The Antitrust Review blog reported that the Solicitor General’s Office submitted a brief to the Supreme Court urging the Court to deny certiorari in the reverse payment case Joblove v. Barr Labs (S.Ct. No. 06-830). Earlier, the Supreme Court had asked for the government’s views on the antitrust effects of settlement agreements between holders of drug patents and generic drug makers enjoying the 180-day market exclusivity after Food and Drug Administration approval. This case involves the same legal issue that was raised in FTC v. Schering-Plough Corp., No. 05-273 (Jun. 26, 2006; denying certiorari), as well as three other recent petitions.

The issue is the appropriate antitrust standard applicable to an agreement between a brand pharmaceutical manufacturer (and patent holder) and a generic market entrant (and alleged patent infringer) whereby the patent holder shares a portion of its future profits with the alleged infringer in exchange for the latter’s agreement to not market its competitive product. The three Circuit Courts of Appeals that have addressed the issue have rendered inconsistent decisions.

These antitrust class actions involve the prescription drug tamoxifen citrate (tamoxifen), a drug for the treatment of breast cancer. Zeneca manufactures and markets tamoxifen under the brand-name Nolvadex®. Zeneca’s former parent, Imperial Chemical Industries PLC (ICI), held the patent for tamoxifen, U.S. Patent 4,536,516 (’516 Patent). In 1987, Barr amended its ANDA for tamoxifen to include a Paragraph IV Certification, which prompted a patent infringement suit by ICI (Zeneca’s parent which was then the patent holder). In 1992, the ‘516 Patent was held invalid and unenforceable.

While an appeal from the judgment invalidating the patent was pending in the Federal Circuit, Zeneca and ICI, the patent holders, and Barr, the alleged infringer, agreed to settle the case. Zeneca and ICI agreed to: (1) pay Barr $21 million; (2) pay Barr’s supplier $35.9 million; and (3) supply Barr with Zeneca-manufactured tamoxifen for resale in the United States at a high royalty rate.

In return, Barr agreed to: (1) abandon its successful challenge of the tamoxifen patent; (2) withdraw its Paragraph IV Certification to manufacture and market generic tamoxifen prior to the patent’s expiration; and, if possible, and (3) prevent competitive entry by future generic manufacturers.Now, the FTC alleges that the Agreements unlawfully restrained competition in the market for tamoxifen in violation of Sections 1 and 2 of the Sherman Act, 15 U.S.C. §§ 1, 2, and analogous state statutes. The question presented being:

“Under what circumstances is an agreement by a brand pharmaceutical manufacturer (and patent holder) to share a portion of its future profits with a generic market entrant (and alleged patent infringer), in exchange for the generic’s agreement not to market its product, a violation of the antitrust laws?”

In FTC v. Schering-Plough, the Solicitor General urged that no conflict existed that would warrant the Court’s review of this issue, based on the same body of case law that exists today.

Oddly, while stating up-front that this case “raises important and complex issues“:

There may be particular reason to be concerned about the competitive consequences of a settlement that includes a substantial payment from the patent holder to the alleged infringer. Such a “reverse payment” can be a device for the sharing of the monopoly rents that are preserved when the alleged infringer is induced to stay out of the relevant market and drop its challenge to the validity of the patent.

and while noting that “the court of appeals adopted an insufficiently stringent standard for scrutinizing patent settlements that include reverse payments”:

The dissenting opinion below correctly suggested that a court reviewing an antitrust challenge to a settlement of a patent infringement claim that includes a reverse payment should apply the rule of reason—and that, in doing so, a court should consider “the strength of the patent as it appeared at the time at which the parties settled.” Pet. App. 125a-126a. The panel majority, however, rejected that approach and instead held that such a settlement would be valid unless (1) the settlement “extend[ed] * * * the monopoly beyond the pat-ent’s scope”; (2) the settlement involved fraud; or (3) the underlying lawsuit was “objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits.” Id. at 52a (internal quotation marks and citation omitted). That standard is erroneous.

