCD monitors at every table. The courtroom should see plenty of use once it opens for business, as even with the new courtroom, the ITC still has more ALJs than available space. Although the ITC saw a 30% decrease in newly instituted investigations in 2012 after a record setting number in 2011, the ALJs continue to manage a near record level of active investigations.

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November 2, 2012

Gore Asks Supreme Court to Review Joint Inventorship Standard

Thumbnail image for Thumbnail image for Supreme Court.jpgOn October 12, 2012, W.L. Gore & Associates Inc. ("Gore") filed a petition for writ of certiorari with the U.S. Supreme Court, asking the High Court to review the Federal Circuit's denial of joint-inventor status to one of Gore's engineers. The patent-in-suit, U.S. Patent No. 6,436,135 ("the '135 patent") lists Dr. David Goldfarb ("Goldfarb") as the sole inventor (Bard is the assignee.), and Gore argues that Peter Cooper ("Cooper"), head of Gore's vascular prosthetic research program, should be listed as a joint inventor. Gore alleges that the Federal Circuit erred in setting forth a new standard for joint inventorship that directly conflicts with legislative intent and the plain text of the Patent Act.

In the district court, the jury held that Gore willfully infringed Bard's patent, and the judge doubled the jury's damage award, granting $371 million to Bard. The Federal Circuit affirmed the district court's decision in February 2012, and Gore filed a combined petition for panel rehearing and rehearing en banc. In June 2012, the Federal Circuit granted the motion for rehearing en banc, "for the limited purpose of authorizing the panel to revise the portion of its opinion addressing willfulness." Gore then filed the instant petition.

In the petition, Gore alleges that in 1971, it began a research program focused on the use of stretched Teflon® ("Gore-Tex®") in vascular prosthetics, or artificial blood vessels. Gore created implantable vessels with varying features, and hired doctors to implant the vessels and to report which ones were successful. Cooper then started an additional experiment involving the porousity of the tubes. Cooper sent small, medium, and large-pore tubes to the physicians, and the results showed that the large-pore tubes (which had a greater "internodal" distance" or "fibril length") were the winners. Based on this, Cooper conceived of the instant invention on May 1, 1973.

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October 16, 2012

FTC Asserts K-Dur Applies to Authorized Generic Deals

shaking hands.jpgThe Federal Trade Commission ("FTC") on October 5, 2012, again filed an amicus curiae brief asking a federal district court in New Jersey to apply the ruling in K-Dur to an authorized generic deal. The present deal under scrutiny is an agreement in which Teva Pharmaceutical Industries Ltd. ("Teva") promised to delay launching a generic version of the drug Lamictal® (lamotrigine), while GlaxoSmithKline PLC ("GSK") granted Teva an exclusive license to market a generic product thereby excluding the marketing an authorized generic.

The FTC encouraged the District Court to apply broadly the Third Circuit ruling in K-Dur that a payment from a patent holder to a generic drug company to delay the generic from entering the market is "prima facie evidence of an unreasonable restraint on trade." In re K-Dur Antitrust Litig., 686 F.3d 197, 218 (3rd Cir. 2012). However, as pointed out by Frommer Lawrence & Haug Associate Richard Kurz in an article recently published by FDAnews, it is unclear whether the Third Circuit considered authorized generic deals in the K-Dur ruling. This particular distinction is targeted by Teva and GSK claiming that, in contrast to K-Dur, no monetary payment occurred in the agreement under question.

Nonetheless, the FTC argues that the settlement between GSK and Teva is anticompetitive and should be prohibited in view of the findings in K-Dur. According to the FTC, under the Hatch-Waxman Act, Teva was entitled to receive 180 days of marketing exclusivity during which other generics were not approved to launch their product. However, this exclusivity does not preclude the brand company from launching an authorized generic during this period thereby competing with the generic. Competition from an authorized generic has the potential to reduce the profits of the generic supplier during this period by approximately half. Thus, under the settlement terms, Teva received the benefit of extra profits, anticipated to be hundreds of millions of dollars, during its generic exclusivity period while GSK enjoyed an extended period of brand exclusivity. The FTC argues that both of theses consequences hurt consumers. The FTC also asserts that prohibiting these types of "no-authorized generic" agreements would not generally prevent settlements as feared by Teva.

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October 1, 2012

Pay-for-Delay: U.S. Supreme Court Is Asked to Resolve the Differing Antitrust Standards Used for Pharmaceutical Patent Settlement Agreements

Thumbnail image for Thumbnail image for drugmoney.jpegOn September 21, FTC Commissioner Thomas Rosch commented on the differing antitrust standards that have been adopted by the U.S. Courts of Appeals when considering the legality of pharmaceutical patent settlements that include payments to patent challengers. A recent decision by the Third Circuit, In re K-Dur Antitrust Litigation ("K-Dur"), found that such "pay for delay" settlements create a rebuttable presumption that the settlement is anticompetitive. In contrast, in FTC v. Watson Pharmaceuticals, Inc. ("Androgel") the Eleventh Circuit recently held that such settlements are legal so long as they fall within the "scope of the patent" and there is not evidence of sham litigation or fraud in obtaining the patent. Rosch believes that this split between the circuits makes it likely that the Supreme Court will decide to consider the legality of such "pay-for-delay" settlements.

Pharmaceutical patent litigation often occurs under a legal framework called the Hatch-Waxman Act, in which a generic pharmaceutical manufacturer files an abbreviated new drug application ("ANDA") with a Paragraph IV certification that the branded pharmaceutical manufacturer's patents are invalid, not infringed, or unenforceable. Under this framework, the ANDA filing allows the patent owner to file a patent infringement lawsuit against the generic manufacturer before any infringing product is sold. Unlike other patent infringement lawsuits, this framework creates a situation in which the patent owner may not have suffered a monetary loss (called damages) at the time the patent litigation is settled. This situation leads to some settlements that include a payment from the patent owner to the generic manufacturer along with an agreement that the generic manufacturer will refrain from selling an infringing product for some period of time. The FTC refers to this type of settlement as "pay-for-delay."

As Rosch explains, the FTC has attacked "pay-for-delay" settlements as a violation of antitrust laws for several years. Many courts, however, have followed the Eleventh Circuit's scope of the patent test and have found such settlements legal because a patent gives its owner the right to exclude others from selling a patented product. Further, from a judicial policy perspective, it is preferable that parties settle litigation. Indeed, using this test the Eleventh Circuit previously found that the same settlement agreement at issue in the Third Circuit's K-Dur decision was legal. Adopting a different test, however, the Third Circuit decided that the settlement is potentially a violation of antitrust laws and remanded the question to the district court for further consideration.

Continue reading "Pay-for-Delay: U.S. Supreme Court Is Asked to Resolve the Differing Antitrust Standards Used for Pharmaceutical Patent Settlement Agreements " »

September 27, 2012

FLH Partner Malkin Quoted in FDAnews Article on Jazz's Recent Xyrem Markman Ruling

sleepingperson.pngIn a September 26 FDAnews article FLH Partner Brian J. Malkin was quoted regarding the latest decision. The article, "Jazz Appears to Win on Patent Claim Terms in Xyrem Fight." The article concerned a recent development in Jazz Pharmaceuticals' ("Jazz's") suit against generic competitor Roxane Laboratories ("Roxane"), where in an unpublished opinion, the District Court of New Jersey Judge Esther Salas Jazz appeared to side with virtually all of Jazz's claim constructions for the disputed terms in the patents-at-issue for Xyrem® (sodium oxybate), indicated for excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Malkin was quoted in the article as reproduced in the following passage:

One major upside for Jazz is that it could make it harder for Roxane to negotiate more favorable terms if it chooses to settle, Brian Malkin, a partner at Frommer Lawrence & Haug, noted.