The SG turned around and pleaded that “this case does not present a good vehicle for addressing the question presented”:

Although the court of appeals applied an erroneous standard for scrutinizing patent infringement settlements that include reverse payments, this case is not an attractive vehicle for the Court’s consideration of the difficult and context-sensitive questions involved in assessing the legality of such settlements. The federal antitrust claims in this case appear to be moot, the factual setting is atypical and unlikely to recur, and subsequent regulatory changes may undercut one of the theories of competitive harm advanced by petitioners. For those reasons, the petition should be denied.

In their complaint in this case, petitioners sought injunctive and declaratory relief under Sections 1 and 2 of the Sherman Act, 15 U.S.C. 1 and 2. See C.A. App. A64-A67. Specifically, petitioners sought “the issuance of an injunction prohibiting [respondents’] continued compliance with the terms of the unlawful Agreement[s]”: i.e., the settlement that terminated the patent infringement litigation. See id. at A67. Zeneca’s patent, however, expired in 2002—and it is undisputed that the settlement ceased to have any effect at that time. As a result, an injunction prohibiting compliance with the settlement would have no operative force. Because petitioners did not seek any other equitable relief, the Sherman Act claims in this case appear to be moot.

The settlement challenged in this case involves an unusual factual setting that will almost certainly not recur, and thus there is a risk that the Court’s resolution of this case could turn on its unique facts in a way that would not provide clear guidance for other, more common factual settings. The government is not aware of any other Hatch-Waxman patent settlements arising after a district court judgment of invalidity, and none is likely to occur in the future in light of this Court’s decision in U.S. Bancorp Mortgage Co. v. Bonner Mall Partnership, 513 U.S. 18 (1994), which should prevent a patent holder from obtaining vacatur of a judgment of invalidity by settling the case while the appeal is pending.

Changes in the regulatory context have also altered the regulatory dynamic with respect to one of the theories of competitive harm advanced by petitioners, who argued in part below that Barr’s agreement to assert its exclusivity rights could preclude competition from other generics. See Pet. App. 59a-68a. In 2003, Congress amended the Hatch-Waxman Act to provide for forfeiture of the 180-day exclusivity period for various reasons, including the withdrawal of a paragraph IV certification. See 21 U.S.C. 355(j)(5)(B)(iv) and (D) (Supp. IV 2004).8 Congress also provided that any generic manufacturer that filed an ANDA with a paragraph IV certification on the same day as the first filer would be treated as a first filer itself (and thus would be able to take advantage of the 180-day exclusivity period as against other, later filers). See 21 U.S.C. 355(j)(5)(B)(iv)(II)(BB) (Supp. IV 2004). As a practical matter, therefore, it may now be more difficult for a first-filing generic manufacturer to enter into a settlement and then use the 180-day exclusivity period effectively to lock other generic manufacturers out of the market, as Barr attempted to do in this case.

More at:

Pharmalot and the Orange Book blog.

The Solicitor General’s Office Brief.

Posted May 25th, 2007 by Stephen Albainy-Jenei in IP Litigation
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Hal Wegner at Foley & Lardner circulated a note about a letter by Chief Justice Paul Michel of the United States Court of Appeals for the Federal Circuit.

Hal writes:

One of the two most divisive points ripping apart patent reform legislation is the ever more contentious debate over apportionment of damages, as witnessed by the differing views of former AIPLA President William Rooklidge in contrast to Georgetown University Law Professor John R. Thomas.

Now, the Chief Judge has formally weighed in with the United States Senate, saying that the “courts are ill-equipped” to implement the proposed legislation which would “invite[ ] an unseemly battle of ‘hired gun’ experts opining on the basis of indigestible quantity of economic data.”

Writing in terms that Senators can understand (as a former staff member of the United States Senate before joining the bench nearly twenty years ago), the Chief Judge concludes that he is “unaware of any convincing demonstration of the need for [this] provision….”

His full remarks are found in his letter to Senators Patrick Leahy, Orrin Hatch and (via cc) Arlen Specter dated May 3, 2007 (attached).

See the full letter here: michellettermay3rd.pdf

Posted May 24th, 2007 by Stephen Albainy-Jenei in IP Laws
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What Is It?