Meanwhile, Jazz was also issued another Xyrem patent Sept. 11, which the company is submitting for listing in the FDA's Orange Book. This move could prolong the case, Malkin said, as Roxane would have to amend its ANDA, likely by filing a Paragraph IV certification.

Finally, Jazz has outstanding citizen petitions related to Xyrem generics, including a July petition that demands the FDA rescind its acceptance of the Roxane ANDA because Roxane did not submit material related to a proposed risk management strategy for Xyrem when it originally filed the application (Generic Line, Aug. 1). FDA rulings on the citizen petitions are due on Nov. 18 for the earlier bioequivalence standards petition and on Dec. 10 for the July petition, Faerm said.

Malkin believes the FDA will deny Jazz's citizen petition, given that it already accepted Roxane's ANDA. However, the courts may be more apt to side with Jazz, given this latest opinion

Continue reading "FLH Partner Malkin Quoted in FDAnews Article on Jazz's Recent Xyrem Markman Ruling" »

September 7, 2012

Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review

Thumbnail image for vaccine.jpgOn September 6, District of Columbia District Judge Amy Berman Jackson granted FDA's motion to dismiss claims brought by K-V Pharmaceutical Company ("K-V") either because the claims were unreviewable as discretionary FDA enforcement activities or failed to state a claim. Jackson's Memorandum Opinion helps solidify FDA's position that its discretion not to take an enforcement action is presumed to be immune from review unless Congress has otherwise provided "meaningful standards . .. for defining the limits of that discretion." (citing Heckler v. Chaney),

Makena™ is essentially a story about K-V's bid to take advantage of provisions under the Orphan Drug Act to obtain seven years of exclusivity to market the active ingredient in Makena™ (17-hydroxyprogesterone caproate) for women who have had a singleton pregnancy and a history of prior preterm delivery. Under the Orphan Drug Act, no other company can obtain approval to market the same active ingredient for this indication, which affects less than 200,000 patients per year in the United States, until this exclusivity would have expired. Prior to approval of Makena™, however, pharmacies had been compounding the same active ingredient for individual patients based on individual prescriptions--not a marketed product--at far less cost, around $10-20 per injection rather than the initial price of Makena™ at $1500 per injection, or up to $30,000 for the entire treatment. For more background, see, for example, an earlier blog here.

K-V had hoped that orphan drug approval would block competitors for seven years and its approval would make FDA take additional enforcement actions against pharmacies that had been routinely compounding the same active ingredient for the same indication. Indeed, many had feared, including a number of Congressmen, that FDA would take such actions, causing the cost of treatment to dramatically rise, under a general assumption that an approved drug product would be preferred, from a public health perspective, over a compounded product.

Continue reading "Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review" »

August 21, 2012

FLH Partner Malkin Quoted in FDANews Article on K-Dur® Pay-for-Delay Ruling

Thumbnail image for Money in hand.jpgOn August 21, FLH Partner Brian J. Malkin was quoted in an FDAnews Article on a August 17 ruling refusing to stay a ruling regarding a settlement for K-Dur® 20 (potassium chloride) that was found to be presumptively anticompetitive. As part of the settlement in question, Upsher-Smith Laboratories ("Upsher-Smith") did not agree that the patent-at-issue was valid, infringed, and enforceable, but did agree to refrain from marketing its generic potassium chloride supplement or any similar product until September 1, 2001, when it would receive a non-royalty, non-exclusive license under the patent to make and sell its generic version. Upsher-Smith also granted the innovator, Schering-Plough Corporation ("Schering-Plough") a license to several Upsher-Smith products, including Niacor-SR, a sustained niacin product. Schering-Plough also agreed to pay Upsher-Smith $60 million over three years plus additional royalties depending on its sales of Niacor-SR. After the settlement, however, Schering-Plough abandoned its plans to market Niacor-SR.

The Third Circuit originally held:

Specifically, the finder of fact must treat any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market as prima facie evidence of an unreasonable restraint of trade, which could be rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.
For more background on this case, please see one of our blogs here.

Malkin was cited in the article in the following manner:

Both brand and generic-drug makers are likely to try to find more creative ways to craft settlements if pay-for-delay deals are ultimately found to violate antitrust law, Brian Malkin a partner at Frommer Lawrence & Haug, told DID. For example, such settlements could involve more than just the drug product at issue in the case, making it less clear whether there is a pay-for-delay element.

A high court ruling against pay-for-delay could also affect companies' willingness to litigate certain patent cases, Malkin added.

Meanwhile, Congress may be waiting to see if and how the Supreme Court rules on this issue, Malkin said. A representative from Sen. Orrin Hatch's (R-Utah) office told him earlier this year that legislation targeting pay-for-delay deals is "likely on the backburner."

Meanwhile, Defendants Merck & Co. Inc. (the successor-in-interest after Schering-Plough) and Upsher-Smith have asked the U.S. Supreme Court to look into the Third Circuit's pay-for-delay ruling. In particular, the K-Dur ruling differs from other circuits that have found such payments legal in the context of a patent that is presumptively valid and an agreement to market by the expiration date of the patents-at-issue in return for ending the litigation. The U.S. Federal Trade Commission ("FTC") Chairman, Jon Leibowitz, has reportedly commended the Third Circuit for having "gotten it just right" in K-Dur,as the FTC plant to expand the holding into other cases pending in the Third Circuit and possibly other circuits pending the Supreme Court's deliberation whether to hear the appeal.

August 13, 2012

Federal Circuit Weighs in on Use Code Remand

Thumbnail image for Thumbnail image for Thumbnail image for federalcircuit.jpgThe U.S. Court of Appeals for the Federal Circuit recently rendered a follow-up ruling on remand from the Supreme Court's April 2012 decision regarding Orange Book use codes for method-of-use patents Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. The Federal Circuit held, in a July 30 ruling, that: (i) a district court can issue a mandatory injunction requiring the owner of the NDA for the brand product to correct a use code which inaccurately describes the FDA-approved, patented use, but (ii) the court must first give the NDA holder the opportunity to correct the use code, rather than direct the company to use precise language for the code.

Nevertheless, the Circuit went on to state: (i) the NDA holder does not have "unbounded discretion" in proposing a new use code, and (ii) the district court has the power to construe the scope of the patent claims and provide limits on the appropriate scope of the corresponding use code. If the court determines that the new code is inaccurate and/or overbroad, the judge at that point can correct the error.

This latest development comes in the wake of the U.S. Supreme Court's decision arising from Caraco's proposed section (viii) labeling carve-out for use of the diabetes drug repaglinide (on which we have previously reported here, for example). The patent at issue claimed use of repaglinide in combination with the drug metformin. Caraco wanted to omit the combination therapy, and label its generic version to treat diabetes with repaglinide only. Novo Nordisk admitted that the patent did not cover the use of repaglanide alone, but then changed its use code in the Orange Book to wording that was broad enough to cover repagalanide alone.

Continue reading "Federal Circuit Weighs in on Use Code Remand" »

August 9, 2012

Genzyme's Synvisc-One® Patent Found Not infringed and Invalid by Jury

knee.jpgOn August 3, a jury in the U.S. District Court for the District of Massachusetts found Genzyme's U.S. Patent Number 7,931,030 ("the '030 patent) was both not infringed by Seikagaku Corp. and its U.S. distributor, Zimmer Inc., and invalid as obvious in light of the prior art.

Genzyme obtained FDA approval in February 2009 to market Synvisc-One®, an injectable hyaluronic acid gel to treat osteoarthritic pain in the knee. According to Genzyme, Synvisc-One® was an improvement over prior treatments since only one injection of Synvisc-One® was required at least every six months compared to existing drugs that require three injections one week apart for similar pain relief. Synvisc-One® was the only single injection treatment until the FDA approved Gel-One®, a similar treatment also containing hyaluronic acid produced by Seikagaku, in March 2011. One month later, Genzyme filed a complaint alleging that Gel-One® infringed U.S. Patent Number 5,399,351 ("the '351 patent"). Genzyme then amended its complaint to add the '030 patent to the suit in June 2011 and agreed to drop claims concerning the '351 patent in February 2012.