Camargo Pharmaceutical Services is offering a one-day training workshop to help those without drug expertise understand the basic aspects of drug discovery; drug effects, clinical development and testing of drugs; bioanalytical chemistry, and drug absorption, distribution, metabolism, and excretion in the body.

Who Should Attend?

This course is designed for people working in pharmaceutical drug development or medical communication who do not have strong drug science backgrounds. It is aimed at clinicians, medical writers, CRAs, study coordinators, data managers, statisticians, and others.

Who Is Giving It?

This course will be presented by Raymond H. Farmen, Ph.D. Known for his lively and entertaining presentation style, Dr. Farmen earned his Ph.D. in Pharmacology and did post-doctoral work in Biochemistry. He has over 25 years of experience in the pharmaceutical industry, working in pharmacokinetics, drug manufacture, and bioanalytical chemistry. Dr. Farmen has authored more than 45 abstracts and publications and has been an invited speaker at more than 20 national and international conferences.

Where Is It?

Camargo Pharmaceutical Services Headquarters, 10151 Carver Road, Suite 200, Cincinnati, OH 45052-4760

What Does It Cost?

$950 (US) including all course materials, continental breakfast, and lunch

How Do I Register?

Click here to register or contact Lisa Bostrom at 513.618.0345; learning@camargopharma.com

Posted May 23rd, 2007 by Stephen Albainy-Jenei in Conferences
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The U.S. Court of Appeals for the Federal Circuit smacked down Pfizer’s bid to get the court to reconsider a March 22 ruling that the patent on its hypertension drug Norvasc was invalid. See Pfizer v. Apotex (06-1261). The earlier ruling allowed Mylan Labs to make a generic version of Norvasc.

Mylan entered the market the day after a March 22 decision that invalidated the Norvasc patent but it lost in its efforts to prevent Apotex from entering the market before September. Apotex, the generic challenger that won the lawsuit over the patent’s validity, also may enter the market immediately. The patent expired March 25, three days after the court ruling. Pfizer had been given an additional six months of exclusivity for agreeing to test the drug for pediatric use.

Mylan was the first to challenge the patent and the only company to get FDA approval and so argued it has exclusive rights for six months. Apotex said that it should be the only generic company in the market because it won the appeals court decision. Teva claimed that since key provisions of the patent were invalidated, everyone should be allowed into the market.

The FDA came back and decided that, since the patent expired, Mylan wasn’t entitled to the six-months of exclusive rights for being the first to challenge the patent. However, the agency also ruled that, since only a portion of the Norvasc patent was invalidated, only Apotex could enter the market before Pfizer’s six-month exlusivity period ends in September — effectively shutting out Teva. Noteably, three of the 12 Fed Circuit judges, Judge Newman, Judge Lourie and Judge Rader, dissented.From Judge Newman:

Both sides acknowledge that the effects of chemical changes on properties of medicinal products is not predictable; the difference residing in the panel’s acceptance of the long-discredited “obvious to try” standard, on which the panel superimposes the theory that the skill of these inventors guided them to trial of the besylate salt (despite the prior art’s preference for the maleate salt), thereby negating patentability. The panel’s application of the obvious-to-try standard is in direct conflict with precedent; it has long been the law that “patentability shall not be negated by the manner in which the invention is made.”

From Judge Lourie:

… rather than give deference to the district court’s fact-findings, the panel substituted its own finding that a reasonable expectation of success existed in the art. See Pfizer, 480 F.3d at 1361, 1364-65 … Much public discussion has occurred, and even judicial comments in opinions, that we should defer to district court judges concerning certain aspects of claim construction, which we have held is a matter of law. Be that as it may, it is undisputed that we must defer to fact-findings by a district court, unless they are clearly erroneous, and I do not believe that they were here.

The panel concluded that the improvement of the invention, which related to drug formulation, viz., increased stability and decreased stickiness, was “insufficient” to meet the standards of patentability. … I read that conclusion as improperly requiring a compound to possess a specific type of improvement over the prior art—in this case, improved therapeutic properties—to be patentable, negating other important properties, a conclusion that is not compelled by our case law and not sound. Any useful and unexpected property should be eligible to overcome a prima facie obviousness determination.

Chemical and pharmaceutical compounds often can be found to be prima facie obvious, as they are based on prior work that could reasonably suggest them, see KSR Int’l Co. v. Teleflex Inc., — S.Ct. —, 2007 WL 1237837 (Apr. 30, 2007), but commercialization of such compounds may depend on their possession of unexpected properties. Such properties may be biological or physical. A failure to recognize all such properties that may be relevant to the value of such a compound may doom the compound to being poured down the drain rather than becoming an important therapeutic. The general public, innovative companies, and, ultimately, generic companies, depend upon faithful adherence to this principle. In addition, our cases hold that unexpected properties make for non-obviousness, see Papesch, 315 F.2d 381, and this decision disdains such properties if they are not biological. That is a conflict with our precedent that needs resolution.

From Judge Rader:

… ‘obvious to try’ jurisprudence has a very limited application in cases of this nature. With unpredictable pharmaceutical inventions, this court more wisely employs a reasonable expectation of success analysis. In this case, salt selection is unpredictable, thus rebutting, as most other courts found, any reasonable expectation of success. Although the panel gives “lip service” to the principle that ‘obvious to try’ does not work in this field, it nonetheless appears to be the basis for its decision in this case. In addition, the panel discerned a reasonable expectation of success by giving undue emphasis to the inventor’s subjective hopes for the outcome of his experiments.

The panel also found that amlodipine besylate was not patentable since it was made by a routine testing or a “well known problem solving strategy.” This clearly violates the statutory mandate that “patentability shall not be negatived by manner in which the invention was made.” 35 U.S.C. 103(a). Many if not most pharmaceutical inventions are discovered through a routine screening protocol or through an established trial and error process. Pharmaceutical inventions discovered by these routine screening methods include not only new formulations and salt forms, but also include the active pharmaceutical compounds themselves. Thus, this decision calls into question countless pharmaceutical patents, which in turn could have a profoundly negative effect on investments into the design and development of new life-saving pharmaceuticals.

More from the Orange Book blog.

Posted May 22nd, 2007 by Stephen Albainy-Jenei in IP Litigation
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EFF Wants You to Help Stop Broadcasting Treaty Flip-Flop

The Electronic Frontier Foundation (EFF) wants to mobilize businesses, public interest groups, and creative industry representatives to stand up against what it sees as over-broad protection of broadcast material. The World Intellectual Property Organization (WIPO) has been debating a treaty that could severly inhibit digital devices like DVR’s and grant broadcasters and cablecasters copyright-like rights over everything they transmit. A draft version of the Broadcasting Treaty is on the fast track and they want your help to stop it.

On June 18-22, WIPO’s Standing Committee on Copyright and Related Rights (SCCR) will be holding a special session to determine whether there’s enough agreement on this new draft to go forward with an already-scheduled inter-governmental Diplomatic Conference in November, at which the new draft could become international law.

EFF wants you to help convince the US WIPO delegation not to support this draft at the June meeting. Particularly if one or more of your senators is a member of the Judiciary Committee, which has oversight over US intellectual property policy. If you want to voice your opinion, EFF has a fillable form here.

IP Kat Blogger Makes A Move

The Human Law Mediation blog reports that IP Kat blogger, Jeremy Phillips is joining the UK law firm Olswang. Jeremy Phillips is the author of the IP Kat blog. The press release states that:

“Jeremy worked as an academic at several universities, was the founder of Trademark World, Patent World, Copyright World and Managing Intellectual Property magazines, and has been the Editor of the European Trade Mark Reports and the Journal of Intellectual Property Law and Practice since 1996 and 2005 respectively. Jeremy is currently the Research Director and a Council Member of the Intellectual Property Institute and a visiting professor to the World Intellectual Property Organization. He also launched IPKat, the highly regarded IP blog.”

 

Gene-Chip Company Moves to Iceland To Circumvent IP Laws; Now Headed For an IPO

Earlier, NimbleGen Systems Inc. fled to Iceland in 2002 in order to circumvent U.S. patents controlled by Santa Clara, Calif.-based Affymetrix Inc. that were blocking NimbleGen’s ability to market its gene chips in the U.S. Affymetrix hadn’t applied for patent protection in Iceland so NimbleGen moved there to set up shop for making and using the gene chips offshore. Basically, NimbleGen receives samples from patent-protected countries and ship back only the results (data) from the chip analysis.