Following this jury verdict, U.S. District Judge Douglas Woodlock vacated a preliminary injunction issued on December 30, 2012 barring Zimmer from providing free samples of Gel-One® and from selling Gel-One® at less than $547.60 per injection. Judge Woodlock also refused to grant a judgment as a matter of law after the jury verdict.

The use of a jury in this case as opposed to a bench trial in front of a judge is consistent with the significant increase in the use of juries in patent cases since the 1980s according to a 2011 Patent Litigation Study by PricewaterhouseCoppers. However, the outcome in this trial, favoring in the alleged infringer, is contrary to the general trend demonstrating that patent holders are more likely to win in front of a jury instead of a judge according to the same study.

July 23, 2012

Myriad's Re-Argument in the Federal Circuit Still Leaves the Outcome Open

federalcircuit.jpgOn July 20, the United States Court of Appeals for the Federal Circuit heard re-argument in Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. On the panel were Judges Alan Lourie, William Bryson, and Kimberly Moore. The Federal Circuit decided in 2011 that certain claims to isolated DNA were patent-eligible under 35 U.S.C. § 101, but the United States Supreme Court vacated the Federal Circuit's judgment and remanded for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) ("Prometheus"). Association for Molecular Pathology v. Myriad Genetics, Inc., 132 S. Ct. 1794, 1794 (2012) (granting certiorari, vacating, and remanding). (For a previous discussion on Myriad supplemental briefing for the Federal Circuit see our blog here.)

Myriad Genetics ("Myriad") argued that nothing in Prometheus should change the conclusion that isolated genes are patent-eligible. More specifically, Myriad addressed the Prometheus Court's concern that access to products of nature should not be "preempted." In response to this concern, Myriad explained that nothing in Prometheus altered the Supreme Court's earlier decision in Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), which held that a genetically-engineered bacterium constituted patentable subject matter, and placed great importance on the fact that the bacterium was human-made. Additionally, Myriad addressed the effect of Prometheus on Claim 20 of U.S. Pat. No. 5,747,282 ("Claim 20"), which recites:

A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Myriad argued that unlike the claim in Prometheus, which claimed a method based on a routine idea, Claim 20 applies routine steps to a new composition of matter (i.e., the transformed eukaryotic host cell containing an altered BRCA1 gene).

The Association for Molecular Pathology ("AMP") argued that the breath of the claims at issue is "stunning." It argued that because of this breadth, the claims preempt the use of products of nature, and therefore must therefore are invalid under section 101 as interpreted by Prometheus. Judge Moore was not persuaded by this argument and recited a quote from Prometheus that explained that patent eligibility has never been decided based upon whether a law of nature is "sufficiently narrow." Therefore, Judge Moore said that AMP's preemption argument was "a waste of time and space." Regarding Claim 20, AMP argued that this claim was invalid under Prometheus because it simply recited "putting the stuff all together in the cell and seeing what happens." Especially interesting was AMP's response to a question from Judge Lourie, who inquired whether a method of using penicillin would be patent-eligible. Although the argument was not entirely clear, it appears that AMP was arguing that a method for using penicillin's anti-bacterial properties is "clearly not patentable."

Continue reading "Myriad's Re-Argument in the Federal Circuit Still Leaves the Outcome Open" »

July 17, 2012

FDA E-Mail Whistle-Blower Investigation Continues as New Documents Are Revealed

whistle.bmpIn February 2012, FDA Lawyers Blog wrote regarding FDA's secret e-mail monitoring of whistle-blowers in the Center for Devices and Radiological Health ("CDRH"). Now it appears that FDA's surveillance program, which began as an effort to determine whether five FDA scientists were leaking trade secret information, may have been much broader than previously known. According to a New York Times article published on July 15, an FDA contractor inadvertently posted a database containing more than 80,000 surveillance-related documents onto a public website. These documents revealed the extent of the surveillance program that tracked communications between the scientists and Congressional officials, journalists, and others. The surveillance software utilized by FDA allegedly tracked keystrokes, intercepted personal e-mails, and took screen shots of letters being drafted to members of Congress, the Office of the President, and the Office of Special Counsel ("OSC"), an independent federal agency which investigates whistle-blower retaliation claims.

Federal agencies have broad power to monitor employees' computer usage. In fact, FDA computers warn employees when logging on that they have "no reasonable expectation of privacy," and that the Agency may intercept data for any lawful government purposes. However, it is still possible that FDA acted unlawfully when intercepting certain legally protected communications, such as, attorney-client communications, whistle-blower complaints, and workplace grievance filings. The OSC sent a memorandum to all government agencies in June identifying the legal restrictions and guidelines that agencies should consider with regard to monitoring employee communications. Members of Congress have demanded an investigation into the legality of the FDA's program.

Written by Douglas Oosterhouse

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FDA defended the program, saying it restricted surveillance to the five scientists suspected of leaking trade secret information. The Agency established the operation after the Inspector General at the Department of Health and Human Services refused to launch a criminal investigation into the scientists' alleged wrongdoing. FDA officials acknowledge that the operation intercepted communications that the scientists had with Congressional officials, journalists, and others, but FDA maintained that the e-mails "were collected without regard to the identity of the individuals with whom the user may have been corresponding." Additionally, FDA claimed that they did not intend to prevent employees from making these communications, and that individuals outside of the agency were not targets of the operation.

Continue reading "FDA E-Mail Whistle-Blower Investigation Continues as New Documents Are Revealed" »

July 9, 2012

FLH Partner Andrew S. Wasson Speaks at FDLI's Inaugural Intellectual Property Throughout the Drug Development Lifecycle Conference on July 17 in Washington, D.C.

FDLILogo.jpgFDA Lawyers Blog is pleased to announce that Andrew S. Wason, Partner, in our New York office is a key presenter at the Food and Drug Law Institute's ("FDLI's") Intellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges Conference in Washington, D.C. on July 17, 2012. FDLI's new Conference will address the intellectual property issues most important to patent litigators and in-house counsel in the pharmaceutical and generic industries, as well as the critical regulatory issues affecting these industries.

Course Topics:

  • The Role of IP During Drug Discovery and Pre-Clinical Drug Development
  • Brand Development Through IP in the Clinical Testing Phase
  • Post-Marketing IP Protection and Enforcement
  • Third Party IP: Preserving Freedom to Operate
This conference is designed for professionals in regulatory affairs, legal, and marketing, in the pharmaceutical and generic industries, as well as consulting, pharmacy and management representatives. This conference also targets intellectual property, and more specifically, patent attorneys.

FDA Lawyers Blog readers can join us at this program and receive a 15% discount off registration by using the promotional code: IPSP2012. Please feel free to share this code with your colleagues.

For more information and to register, visit the course website. We hope to see you there!