After a court decision requiring competitor Illumina to pay about $16.7 million in damages to Affymetrix for infringing on five patents, Affymetrix has changed it’s business model and has now agreed to license its technology to NimbleGen. NimbleGen now hopes to cash in on the gene chip market, which could reach $900 million by 2012.

NimbleGen filed with federal securities regulators in March to raise as much as $75 million through an IPO.

Posted May 21st, 2007 by Stephen Albainy-Jenei in Current Affairs
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The General Counsel for the Department of Commerce (DOC), as overlord of the U.S. Patent and Trademark Office (USPTO), sent its own views on the provisions of H.R. 1908, the “Patent Reform Act of 2007,” to Howard L. Herman Chairman of the Subcommittee on Courts, the Internet, and Intellectual Property, Committee on the Judiciary. This patent bill is a revised version of legislation considered in the last Congress to modernize the U.S. patent system through changes designed to improve patent quality, reduce patent litigation costs and further international harmonization of patent laws.

The letter lobbies for adding provisions that are not currently in the bill but that the USPTO believes “could usefully modernize the U.S. patent system” emphasizing that they are merely considering “what will benefit U.S. inventors and the American public.” So they say.

Under the heading “Quality Is A Shared Responsibility,” the letter outlines the euphemistically-named Applicant Quality Submissions (AQSs). Basically, from the Patent Office’s perspective, their work is much easier under the disclosure rules of the Accelerated Examination Program and the letter states that the “USPTO looks forward to taking the success of this model … to lower pendency, raise productivity and increase quality, and apply it to all patent examinations.” (emphasis added)

The letter does make a nod towards the Draconian penalties under inequitable conduct for innocently omitting information. The DOC calls for legislative action to change the appropriate standards as:

First, the standard for finding intent could be explicitly separated from the materiality of the withholding, requiring proof that the misrepresentation was knowing, with intent to deceive. Second, the doctrine could be changed to a standard requiring a finding that the information would have been relevant to a reasonable examiner. The “relevance” standard could usefully be framed in terms of whether a reasonable examiner would have allowed the patent, without more, but for the misrepresentation or omission.

With respect to materiality, Congress may wish to consider requiring the USPTO to define the term (as it does now) and limit the courts to finding inequitable conduct only in circumstances in which information that the USPTO has defined as material is misrepresented or withheld.

The letter makes further points on Interlocutory Appeals and Post-Grant Review while providing a big thank you for specifically authorizing the USPTO “to promulgate such rules, regulations and orders that the Director determines appropriate to carry out the provisions of Title 35 or any other applicable law or that the Director determines necessary to govern the operation and organization of the USPTO.”

See these and other points here: commerce-dept-letter-on-patent-reform.pdf.

Posted May 18th, 2007 by Stephen Albainy-Jenei in Current Affairs
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A letter went out today to Speaker of the House Nancy Pelosi, Senate Majority Leader Harry Reid, House Minority Leader John Boehner, Senate Minority Leader, and Mitch McConnell from 111 companies across 27 states expressing concern over certain provisions of patent reform legislation (H.R. 1908/S. 1145 – The Patent Reform Act of 2007) currently under consideration by Congress. 

The letter is signed by companies, associations, venture capital firms and academic institutions across various industries – electronics, telecommunications, life sciences, computer hardware, financial services, chemical, and biotechnology. 

While calling to improve intellectual property protections, strengthen the patent system, and end the diversion of patent fees, the letter states that: 

However, we strongly believe that certain provisions, such as those dealing with apportionment of monetary damages for patent infringement, expansive PTO rule making authority, an open-ended post grant opposition system, and a narrow grace period will not strengthen our patent system but instead will fundamentally undermine patent certainty, discourage investment in innovative technologies, and reduce publication and collaborative activities among academic scientists. 

There is a concern that the reform could lead to an inability to rely on valid patents, weakened protections against infringement and a decreased access to capital, which would hurt U.S. competitiveness.