July 3, 2012

Infringement Contention Failure Leads to Summary Judgment of Non-infringement

gavelgold.jpgOn June 28, Judge Katherine B. Forrest of the United States District Court for the Southern District of New York granted summary judgment of non-infringement to SAP AG and SAP America, Inc. ("SAP") due to DataTern, Inc.'s ("DataTern") failure to serve patent infringement contentions. SAP AG v. DataTern, Inc., No. 1:11-cv-02648. The ruling stems from a suit filed by SAP, seeking a declaratory judgment that it has not infringed U.S. Pat. No. 5,937,402 ("the '402 patent"). DataTern counterclaimed, asserting infringement of the '402 patent. Although Judge Richard J. Holwell was originally the presiding judge over this case, he stepped down from the bench in February 2012, and the case was reassigned to Judge Forrest. Shortly after taking over the case, Judge Forrest issued an order, mandating that DataTern serve its infringement contentions for the '402 patent by March 23, 2012. Broadly speaking, infringement contentions are the patent holder's assertion of which claims of the patent-in- suit it believes are infringed by which products or methods of use of the accused infringer. Specifically, the patent holder must produce a "claim chart", identifying where each element of each asserted claim is found in each accused product or method of use. The patent holder must also indicate how it intends to satisfy each element of the asserted claims for infringement.

DataTern failed to serve the infringement contentions for the '402 patent by the deadline that Judge Forrest set. Accordingly, on April 26, 2012, SAP filed a motion for partial summary judgment, seeking a judgment that it has not infringed the '402 patent. In opposition, DataTern alleged that it has not served infringement contentions because SAP failed to timely provide it with the source code necessary to formulate the contentions. Judge Forrest was unconvinced by this argument and pointed out that DataTern had never filed a motion to compel discovery. Accordingly, Judge Forrest concluded that any alleged failure by SAP to provide source code could not excuse DataTern's failure to file infringement contentions.

DataTern additionally argued that under Judge Forrest's Procedures for Patent Cases, a party may amend its infringement contentions "upon a timely showing of good cause." Judge Forrest rejected this argument. She explained that a prerequisite to amending infringement contentions is to serve initial infringement contentions for the relevant patent in compliance with the court's orders. Judge Forrest noted that if this rule were read otherwise, patent holders in multi-patent cases could serve infringement contentions with respect to one patent, and then "amend" the contentions to include the other patents in suit. Further, Judge Forrest noted that even if DataTern's late contentions were considered "amendments," they would not be accepted, because DataTern had failed to show good cause for the delay, as required by the rule.

Continue reading "Infringement Contention Failure Leads to Summary Judgment of Non-infringement" »

June 26, 2012

Isolated DNA Patentability: ACLU and Myriad Complete Supplemental Briefing Based on Prometheus

Supreme Court.jpgOn June 15, supplemental briefing was completed in Association for Molecular Pathology v. Myriad Genetics, Inc. at the Federal Circuit. The parties had been Ordered to file simultaneous briefs addressing the question: "What is the applicability of the Supreme Court's decision in Mayo [v. Prometheus] to Myriad's isolated DNA claims and to method claim 20 of the '282 patent [U.S. Patent No. 5,747,282]?" In addition, the Federal Circuit invited amicus briefs. As many as seventy organizations and individuals answered this invitation, as well as the United States (who received an express invitation). Oral argument for this appeal is scheduled for Friday, July 20, 2012.

This case considers a fundamental issue, namely: What subject matter is eligible for patent protection? This is a threshold question of patentability, previously reported here, which the United States Supreme Court recently considered in Mayo Collaborative Services v. Prometheus Laboratories, Inc. After deciding Prometheus, the Supreme Court vacated the Federal Circuit's previous decision in Myriad and set this present appeal in motion by remanding the case to the Federal Circuit for reconsideration in light of Prometheus. As demonstrated by their briefing, however, both the Plaintiffs and Myriad have very different takes on what Prometheus stands for--and what subject matter is patentable.

The Plaintiffs argue that claiming isolated DNA does no more than to patent laws of nature and products of nature; in other words, the correlation between the patented DNA and the BRCA proteins it encodes. Plaintiffs assert that the product is the DNA itself and "another entity cannot invent a DNA molecule that encodes for the same protein and embodies a person's BRCA1 and BRCA2 genetic information" because Myriad's patents stand in the way. Thus, Plaintiffs state, "[a]s a consequence, no other laboratory in the U.S. has been able to provide clinical testing of these genes . . . ."

Continue reading "Isolated DNA Patentability: ACLU and Myriad Complete Supplemental Briefing Based on Prometheus" »