See the complete letter: cross-coalition-letter.pdf

See more commentary at Peter Zura’s 271 Patent Blog and Patently-O.

Posted May 16th, 2007 by Stephen Albainy-Jenei in IP Laws
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The U.S. Supreme Court rebuffed an appeal from Amgen, which tried to have the Supreme Court review the Federal Circuit’s practice of drawing its own conclusions about patent claims rather than relying solely on findings made by the trial court. See Amgen Inc. v. Hoechst Marion Roussel Inc. and Transkaryotic Therapies Inc., 06-1291.

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

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

The Federal Circuit has ruled that appeals courts can do their own examination of facts surrounding a patent claim. Appeals courts generally review the interpretation of laws rather than the particular facts of a case, but the Federal Circuit has determined that a lower court’s patent analysis can be called into question.

Amgen contends that Federal Circuit’s willingness to reconsider the factual aspects of the case “produces incorrect results and causes litigants and district courts to waste tremendous resources”

The final outcome in a patent lawsuit depends on whether a patent claim covers “the alleged infringer’s product or process,” which requires a determination of “what the words in the claim mean.” The issue here is what is the proper standard of review of factual findings underlying patent claim construction. See Markman v. Westview Instruments Inc., 517 U.S. 370 (1996).

The Supreme Court’s ruling in Markman set out that the trial court must decide the proper meaning of claim construction but the Federal Circuit has wrestled with the standard of review for fact findings underlying claim construction, and further, the extent to which the trial court may base its claim construction on extrinsic evidence.

However, an en banc panel of the Federal Circuit held that all aspects of claim construction are reviewed de novo. See Cybor Corp. v. FAS Techs. Inc. The factual findings involved in claim construction include the level of ordinary skill in the art at the time of filing, the background of the technology and the customary meaning of technical claim terms to one of ordinary skill in the art.

The Federal Circuit held that Markman did not compel deferential appellate review of factual findings underlying claim interpretations, concluding instead that “[n]othing in the Supreme Court’s opinion supports the view . . . that claim construction may involve subsidiary or underlying questions of fact.”

In the present case, the district court heard testimony on the background of the technology and the customary meaning of technical claim terms to assist in the court’s interpretation of terms such as “therapeutically effective amount.” The question then remains “How does a court decipher the plain and customary meaning of a term as understood by one skilled in the art without resorting to extrinsic evidence about how one skilled in the art would construe the term?”

Many argue that the District Court should find the facts necessary for claim construction, including the definition for one of ordinary skill in the art and the customary meaning of claim terms. They also argue that a determination of whether a patentee has successfully rebutted the presumption of prosecution history estoppel is based on factual underpinnings that should be subject to deference on appellate review.

The Federal Circuit has held that the issue of whether a patentee has successfully rebutted a Festo presumption of surrender of equivalents is a question of law to be reviewed de novo.

In the petition for rehearing at the Federal Circuit, Judge Michel and Judge Rader dissented stating:

In my view, four practical problems have emerged under the Markman-Cybor regime: (1) a steadily high reversal rate; (2) a lack of predictability about appellate outcomes, which may confound trial judges and discourage settlements; (3) loss of the comparative advantage often enjoyed by the district judges who heard or read all of the evidence and may have spent more time on the claim constructions than we ever could on appeal; and (4) inundation of our court with the minutia of construing numerous disputed claim terms (in multiple claims and patents) in nearly every patent case.

On its face, a review of claim construction seems to be a factual decision within the discretion of the trial judge and only reversible for clear error. Since each dispute raises unique factual situations and unique experimental evidence, the trial judge is best situated to guide the inquiry and determine the result. Therefore, appellate courts should only reverse if the trial judge exceeded discretion in determining reliability and fit of various experts’ evidence.

However, a decision to admit or exclude expert testimony is one that depends on an interpretation of the rules of evidence and so it could be argued to be a matter of law reviewable de novo by the appellate court. While most courts seem to follow the “abuse of discretion” standard of review, by letting this ruling stand the Supreme Court seems to agree with the majority to look at claim construction de novo.

Posted May 15th, 2007 by Stephen Albainy-Jenei in Current Affairs
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